Bill Text: VA SB568 | 2024 | Regular Session | Comm Sub
Bill Title: Crisis stabilization services; facilities licensed by DBHDS, nursing homes.
Spectrum: Partisan Bill (Democrat 1-0)
Status: (Passed) 2024-04-04 - Governor: Acts of Assembly Chapter text (CHAP0513) [SB568 Detail]
Download: Virginia-2024-SB568-Comm_Sub.html
Be it enacted by the General Assembly of Virginia:
1. That §§54.1-3401, 54.1-3423, and 54.1-3434.02 of the Code of Virginia are amended and reenacted as follows:
§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.
"Agent" means an authorized person who acts on
behalf of or at the direction of a manufacturer, distributor, or dispenser.
It "Agent" does not include a common or contract carrier,
public warehouseman, or employee of the carrier or warehouseman.
"Anabolic steroid" means any drug or hormonal substance, chemically and pharmacologically related to testosterone, other than estrogens, progestins, corticosteroids, and dehydroepiandrosterone.
"Animal" means any nonhuman animate being endowed with the power of voluntary action.
"Automated drug dispensing system" means a mechanical or electronic system that performs operations or activities, other than compounding or administration, relating to pharmacy services, including the storage, dispensing, or distribution of drugs and the collection, control, and maintenance of all transaction information, to provide security and accountability for such drugs.
"Biological product" means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings.
"Biosimilar" means a biological product that is highly similar to a specific reference biological product, notwithstanding minor differences in clinically inactive compounds, such that there are no clinically meaningful differences between the reference biological product and the biological product that has been licensed as a biosimilar pursuant to 42 U.S.C. §262(k) in terms of safety, purity, and potency of the product.
"Board" means the Board of Pharmacy.
"Bulk drug substance" means any substance that is
represented for use, and that, when used in the compounding, manufacturing,
processing, or packaging of a drug, becomes an active ingredient or a finished
dosage form of the drug; however, "bulk drug substance" shall
does not include intermediates that are used in the synthesis of such
substances.
"Change of ownership" of an existing entity permitted, registered, or licensed by the Board means (i) the sale or transfer of all or substantially all of the assets of the entity or of any corporation that owns or controls the entity; (ii) the creation of a partnership by a sole proprietor, the dissolution of a partnership, or change in partnership composition; (iii) the acquisition or disposal of 50 percent or more of the outstanding shares of voting stock of a corporation owning the entity or of the parent corporation of a wholly owned subsidiary owning the entity, except that this shall not apply to any corporation the voting stock of which is actively traded on any securities exchange or in any over-the-counter market; (iv) the merger of a corporation owning the entity or of the parent corporation of a wholly-owned subsidiary owning the entity with another business or corporation; or (v) the expiration or forfeiture of a corporation's charter.
"Co-licensed partner" means a person who, with at least one other person, has the right to engage in the manufacturing or marketing of a prescription drug, consistent with state and federal law.
"Compounding" means the combining of two or more ingredients to fabricate such ingredients into a single preparation and includes the mixing, assembling, packaging, or labeling of a drug or device (i) by a pharmacist, or within a permitted pharmacy, pursuant to a valid prescription issued for a medicinal or therapeutic purpose in the context of a bona fide practitioner-patient-pharmacist relationship, or in expectation of receiving a valid prescription based on observed historical patterns of prescribing and dispensing; (ii) by a practitioner of medicine, osteopathy, podiatry, dentistry, or veterinary medicine as an incident to his administering or dispensing, if authorized to dispense, a controlled substance in the course of his professional practice; or (iii) for the purpose of, or as incident to, research, teaching, or chemical analysis and not for sale or for dispensing. The mixing, diluting, or reconstituting of a manufacturer's product drugs for the purpose of administration to a patient, when performed by a practitioner of medicine or osteopathy licensed under Chapter 29 (§54.1-2900 et seq.), a person supervised by such practitioner pursuant to subdivision A 6 or 19 of § 54.1-2901, or a person supervised by such practitioner or a licensed advanced practice registered nurse or physician assistant pursuant to subdivision A 4 of § 54.1-2901 shall not be considered compounding.
