Unconstitutional, Heretical, Moralistic Garbage:
Back To The Mad Hatter Memorial Page
----------
Chapter 34.
Drug Control Act.
----------
Article 1.
General Provisions.
§ 54.1-3400. Citation.
This chapter may be cited as "The Drug Control Act."
§ 54.1-3401. Definitions.
As used in this chapter, unless the context requires a
different meaning:
"Administer" means the direct application of a
controlled substance, whether by injection, inhalation, ingestion
or any other means, to the body of a patient or research subject
by (i) a practitioner or by his authorized agent and under his
direction, or (ii) the patient or research subject at the
direction and in the presence of the practitioner.
"Advertisement" means all representations
disseminated in any manner or by any means, other than by
labeling, for the purpose of inducing, or which are likely to
induce, directly or indirectly, the purchase of drugs or devices.
"Anabolic steroid" means any drug or hormonal
substance, chemically and pharmacologically related to
testosterone, other than estrogens, progestins, and
corticosteroids, that promotes muscle growth.
"Animal" means any nonhuman animate being endowed
with the power of voluntary action.
"Agent" means an authorized person who acts on
behalf of or at the direction of a manufacturer, distributor, or
dispenser. It does not include a common or contract carrier,
public warehouseman, or employee of the carrier or warehouseman.
"Board" means the Board of Pharmacy.
"Compound" means the taking of two or more ingredients and fabricating them into a single preparation, usually referred to as a dosage form.
"Controlled substance" means a drug, substance or
immediate precursor in Schedules I through VI of this chapter.
The term shall not include distilled spirits, wine, malt
beverages, or tobacco as those terms are defined or used in Title
3.1 or Title 4.1.
"DEA" means the Drug Enforcement Administration,
United States Department of Justice, or its successor agency.
"Deliver" or "delivery" means the actual,
constructive, or attempted transfer of any item regulated by this
chapter, whether or not there exists an agency relationship.
"Device" means instruments, apparatus, and
contrivances, including their components, parts and accessories,
intended for use in the diagnosis, cure, mitigation, treatment,
or prevention of disease in man or animals or to affect the
structure or any function of the body of man or animals.
"Dialysis solution" means either the commercially
available, unopened, sterile solutions whose purpose is to be
instilled into the peritoneal cavity during the medical procedure
known as peritoneal dialysis, or commercially available solutions
whose purpose is to be used in the performance of hemodialysis,
not to include any solutions administered to the patient
intravenously.
"Dispense" means to deliver a drug to an ultimate
user or research subject by or pursuant to the lawful order of a
practitioner, including the prescribing and administering,
packaging, labeling or compounding necessary to prepare the
substance for that delivery.
"Dispenser" means a practitioner who dispenses.
"Distribute" means to deliver other than by
administering or dispensing a controlled substance.
"Distributor" means a person who distributes.
"Drug" means (i) articles or substances recognized
in the official United States Pharmacopoeia National Formulary or
official Homeopathic Pharmacopoeia of the United States, or any
supplement to any of them; (ii) articles or substances intended
for use in the diagnosis, cure, mitigation, treatment or
prevention of disease in man or animals; (iii) articles or
substances, other than food, intended to affect the structure or
any function of the body of man or animals; or (iv) articles or
substances intended for use as a component of any article
specified in clause (i), (ii) or (iii). "Drug" does not
include devices or their components, parts or accessories.
"Hashish oil" means any oily extract containing one
or more cannabinoids, but shall not include any such extract with
a tetrahydrocannabinol content of less than twelve percent by
weight.
"Immediate precursor" means a substance which the
Board of Pharmacy has found to be and by regulation designates as
being the principal compound commonly used or produced primarily
for use, and which is an immediate chemical intermediary used or
likely to be used in the manufacture of a controlled substance,
the control of which is necessary to prevent, curtail, or limit
manufacture.
"Label" means a display of written, printed or
graphic matter upon the immediate container of any article. A
requirement made by or under authority of this chapter that any
word, statement or other information appear on the label shall
not be considered to be complied with unless such word, statement
or other information also appears on the outside container or
wrapper, if any, of the retail package of such article, or is
easily legible through the outside container or wrapper.
"Labeling" means all labels and other written,
printed or graphic matter on an article or any of its containers
or wrappers, or accompanying such article.
"Manufacture" means the production, preparation,
propagation, compounding, conversion or processing of any item
regulated by this chapter, either directly or indirectly by
extraction from substances of natural origin, or independently by
means of chemical synthesis, or by a combination of extraction
and chemical synthesis, and includes any packaging or repackaging
of the substance or labeling or relabeling of its container. This
term does not include the preparing, compounding, packaging or
labeling of a controlled substance by a practitioner as an
incident to his administering or dispensing of a controlled
substance or marijuana in the course of his professional
practice, or by a practitioner, or by his authorized agent under
his supervision, for the purpose of, or as an incident to,
research, teaching, or chemical analysis and not for sale.
"Manufacturer" means every person who manufactures.
"Marijuana" means any part of a plant of the genus
Cannabis whether growing or not, its seeds or resin; and every
compound, manufacture, salt, derivative, mixture, or preparation
of such plant, its seeds, or its resin. Marijuana shall not
include any oily extract containing one or more cannabinoids
unless such extract contains less than twelve percent of
tetrahydrocannabinol by weight, or the mature stalks of such
plant, fiber produced from such stalk, oil or cake made from the
seeds of such plant, any other compound, manufacture, salt,
derivative, mixture or preparation of such mature stalks, fiber,
oil, or cake, or the sterilized seed of such plant which is
incapable of germination.
"Medical equipment supplier" means any person, as
defined in § 1-13.19, engaged in the delivery to the ultimate
consumer, pursuant to the lawful order of a practitioner, of
hypodermic syringes and needles, medicinal oxygen, Schedule VI
controlled devices, those Schedule VI controlled substances with
no medicinal properties which are used for the operation and
cleaning of medical equipment and solutions for peritoneal
dialysis.
"Narcotic drug" means any of the following, whether
produced directly or indirectly by extraction from substances of
vegetable origin, or independently by means of chemical
synthesis, or by a combination of extraction and chemical
synthesis: (i) opium, opiates, and any salt, compound,
derivative, or preparation of opium or opiates; (ii) any salt,
compound, isomer, derivative, or preparation thereof which is
chemically equivalent or identical with any of the substances
referred to in clause (i), but not including the isoquinoline
alkaloids of opium; (iii) opium poppy and poppy straw; (iv) coca
leaves and any salt, compound, derivative, or preparation of coca
leaves, and any salt, compound, isomer, derivative, or
preparation thereof which is chemically equivalent or identical
with any of these substances, but not including decocainized coca
leaves or extraction of coca leaves which do not contain cocaine
or ecgonine.
"New drug" means: (i) any drug, except a new animal
drug or an animal feed bearing or containing a new animal drug,
the composition of which is such that such drug is not generally
recognized, among experts qualified by scientific training and
experience to evaluate the safety and effectiveness of drugs, as
safe and effective for use under the conditions prescribed,
recommended, or suggested in the labeling, except that such a
drug not so recognized shall not be deemed to be a "new
drug" if at any time prior to the enactment of this chapter
it was subject to the Food and Drugs Act of June 30, 1906, as
amended, and if at such time its labeling contained the same
representations concerning the conditions of its use; or (ii) any
drug, except a new animal drug or an animal feed bearing or
containing a new animal drug, the composition of which is such
that such drug, as a result of investigations to determine its
safety and effectiveness for use under such conditions, has
become so recognized, but which has not, otherwise than in such
investigations, been used to a material extent or for a material
time under such conditions.
"Official compendium" means the official United
States Pharmacopoeia National Formulary, official Homeopathic
Pharmacopoeia of the United States, or any supplement to any of
them.
"Official written order" means an order written on a
form provided for that purpose by the United States Drug
Enforcement Administration, under any laws of the United States
making provision therefor, if such order forms are authorized and
required by federal law, and if no such order form is provided
then on an official form provided for that purpose by the Board
of Pharmacy.
"Opiate" means any substance having an
addiction-forming or addiction-sustaining liability similar to
morphine or being capable of conversion into a drug having such
addiction-forming or addiction-sustaining liability. It does not
include, unless specifically designated as controlled under
Article 4 (§ 54.1-3437 et seq.) of this chapter, the
dextrorotatory isomer of 3-methoxy-n-methylmorphinan and its
salts (dextromethorphan). It does include its racemic and
levorotatory forms.
"Opium poppy" means the plant of the species Papaver
somniferum L., except the seeds thereof.
"Original package" means the unbroken container or
wrapping in which any drug or medicine is enclosed together with
label and labeling, put up by or for the manufacturer,
wholesaler, or distributor for use in the delivery or display of
such article.
"Person" means both the plural and singular, as the
case demands, and includes individual, partnership, corporation,
association, governmental agency, trust, or other institution or
entity.
"Poppy straw" means all parts, except the seeds, of
the opium poppy, after mowing.
"Practitioner" means a physician, dentist, licensed
nurse practitioner pursuant to § 54.1-2957.01, licensed
physician assistant pursuant to § 54.1-2952.1, pharmacist
pursuant to § 54.1-3300, TPA-certified optometrist pursuant to
Article 5 (§ 54.1-3222 et seq.) of Chapter 32 of this title,
veterinarian, scientific investigator, or other person licensed,
registered or otherwise permitted to distribute, dispense,
prescribe and administer, or conduct research with respect to, a
controlled substance in the course of professional practice or
research in this Commonwealth.
"Prescriber" means a practitioner who is authorized
pursuant to §§ 54.1-3303 and 54.1-3408 to issue a prescription.
"Prescription" means an order for drugs or medical supplies, written or signed or transmitted by word of mouth, telephone, telegraph or other means of communication to a pharmacist by a duly licensed physician, dentist, veterinarian or other practitioner, authorized by law to prescribe and administer such drugs or medical supplies.
"Prescription drug" means any drug required by
federal law or regulation to be dispensed only pursuant to a
prescription, including finished dosage forms and active
ingredients subject to § 503 (b) of the Federal Food, Drug, and
Cosmetic Act.
"Production" or "produce" includes the
manufacture, planting, cultivation, growing or harvesting of a
controlled substance or marijuana.
"Proprietary medicine" means a completely compounded
nonprescription drug in its unbroken, original package which does
not contain any controlled substance or marijuana as defined in
this chapter and is not in itself poisonous, and which is sold,
offered, promoted or advertised directly to the general public by
or under the authority of the manufacturer or primary
distributor, under a trademark, trade name or other trade symbol
privately owned, and the labeling of which conforms to the
requirements of this chapter and applicable federal law. However,
this definition shall not include a drug which is only advertised
or promoted professionally to licensed practitioners, a narcotic
or drug containing a narcotic, a drug which may be dispensed only
upon prescription or the label of which bears substantially the
statement "Warning - may be habit-forming," or a drug
intended for injection.
"Sale" includes barter, exchange, or gift, or offer
therefor, and each such transaction made by any person, whether
as individual, proprietor, agent, servant or employee.
"Warehouser" means any person, other than a
wholesale distributor, engaged in the business of selling or
otherwise distributing prescription drugs or devices to any
person who is not the ultimate user or consumer. No person shall
be subject to any state or local tax by reason of this
definition.
"Wholesale distribution" means distribution of
prescription drugs to persons other than consumers or patients,
subject to the exceptions set forth in § 54.1-3401.1.
"Wholesale distributor" means any person engaged in
wholesale distribution of prescription drugs including, but not
limited to, manufacturers; repackers; own-label distributors;
private-label distributors; jobbers; brokers; warehouses,
including manufacturers' and distributors' warehouses, chain drug
warehouses conducting wholesale distributions, and wholesale drug
warehouses; independent wholesale drug traders; and retail
pharmacies conducting wholesale distributions. No person shall be
subject to any state or local tax as a wholesale merchant by
reason of this definition.
The words "drugs" and "devices" as used in
Chapter 33 (§ 54.1-3300 et seq.) of this title and in this
chapter shall not include surgical or dental instruments,
physical therapy equipment, X-ray apparatus or glasses or lenses
for the eyes.
The terms "pharmacist," "pharmacy" and
"practice of pharmacy" as used in this chapter shall be
defined as provided in Chapter 33 of this title unless the
context requires a different meaning.
§ 54.1-3401.1. Practices not considered wholesale
distribution.
A. Wholesale distribution, as defined in § 54.1-3401, shall
not include:
1. Intracompany sales, including any transaction or transfer
between any division, subsidiary, parent, and/or affiliated or
related company under the common ownership and control of a
corporate entity;
2. The purchase or other acquisition by a hospital or other
health care entity that is a member of a group purchasing
organization of a drug for its own use from the group purchasing
organization or from other hospitals or health care entities that
are members of such organization;
3. The sale, purchase, or trade of a drug or an offer to sell,
purchase, or trade a drug by a charitable organization, described
in § 501 (c) (3) of the Internal Revenue Code of 1986, to a
nonprofit affiliate of such organization to the extent otherwise
permitted by law;
4. The sale, purchase, or trade of a drug or an offer to sell,
purchase, or trade a drug among hospitals or other health care
entities that are under common control;
5. The sale, purchase, or trade of a drug or an offer to sell,
purchase, or trade a drug for emergency medical reasons;
6. The sale, purchase, or trade of a drug or an offer to sell,
purchase, or trade a drug, or the dispensing of a drug pursuant
to a prescription;
7. The distribution of drug samples by manufacturers'
representatives or distributors' representatives; or
8. The sale, purchase, or trade of or the offer to sell,
purchase, or trade blood and blood components intended for
transfusion.
B. For the purposes of this section:
"Blood" means whole blood collected from a single
donor and processed either for transfusion or further
manufacturing.
"Blood component" means that part of blood separated
by physical or mechanical means.
"Common control" means the power to direct or cause
the direction of the management and policies of a person or an
organization, whether by ownership of stock, voting rights, by
contract, or otherwise.
"Drug sample" means a unit of a prescription drug
that is not intended to be sold and is intended to promote the
sale of the drug.
"Emergency medical reasons" includes transfers of prescription drugs by a retail pharmacy to another retail pharmacy to alleviate a temporary shortage arising from delays in or interruptions of regular distribution schedules.
§ 54.1-3402. Proprietor of pharmacy exempted.
This article shall not be construed to require the proprietor
of a pharmacy to register as a manufacturer or distributor if the
products manufactured or purchased are labeled under the name of
the pharmacy and dispensed within the premises and not sold for
distribution and resale outside the premises.
§ 54.1-3403. Chapter not applicable to economic poisons.
This chapter shall not be construed to apply (i) to poisons
used for the control of insects, animal pests, weeds, fungus
diseases or other substances sold for use in agricultural,
horticultural or related arts and sciences when such substances
which are poisons within the meaning of this chapter are sold in
original unbroken packages bearing a label having plainly printed
upon it the name of the contents and the word POISON and an
effective antidote or (ii) to any person, persons, corporations
or associations engaged in the business of selling, making,
compounding or manufacturing industrial chemicals for
distribution or sale at wholesale or for making, compounding or
manufacturing other products.