"Controlled substance" means a drug, substance, or
immediate precursor in Schedules I through VI of this chapter. The term shall
"Controlled substance" does not include distilled spirits, wine,
malt beverages, or tobacco as those terms are defined or used in Title 3.2 or
Title 4.1. The term "controlled substance" includes a controlled
substance analog that has been placed into Schedule I or II by the Board
pursuant to the regulatory authority in subsection D of §54.1-3443.
"Controlled substance analog" means a substance the chemical structure of which is substantially similar to the chemical structure of a controlled substance in Schedule I or II and either (i) which has a stimulant, depressant, or hallucinogenic effect on the central nervous system that is substantially similar to or greater than the stimulant, depressant, or hallucinogenic effect on the central nervous system of a controlled substance in Schedule I or II or (ii) with respect to a particular person, which such person represents or intends to have a stimulant, depressant, or hallucinogenic effect on the central nervous system that is substantially similar to or greater than the stimulant, depressant, or hallucinogenic effect on the central nervous system of a controlled substance in Schedule I or II. "Controlled substance analog" does not include (a) any substance for which there is an approved new drug application as defined under §505 of the federal Food, Drug, and Cosmetic Act (21 U.S.C. §355) or that is generally recognized as safe and effective pursuant to §§501, 502, and 503 of the federal Food, Drug, and Cosmetic Act (21 U.S.C. §§351, 352, and 353) and 21 C.F.R. Part 330; (b) with respect to a particular person, any substance for which an exemption is in effect for investigational use for that person under §505 of the federal Food, Drug, and Cosmetic Act to the extent that the conduct with respect to that substance is pursuant to such exemption; or (c) any substance to the extent not intended for human consumption before such an exemption takes effect with respect to that substance.
"DEA" means the Drug Enforcement Administration, U.S. 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, including delivery of a Schedule VI prescription device to an ultimate user or consumer on behalf of a medical equipment supplier by a manufacturer, nonresident manufacturer, wholesale distributor, nonresident wholesale distributor, warehouser, nonresident warehouser, third-party logistics provider, or nonresident third-party logistics provider at the direction of a medical equipment supplier in accordance with §54.1-3415.1.
"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 care technician" or "dialysis patient care technician" means an individual who is certified by an organization approved by the Board of Health Professions pursuant to Chapter 27.01 (§ 54.1-2729.1 et seq.) and who, under the supervision of a licensed physician, an advanced practice registered nurse, a physician assistant, or a registered nurse, assists in the care of patients undergoing renal dialysis treatments in a Medicare-certified renal dialysis facility.
"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. However, "dispensing
shall" does not include the transportation of drugs mixed,
diluted, or reconstituted in accordance with this chapter to other sites
operated by such practitioner or that practitioner's medical practice for the
purpose of administration of such drugs to patients of the practitioner or that
practitioner's medical practice at such other sites. For practitioners of
medicine or osteopathy, "dispense" shall includes only
include the provision of drugs by a practitioner to patients to take with
them away from the practitioner's place of practice.
"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; (iv) articles or substances intended for use as a component of any article specified in clause (i), (ii), or (iii); or (v) a biological product. "Drug" does not include devices or their components, parts, or accessories.
"Drug product" means a specific drug in dosage form from a known source of manufacture, whether by brand or therapeutically equivalent drug product name.
"Electronic prescription" means a written prescription that is generated on an electronic application and is transmitted to a pharmacy as an electronic data file; Schedule II through V prescriptions shall be transmitted in accordance with 21 C.F.R. Part 1300.
"Facsimile (FAX) prescription" means a written prescription or order that is transmitted by an electronic device over telephone lines that sends the exact image to the receiving pharmacy in hard copy form.
"FDA" means the U.S. Food and Drug Administration.
"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.
"Interchangeable" means a biosimilar that meets safety standards for determining interchangeability pursuant to 42 U.S.C. § 262(k)(4).
"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, 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
"Manufacture" does not include compounding.
"Manufacturer" means every person who manufactures, a manufacturer's co-licensed partner, or a repackager.
"Marijuana" means any part of a plant of the genus Cannabis whether growing or not, its seeds, or its resin; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds, its resin, or any extract containing one or more cannabinoids. "Marijuana" does not include (i) the mature stalks of such plant, fiber produced from such stalk, or oil or cake made from the seeds of such plant, unless such stalks, fiber, oil, or cake is combined with other parts of plants of the genus Cannabis; (ii) industrial hemp, as defined in §3.2-4112, that is possessed by a person registered pursuant to subsection A of §3.2-4115 or his agent; (iii) industrial hemp, as defined in §3.2-4112, that is possessed by a person who holds a hemp producer license issued by the U.S. Department of Agriculture pursuant to 7 C.F.R. Part 990; (iv) a hemp product, as defined in §3.2-4112; (v) an industrial hemp extract, as defined in § 3.2-5145.1; or (vi) any substance containing a tetrahydrocannabinol isomer, ester, ether, salt, or salts of such isomer, ester, or ether that has been placed by the Board of Pharmacy into one of the schedules set forth in the Drug Control Act (§54.1-3400 et seq.) pursuant to §54.1-3443.
"Medical equipment supplier" means any person, as defined in §1-230, 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 that are used for the operation and cleaning of medical equipment, solutions for peritoneal dialysis, and sterile water or saline for irrigation.
"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; or (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.
"Nuclear medicine technologist" means an individual who holds a current certification with the American Registry of Radiological Technologists or the Nuclear Medicine Technology Certification Board.
"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 U.S. 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 "Opiate" does not include, unless
specifically designated as controlled under Article 4 (§54.1-3437 et seq.),
the dextrorotatory isomer of 3-methoxy-n-methylmorphinan and its salts
(dextromethorphan). It "Opiate" 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.
"Outsourcing facility" means a facility that is engaged in the compounding of sterile drugs and is currently registered as an outsourcing facility with the U.S. Secretary of Health and Human Services and that complies with all applicable requirements of federal and state law, including the Federal Food, Drug, and Cosmetic Act.
"Person" means both the plural and singular, as the case demands, and includes an individual, partnership, corporation, association, governmental agency, trust, or other institution or entity.
"Pharmacist-in-charge" means the person who, being licensed as a pharmacist, signs the application for a pharmacy permit and assumes full legal responsibility for the operation of the relevant pharmacy in a manner complying with the laws and regulations for the practice of pharmacy and the sale and dispensing of controlled substances; the "pharmacist-in-charge" shall personally supervise the pharmacy and the pharmacy's personnel as required by §54.1-3432.
"Poppy straw" means all parts, except the seeds, of the opium poppy, after mowing.
"Practitioner" means a physician, dentist, licensed advanced practice registered nurse 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, 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 the 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 (21 U.S.C. §353(b)).
"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
"proprietary medicine" does not include a drug that is only
advertised or promoted professionally to licensed practitioners, a narcotic or
drug containing a narcotic, a drug that 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.
"Radiopharmaceutical" means any drug that exhibits
spontaneous disintegration of unstable nuclei with the emission of nuclear
particles or photons and includes any non-radioactive reagent kit or
radionuclide generator that is intended to be used in the preparation of any
such substance, but does not include drugs such as carbon-containing compounds
or potassium-containing salts that include trace quantities of naturally
occurring radionuclides. The term "Radiopharmaceutical"
also includes any biological product that is labeled with a radionuclide or
intended solely to be labeled with a radionuclide.
"Reference biological product" means the single biological product licensed pursuant to 42 U.S.C. §262(a) against which a biological product is evaluated in an application submitted to the U.S. Food and Drug Administration for licensure of biological products as biosimilar or interchangeable pursuant to 42 U.S.C. §262(k).