§ 54.1-3404. Persons required to keep record of drugs;
contents and form of record.
A. Every person manufacturing, compounding, processing,
selling, dispensing or otherwise disposing of drugs in Schedules
I, II, III, IV or V shall take a complete and accurate inventory
of all stocks of Schedules I through V drugs on the date he first
engages in business. An inventory taken by use of an oral
recording device shall be promptly reduced to writing and
maintained in a written, typewritten or printed form. Such
inventory shall be made either as of the opening of business or
as of the close of business on the inventory date.
B. Every two years following the date on which the initial
inventory is taken, every person described herein shall take a
new inventory of all stocks of Schedules I through V drugs. The
biennial inventory shall be taken (i) on the day of the year in
which the initial inventory was taken; or (ii) on the date of the
person's regular general physical inventory, if any, which date
is nearest to and does not vary by more than six months from the
biennial date that would otherwise apply; or (iii) on any other
fixed date which does not vary by more than six months from the
biennial date that would otherwise apply. If the person elects to
take the biennial inventory on his regular general physical
inventory date or another fixed date, he shall notify the Board
of his election and of the date on which the biennial inventory
will be taken.
the date of selling, administering, or dispensing, the name
and address of the person to whom or for whose use, or the owner
and species of animal for which the drugs were sold, administered
or dispensed, and the kind and quantity of drugs. Any person
selling, administering, dispensing or otherwise disposing of such
drugs shall make and sign such record at the time of each
transaction. The keeping of a record required by or under the
federal laws, containing substantially the same information as is
specified above, shall constitute compliance with this section,
except that every such record shall contain a detailed list of
any drugs lost, destroyed or stolen, the kind and quantity of
such drugs, and the date of the discovery of such loss,
destruction or theft. The form of records shall be prescribed by
the Board.
E. Whenever any registrant or licensee discovers a theft or any other unusual loss of any controlled substance, he shall immediately report such theft or loss to the Board. If the registrant or licensee is unable to determine the exact kind and quantity of the drug loss, he shall immediately make a complete inventory of all Schedule I through V drugs.
Within thirty days after the discovery of a loss of drugs, the
registrant or licensee shall furnish the Board with a listing of
the kind, quantity and strength of such drugs lost.
F. All records required pursuant to this section shall be
maintained completely and accurately for two years from the date
of the transaction recorded.
§ 54.1-3405. Access to and copies of records; inspections.
Every person required to prepare or obtain, and keep, records,
and any carrier maintaining records with respect to any shipment
containing any drug, and every person in charge or having custody
of such records shall, upon request of an agent designated by the
Board, permit such agent at reasonable times to have access to
and copy such records.
Any agent designated by the Superintendent of the Department of State Police to conduct drug diversion investigations shall, for the purpose of such investigations, also be permitted access at reasonable times to all such records relevant to a specific investigation and be allowed to inspect and copy such records. However, agents designated by the Superintendent of the Department of State Police to conduct drug diversion investigations shall not copy and remove patient records unless such patient records are relevant to a specific investigation. Any agent designated by the Superintendent of the Department of State Police shall allow the person or carrier maintaining such records, or agent thereof, to examine any copies of records before their removal from the premises. If the agent designated by the Superintendent of State Police copies records on magnetic storage media, he will deliver a duplicate of the magnetic storage media on which the copies are stored to the person or carrier maintaining such records or an agent thereof, prior to removing the copies from the premises. If the original of any record is removed by any agent designated by the Superintendent of State Police, a receipt therefor shall be left with the person or carrier maintaining such records or an agent thereof, and a copy of the removed record shall be provided the person or carrier maintaining such records within a reasonable time thereafter.
For the purposes of verification of such records and of
enforcement of this chapter, agents designated by the Board or by
the Superintendent are authorized, upon presenting appropriate
credentials to the owner, operator, or agent in charge, to enter,
at reasonable times, any factory, warehouse, establishment, or
vehicle in which any drug is held, manufactured, compounded,
processed, sold, delivered, or otherwise disposed of; and to
inspect, within reasonable limits and in a reasonable manner,
such factory, warehouse, establishment, or vehicle, and all
pertinent equipment, finished and unfinished material, containers
and labeling, including records, files, papers, processes,
controls, and facilities, bearing on violation of this chapter;
and to inventory and obtain samples of any stock of any drugs.
If a sample of any drug is obtained, the agent making the
inspection shall, upon completion of the inspection and before
leaving the premises, give to the owner, operator, or agent in
charge a receipt describing the sample. No inspection shall
extend to financial data, sales data other than shipment data,
pricing data, personnel data or research data.
Any information obtained by a designated State Police agent
during an inspection under this section which constitutes
evidence of a violation of any provision of this chapter shall be
reported to the Department of Health Professions upon its
discovery.
Any information obtained by an agent designated by the Board
during an inspection under this section which constitutes
evidence of a violation of Article 1 (§ 18.2-247 et seq.) of
Chapter 7 of Title 18.2 shall be reported to the Department of
State Police upon its discovery.
§ 54.1-3406. Records confidential.
No agent of the Board or agent designated by the
Superintendent of the Department of State Police having knowledge
by virtue of his office of any prescriptions, papers, records, or
stocks of drugs shall divulge such knowledge, except in
connection with a criminal investigation authorized by the
Attorney General or attorney for the Commonwealth or with a
prosecution or proceeding in court or before a regulatory board
or officer, to which investigation, prosecution or proceeding the
person to whom such prescriptions, papers or records relate is a
subject or party.
This section shall not be construed to prohibit the Board president or his designee and the Director of the Department of Health Professions from discharging their duties as provided in this title.
§ 54.1-3407. Analysis of controlled substances.
A licensed physician or pharmacist may receive controlled
substances from or on behalf of a patient for qualitative or
quantitative analysis purposes only, without an official order
form, if within twenty-four hours of its receipt the physician or
pharmacist mails or delivers the entire sample to a laboratory
operated by the Commonwealth and designated by the Board to
receive such substances. If the sample is mailed, it shall be
sent by registered or certified mail, postage prepaid, with
return receipt requested. If personally delivered, a receipt
shall be obtained from such laboratory. All receipts or returns
shall be kept on file for three years and shall be available for
inspection by the Board at any reasonable time.
§ 54.1-3408. Professional use by practitioners.
A. A practitioner of medicine, osteopathy, podiatry, dentistry, or veterinary medicine or a licensed nurse practitioner pursuant to § 54.1-2957.01 a licensed physician assistant pursuant to § 54.1-2952.1, or a TPA-certified optometrist pursuant to Article 5 (§ 54.1-3222 et seq.) of Chapter 32 of this title shall only prescribe, dispense, or administer controlled substances in good faith for medicinal or therapeutic purposes within the course of his professional practice.
The prescribing practitioner's order may be on a written
prescription or pursuant to an oral prescription as authorized by
this chapter. The prescriber may administer drugs and devices, or
he may cause them to be administered by a nurse, physician
assistant or intern under his direction and supervision, or he
may prescribe and cause drugs and devices to be administered to
patients in state-owned or state-operated hospitals or facilities
licensed as hospitals by the Board of Health or psychiatric
hospitals licensed by the State Mental Health, Mental Retardation
and Substance Abuse Services Board by other persons who have been
trained properly to administer drugs and who administer drugs
only under the control and supervision of the prescriber or a
pharmacist or a prescriber may cause drugs and devices to be
administered to patients by emergency medical services personnel
who have been certified and authorized to administer such drugs
and devices pursuant to Board of Health regulations governing
emergency medical services and who are acting within the scope of
such certification. A prescriber may authorize a certified
respiratory therapy practitioner as defined in § 54.1-2954 to
administer by inhalation controlled substances used in inhalation
or respiratory therapy.
Pursuant to an oral or written order or standing protocol
issued by the prescriber within the course of his professional
practice, such prescriber may authorize registered nurses and
licensed practical nurses to possess (i) epinephrine for
administration in treatment of emergency medical conditions and
(ii) heparin and sterile normal saline to use for the maintenance
of intravenous access lines.
A prescriber may authorize, pursuant to a protocol approved by
the Board of Nursing, the administration of vaccines to adults
for immunization, when a practitioner with prescriptive authority
is not physically present, (i) by licensed pharmacists, (ii) by
registered nurses or (iii) licensed practical nurses under the
immediate and direct supervision of a registered nurse. A
prescriber acting on behalf of and in accordance with established
protocols of the Department of Health may authorize the
administration of vaccines to any person by a pharmacist or nurse
when the prescriber is not physically present.
A dentist may cause Schedule VI topical drugs to be
administered under his direction and supervision by either a
dental hygienist or by an authorized agent of the dentist.
No written prescription order form shall include more than one
prescription. This provision shall not apply, however, to the
entry of any order on a patient's chart in any hospital or any
long-term care facility, as defined in Board regulations, in
Virginia or to a prescription ordered through the pharmacy
operated by the Department of Corrections, the central pharmacy
of the Department of Health, or the central outpatient pharmacy
operated by the Department of Mental Health, Mental Retardation
and Substance Abuse Services.
Such a prescription shall be written, dated, and signed by the
person prescribing on the day when issued, and shall bear the
full name and address of the patient for whom the drug is
prescribed, and the full name, address, and registry number under
the federal laws of the person prescribing, if he is required by
those laws to be so registered.
This section shall not prevent the administration of drugs by a person who has satisfactorily completed a training program for this purpose approved by the Board of Nursing and who administers such drugs in accordance with a physician's instructions pertaining to dosage, frequency, and manner of administration, and in accordance with regulations promulgated by the Board of Pharmacy relating to security and record keeping, when the drugs administered would be normally self-administered by (i) a resident of a facility licensed or certified by the State Mental Health, Mental Retardation and Substance Abuse Services Board; (ii) a resident of any adult care residence which is licensed by the Department of Social Services; (iii) a resident of the Virginia Rehabilitation Center for the Blind; (iv) a resident of a facility approved by the Board or Department of Juvenile Justice for the placement of children in need of services or delinquent or alleged delinquent youth; (v) a program participant of an adult day-care center licensed by the Department of Social Services; or (vi) a resident of any facility authorized or operated by a state or local government whose primary purpose is not to provide health care services.
Nothing in this title shall prohibit the administration of
normally self-administered oral or topical drugs by unlicensed
individuals to a person in his private residence.
This section shall not interfere with any prescriber issuing
prescriptions in compliance with his authority and scope of
practice and the provisions of this section to a Board agent for
use pursuant to subsection G of § 18.2-258.1. Such prescriptions
issued by such prescriber shall be deemed to be valid
prescriptions. This section shall not prohibit a prescriber from
using preprinted prescriptions for drugs classified in Schedule
VI if all requirements concerning dates, signatures, and other
information specified above are otherwise fulfilled.
B. The written prescription referred to in subsection A of
this section shall be written with ink or individually typed and
each prescription shall be manually signed by the prescriber. The
prescription may be prepared by an agent for his signature. The
prescription shall contain the name, address, telephone number,
and federal controlled substances registration number assigned to
the prescriber. The prescriber's information shall be either
preprinted upon the prescription blank, typewritten, rubber
stamped, or printed by hand.
The oral prescription referred to in subsection A of this
section shall be transmitted to the pharmacy of the patient's
choice by the prescriber or his authorized agent. For the
purposes of this section, an authorized agent of the prescriber
shall be an employee of the prescriber who is under his immediate
and personal supervision, or if not an employee, an individual
who holds a valid license allowing the administration or
dispensing of drugs and who is specifically directed by the
prescriber.
" [] Dispense As Written
[] Voluntary Formulary Permitted
__________________
Signature of prescriber
If neither box is marked, a Voluntary Formulary product must
be dispensed."
D. Prescribers' orders, whether written as chart orders or prescriptions, for Schedules II, III, IV and V controlled drugs to be administered to (i) patients or residents of long-term care facilities served by a Virginia pharmacy from a remote location or (ii) patients receiving parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion therapy and served by a home infusion pharmacy from a remote location, may be transmitted to that remote pharmacy by an electronic communications device over telephone lines which send the exact image to the receiver in hard-copy form, and such facsimile copy shall be treated as a valid, original prescription order.
§ 54.1-3408.1. Prescription in excess of recommended
dosage in certain cases.
In the case of a patient with intractable pain, a physician may prescribe a dosage in excess of the recommended dosage of a pain relieving agent if he certifies the medical necessity for such excess dosage in the patient's medical record. Any person who prescribes, dispenses or administers an excess dosage in accordance with this section shall not be in violation of the provisions of this title because of such excess dosage, if such excess dosage is prescribed, dispensed or administered in good faith for accepted medicinal or therapeutic purposes.
Nothing in this section shall be construed to grant any person
immunity from investigation or disciplinary action based on the
prescription, dispensing or administration of an excess dosage in
violation of this title.
§ 54.1-3409. Professional use by veterinarians.
A veterinarian may not prescribe controlled substances for
human use and shall only prescribe, dispense or administer a
controlled substance in good faith for use by animals within the
course of his professional practice. He may prescribe, on a
written prescription or on oral prescription as authorized by §
54.1-3410. He may administer drugs, and he may cause them to be
administered by an assistant or orderly under his direction and
supervision. Such a prescription shall be dated and signed by the
person prescribing on the day when issued, and shall bear the
full name and address of the owner of the animal, and the species
of the animal for which the drug is prescribed and the full name,
address and registry number, under the federal laws of the person
prescribing,
§ 54.1-3410. When pharmacist may sell and dispense drugs.
A. A pharmacist, acting in good faith, may sell and dispense
drugs and devices to any person pursuant to a prescription of a
prescriber as follows:
1. A drug listed in Schedule II shall be dispensed only upon
receipt of a written prescription that is properly executed,
dated and signed by the person prescribing on the day when issued
and bearing the full name and address of the patient for whom, or
of the owner of the animal for which, the drug is dispensed, and
the full name, address, and registry number under the federal
laws of the person prescribing, if he is required by those laws
to be so registered. If the prescription is for an animal, it
shall state the species of animal for which the drug is
prescribed;
2. In emergency situations, Schedule II drugs may be dispensed
pursuant to an oral prescription in accordance with the Board's
regulations;
3. Whenever a pharmacist dispenses any drug listed within
Schedule II on a prescription issued by a prescriber, he shall
affix to the container in which such drug is dispensed, a label
showing the prescription serial number or name of the drug; the
date of initial filling; his name and address, or the name and
address of the pharmacy; the name of the patient or, if the
patient is an animal, the name of the owner of the animal and the
species of the animal; the name of the prescriber by whom the
prescription was written; and such directions as may be stated on
the prescription.