"Remote dispensing system" means a profile-driven automated drug dispensing system that performs operations or activities relative to the storage, packaging, labeling, or dispensing of medications employing bidirectional audio-visual technology to facilitate pharmacist communication with a patient, authorized agent of the patient, or person licensed to administer drugs, and collects, controls, and maintains all information online. Drugs intended to be administered by the patient or a person not licensed to administer drugs must fully comply with the labeling requirements in §§54.1-3410 and 54.1-3463 and Board regulations. Directions for use may only be abbreviated when drugs are administered exclusively by persons licensed to administer drugs.
"Sale" includes barter, exchange, or gift, or offer therefor, and each such transaction made by any person, whether as an individual, proprietor, agent, servant, or employee.
"Tetrahydrocannabinol" means any naturally occurring or synthetic tetrahydrocannabinol, 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 and any preparation, mixture, or substance containing, or mixed or infused with, any detectable amount of tetrahydrocannabinol. For the purposes of this definition, "isomer" means the optical, position, and geometric isomers.
"Therapeutically equivalent drug products" means drug products that contain the same active ingredients and are identical in strength or concentration, dosage form, and route of administration and that are classified as being therapeutically equivalent by the U.S. Food and Drug Administration pursuant to the definition of "therapeutically equivalent drug products" set forth in the most recent edition of the Approved Drug Products with Therapeutic Equivalence Evaluations, otherwise known as the "Orange Book."
"Third-party logistics provider" means a person that provides or coordinates warehousing of or other logistics services for a drug or device in interstate commerce on behalf of a manufacturer, wholesale distributor, or dispenser of the drug or device but does not take ownership of the product or have responsibility for directing the sale or disposition of the product.
"Total tetrahydrocannabinol" means the sum, after the application of any necessary conversion factor, of the percentage by weight of tetrahydrocannabinol and the percentage by weight of tetrahydrocannabinolic acid.
"USP-NF" means the current edition of the United States Pharmacopeia-National Formulary.
"Warehouser" means any person, other than a wholesale distributor, manufacturer, or third-party logistics provider, engaged in the business of (i) selling or otherwise distributing prescription drugs or devices to any person who is not the ultimate user or consumer and (ii) delivering Schedule VI prescription devices to the ultimate user or consumer pursuant to §54.1-3415.1. No person shall be subject to any state or local tax by reason of this definition.
"Wholesale distribution" means (i) distribution of prescription drugs to persons other than consumers or patients and (ii) delivery of Schedule VI prescription devices to the ultimate user or consumer pursuant to §54.1-3415.1, subject to the exemptions set forth in the federal Drug Supply Chain Security Act.
"Wholesale distributor" means any person other than a manufacturer, a manufacturer's co-licensed partner, a third-party logistics provider, or a repackager that engages in wholesale distribution.
The words "drugs" and "devices" as used in
Chapter 33 (§54.1-3300 et seq.) and in this chapter shall do 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
have the same meanings as provided in Chapter 33 (§54.1-3300 et seq.)
unless the context requires a different meaning.
§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 or laboratory analysis with controlled substances in Schedules II through VI or marijuana. Practitioners registered under federal law to conduct research with Schedule I substances, other than marijuana, may conduct research with Schedule I controlled substances within the Commonwealth upon furnishing the evidence of that federal registration.
D. The Board may register other persons or entities to possess controlled substances listed on Schedules II through VI upon a determination that (i) there is a documented need, (ii) the issuance of the registration is consistent with the public interest, (iii) the possession and subsequent use of the controlled substances complies with applicable state and federal laws and regulations, and (iv) the subsequent storage, use, and recordkeeping of the controlled substances will be under the general supervision of a licensed pharmacist, practitioner of medicine, osteopathy, podiatry, dentistry, or veterinary medicine as specified in the Board's regulations. The Board shall consider, at a minimum, the factors listed in subsection A in determining whether the registration shall be issued. Notwithstanding the exceptions listed in § 54.1-3422 A, the Board may mandate a controlled substances registration for sites maintaining certain types and quantities of Schedules II through VI controlled substances as it may specify in its regulations. The Board shall promulgate regulations related to requirements or criteria for the issuance of such controlled substances registration, storage, security, supervision, and recordkeeping.