B. A drug controlled by Schedules III through VI or a device
controlled by Schedule VI shall be dispensed upon receipt of a
written or oral prescription as follows:
1. If the prescription is written, it shall be properly
executed, dated and signed by the person prescribing on the day
when issued and bear the full name and address of the patient for
whom, or of the owner of the animal for which, the drug is
dispensed, and the full name and address of the person
prescribing. If the prescription is for an animal, it shall state
the species of animal for which the drug is prescribed.
2. If the prescription is oral, the prescriber shall furnish the pharmacist with the same information as is required by law in the case of a written prescription for drugs and devices, except for the signature of the prescriber.
A pharmacist who dispenses a Schedule III through VI drug or
device shall label the drug or device as required in subdivision
A 3 of this section.
C. A drug controlled by Schedule VI may be refilled without authorization from the prescriber if, after reasonable effort has been made to contact him, the pharmacist ascertains that he is not available and the patient's health would be in imminent danger without the benefits of the drug. The refill shall be made in compliance with the provisions of § 54.1-3411.
If the written or oral prescription is for a Schedule VI drug
or device and does not contain the address or registry number of
the prescriber, or the address of the patient, the pharmacist
need not reduce such information to writing if such information
is readily retrievable within the pharmacy.
D. Pursuant to authorization of the prescriber, an agent of
the prescriber on his behalf may orally transmit a prescription
for a drug classified in Schedules III through VI if, in such
cases, the written record of the prescription required by this
subsection specifies the full name of the agent of the prescriber
transmitting the prescription.
§ 54.1-3411. When prescriptions may be refilled.
Prescriptions may be refilled as follows:
1. A prescription for a drug in Schedule II may not be
refilled.
2. A prescription for a drug in Schedules III or IV may not be
filled or refilled more than six months after the date on which
such prescription was issued and no such prescription may be
authorized to be refilled, nor be refilled, more than five times,
except that any prescription for such a drug after six months
from the date of issue, or after being refilled five times, may
be renewed by the prescriber issuing it either in writing, or
orally, if promptly reduced to writing and filed by the
pharmacist filling it.
3. A prescription in Schedule VI may not be refilled, unless
authorized by the prescriber either on the face of the original
prescription or orally by the prescriber except as provided in
subdivision 4 of this section. Oral instructions shall be reduced
promptly to writing by the pharmacist and filed on or with the
original prescription.
4. A prescription for a drug controlled by Schedule VI may be
refilled without authorization from the prescriber if: reasonable
effort has been made to communicate with the prescriber, and the
pharmacist has determined that he is not available and the
patient's health would be in imminent danger without the benefits
of the drug. The pharmacist shall inform the patient of the
prescriber's unavailability and that the refill is being made
without his authorization. The pharmacist shall promptly inform
the prescriber of such refill. The date and quantity of the
refill, the prescriber's unavailability and the rationale for the
refill shall be noted on the reverse side of the prescription.
§ 54.1-3412. Date of dispensing; initials of pharmacist;
automated data processing system.
The pharmacist dispensing any prescription shall record the
date of dispensing and his initials on the prescription or in an
automated data processing system used for the storage and
retrieval of dispensing information for prescriptions pursuant to
regulations promulgated by the Board.
§ 54.1-3413. Manufacturing and administering Schedule I
drugs.
It shall be lawful for a person to manufacture, and for a
practitioner to administer, Schedule I drugs if:
1. The manufacturer and practitioner are expressly authorized
to engage in such activities by the Attorney General of the
United States, or pursuant to the federal Food, Drug and Cosmetic
Act;
2. The manufacturer or dispenser is registered under all
appropriate provisions of this chapter;
3. Any Schedule I drug so manufactured is sold or furnished on
an official written order to a practitioner or other authorized
person only; and
4. The manufacturer and practitioner comply with all other requirements of this chapter.
§ 54.1-3414. Official orders for Schedule II drugs.
An official written order for any Schedule II drug shall be
signed by the purchasing licensee or by his agent. The original
shall be presented to the person who supplies the drug or drugs.
If such person accepts the order, each party to the transaction
shall preserve his copy of the order for two years in such a way
as to be readily accessible for inspection by any public officer
or employee engaged in the enforcement of this chapter. It shall
be deemed a compliance with this section if the parties to the
transaction have complied with the federal laws respecting the
requirements governing the use of order forms.
§ 54.1-3415. Distribution of drugs in Schedules II through
VI by manufacturers and wholesalers.
A. A permitted manufacturer or wholesaler may distribute
Schedule II drugs to any of the following persons, but only on
official written orders:
1. To a manufacturer or wholesaler who has been issued permits
pursuant to this chapter;
2. To a pharmacist;
3. To a person who has been issued a controlled substance
registration certificate pursuant to § 54.1-3422, if the
certificate of such person authorizes such purchase;
4. On a special written order accompanied by a certificate of
exemption, as required by the federal laws, to a person in the
employ of the United States government or of any state,
territorial, district, county, municipal, or insular government,
purchasing, receiving or possessing drugs by reason of his
official duties;
5. To a master of a ship or a person in charge of any aircraft
upon which no physician is regularly employed, for the actual
medical needs of persons on board such ship or aircraft when not
in port. However, such drugs shall be sold to a master of such
ship or person in charge of such aircraft pursuant to a special
order form approved by a commissioned medical officer or acting
assistant surgeon of the United States Public Health Service; and
6. To a person in a foreign country in compliance with the
provisions of the relevant federal laws.
B. A permitted manufacturer or wholesaler may distribute drugs
classified in Schedule III through Schedule VI and devices to all
persons listed in subsection A of this section without an
official written order. However, this section shall not be
construed to prohibit the distribution of a Schedule VI drug or
device to any person who is otherwise authorized by law to
administer, prescribe or dispense such drug or device.
§ 54.1-3416. No prescription for preparations listed
pursuant to Schedule V.
A preparation listed pursuant to Schedule V may be dispensed
without a prescription if:
1. The preparation is dispensed only by a pharmacist directly
to the person requesting the preparation;
2. The preparation is dispensed only to a person who is at
least eighteen years of age;
3. The pharmacist requires the person requesting the
preparation to furnish suitable identification including proof of
age when appropriate;
4. The pharmacist does not dispense to any one person, or for
the use of any one person or animal, any narcotic drug
preparation or preparations, when he knows, or can by reasonable
diligence ascertain, that such dispensing will provide the person
to whom or for whose use, or the owner of the animal for the use
of which, such preparation is dispensed, within 48 consecutive
hours, with more than 200 milligrams of opium, or more than 270
milligrams of codeine, or more than 130 milligrams of
dihydrocodeinone, or more than 65 milligrams of ethylmorphine, or
more than 32 5/10 milligrams of diphenoxylate. In dispensing such
a narcotic drug preparation, the pharmacist shall exercise
professional discretion to ensure that the preparation is being
dispensed for medical purposes only.
Any pharmacist shall, at the time of dispensing, make and keep
a record showing the date of dispensing, the name and quantity of
the preparation, the name and address of the person to whom the
preparation is dispensed, and enter his initials thereon. Such
records shall be maintained as set forth in § 54.1-3404 and the
regulations of the Board.
§ 54.1-3417. Disposing of stocks of Schedules II through V
drugs.
The owner of any stocks of drugs included in Schedules II
through V obtained in compliance with this chapter, upon
discontinuance of dealing in such drugs, may dispose of such
stocks only on an official written order as follows:
1. A pharmacy or practitioner or an agent or agents of a
pharmacy or practitioner under specific written authorization
from the owner of such pharmacy or such practitioner, may dispose
of such stocks to a manufacturer or wholesaler holding a valid
license to deal in such drugs, or to another pharmacy or
practitioner.
2. A manufacturer or wholesaler may dispose of such stocks
only to a manufacturer or wholesaler holding a valid permit to
deal in such drugs.
§ 54.1-3418. Sale of aqueous or oleaginous solutions.
A pharmacist, only upon an official written order, may sell to
a physician, dentist, or veterinarian, in quantities not
exceeding one ounce at any one time, aqueous or oleaginous
solutions compounded by the pharmacist, of which the content of
narcotic drugs does not exceed a proportion greater than twenty
percent of the complete solution, to be used for medical
purposes.
§ 54.1-3419. Dispensing of insulin preparations.
Any insulin preparation shall be dispensed only by or under the supervision of a licensed
pharmacist.
§ 54.1-3420. Distribution of certain drugs; written
request or confirmation of receipt.
No manufacturer or distributor of controlled substances shall distribute or dispense any substance listed on Schedules II through V to any person, whether a practitioner of the healing arts or some other profession, except with the written request or confirmation of receipt of the practitioner. Such request or confirmation shall be maintained as required by this chapter.
Subject to the foregoing provisions, no person shall be prohibited from distributing controlled substances listed on Schedules II through V for charitable uses or for use in research or investigations.
§ 54.1-3420.1. Identification required for filling
prescriptions.
Before dispensing any drug listed on Schedules II through V, a
pharmacist may require proof of identity from any patient
presenting a prescription or requesting a refill of a
prescription.
§ 54.1-3421. New drugs.
A. No person shall sell, deliver, offer for sale, hold for
sale or give away any new drug unless:
1. An application with respect to the drug has been approved
and the approval has not been withdrawn under § 505 of the
federal act; or
2. When not subject to the federal act, such drug has been
tested and has been found to be safe for use and effective in use
under the conditions prescribed, recommended, or suggested in its
labeling.
Prior to selling or offering a new drug for sale, an
application shall be filed with the Board setting forth full
reports of investigations which show whether or not the drug is
safe and effective, a full list of the components of the drug, a
full statement of the composition of the drug, a full description
of the methods used in, and the facilities and controls used for,
the manufacture, processing and packing of such drug, such
samples of such drug and its components as the Board may require
and specimens of the proposed labeling for such drug.
B. An application provided for in subsection A shall become
effective 180 days after filing. If the Board finds, after due
notice to the applicant and providing him an opportunity for a
hearing, that the drug is not safe or not effective under the
conditions prescribed, recommended or suggested in the proposed
labeling; or the methods used in, and the facilities and controls
used for, the manufacture, processing, and packing of such drugs
are inadequate to preserve its identity, strength, quality, and
purity; or based on a fair evaluation of all material facts, such
labeling is false or misleading in any particular, the Board
shall, prior to the effective date of the application, issue an
order refusing to approve the application.
C. An order refusing to approve an application may be revoked
by the Board.
D. The Board shall promulgate regulations for exempting from
this section drugs intended solely for investigational use by
experts qualified by scientific training and experience to
investigate the safety and effectiveness of drugs. Such
regulations may, among other conditions relating to the
protection of the public health, provide for conditioning such
exemption upon:
1. Submission to the Board, before any clinical testing of a
new drug is undertaken, of reports, by the manufacturer or the
sponsor of the investigation of such drug, of preclinical tests,
including tests on animals, which are adequate to justify the
proposed clinical testing;
2. Obtaining from the manufacturer or the sponsor of the
investigation of a new drug proposed to be distributed to
investigators for clinical testing an agreement signed by each of
the investigators stating that patients to whom the drug is
administered will be under their personal supervision, or under
the supervision of investigators responsible to them, and that
they will not supply such drug to any other investigator or
clinic, for administration to human beings; and
3. Establishment and maintenance of records, and the making of
such reports to the Board by the manufacturer or the sponsor of
the investigation of the drug, of data, including but not limited
to analytical reports by investigators, obtained as the result of
such investigational use of the drug, as the Board requires to
evaluate the safety and effectiveness of the drug.
The regulations shall provide that such exemption shall be
conditioned upon the manufacturer, or the sponsor of the
investigation, requiring that experts using the drugs for
investigational purposes certify to such manufacturer or sponsor
that they will inform any human beings to whom such drugs, or any
controls used in connection therewith, are being administered, or
their representatives, that such drugs are being used for
investigational purposes and will obtain the consent of such
human beings or their representatives, except where they deem it
not feasible or, in their professional judgment, contrary to the
best interests of such human beings. This subsection shall not be
construed to require any clinical investigator to submit reports
directly to the Board on the investigational use of drugs. The
Board may promulgate regulations in accordance with the federal
act.
E. In the case of any drug for which approval of an
application filed pursuant to this section is in effect, the
applicant shall establish and maintain records, and make reports
to the Board of data relating to clinical experience as well as
other data or information as the Board, by general regulation, or
by order with respect to such application, may prescribe.
However, the regulations and orders issued under this section
shall have due regard for the professional ethics of the medical
profession and the interests of patients and shall provide where
the Board deems it to be appropriate, for the examination, upon
request, by the persons to whom such regulations or orders are
applicable, of similar information received or otherwise obtained
by the Board.
Every person required under this section to maintain records
and every person in custody of the records shall, upon request of
an officer or employee designated by the Board, permit such
officer or employee at all reasonable times to have access to and
copy and verify such records.
F. The Board may, after affording an opportunity for public
hearing and judicial appeal, revoke an application approved
pursuant to this section if it finds that the drug, based on
evidence acquired after such approval, may not be safe or
effective for its intended use, or that the facilities or
controls used in the manufacture, processing, or labeling of such
drug may present a hazard to the public health.
G. None of the foregoing provisions of this section shall be
deemed to apply to a drug subject to the federal act intended
solely for investigational use and for which a notice of claimed
investigational exemption for a new drug has been filed.
§ 54.1-3422. Controlled substances registration
certificate required in addition to other requirements;
exemptions.
A. Every person who manufactures, distributes or dispenses any
substance which is controlled in Schedules I through V or who
proposes to engage in the manufacture, distribution or dispensing
of any such controlled substance except permitted pharmacies,
those persons who are licensed pharmacists, and those persons who
are licensed practitioners of medicine, osteopathy, podiatry,
dentistry, or veterinary medicine shall obtain annually a
controlled substances registration certificate issued by the
Board. This registration shall be in addition to other licensing
or permitting requirements enumerated in this chapter or
otherwise required by law.
B. Registration under this section and under all other
applicable registration requirements shall entitle the registrant
to possess, manufacture, distribute, dispense, or conduct
research with those substances to the extent authorized by this
registration and in conformity with the other provisions of this
chapter.
C. The following persons need not register and may possess
controlled substances in Schedules I through V:
1. An agent or employee of any holder of a controlled
substance registration certificate if he is acting in the usual
course of his business or employment;
2. A common or contract carrier or warehouseman, or his
employee, whose possession is in the usual course of business or
employment; or
3. An ultimate user or a person in possession of any
controlled substance pursuant to a lawful order of a prescriber
or in lawful possession of a Schedule V substance.
D. A separate registration is required at each principal place
of business or professional practice where the applicant
manufactures, distributes, or dispenses controlled substances.
§ 54.1-3423. Board to issue registration unless
inconsistent with public interest; authorization to conduct
research; application and fees.