E. The Board may register a public or private animal shelter as defined in §3.2-6500 to purchase, possess, and administer certain Schedule II through VI controlled substances approved by the State Veterinarian for the purpose of euthanizing injured, sick, homeless, and unwanted domestic pets and animals and to purchase, possess, and administer certain Schedule VI drugs and biological products for the purpose of preventing, controlling, and treating certain communicable diseases that failure to control would result in transmission to the animal population in the shelter. Controlled substances used for euthanasia shall be administered only in accordance with protocols established by the State Veterinarian and only by persons trained in accordance with instructions by the State Veterinarian. The list of Schedule VI drugs and biological products used for treatment and prevention of communicable diseases within the shelter shall be determined by the supervising veterinarian of the shelter and the drugs and biological products shall be administered only pursuant to written protocols established or approved by the supervising veterinarian of the shelter and only by persons who have been trained in accordance with instructions established or approved by the supervising veterinarian. The shelter shall maintain a copy of the approved list of drugs and biological products, written protocols for administering, and training records of those persons administering drugs and biological products on the premises of the shelter.
F. The Board may register a facility, as defined in §
37.2-100, that provides crisis stabilization unit established pursuant
to §37.2-500 or 37.2-601 services and is licensed by the
Department of Behavioral Health and Developmental Services to. Such
facility may maintain a stock of Schedule Schedules II through
VI controlled substances necessary for immediate treatment of patients admitted
to the crisis stabilization unit such facility, which may be
accessed and administered by a nurse person licensed to administer
drugs pursuant to a written or oral order of a prescriber in the absence of
a prescriber. Schedule II through Schedule V controlled substances shall
only be maintained if so authorized by federal law and Board regulations.
G. The Board may register an entity at which a patient is
treated by the use of instrumentation and diagnostic equipment through which
images and medical records may be transmitted electronically for the purpose of
establishing a bona fide practitioner-patient relationship and is prescribed
Schedule Schedules II through VI controlled substances when such
prescribing is in compliance with federal requirements for the practice of
telemedicine and the patient is not in the physical presence of a practitioner
registered with the U.S. Drug Enforcement Administration. In determining
whether the registration shall be issued, the Board shall consider (i) the
factors listed in subsection A, (ii) whether there is a documented need for
such registration, and (iii) whether the issuance of the registration is
consistent with the public interest.
H. 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.
I. Upon (i) any change in ownership or control of a business, (ii) any change of location of the controlled substances stock, (iii) the termination of authority by or of the person named as the responsible party on a controlled substances registration, or (iv) a change in the supervising practitioner, if applicable, the registrant or responsible party shall immediately surrender the registration. The registrant shall, within 14 days following surrender of a registration, file a new application and, if applicable, name the new responsible party or supervising practitioner.
§54.1-3434.02. Automated drug dispensing systems and remote dispensing systems.