A. The Board shall register an applicant to manufacture or
distribute controlled substances included in Schedules I through
V unless it determines that the issuance of that registration
would be inconsistent with the public interest. In determining
the public interest, the Board shall consider the following
factors:
1. Maintenance of effective controls against diversion of
controlled substances into other than legitimate medical,
scientific, or industrial channels;
2. Compliance with applicable state and local law;
3. Any convictions of the applicant under any federal and
state laws relating to any controlled substance;
4. Past experience in the manufacture or distribution of
controlled substances, and the existence in the applicant's
establishment of effective controls against diversion;
5. Furnishing by the applicant of false or fraudulent material
in any application filed under this chapter;
6. Suspension or revocation of the applicant's federal
registration to manufacture, distribute, or dispense controlled
substances as authorized by federal law; and
7. Any other factors relevant to and consistent with the
public health and safety.
B. Registration under subsection A does not entitle a
registrant to manufacture and distribute controlled substances in
Schedule I or II other than those specified in the registration.
C. Practitioners must be registered to conduct research with
controlled substances in Schedules II through V. Practitioners
registered under federal law to conduct research with Schedule I
substances may conduct research with Schedule I substances within
this Commonwealth upon furnishing the evidence of that federal
registration.
D. Applications for controlled substances registration
certificates and renewals thereof shall be made on a form
prescribed by the Board and such applications shall be
accompanied by a fee in an amount to be determined by the Board.
§ 54.1-3424. Suspension or revocation of registration,
license or permit; limitation to particular controlled substance;
controlled substances placed under seal; sale of perishables and
forfeiture; notification to DEA.
A. A registration to manufacture, distribute, or dispense a
controlled substance may be suspended or revoked by the Board
upon a finding that the registrant:
1. Has furnished false or fraudulent material information in
an application filed under this chapter;
2. Has been convicted of a felony under any state or federal
law relating to any controlled substance;
3. Has had his federal registration to manufacture, distribute
or dispense controlled substances suspended or revoked;
4. Has violated or cooperated with others in violating any
provision of this chapter or regulations of the Board relating to
the manufacture, distribution or dispensing of controlled
substances.
B. The Board may limit revocation or suspension of a
registration to the particular controlled substance with respect
to which grounds for revocation or suspension exist.
C. If the Board suspends or revokes a registration, or if the
license or permit of a person possessing Schedule I through V
controlled substances under an exemption in § 54.1-3422 A is
suspended or revoked by the issuing board, all controlled
substances owned or possessed by the registrant, licensee or
permittee at the time of suspension or the effective date of the
revocation order may be placed under seal. No disposition may be
made of substances under seal until the time for taking an appeal
has elapsed or until all appeals have been concluded unless a
court orders the sale of perishable substances and the deposit of
the proceeds of the sale with the court. Upon a revocation order
becoming final, all controlled substances shall be forfeited to
the Commonwealth.
D. The Board shall promptly notify the DEA of all orders
suspending or revoking registration and all forfeitures of
controlled substances.
§ 54.1-3425. Issuance of limited permits to humane
societies.
The Board may issue, upon such terms and conditions as it
finds proper, to any humane society making application, a limited
permit only for the purpose of buying, possessing, and using any
drug approved by the State Veterinarian for the purpose of
euthanizing injured, sick, homeless, and unwanted domestic pets
and animals. The application and renewal thereof for such a
special permit shall be accompanied by a fee as determined by the
Board.
§ 54.1-3426. Regulations for special packaging.
A. The Board shall adopt standards for special packaging
consistent with those promulgated pursuant to the federal Poison
Prevention Packaging Act of 1970. The Board may exempt any drug
from the requirements of special packaging and shall exempt any
drug exempted pursuant to the Poison Prevention Packaging Act of
1970.
B. A prescriber or a purchaser may direct that a drug, which
is subject to being dispensed in special packaging, be dispensed
in other than special packaging.
§ 54.1-3427. Dispensing drugs without safety closure
container.
When a pharmacist receives the request of any person that a
drug or drugs for such person to be dispensed by the pharmacist
not be placed in a safety closure container, the pharmacist may
dispense such drug or drugs in such nonsafety closure container.
The delivering pharmacist shall not be civilly liable simply by
reason of dispensing a drug or drugs in such a container if the
recipient signs a release covering a period of time or a single
delivery, which release provides that the recipient releases the
pharmacist from civil liability for not using the safety closure
container, unless the pharmacist acted with willful and wanton
disregard of safety.
§ 54.1-3428. Dissemination of information.
The Board may disseminate such information regarding drugs,
devices, and cosmetics as the Board deems necessary in the
interest of public health and the protection of the consumer
against fraud. This section shall not be construed to prohibit
the Board from collecting, reporting, and illustrating the
results of its investigations.
§ 54.1-3429. Revocation of permit issued to manufacturer,
wholesaler or distributor.
The Board may revoke a permit issued to a manufacturer,
wholesaler or distributor for failure to comply with regulations
promulgated pursuant to the provisions of this chapter.
§ 54.1-3430. Display of permit; permits nontransferable;
renewal.
Permits issued under the provisions of this chapter shall be displayed in a conspicuous place in the factory or other place of business for which issued.
Permits shall not be transferable and shall be renewed
annually.
§ 54.1-3431. Admission into evidence of certain
certificates of analysis.
In any administrative hearing, a certificate of analysis of a
chemist, performed in any laboratory operated by the Division of
Forensic Science or authorized by such Division to conduct such
analysis, when such certificate is attested by such chemist,
shall be admissible as evidence. A copy of such certificate shall
be delivered to the parties in interest at least seven days prior
to the date fixed for the hearing.
Any certificate of analysis purporting to be signed by any
chemist shall be admissible as evidence in such hearing without
any proof of the seal or signature or of the official character
of the chemist whose name is signed to it.
Article 2.
Permitting of Pharmacies.
§ 54.1-3432. Supervision by pharmacist.
Every pharmacy shall be under the personal supervision of a
pharmacist on the premises of the pharmacy.
§ 54.1-3433. Certain advertising and signs unlawful.
It shall be unlawful for any place of business which is not a pharmacy as defined in this chapter to advertise or to have upon it or in it as a sign the words, "pharmacy," "pharmacist," "apothecary," "drugstore," "druggist," "drugs," "medicine store," "drug sundries," "prescriptions filled" or any like words indicating that drugs are compounded or sold or prescriptions filled. Each day during which such advertisement appears or such sign is allowed to remain upon or in such place of business shall constitute a separate offense under this section.
§ 54.1-3434. Permit to conduct pharmacy.
No person shall conduct a pharmacy without first obtaining a permit from the Board.
The application for such permit shall be made on a form
provided by the Board and signed by a pharmacist who will be in
full and actual charge of the pharmacy and who will be fully
engaged in the practice of pharmacy at the location designated on
the application.
The application shall show the corporate name and trade name and shall list any pharmacist in addition to the pharmacist-in-charge practicing at the location indicated on the application.
If the owner is other than the pharmacist making the
application, the type of ownership shall be indicated and shall
list any partner or partners, and, if a corporation, then the
corporate officers and directors. Further, if the owner is not a
pharmacist, he shall not abridge the authority of the
pharmacist-in-charge to exercise professional judgment relating
to the dispensing of drugs in accordance with this act and Board
regulations.
The permit shall be issued only to the pharmacist who signs
the application as the pharmacist-in-charge and as such assumes
the full responsibilities for the legal operation of the
pharmacy. This permit and responsibilities shall not be construed
to negate any responsibility of any pharmacist or other person.
Upon termination of practice by the pharmacist-in-charge, or
upon any change in partnership composition, or upon the
acquisition of the existing corporation by another person, the
permit previously issued shall be immediately surrendered to the
Board by the pharmacist-in-charge to whom it was issued, or by
his legal representative, and an application for a new permit may
be made in accordance with the requirements of this chapter. The
Board shall promulgate regulations providing a reasonable time
period for designation of a new pharmacist-in-charge. At the
conclusion of such time period, a pharmacy which has failed to
designate a new pharmacist-in-charge shall not operate as a
pharmacy nor maintain a stock of prescription drugs on the
premises. The Director shall immediately notify the owner of
record that the pharmacy no longer holds a valid permit and that
the owner shall make provision for the proper disposition of all
Schedule II through VI drugs and devices on the premises within
fifteen days of receipt of this notice. At the conclusion of the
fifteen-day period, the Director or his authorized agent shall
seize and indefinitely secure all Schedule II through VI drugs
and devices still on the premises, and notify the owner of such
seizure. The Director may properly dispose of the seized drugs
and devices after six months from the date of the notice of
seizure if the owner has not claimed and provided for the proper
disposition of the property. The Board shall assess a fee of not
less than the cost of storage of said drugs upon the owner for
reclaiming seized property.
The succeeding pharmacist-in-charge shall cause an inventory to be made of all Schedule I, II, III, IV and V drugs on hand. Such inventory shall be completed as of the date he becomes pharmacist-in-charge and prior to opening for business on that date.
The pharmacist to whom such permit is issued shall provide safeguards against diversion of all controlled substances.
An application for a pharmacy permit shall be accompanied by a
fee determined by the Board. All permits shall expire on December
31 of each year.
Every pharmacy must be equipped so that prescriptions can be
properly filled. The Board of Pharmacy shall prescribe the
minimum of such professional and technical equipment, which a
pharmacy shall at all times possess, and such list shall include
as reference the latest revision of the United States
Pharmacopoeia Dispensing Information. No permit shall be issued
or continued for the conduct of a pharmacy until or unless there
is compliance with the provisions of this chapter and regulations
promulgated by the Board.
Each day during which a person is in violation of this section
shall constitute a separate offense.
§ 54.1-3434.01. Notice of pharmacy closing.
Prior to the closing of a pharmacy for more than one week, the
pharmacist-in-charge shall either (i) post a conspicuous notice
at least thirty days prior to the anticipated closing or (ii)
mail a notice, at least 14 days prior to the anticipated closing,
to every current pharmacy customer having refill authority. Each
notice posted or mailed pursuant to this section shall indicate
the date of such closing, if available, and the name of the
pharmacy to which prescriptions will be transferred unless
patients indicate their preference to the contrary. The Board of
Pharmacy shall promulgate regulations providing exceptions to
this requirement.
Article 2.1.
Registration of Nonresident Pharmacies.
§ 54.1-3434.1. Nonresident pharmacies to register with
Board.
A. Any pharmacy located outside this Commonwealth which ships,
mails, or delivers, in any manner, Schedule II through VI drugs
or devices pursuant to a prescription into this Commonwealth
shall be considered a nonresident pharmacy, shall be registered
with the Board, and shall disclose to the Board all of the
following:
1. The location, names, and titles of all principal corporate
officers and all pharmacists who are dispensing prescription
drugs or devices to residents of this Commonwealth. A report
containing this information shall be made on an annual basis and
within thirty days after any change of office, corporate officer,
or principal pharmacist.
2. That it complies with all lawful directions and requests
for information from the regulatory or licensing agency of the
Commonwealth in which it is licensed as well as with all requests
for information made by the Board pursuant to this section. The
nonresident pharmacy shall maintain, at all times, a valid
unexpired license, permit, or registration to conduct the
pharmacy in compliance with the laws of the state in which it is
a resident. As a prerequisite to registering with the Board, the
nonresident pharmacy shall submit a copy of the most recent
inspection report resulting from an inspection conducted by the
regulatory or licensing agency of the state in which it is
located.
3. That it maintains its records of prescription drugs or
dangerous drugs or devices dispensed to patients in this
Commonwealth so that the records are readily retrievable from the
records of other drugs dispensed and provides a copy or report of
such dispensing records to the Board, its authorized agents, or
any agent designated by the Superintendent of the Department of
State Police upon request within seven days of receipt of a
request.
B. Any pharmacy subject to this section shall, during its
regular hours of operation, but not less than six days per week,
and for a minimum of forty hours per week, provide a toll-free
telephone service to facilitate communication between patients in
this Commonwealth and a pharmacist at the pharmacy who has access
to the patient's records. This toll-free number shall be
disclosed on a label affixed to each container of drugs dispensed
to patients in this Commonwealth.
C. The registration fee shall be the fee specified for
pharmacies within Virginia.
§ 54.1-3434.2. Permit to be issued.
No out-of-state pharmacy doing business in this Commonwealth
which has not obtained a permit shall conduct the business of
selling or distributing drugs in Virginia without registering as
a nonresident pharmacy.
Applications for a nonresident pharmacy registration, under
this section, shall be made on a form furnished by the Board. The
Board may require such information as it deems is necessary to
carry out the purpose of the section.
The permit or nonresident pharmacy registration shall be
renewed annually on or before January 1 of each year.
§ 54.1-3434.3. Denial, revocation, and suspension of
registration.
The Board may deny, revoke, or suspend a nonresident pharmacy
registration for conduct which causes serious bodily or serious
psychological injury to a resident of the Commonwealth if the
Board has referred the matter to the regulatory or licensing
agency in the state in which the pharmacy is located and the
regulatory or licensing agency fails to initiate an investigation
within forty-five days of the referral.
§ 54.1-3434.4. Prohibited acts.
It is unlawful for any nonresident pharmacy which is not
registered under this article to advertise its services in
Virginia or for any person who is a resident of Virginia to
advertise the pharmacy services of a nonresident pharmacy which
has not registered with the Board, with the knowledge that the
advertisement will or is likely to induce members of the public
in the Commonwealth to use the pharmacy to dispense
prescriptions.
Article 3.
Wholesale Distributors and Medical Equipment
Suppliers.
§ 54.1-3435. License to act as wholesale distributor;
renewal; fee.
It shall be unlawful for any person to engage in the wholesale
distribution of prescription drugs in this Commonwealth without a
valid unrevoked license issued by the Board. The applicant for
licensure as a wholesale distributor, as defined in § 54.1-3401,
in this Commonwealth shall apply to the Board for a license,
using such forms as the Board may furnish; renew such license
using such forms as the Board may furnish, if granted, annually
on or before January 1 of each year; notify the Board within
thirty days of any substantive change in the information reported
on the application form previously submitted to the Board; and
remit a fee as determined by the Board.
The Board may promulgate such regulations relating to the
storage, handling, and distribution of prescription drugs by
wholesale distributors as it deems necessary to implement this
section, to prevent diversion of prescription drugs, and to
protect the public.
§ 54.1-3435.01. Registration of nonresident wholesale
distributors; renewal; fee.
A. Any person located outside this Commonwealth who engages in
the wholesale distribution of prescription drugs into this
Commonwealth shall be registered with the Board. The applicant
for registration as a nonresident wholesale distributor shall
apply to the Board using such forms as the Board may furnish;
renew such registration, if granted, using such forms as the
Board may furnish, annually on or before January 1 of each year;
notify the Board within thirty days of any substantive change in
the information previously submitted to the Board; and remit a
fee, which shall be the fee specified for wholesale distributors
located within the Commonwealth.
B. The nonresident wholesale distributor shall at all times
maintain a valid, unexpired license, permit, or registration in
the state in which it is located and shall furnish proof of such
upon application and at each renewal.
C. Records of prescription drugs distributed into this
Commonwealth shall be maintained in such a manner that they are
readily retrievable from records of distributions into other
jurisdictions and shall be provided to the Board, its authorized
agent, or any agent designated by the Superintendent of the
Department of State Police upon request within seven days of
receipt of such request.
D. This section shall not apply to persons who distribute
prescription drugs directly to a licensed wholesale distributor
located within this Commonwealth.
§ 54.1-3435.1. Denial, revocation, and suspension of
license as wholesale distributor or of registration as a
nonresident wholesale distributor.
1. Any conviction of the applicant or licensee under federal
or state laws relating to controlled substances, including, but
not limited to, drug samples and wholesale or retail prescription
drug distribution;
2. Any felony conviction of the applicant or licensee;
3. Any misdemeanor conviction of the applicant or licensee for
a crime involving moral turpitude;
4. Conduct in the manufacture or distribution of prescription
drugs contrary to the protection of the health, safety, and
welfare of the public;
5. Fraud or deceit in any application for licensure or permit
under this chapter;
6. Denial, suspension, revocation, or restriction of any
federal or state license previously or currently held by the
applicant or licensee for the manufacture or distribution of any
drug;
7. Violations of licensing requirements under previously held
licenses;
8. Failure to maintain and make available to the Board or to
federal regulatory officials those records required to be
maintained by wholesale distributors of prescription drugs;
9. Violations of the minimum requirements for qualifications,
personnel, storage, and handling of prescription drugs and
maintenance of prescription drug records as set forth in the
federal Prescription Drug Marketing Act of 1987 and Part 205 of
Chapter 21 of the Code of Federal Regulations; or
10. Violations of any provision of this chapter or regulations
of the Board governing wholesale distributors.
B. Wholesale drug distributors shall allow the Board or its
authorized agents to enter and inspect, at reasonable times and
in a reasonable manner, their premises and delivery vehicles, and
to audit their records and written operating procedures. Such
agents shall be required to show appropriate identification prior
to being permitted access to wholesale drug distributors'
premises and delivery vehicles.
§ 54.1-3435.2. Permit to act as medical equipment
supplier; storage; limitation; regulations.
A. Unless otherwise authorized by this chapter or Chapter 33
(§ 54.1-3300 et seq.) of this title, it shall be unlawful for
any person to act as a medical equipment supplier, as defined in
§ 54.1-3401, in this Commonwealth without a valid unrevoked
permit issued by the Board. The applicant for a permit to act as
a medical equipment supplier in this Commonwealth shall apply to
the Board for a permit, using such form as the Board may furnish;
renew such permit, if granted, annually on or before January 1 of
each year; and remit a fee as determined by the Board.
B. Prescription drugs received, stored, and distributed by
authority of this section shall be limited to those Schedule VI
controlled substances with no medicinal properties which are used
for the operation and cleaning of medical equipment and solutions
for peritoneal dialysis.
C. Distribution of any Schedule VI drug or device or of any
hypodermic needle or syringe, or medicinal oxygen by authority of
this section is limited to delivery to the ultimate user upon
lawful order by a prescriber authorized to prescribe such drugs
and devices.
D. The Board may promulgate such regulations relating to the
storage, handling, and distribution of prescription drugs,
devices and controlled paraphernalia by medical equipment
suppliers as it deems necessary to implement this section, to
prevent diversion of prescription drugs and devices and
controlled paraphernalia, and to protect the public.
§ 54.1-3435.3. Denial, revocation, and suspension of
permit as medical equipment supplier.
A. The permit as a medical equipment supplier may be denied,
suspended, or revoked by the Board for any of the following:
1. Any conviction of the applicant or permit holder under
federal or state laws relating to wholesale or retail
distribution or delivery of prescription drugs or devices or
controlled substances;
2. Any felony conviction of the applicant or permit holder;
3. Any misdemeanor conviction of the applicant or permit
holder for a crime involving moral turpitude;
4. Violations of any provision of this chapter or regulations
of the Board governing medical equipment suppliers;
5. Fraud or deceit in any application for licensure or permit
under this chapter; or
6. Engaging in or attempting any fraud upon the consumer.
B. Medical equipment suppliers shall allow the Board or its
authorized agents to enter and inspect, at reasonable times and
in a reasonable manner, their premises and delivery vehicles, and
to audit their records and written operating procedures.
§ 54.1-3435.4. Permit to act as warehouser; regulations.
A. Unless otherwise authorized by this chapter or Chapter 33 (§ 54.1-3300 et seq.) of this title, it shall be unlawful for any person to act as a warehouser, as defined in § 54.1-3401, in this Commonwealth without a valid unrevoked permit issued by the Board. The applicant for a permit to act as a warehouser in this Commonwealth shall apply to the Board for a permit, using such form as the Board may furnish; renew such permit, if granted, annually on or before January 1 of each year; and remit a fee as determined by the Board.
B. The Board may promulgate such regulations relating to the
storage, handling, and distribution of prescription drugs and
devices by warehousers as it deems necessary to implement this
section, to prevent diversion of prescription drugs and devices,
and to protect the public.
C. Warehousers shall allow the Board or its authorized agents
to enter and inspect, at reasonable times and in a reasonable
manner, their premises and delivery vehicles, and to audit their
records and written operating procedures. Such agents shall be
required to show appropriate identification prior to being
permitted access to warehousers' premises and delivery vehicles.
§ 54.1-3435.5. Denial, revocation, and suspension of
permit as warehouser.
The permit as a warehouser may be denied, suspended, or
revoked by the Board for any of the following:
1. Conduct in the distribution of prescription drugs or
devices contrary to the protection of the health, safety, and
welfare of the citizens of this Commonwealth; or
2. Violations of any provisions of this chapter or regulations
of the Board governing warehousers.
§ 54.1-3436.
Repealed by Acts 1992, c. 737.
Article 4.
Permitting of Manufacturers.
§ 54.1-3437. Permit to manufacture drugs.
It shall be lawful to manufacture, make, produce, pack,
package, repackage, relabel or prepare any drug not controlled by
Schedule I after first obtaining the appropriate permit from the
Board. Such permits shall be subject to the Board's regulations
on sanitation, equipment, and safeguards against diversion. This
provision shall not apply to manufacturers or packers of
medicated feeds who manufacture or package no other drugs.
§ 54.1-3437.1. Limited permit for repackaging drugs.
The Board may issue a limited manufacturing permit for the
purpose of repackaging drugs, upon such terms and conditions
approved by the Board, to the pharmacy directly operated by the
Department of Mental Health, Mental Retardation and Substance
Abuse Services and which serves clients of the community services
boards.
§ 54.1-3438. Manufacturing, etc., of drugs or proprietary
medicines, to be supervised by pharmacist.
No drugs or proprietary medicines shall be manufactured, made,
produced, packed, packaged, repackaged, relabeled or prepared
within this Commonwealth, except under the personal and immediate
supervision of a pharmacist or such other person as may be
approved by the Board of Pharmacy after an investigation and a
determination by the Board that they are qualified by scientific
or technical training to perform such duties or supervision as
may be necessary to protect the public health and safety. This
provision shall not apply to manufacturers or packers of
medicated feeds who manufacture or pack no other drugs. Medicated
feeds are hereby defined as products obtained by mixing a
commercial feed and a drug.
§ 54.1-3439. Application for nonrestricted manufacturing
permit; fee.
Every person desiring to manufacture any drug or proprietary
medicines shall annually apply to the Board for a nonrestricted
manufacturing permit. The application shall be accompanied by the
required fee. Separate applications shall be made and separate
permits issued for each specific place of manufacturing. Each
such permit shall expire on December 31.
§ 54.1-3440. Persons to whom nonrestricted permit is
granted.
No person shall be granted a nonrestricted permit as a
manufacturer unless he is of good moral character and properly
equipped as to land, buildings, equipment and safeguards against
diversion to carry out the functions of a manufacturer with due
regard to the protection of the public safety.
§ 54.1-3441. Restricted manufacturing permit; application;
fee; separate application and permit for each place of
manufacturing.
Every person desiring to manufacture a proprietary medicine or
to repackage medical gases shall apply to the Board for a
restricted manufacturing permit. The application shall be
accompanied by the required fee. Separate applications shall be
made and separate permits issued for each separate place of
manufacturing.
§ 54.1-3442. When permit not to be granted; regulations.
No person shall be granted a restricted manufacturing permit
as a manufacturer unless such person is properly equipped as to
buildings and equipment to carry out the functions of a
manufacturer with due regard to the protection of the public
health. The Board shall promulgate regulations in order to carry
out the provisions of this section.
Article 5.
Standards and Schedules.
§ 54.1-3443. Board to administer article.
A. The Board shall administer this article and may add
substances to or deschedule or reschedule all substances
enumerated in the schedules in this article pursuant to the
procedures of the Administrative Process Act (§ 9-6.14:1 et
seq.). In making a determination regarding a substance, the Board
shall consider the following:
1. The actual or relative potential for abuse;
2. The scientific evidence of its pharmacological effect, if
known;
3. The state of current scientific knowledge regarding the
substance;
4. The history and current pattern of abuse;
5. The scope, duration, and significance of abuse;
6. The risk to the public health;
7. The potential of the substance to produce psychic or
physical dependence; and
8. Whether the substance is an immediate precursor of a substance already controlled under this
article.
B. After considering the factors enumerated in subsection A,
the Board shall make findings and issue a regulation controlling
the substance if it finds the substance has a potential for
abuse.
C. If the Board designates a substance as an immediate
precursor, substances which are precursors of the controlled
precursor shall not be subject to control solely because they are
precursors of the controlled precursor.
D. If any substance is designated, rescheduled, or descheduled
as a controlled substance under federal law and notice of such
action is given to the Board, the Board may similarly control the
substance under this chapter after the expiration of 120 days
from publication in the Federal Register of the final order
designating a substance as a controlled substance or rescheduling
or deleting a substance without following the provisions
specified in subsections A and B of this section.
E. Authority to control under this section does not extend to
distilled spirits, wine, malt beverages, or tobacco as those
terms are defined or used in Title 4.1.
F. The Board shall exempt any nonnarcotic substance from a
schedule if such substance may, under the provisions of the
federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.) or
state law, be lawfully sold over the counter without a
prescription.
§ 54.1-3444. Controlled substances included by whatever
name designated.
The controlled substances listed or to be listed in the
schedules in this chapter are included by whatever official,
common, usual, chemical, or trade name designated.
§ 54.1-3445. Placement of substance in Schedule I.
The Board shall place a substance in Schedule I if it finds
that the substance:
1. Has high potential for abuse; and
2. Has no accepted medical use in treatment in the United States or lacks accepted safety for use in treatment under medical supervision.
§ 54.1-3446. Schedule I.
The controlled substances listed in this section are included
in Schedule I:
1. Any of the following opiates, including their isomers,
esters, ethers, salts, and salts of isomers, esters, and ethers,
unless specifically excepted, whenever the existence of these
isomers, esters, ethers and salts is possible within the specific
chemical designation:
Acetylmethadol;
Allylprodine;
Alphamethylfentanyl;
Alphacetylmethadol (except levo-alphacetylmethadol, also known as levo-alpha-acetylmethadol, levomethadyl acetate, or LAAM);
Alphameprodine;
Alphamethadol;
Benzethidine;
Betacetylmethadol;
Betameprodine;
Betamethadol;
Betaprodine;
Clonitazene;
Dextromoramide;
Diampromide;
Diethylthiambutene;
Difenoxin;
Dimenoxadol;
Dimepheptanol;
Dimethylthiambutene;
Dioxaphetylbutyrate;
Dipipanone;
Ethylmethylthiambutene;
Etonitazene;
Etoxeridine;
Furethidine;
Hydroxypethidine;
Ketobemidone;
Levomoramide;
Levophenacylmorphan;
Morpheridine;
Noracymethadol;
Norlevorphanol;
Normethadone;
Norpipanone;
Phenadoxone;
Phenampromide;
Phenomorphan;
Phenoperidine;
Piritramide;
Proheptazine;
Properidine;
Propiram;
Racemoramide;
Trimeperidine.
2. Any of the following opium derivatives, their salts,
isomers and salts of isomers, unless specifically excepted,
whenever the existence of these salts, isomers and salts of
isomers is possible within the specific chemical designation:
Acetorphine;
Acetyldihydrocodeine;
Benzylmorphine;
Codeine methylbromide;
Codeine-N-Oxide;
Cyprenorphine;
Desomorphine;
Dihydromorphine;
Drotebanol;
Etorphine;
Heroin;
Hydromorphinol;
Methyldesorphine;
Methyldihydromorphine;
Morphine methylbromide;
Morphine methylsulfonate;
Morphine-N-Oxide;
Myrophine;
Nicocodeine;
Nicomorphine;
Normorphine;
Phoclodine;
Thebacon.
3. Unless specifically excepted or unless listed in another
schedule, any material, compound, mixture, or preparation, which
contains any quantity of the following hallucinogenic substances,
or which contains any of its salts, isomers, and salts of
isomers, whenever the existence of such salts, isomers, and salts
of isomers is possible within the specific chemical designation
(for purposes of this subdivision only, the term
"isomer" includes the optical, position, and geometric
isomers):
Alpha-ethyltryptamine (some trade or other names: Monase;a-ethyl-1H-indole-3-ethanamine; 3-[2-aminobutyl] indole; a-ET; AET);
4-Bromo-2,5-dimethoxyphenethylamine (some trade or other names: 2-[4-bromo-2,5-dimethoxyphenyl]-1-aminoethane;alpha-desmethyl DOB;2C-B; Nexus);
3,4-methylenedioxy amphetamine;
5-methoxy-3,4-methylenedioxy amphetamine;
3,4,5-trimethoxy amphetamine;
Bufotenine;
Diethyltryptamine;
Dimethyltryptamine;
4-methyl-2,5-dimethoxyamphetamine;
2,5-dimethoxy-4-ethylamphetamine (DOET);
Ibogaine;
Lysergic acid diethylamide;
Mescaline;
Parahexyl (some trade or other names: 3-Hexyl-1-hydroxy-7, 8, 9, 10-tetrahydro-6, 6, 9-trimethyl-6H-dibenzo [b,d] pyran; Synhexyl);
Peyote;
N-ethyl-3-piperidyl benzilate;
N-methyl-3-piperidyl benzilate;
Psilocybin;
Psilocyn;
Tetrahydrocannabinols, except as present in marijuana and dronabinol in sesame oil and encapsulated in a soft gelatin capsule in a drug product approved by the U.S. Food and Drug Administration;
Hashish oil (some trade or other names: hash oil; liquid marijuana; liquid hashish);
2,5-dimethoxyamphetamine (some trade or other names: 2,5-dimethoxy-a-methylphenethylamine; 2,5-DMA);
3,4-methylenedioxymethamphetamine (MDMA), its optical, positional and geometric isomers, salts and salts of isomers;
3,4-methylenedioxy-N-ethylamphetamine (also known as N-ethyl-alpha-methyl-3,4 (methylenedioxy)phenethylamine, N-ethyl MDA, MDE, MDEA);
4-bromo-2,5-dimethoxyamphetamine (some trade or other names: 4-bromo-2,5-dimethoxy-a-methylphenethylamine; 4-bromo-2,5-DMA);
4-methoxyamphetamine (some trade or other names: 4-methoxy-a-methylphenethylamine; paramethoxyamphetamine; PMA);
N-ethyl analog of phencyclidine;
Pyrrolidine analog of phencyclidine;
Thiophene analog of phencyclidine.
4. Unless specifically excepted or unless listed in another
schedule, any material, compound, mixture or preparation which
contains any quantity of the following substances having a
depressant effect on the central nervous system, including its
salts, isomers and salts of isomers whenever the existence of
such salts, isomers and salts of isomers is possible within the
specific chemical designation:
Mecloqualone;
Methaqualone.
5. Unless specifically excepted or unless listed in another
schedule, any material, compound, mixture or preparation which
contains any quantity of the following substances having a
stimulant effect on the central nervous system, including its
salts, isomers and salts of isomers:
Aminorex (some trade or other names; aminoxaphen; 2-amino-5-phenyl-2-oxazoline; 4, 5-dihydro-5-phenyl-2-oxazolamine);
Fenethylline;
Ethylamphetamine;
Cathinone (some trade or other names: 2-amino-1-phenyl-1-propanone, alpha-aminopropiophenone, 2-aminopropiophenone, and norephedrone);
Methcathinone (some other names:
2-(methylamino)-propiophenone; alpha-(methylamino) propiophenone;
2-(methylamino)-1-phenylpropan-1-one;
alpha-N-methylaminopropiophenone; monomethylpropion; ephedrone;
N-methylcathinone; methylcathinone; AL-464; AL-422; AL-463 and UR
1432).
6. Any material, compound, mixture or preparation containing
any quantity of the following substances:
3-methylfentany-(N-[3-methyl -1- (2-phenyethyl) -4- piperidyl] N-phenylpropanamide), its optical and geometric isomers, salts, and salts of isomers;
1-methyl-4-phenyl-4-propionoxypiperidine (MPPP), its optical isomers, salts and salts of isomers;
1-(2-phenylethyl)-4-phenyl-4-acetyloxypiperidine (PEPAP), its optical isomers, salts and salts of isomers;
N-[1-(1-methyl-2-phenyl)ethyl-4-piperidyl]-N-phenylacetamide (acetyl-alpha-methylfentanyl), its optical isomers, salts and salts of isomers;
N-[1-(1-methyl-2-2-thienyl)ethyl-4 piperidyl]-N-phenylpropanamide (alpha-methylthiofentanyl), its optical isomers, salts and salts of isomers;
N-[1-benzyl-4-piperidyl]-N-phenylpropanamide (benzylfentanyl), its optical isomers, salts and salts of isomers;
N-[1-(2-hydroxy-2-phenyl) ethyl-4-piperidyl]-N-phenylpropanamide (beta-hydroxyfentanyl), its optical isomers, salts and salts of isomers;
N-[3-methyl-1-(2-hydroxy-2-phenyl)ethyl-4-piperidyl]-N-phenylpr opanamide (beta-hydroxy-3-methylfentanyl), its optical and geometric isomers, salts and salts of isomers;
N-[3-methyl-1-(2-2-thienyl)ethyl-4-piperidyl]-N-phenylpropanami de (3-methylthiofentanyl), its optical and geometric isomers, salts and salts of isomers;
N-[1-(2-thienyl)methyl-4-piperidyl]-N-phenylpropanamide(thenylf entanyl), its optical isomers, salts and salts of isomers;
N-[1-(2-2-thienyl)ethyl-4-piperidyl]-N-phenylpropanimide(thiofe
ntanyl), its optical isomers, salts and salts of isomers.
§ 54.1-3447. Placement of substance in Schedule II.
The Board shall place a substance in Schedule II if it finds
that:
1. The substance has high potential for abuse;
2. The substance has currently accepted medical use in
treatment in the United States, or currently accepted medical use
with severe restrictions; and
3. The abuse of the substance may lead to severe psychic or
physical dependence.
§ 54.1-3448. Schedule II.
The controlled substances listed in this section are included
in Schedule II:
1. Any of the following substances, except those narcotic
drugs listed in other schedules, whether produced directly or
indirectly by extraction from substances of vegetable origin, or
independently by means of chemical synthesis, or by combination
of extraction and chemical synthesis:
Opium and opiate, and any salt, compound, derivative, or preparation of opium or opiate, excluding apomorphine, thebaine-derived butorphanol, dextrorphan, nalbuphine, nalmefene, naloxone naltrexone and their respective salts, but including the following:
Raw opium;
Opium extracts;
Opium fluid extracts;
Powdered opium;
Granulated opium;
Tincture of opium;
Codeine;
Ethylmorphine;
Etorphine hydrochloride;
Hydrocodone;
Hydromorphone;
Metopon;
Morphine;
Oxycodone;
Oxymorphone;
Thebaine.
Any salt, compound, isomer, derivative, or preparation thereof
which is chemically equivalent or identical with any of the
substances referred to in this subdivision, but not including the
isoquinoline alkaloids of opium.
Opium poppy and poppy straw.
Coca leaves and any salt, compound, derivative, or preparation
of coca leaves, and any salt, compound, derivative, or
preparation thereof which is chemically equivalent or identical
with any of these substances, but not including decocainized coca
leaves or extractions which do not contain cocaine or ecgonine;
cocaine or any salt or isomer thereof.
Concentrate of poppy straw, the crude extract of poppy straw
in either liquid, solid or powder form, which contains the
phenanthrene alkaloids of the opium poppy.
2. Any of the following opiates, including their isomers, esters, ethers, salts, and salts of isomers, whenever the existence of these isomers, esters, ethers and salts is possible within the specific chemical designation:
Alfentanil;
Alphaprodine;
Anileridine;
Bezitramide;
Bulk dextropropoxyphene (nondosage forms);
Dihydrocodeine;
Diphenoxylate;
Fentanyl;
Isomethadone;
Levo-alphacetylmethadol (levo-alpha-acetylmethadol)
(levomethadyl acetate) (LAAM);
Levomethorphan;
Levorphanol;
Metazocine;
Methadone;
Methadone - Intermediate, 4-cyano-2-dimethylamino-4, 4-diphenyl butane;
Moramide - Intermediate, 2-methyl-3-morpholino-1, 1-diphenyl-propane-carboxylic acid;
Pethidine;
Pethidine - Intermediate - A, 4-cyano-1-methyl-4-phenylpiperidine;
Pethidine - Intermediate - B, ethyl-4-phenylpiperidine-4-carboxylate;
Pethidine - Intermediate - C, 1-methyl-4-phenylpiperidine-4-carboxylic acid;
Phenazocine;
Piminodine;
Racemethorphan;
Racemorphan.
3. Any material, compound, mixture or preparation which
contains any quantity of the following substances having a
potential for abuse associated with a stimulant effect on the
central nervous system:
Amphetamine, its salts, optical isomers, and salts of its optical isomers;
Phenmetrazine and its salts;
Any substance which contains any quantity of methamphetamine, including its salts, isomers, and salts of isomers;
Methylphenidate.
4. Unless specifically excepted or unless listed in another
schedule, any material, compound, mixture, or preparation which
contains any quantity of the following substances having a
depressant effect on the central nervous system, including its
salts, isomers, and salts of isomers whenever the existence of
such salts, isomers, and salts of isomers is possible within the
specific chemical designation:
Amobarbital;
Glutethimide
Secobarbital;
Pentobarbital;
Phencyclidine.
5. Any of the following hallucinogenic substances:
Dronabinol (synthetic) in sesame oil and encapsulated in a soft gelatin capsule in a drug product approved by the U.S. Food and Drug Administration;
Nabilone.
6. Unless specifically excepted or unless listed in another
schedule, any material, compound, mixture, or preparation which
contains any quantity of the following substances which are
immediate precursors to amphetamine and methamphetamine or
phencyclidine:
Phenylacetone;
1-phenylcyclohexylamine;
1-piperidinocyclohexanecarbonitrile.
§ 54.1-3449. Placement of substance in Schedule III.
The Board shall place a substance in Schedule III if it finds
that:
1. The substance has a potential for abuse less than the
substances listed in Schedules I and II;
2. The substance has currently accepted medical use in
treatment in the United States; and
3. Abuse of the substance may lead to moderate or low physical
dependence or high psychological dependence.
§ 54.1-3450. Schedule III.
The controlled substances listed in this section are included
in Schedule III:
1. Unless specifically exempted or listed in another schedule,
any material, compound, mixture, or preparation which contains
any quantity of the following substances having a depressant
effect on the central nervous system:
Any substance which contains any quantity of a derivative of
barbituric acid, or any salt of a derivative of barbituric acid,
except those substances which are specifically listed in other
schedules;
Any compound, mixture or preparation containing amobarbital, secobarbital, or pentobarbital or any salt of amobarbital, secobarbital, or pentobarbital and one or more other active medicinal ingredients which are not listed in Schedules II through V;
Any suppository dosage form containing amobarbital, secobarbital, or pentobarbital or any salt of amobarbital, secobarbital, or pentobarbital and approved by the Food and Drug Administration for marketing only as a suppository;
Chlorhexadol;
Lysergic acid;
Lysergic acid amide;
Methyprylon;
Sulfondiethylmethane;
Sulfonethylmethane;
Sulfonmethane;
Tiletamine - zolazepam or any salt thereof;
Nalorphine.
2. Any material, compound, mixture, or preparation containing
limited quantities of any of the following narcotic drugs, or any
salts thereof:
Not more than 1.8 grams of codeine, or any of its salts, per 100 milliliters or not more than 90 milligrams per dosage unit, with an equal or greater quantity of an isoquinoline alkaloid of opium;
Not more than 1.8 grams of codeine, or any of its salts, per 100 milliliters or not more than 90 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts;
Not more than 300 milligrams of dihydrocodeinone, or any of its salts, per 100 milliliters or not more than 15 milligrams per dosage unit, with a fourfold or greater quantity of an isoquinoline alkaloid of opium;
Not more than 300 milligrams of dihydrocodeinone, or any of its salts, per 100 milliliters or not more than 15 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts;
Not more than 1.8 grams of dihydrocodeine, or any of its salts, per 100 milliliters or not more than 90 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts;
Not more than 300 milligrams of ethylmorphine, or any of its salts, per 100 milliliters or not more than 15 milligrams per dosage unit, with one or more ingredients in recognized therapeutic amounts;
Not more than 500 milligrams of opium per 100 milliliters or per 100 grams, or not more than 25 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts;
Not more than 50 milligrams of morphine, or any of its salts,
per 100 milliliters or per 100 grams with one or more active,
nonnarcotic ingredients in recognized therapeutic amounts.
3. Unless specifically excepted or unless listed in another
schedule, any material, compound, mixture, or preparation which
contains any quantity of the following substances having a
stimulant effect on the central nervous system, including its
salts, isomers (whether optical, position, or geometric), and
salts of such isomers whenever the existence of such salts,
isomers, and salts of isomers is possible within the specific
chemical designation:
Benzphetamine;
Chlorphentermine;
Clortermine;
Phendimetrazine.
4. The Board may except by regulation any compound, mixture,
or preparation containing any stimulation or depressant substance
listed in subdivision 1 from the application of all or any part
of this chapter if the compound, mixture, or preparation contains
one or more active medicinal ingredients not having a stimulant
or depressant effect on the central nervous system, and if the
admixtures are included therein in combinations, quantity,
proportion, or concentration that vitiate the potential for abuse
of the substances which have a stimulant or depressant effect on
the central nervous system.
5. Unless specifically excepted or unless listed in another
schedule, any material, compound, mixture, or preparation
containing any quantity of the following substances, including
its salts, isomers, and salts of isomers whenever the existence
of such salts of isomers is possible within the specific chemical
designation:
Anabolic steroids, including, but not limited to:
Boldenone (Dehydrotestosterone);
Clostebol (4-Chlorotestosterone) (Chlorotestosterone);
Dromostanolone (Drostanolone);
Ethylestrenol;
Fluoxymesterone;
Formyldienolone (Formebolone);
Mesterolone;
Methandriol (methylandrostenediol);
Methandrostenolone (Methandienone) (Dehydromethyltestosterone);
Methenolone;
17-Methyltestosterone (Methyltestosterone);
Mibolerone;
Nandrolone (19-Nortestosterone);
Norethandrolone;
Oxandrolone;
Oxymesterone (Oxymestrone);
Oxymetholone (Anasterone);
Stanolone (4-Dihydrotestosterone) (Dihydrotestosterone);
Stanozolol (Androstanazole);
Testolactone (1-Dehydrotestololactone);
Testosterone;
Trenbolone (Trienbolone) (Trienolone); and
Any salt, ester, or isomer of a drug or substance described or
listed in this paragraph, if that salt, ester, or isomer promotes
muscle growth. However, such term does not include an anabolic
steroid which is expressly intended for administration through
implants to cattle or other nonhuman species and which has been
approved by the United States Secretary of Health and Human
Services for such administration. If any person prescribes,
dispenses, or distributes any such steroid for human use, such
person shall be considered to have prescribed, dispensed, or
distributed an anabolic steroid within the meaning of this
subdivision.
§ 54.1-3451. Placement of substance in Schedule IV.
The Board shall place a substance in Schedule IV if it finds
that:
1. The substance has a low potential for abuse relative to
substances in Schedule III;
2. The substance has currently accepted medical use in
treatment in the United States; and
3. Abuse of the substance may lead to limited physical dependence or psychological dependence relative to the substances in Schedule III.
§ 54.1-3452. Schedule IV.
The controlled substances listed in this section are included
in Schedule IV unless specifically excepted or listed in another
schedule:
1. Any material, compound, mixture, or preparation which
contains any quantity of the following substances having a
potential for abuse associated with a depressant effect on the
central nervous system:
Alprazolam;
Barbital;
Bromazepam;
Camazepam;
Chloral betaine;
Chloral hydrate;
Chlordiazepoxide;
Clobazam;
Clonazepam;
Clorazepate;
Clotiazepam;
Cloxazolam;
Delorazepam;
Diazepam;
Estazolam;
Ethchlorvynol;
Ethinamate;
Ethyl loflazepate;
Fludiazepam;
Flunitrazepam;
Flurazepam;
Halazepam;
Haloxazolam;
Ketazolam;
Loprazolam;
Lorazepam;
Lormetazepam;
Mebutamate;
Medazepam;
Methohexital;
Meprobamate;
Methylphenobarbital;
Midazolam;
Nimetazapam;
Nitrazepam;
Nordiazepam;
Oxazepam;
Oxazolam;
Paraldehyde;
Pentazocine;
Petrichloral;
Phenobarbital;
Pinazepam;
Prazepam;
Quazepam;
Temazepam;
Tetrazepam;
Triazolam;
Zolpidem.
2. Any compound, mixture or preparation which contains any
quantity of the following substances including any salts or
isomers thereof:
Fenfluramine.
3. Unless specifically excepted or unless listed in another
schedule, any material, compound, mixture, or preparation which
contains any quantity of the following substances having a
stimulant effect on the central nervous system, including its
salts, isomers (whether optical, position, or geometric), and
salts of such isomers whenever the existence of such salts,
isomers, and salts of isomers is possible within the specific
chemical designation:
Cathine (+)-norpseudoephedrine;
Diethylpropion;
Fencamfamin;
Fenproprex;
Mazindol;
Mefenorex;
Phentermine;
Pemoline (including organometallic complexes and chelates thereof);
Pipradrol;
SPA (-)-1-dimethylamino-1,2-diphenylethane.
Dextropropoxyphene (alpha-(+)-4-dimethylamino-1,2-diphenyl-3-methyl-2-propionoxy butane);
Not more than 1 milligram of difenoxin and not less than 25
micrograms of atropine sulfate per dosage unit.
5. The Board may except by regulation any compound, mixture,
or preparation containing any depressant substance listed in
subdivision 1 from the application of all or any part of this
chapter if the compound, mixture, or preparation contains one or
more active medicinal ingredients not having a depressant effect
on the central nervous system, and if the admixtures are included
therein in combinations, quantity, proportion, or concentration
that vitiate the potential for abuse of the substances which have
a depressant effect on the central nervous system.
§ 54.1-3453. Placement of substance in Schedule V.
The Board shall place a substance in Schedule V if it finds
that:
1. The substance has low potential for abuse relative to the
controlled substances listed in Schedule IV;
2. The substance has currently accepted medical use in
treatment in the United States; and
3. The substance has limited physical dependence or
psychological dependence liability relative to the controlled
substances listed in Schedule IV.
§ 54.1-3454. Schedule V.
The controlled substances listed in this section are included
in Schedule V:
Buprenorphine.
2. Any compound, mixture, or preparation containing limited
quantities of any of the following narcotic drugs, which also
contains one or more nonnarcotic active medicinal ingredients in
sufficient proportion to confer upon the compound, mixture, or
preparation, valuable medicinal qualities other than those
possessed by the narcotic drug alone:
Not more than 200 milligrams of codeine, or any of its salts, per 100 milliliters or per 100 grams;
Not more than 100 milligrams of dihydrocodeine, or any of its salts, per 100 milliliters or per 100 grams;
Not more than 100 milligrams of ethylmorphine, or any of its salts, per 100 milliliters or per 100 grams;
Not more than 2.5 milligrams of diphenoxylate and not less than 25 micrograms of atropine sulfate per dosage unit;
Not more than 100 milligrams of opium per 100 milliliters or per 100 grams;
Not more than 0.5 milligrams of difenoxin and not less than 25
micrograms of atropine sulfate per dosage unit.
The Board may except by regulation any compound, mixture or
preparation containing any depressant substance listed in
subdivision 2 from the application of all or any part of this
chapter and such substances so excepted may be dispensed pursuant
to § 54.1-3416.
3. Unless specifically excepted or listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a stimulant effect on
the central nervous system, including its salts, isomers, and
salts of isomers:
Pyrovalerone.
§ 54.1-3455. Schedule VI.
The following classes of drugs and devices shall be controlled
by Schedule VI:
1. Any compound, mixture, or preparation containing any
stimulant or depressant drug exempted from Schedules III, IV or V
and designated by the Board as subject to this section.
2. Every drug, not included in Schedules I, II, III, IV or V,
or device, which because of its toxicity or other potentiality
for harmful effect, or the method of its use, or the collateral
measures necessary to its use, is not generally recognized among
experts qualified by scientific training and experience to
evaluate its safety and efficacy as safe for use except by or
under the supervision of a practitioner licensed to prescribe or
administer such drug or device.
3. Any drug, not included in Schedules I, II, III, IV or V, or
device, required by federal law to bear on its label the legend:
"Caution: Federal Law Prohibits Dispensing Without
Prescription" or which bears the legend "Caution:
Federal Law Restricts This Device To Sales By Or Use On The Order
Of A Physician" or which bears the legend: "Caution:
Federal Law Restricts This Drug To Use By Or On The Order Of A
Veterinarian."
§ 54.1-3456. Designer drugs.
Any drug not listed on Schedule I or II in this chapter, which
is privately compounded, with the specific intent to circumvent
the provisions of this chapter, to emulate or simulate the
effects of another drug or class of drugs listed on Schedule I or
II in this chapter through chemical changes such as the addition,
subtraction or rearranging of a radical or the addition,
subtraction or rearranging of a substituent, shall be considered
to be listed on the same schedule as the drug or class of drugs
which it imitates in the same manner as any isomer, ester, ether,
salts of isomers, esters and ethers of such drug or class of
drugs.
Article 6.
Misbranded and Adulterated Drugs and
Cosmetics.
§ 54.1-3457. Prohibited acts.
The following acts shall be prohibited:
1. The manufacture, sale, or delivery, holding or offering for
sale of any drug, device, or cosmetic that is adulterated or
misbranded.
2. The adulteration or misbranding of any drug, device, or
cosmetic.
3. The receipt in commerce of any drug, device, or cosmetic
that is adulterated or misbranded, and the delivery or proffered
delivery thereof for pay or otherwise.
4. The sale, delivery for sale, holding for sale, or offering
for sale of any article in violation of § 54.1-3421.
5. The dissemination of any false advertisement.
6. The refusal to permit entry or inspection, or to permit the
taking of a sample, or to permit access to or copying of any
record.
7. The giving of a false guaranty or undertaking.
8. The removal or disposal of a detained article in violation
of § 54.1-3459.
9. The alteration, mutilation, destruction, obliteration, or
removal of the whole or any part of the labeling of, or the doing
of any other act with respect to a drug, device, or cosmetic, if
such act is done while such article is held for sale and results
in such article being adulterated or misbranded.
10. The forging, counterfeiting, simulating, or falsely
representing, or without proper authority using any mark, stamp,
tag, label, or other identification device authorized or required
by regulations promulgated under the provisions of this chapter
or of the federal act.
11. The using by any person to his own advantage, or
revealing, other than to the Board or its authorized
representative or to the courts when relevant in any judicial
proceeding under this chapter of any information acquired under
authority of this chapter concerning any method or process which
as a trade secret is entitled to protection.
12. The using, on the labeling of any drug or in any advertisement relating to such drug, of any representation or suggestion that an application with respect to such drug is effective under § 54.1-3421, or that such drug complies with the provisions of such section.
13. In the case of a drug distributed or offered for sale in
this Commonwealth, the failure of the manufacturer, packer, or
distributor thereof to maintain for transmittal, or to transmit,
to any practitioner licensed by applicable law to administer such
drug who makes written request for information as to such drug,
true and correct copies of all printed matter which is required
to be included in any package in which that drug is distributed
or sold, or such other printed matter as is approved under the
federal act. This subdivision shall not be construed to exempt
any person from any labeling requirement imposed by or under
other provisions of this chapter.
14. Placing or causing to be placed upon any drug or device or
container, with intent to defraud, the trade name or other
identifying mark, or imprint of another or any likeness of any of
the foregoing; or selling, dispensing, disposing of or causing to
be sold, dispensed or disposed of, or concealing or keeping in
possession, control or custody, with intent to sell, dispense or
dispose of, any drug, device or any container thereof, with
knowledge that the trade name or other identifying mark or
imprint of another or any likeness of any of the foregoing has
been placed thereon in a manner prohibited by this section or
making, selling, disposing of, or causing to be made, sold or
disposed of, or keeping in possession, control or custody, or
concealing any punch, die, plate, stone, or other thing designed
to print, imprint, or reproduce the trademark, trade name, or
other identifying mark, imprint, or device of another or any
likeness of any of the foregoing upon any drug or container or
labeling thereof so as to render such drug a counterfeit drug.
15. The doing of any act which causes a drug to be a
counterfeit drug, or the sale or dispensing, or the holding for
sale or dispensing, of a counterfeit drug.
16. Dispensing or causing to be dispensed, except as provided in § 32.1-87 relating to the Virginia Voluntary Formulary, a different drug or brand of drug in place of the drug or brand of drug ordered or prescribed without the permission of the person ordering or prescribing.
§ 54.1-3458. Violations.
A. Any person who violates any of the provisions of §
54.1-3457 shall be guilty of a Class 2 misdemeanor.
B. No person shall be subject to the penalties of this section
for having violated subdivisions 1 and 3 of § 54.1-3457 if he
establishes a guaranty or undertaking signed by, and containing
the name and address of, the person residing in this Commonwealth
from whom he received in good faith the article, to the effect
that such article is not adulterated or misbranded within the
meaning of this chapter.
C. No publisher, radio-broadcast licensee, or agency or medium
for the dissemination of an advertisement, except the
manufacturer, packer, distributor, or seller of the article to
which a false advertisement relates, shall be liable under this
section for the dissemination of such false advertisement, unless
he has refused, on the request of the Board, to furnish the Board
the name and post-office address of the manufacturer, packer,
distributor, seller, or advertising agency, residing in this
Commonwealth who caused him to disseminate such advertisement.
§ 54.1-3459. Tagging of adulterated or misbranded drugs,
devices, or cosmetics; condemnation; destruction; expenses.
A. Whenever a duly authorized agent of the Board finds, or has
probable cause to believe, that any drug, device, or cosmetic is
adulterated, or so misbranded as to be dangerous or fraudulent,
within the meaning of this chapter or is in violation of §
54.1-3457, he shall affix to such article a tag or other
appropriate marking, giving notice that such article is, or is
suspected of being, adulterated or misbranded or in violation of
§ 54.1-3457 and has been detained. The tag shall also warn all
persons not to remove or dispose of such article by sale or
otherwise until permission for removal or disposal is given by an
authorized agent or the court. It shall be unlawful for any
person to remove or dispose of such detained article by sale or
otherwise without permission.
B. When an article is adulterated or misbranded or is in
violation of § 54.1-3421, the Board may petition the circuit
court in whose jurisdiction the article is detained for
condemnation of such article. When an authorized agent finds that
an article which has been detained is not adulterated or
misbranded, or in violation of § 54.1-3421, he shall remove the
tag or other marking.
C. If the court finds that a detained article is adulterated
or misbranded, or in violation of § 54.1-3421, such article
shall, after entry of the decree, be destroyed at the expense of
the claimant, under the supervision of an authorized agent, and
all court costs and fees, and storage and other proper expenses,
shall be levied against the claimant or his agent. When the
adulteration or misbranding can be corrected by proper labeling
or processing of the article, the court shall order the article
to be properly labeled or processed. The expense of the
supervision shall be paid by the claimant. The article shall be
returned to the claimant and the bond shall be discharged on the
representation to the court by the Board that the article is no
longer in violation of this chapter, and that the expenses of
such supervision have been paid.
§ 54.1-3460. Poisonous or deleterious substance, or color
additive.
Any added poisonous or deleterious substance, or any color
additive, shall with respect to any particular use or intended
use be deemed unsafe with respect to any drug, device, or
cosmetic, unless there is a regulation allowing limited use of a
quantity of such substance, and the use or intended use of such
substance conforms to the terms prescribed by regulation. While
such regulations relating to such substance are in effect, a drug
or cosmetic shall not, by reason of bearing or containing such
substance in accordance with the regulations, be considered
adulterated.
§ 54.1-3461. Adulterated drug or device.
A. A drug or device shall be deemed to be adulterated:
1. If it consists in whole or in part of any filth, putrid or
decomposed substance;
2. If it has been produced, prepared, packed, or held under insanitary conditions whereby it has
been contaminated with filth, or whereby it has been rendered
injurious to health;
3. If it is a drug and the methods used in, or the facilities
or controls used for, its manufacture, processing, packing, or
holding do not conform to or are not operated or administered in
conformity with current good manufacturing practice to assure
that such drug meets the requirements of this chapter;
4. If it is a drug and its container is composed, in whole or
in part, of any poisonous or deleterious substance which may
render the contents injurious to health;
5. If it is a drug and it bears or contains, for purposes of
coloring only, a color additive which is unsafe within the
meaning of the federal act or § 54.1-3460; or
6. It is a color additive, the intended use of which in or on
drugs is for purposes of coloring only, and is unsafe within the
meaning of the federal act or § 54.1-3460.
B. A drug or device shall be deemed to be adulterated if it
purports to be or is represented as a drug the name of which is
recognized in an official compendium, and its strength differs
from, or its quality or purity falls below, the standard set
forth in such compendium. Such determination of strength,
quality, or purity shall be made in accordance with the tests or
methods of assay set forth in such compendium, or in the absence
of or inadequacy of such tests or methods of assay, those
prescribed under authority of the federal act. No drug defined in
an official compendium shall be deemed to be adulterated under
this subsection because it differs from the standard of strength,
quality, or purity set forth in such compendium, if the
difference in strength, quality, or purity from such standard is
plainly stated on its label.
Whenever a drug is recognized in both the United States
Pharmacopoeia National Formulary and the Homeopathic
Pharmacopoeia of the United States it shall be subject to the
requirements of the United States Pharmacopoeia National
Formulary unless it is labeled and offered for sale as a
homeopathic drug, in which case it shall be subject to the
provisions of the Homeopathic Pharmacopoeia of the United States
and not to those of the United States Pharmacopoeia National
Formulary.
C. A drug or device shall be deemed to be adulterated if it is
not subject to the provisions of subsection B of this section and
its strength differs from, or its purity or quality falls below,
that which it purports or is represented to possess.
D. A drug or device shall be deemed to be adulterated if it is
a drug and any substance has been (i) mixed or packed with it so
as to reduce its quality or strength or (ii) substituted wholly
or in part for it.
§ 54.1-3462. Misbranded drug or device.
A drug or device shall be deemed to be misbranded:
1. If its labeling is false or misleading in any particular.
2. If its package does not bear a label containing the name
and place of business of the manufacturer, packer, or
distributor. However, all prescription drugs intended for human
use and devices shall bear a label containing the name and place
of business of the manufacturer of the final dosage form of the
drug and, if different, the name and place of business of the
packer or distributor and an accurate statement of the quantity
of the contents in terms of weight, measure, or numerical count.
Reasonable variations shall be permitted, and exemptions for
small packages shall be allowed in accordance with regulations of
the Board.
3. If any word, statement, or other information required by or
under authority of this chapter to appear on the label or
labeling is not prominently placed with such conspicuousness, as
compared with other words, statements, designs or devices, in the
labeling, and in such terms as to render it likely to be read and
understood by the ordinary individual under customary conditions
of purchase and use.
4. If it is for use by man and contains any quantity of the
narcotic or hypnotic substances alpha-eucaine, barbituric acid,
beta-eucaine, bromal, carbromal, chloral, coca, cocaine, codeine,
morphine, opium, paraldehyde, or sulfonmethane, or any chemical
derivative of such substances, which derivative, after
investigation has been found to be and designated as, habit
forming, by regulations issued by the Board under this chapter,
unless its label bears the name and quantity or proportion of
such substance or derivative and in juxtaposition therewith the
statement "Warning - May Be Habit Forming."
5. If it is a drug, unless its label bears, to the exclusion
of any other nonproprietary name, except the applicable
systematic chemical name or the chemical formula, the established
name of the drug, and in case it is fabricated from two or more
ingredients, the established name and quantity of each active
ingredient, including the kind and quantity or proportion of any
alcohol, and the established name and quantity or proportion of
any bromides, ether, chloroform, acetanilid, acetphenetidin,
amidopyrine, antipyrine, atropine, hyoscine, hyoscyamine,
arsenic, digitalis, digitalis glucosides, mercury, ouabain,
strophanthin, strychnine, thyroid, or any derivative or
preparation of any such substances. However, the requirement for
stating the quantity of the active ingredients, other than the
quantity of those specifically named in this subdivision, shall
apply only to prescription drugs. Any prescription drug shall
have the established name of the drug or ingredient printed on
its label prominently and in type at least half as large as that
used for any proprietary name or designation for such drug or
ingredient. Exemptions may be allowed under regulations of the
Board.
As used in this subdivision, the term "established
name," with respect to a drug or ingredient, means the
applicable official name designated pursuant to § 508 of the
federal act, or if there is no such name and such drug, or such
ingredient, is an article recognized in an official compendium,
then the official title in such compendium or if neither exists,
then the common or usual name, if any, of such drug or of such
ingredient. Whenever, an article is recognized in the United
States Pharmacopoeia National Formulary and in the Homeopathic
Pharmacopoeia under different official titles, the official title
used in the United States Pharmacopoeia National Formulary shall
apply unless it is labeled and offered for sale as a homeopathic
drug, in which case the official title used in the Homeopathic
Pharmacopoeia shall apply.
6. Unless its labeling bears adequate directions for use and
such adequate warnings against use in those pathological
conditions or by children where its use may be dangerous to
health, or against unsafe dosage or methods or duration of
administration or application, in such manner and form, as are
necessary for the protection of users. The Board shall promulgate
regulations exempting such drug or device from such requirements
when these requirements are not necessary to protect the public
health and the articles are also exempted under regulations
issued under § 502(f) of the federal act.
7. If it purports to be a drug the name of which is recognized
in an official compendium, unless it is packaged and labeled as
prescribed. The method of packing may be modified with the
consent of the Board, or if consent is obtained under the federal
act. Whenever a drug is recognized in both the United States
Pharmacopoeia National Formulary and the Homeopathic
Pharmacopoeia of the United States, it shall be subject to the
requirements of the United States Pharmacopoeia National
Formulary with respect to packaging and labeling unless it is
labeled and offered for sale as a homeopathic drug, in which case
it shall be subject to the provisions of the Homeopathic
Pharmacopoeia of the United States and not to those of the United
States Pharmacopoeia National Formulary. However, in the event of
inconsistency between the requirements of this subdivision and
those of subdivision 5 as to the name by which the drug or its
ingredients shall be designated, the requirements of subdivision
5 shall prevail.
8. If it is dangerous to health when used in the dosage, or
with the frequency or duration prescribed, recommended, or
suggested in the labeling or advertising.
9. If it is, or purports to be, or is represented as a drug
composed wholly or partly of insulin, unless it is from a batch
for which a certificate or release has been issued pursuant to §
506 of the federal act, and such certificate or release is in
effect with respect to such drug.
10. If it is, or purports to be, or is represented as a drug
composed wholly or partly of any kind of penicillin,
streptomycin, chlortetracycline, chloramphenicol, bacitracin, or
any other antibiotic drug, or any derivative, unless it is from a
batch, for which a certificate or release has been issued
pursuant to § 507 of the federal act, and such certificate or
release is in effect for such drug. This subdivision shall not
apply to any drug or class of drugs exempted by regulations
promulgated under § 507(c) or (d) of the federal law.
For the purpose of this subdivision the term "antibiotic
drug" means any drug intended for use by man containing any
quantity of any chemical substance which is produced by
microorganisms and which has the capacity to inhibit or destroy
microorganisms in dilute solution, including, the chemically
synthesized equivalent of any such substance.
11. If it is a color additive, the intended use of which in or
on drugs is for coloring only, unless its packaging and labeling
are in conformity with such packaging and labeling requirements
applicable to such color additive, prescribed under the
provisions of the federal act.
12. In the case of any prescription drug distributed or offered for sale in this Commonwealth, unless the manufacturer, packer, or distributor includes in all advertisements and other descriptive printed matter a true statement of (i) the established name, as defined in this section, printed prominently and in type at least half as large as that used for any trade or brand name, (ii) the formula showing quantitatively each ingredient of such drug to the extent required for labels under this section, and (iii) such other information in brief summary relating to side effects, contraindications, and effectiveness as are required in regulations issued under the federal act.
13. If a trademark, trade name or other identifying mark, imprint or device of another or any likeness of the foregoing has been placed thereon or upon its container with intent to defraud.
Drugs and devices which are, in accordance with the practice
of the trade, to be processed, labeled or repacked in substantial
quantities at establishments other than those where originally
processed or packed shall be exempt from any labeling or
packaging requirements of this chapter if such drugs and devices
are being delivered, manufactured, processed, labeled, repacked
or otherwise held in compliance with regulations issued by the
Board.
§ 54.1-3463. Exemption of drugs dispensed by filling or
refilling prescription.
A. Any drug dispensed by filling or refilling a written or
oral prescription of a prescriber shall be exempt from the
requirements of § 54.1-3462 except subdivisions 1, 9, and 10,
and the packaging requirements of subdivision 7, if the drug
bears a label containing the name and address of the dispenser,
the serial number and date of the prescription or of its filling,
the name of the prescriber and the name of the patient, and the
directions for use and cautionary statements, if any, contained
in such prescription.
B. This section shall not be construed to relieve any person
from any requirement prescribed by or under authority of law with
respect to drugs now included or which may hereafter be included
within the classifications of narcotic drugs or marijuana as
defined in the applicable federal and state laws relating to
narcotic drugs and marijuana.
§ 54.1-3464. Adulterated cosmetics.
A cosmetic shall be deemed to be adulterated:
1. If it bears or contains any poisonous or deleterious
substance which may render it injurious to users under the
conditions of use prescribed in the labeling or advertisement, or
under such conditions of use as are customary or usual. This
provision shall not apply to coal-tar hair dye, the label of
which bears the following legend conspicuously displayed thereon:
"Caution - This product contains ingredients which may cause
skin irritation on certain individuals and a preliminary test
according to accompanying directions should first be made. This
product must not be used for dyeing the eyelashes or eyebrows; to
do so may cause blindness," and the labeling of which bears
adequate directions for such preliminary testing. For the purpose
of this subdivision and subdivision 5, the term "hair
dye" shall not include eyelash or eyebrow dyes;
2. If it consists in whole or in part of any filthy, putrid,
or decomposed substance;
3. If it has been produced, prepared, packed, or held under
insanitary conditions whereby it may have become contaminated
with filth, or whereby it may have been rendered injurious to
health;
4. If its container is composed, in whole or in part, of any
poisonous or deleterious substance which may render the contents
injurious to health;
5. If it is not a hair dye, and it is or it bears or contains
a color additive which is unsafe within the meaning of the
federal act or § 54.1-3460.
§ 54.1-3465. Misbranded cosmetics.
A cosmetic shall be deemed to be misbranded:
1. If its labeling is false or misleading in any particular;
2. If in package form unless it bears a label containing the
name and place of business of the manufacturer, packer, or
distributor and an accurate statement of the quantity of the
contents in terms of weight, measure, or numerical count.
However, reasonable variations shall be permitted, and exemptions
for small packages shall be established by the Board;
3. If any word, statement, or other information required by or
under authority of this chapter to appear on the label or
labeling is not prominently placed thereon with such
conspicuousness, as compared with other words, statements,
designs, or devices, in the labeling, and in such terms as to
render it likely to be read and understood by the ordinary
individual under customary conditions of purchase and use;
4. If its container is so made, formed or filled as to be
misleading;
5. If it is a color additive, unless its packaging and
labeling are in conformity with packaging and labeling
requirements applicable to such color additive under the
provisions of the federal act. This subdivision shall not apply
to packages of color additives which, with respect to their use
for cosmetics, are marketed and intended for use only in or on
hair dyes.
A cosmetic which is, in accordance with the practice of the
trade, to be processed, labeled or repacked in substantial
quantities at an establishment other than the establishment where
it was originally processed or packed, is exempted from the
affirmative labeling requirements of this chapter while it is in
transit in commerce from the one establishment to the other, if
such transit is made in good faith for such completion purposes
only; but it is otherwise subject to all applicable provisions of
this chapter.
Article 7.
Controlled Paraphernalia.
§ 54.1-3466. Possession or distribution of controlled
paraphernalia; meaning of controlled paraphernalia; evidence;
exceptions.
Except as authorized in this chapter, it shall be a
misdemeanor for any person to possess or distribute controlled
paraphernalia which shall mean a hypodermic syringe, needle or
other instrument or implement or combination thereof adapted for
the administration of controlled dangerous substances by
hypodermic injections under circumstances which reasonably
indicate an intention to use such controlled paraphernalia for
purposes of illegally administering any controlled drug, or
gelatin capsules, glassine envelopes or any other container
suitable for the packaging of individual quantities of controlled
drugs in sufficient quantity to and under circumstances which
reasonably indicate an intention to use any such item for the
illegal manufacture, distribution, or dispensing of any such
controlled drug. Evidence of such circumstances shall include,
but not be limited to, close proximity of any such controlled
paraphernalia to any adulterants or equipment commonly used in
the illegal manufacture and distribution of controlled drugs
including, but not limited to, scales, sieves, strainers,
measuring spoons, staples and staplers, or procaine
hydrochloride, mannitol, lactose, quinine, or any controlled drug
or any machine, equipment, instrument, implement, device or
combination thereof which is adapted for the production of
controlled drugs under circumstances which reasonably indicate an
intention to use such item or combination thereof to produce,
sell, or dispense any controlled drug in violation of the
provisions of this chapter.
The provisions of this section shall not apply to persons who
have acquired possession and control of controlled paraphernalia
in accordance with the provisions of this article or to any
person who owns or is engaged in breeding or raising livestock,
poultry or other animals to which hypodermic injections are
customarily given in the interest of health, safety, or good
husbandry; or to hospitals, physicians, pharmacists, dentists,
podiatrists, veterinarians, funeral directors and embalmers,
persons to whom a permit has been issued, manufacturers,
wholesalers or their authorized agents or employees when in the
usual course of their business, if the controlled paraphernalia
lawfully obtained continues to be used for the legitimate
purposes for which they were obtained.
§ 54.1-3467. Distribution of hypodermic needles or
syringes, gelatin capsules, quinine or any of its salts.
Distribution by any method, of any hypodermic needles or
syringes, gelatin capsules, quinine or any of its salts, in
excess of one-fourth ounce shall be restricted to licensed
pharmacists or to others who have received a license or a permit
from the Board.
§ 54.1-3468. Conditions to dispensing device, item, or
substance; records.
In dispensing any device, item or substance, the pharmacist or
other licensed or permitted person referred to in § 54.1-3467
shall:
1. Require the person requesting such device, item or
substance to furnish suitable identification, including proof of
age when appropriate;
2. Require the person requesting such item, device or
substance to furnish written legitimate purposes for which such
item, device or substance is being purchased, except in cases of
telephone orders for such item, device or substance from
customers of known good standing;
3. At the time of dispensing, make and keep a record showing
the date of dispensing, the name and quantity of the device, item
or substance, the price at which it was sold, the name and
address of the person to whom the device, item or substance was
dispensed, the reason for its purchase and enter his initials
thereon.
No such devices, substances or items shall be sold or distributed to persons under the age of sixteen years except by a physician for legitimate purposes or upon his prescription. Records shall be maintained pursuant to this chapter and the Board's regulations and shall be made available for inspection to any law-enforcement officer or agent of the Board. Persons violating the provisions of this section shall be guilty of a Class 1 misdemeanor.
§ 54.1-3469. Storage, usage, and disposition of controlled
paraphernalia.
Each person, association or corporation which has lawfully
obtained possession of any of the controlled paraphernalia
mentioned in § 54.1-3467 shall exercise reasonable care in the
storage, usage and disposition of such devices or substances to
ensure that they are not diverted for reuse for any purposes
other than those for which they were lawfully obtained. Any
person who permits or causes, directly or indirectly, such
controlled paraphernalia to be used for any other purpose than
that for which it was lawfully obtained shall be guilty of a
Class 1 misdemeanor.
§ 54.1-3470. Obtaining controlled paraphernalia by fraud,
etc.
A. No person shall obtain or attempt to obtain any item,
device or substance referred to in § 54.1-3467 by fraud, deceit,
misrepresentation, or subterfuge or by giving a false name or a
false address.
B. No person shall furnish false or fraudulent information in
or omit any information from, or willfully make a false statement
in obtaining or attempting to obtain any of the instruments or
substances referred to in § 54.1-3467.
C. No person shall, for the purpose of obtaining any such
instrument or substance, falsely claim to be a manufacturer,
wholesaler, pharmacist, practitioner of the healing arts, funeral
director, embalmer or veterinarian.
Persons violating the provisions of this section shall be
guilty of a Class 1 misdemeanor.
§ 54.1-3471. Issuance of permits to certain persons other
than registered pharmacists.
The Board shall, upon written application, on a form furnished
by the Board, issue a permit to any person other than a licensed
pharmacist who in the usual course of business sells any item
referred to in § 54.1-3467 as a wholesale distributor or
distributes at retail to any persons who own or breed or raise
livestock, poultry, or other animals to which such items, devices
or substances are customarily given to or used upon in the
interest of health, safety, or good husbandry. This permit shall
not authorize the sale or distribution of these items, devices or
substances for human use and the permitted person shall exercise
reasonable diligence to assure that the items distributed are not
for the purpose of human consumption.
§ 54.1-3472. Article inapplicable to certain persons.
The provisions of this article shall not apply to legitimate distribution by or possession of controlled paraphernalia by physicians, dentists, podiatrists, veterinarians, funeral directors and embalmers.