A. Hospitals or nursing homes licensed pursuant to
Title 32.1 or, state facilities as defined in §37.2-100 established
pursuant to Title 37.2, facilities as defined in §37.2-100 that are
licensed by the Department of Behavioral Health and Developmental Services and
provide site-based crisis stabilization services, or other facilities
authorized by the Board may use automated drug dispensing systems and
remote dispensing systems, as defined in §54.1-3401, upon meeting the
following conditions:
1. Drugs are placed in the automated drug dispensing system
or remote dispensing system in a such hospital, nursing
home, or facility and are under the control of a pharmacy providing
services to the hospital, nursing home, or facility;
2. The pharmacist-in-charge of the pharmacy providing services
to the hospital, nursing home, or facility has established procedures
for assuring ensuring the accurate stocking and proper storage of
drugs in the automated drug dispensing system or remote dispensing system
and for ensuring accountability for and security of all drugs utilized in
the automated drug dispensing such system until the time such drugs
are removed from the automated drug dispensing such system for
administration to the patients;
3. Removal of drugs from any automated drug dispensing system or remote dispensing system for administration to patients can only be made pursuant to a valid prescription or lawful order of a prescriber;
4. Adequate security for automated drug dispensing systems
or remote dispensing systems is provided, as evidenced by written policies
and procedures, for (i) preventing unauthorized access, (ii) complying with
federal and state regulations on prescribing and dispensing controlled
substances, (iii) maintaining patient confidentiality, and (iv) assuring
ensuring compliance with the requirements of this section;
5. Accountability for drugs dispensed from automated drug
dispensing systems or remote dispensing systems is vested in the
pharmacist-in-charge of a pharmacy located within the hospital, nursing
home, or facility or the pharmacist-in-charge of any the
outside pharmacy providing pharmacy services to the hospital, nursing home,
or facility;
6. Filling and stocking of all drugs in automated drug
dispensing systems or remote dispensing systems shall be performed under
the direction of the pharmacist-in-charge. The task of filling and stocking of
drugs into an automated drug dispensing such system shall be
performed by a pharmacist or a registered pharmacy technician, who shall be an
employee of the provider pharmacy and shall be properly trained in accordance
with established standards set forth in a policy and procedure manual
maintained by the provider pharmacy. The pharmacist stocking and filling the
automated drug dispensing such system or the pharmacist-in-charge,
if the automated drug dispensing such system is stocked and
filled by a registered pharmacy technician, shall be responsible for the proper
and accurate stocking and filling of the automated drug dispensing system or
remote dispensing system; and
7. Except when the automated drug dispensing system is used exclusively for administration of drugs for emergencies, a pharmacy located outside of the hospital, nursing home, or facility it services according to this subsection shall first obtain a controlled substances registration issued in the name of the pharmacy at the address of the hospital, nursing home, or facility and a registration from the Drug Enforcement Administration, if required, prior to stocking controlled substances in Schedules II through VI.
B. Drugs Except as authorized by the Board, drugs
placed into and removed from automated drug dispensing systems or remote
dispensing systems for administration to patients shall be in the
manufacturer's or distributor's sealed original packaging or in unit-dose
containers packaged by the pharmacy. Drugs in multi-dose packaging, other
than those administered orally, or in a liquid, injectable, or inhaled
formulation may be placed in such a device if approved by the
pharmacist-in-charge in consultation with a standing hospital committee
comprised of pharmacy, medical, and nursing staff of the hospital,
nursing home, or facility.
C. The pharmacist-in-charge in a pharmacy located within a
hospital, nursing home, or facility or the pharmacist-in-charge of any
outside pharmacy providing pharmacy services to a hospital, nursing home, or
facility shall be responsible for establishing procedures for (i)
periodically inspecting and auditing automated drug dispensing systems and
remote dispensing systems to assure ensure the proper
storage, security, and accountability for all drugs placed in and removed from
automated drug dispensing systems and remote dispensing systems, and
(ii) reviewing the operation and maintenance of automated drug dispensing
systems and remote dispensing systems. This For hospitals with
a pharmacy located within the hospital, monitoring shall be reviewed by a
pharmacist while on the premises of the hospital and in accordance with the
pharmacist-in-charge's procedures and the Board of Pharmacy's regulations.
D. The Board of Pharmacy shall promulgate regulations
establishing minimum requirements for random periodic inspections and monthly
audits of automated drug dispensing systems and remote dispensing systems
to assure ensure the proper storage, security, and accountability
of all drugs placed in and removed from automated drug dispensing
such systems and for reviewing the operation and maintenance of
automated drug dispensing such systems.
E. Notwithstanding this section, the Board shall promulgate regulations for the use of a remote dispensing system to store drugs previously dispensed and labeled by the provider pharmacy in compliance with current laws and regulations. Such regulations shall identify the location where such system may be placed and requirements to ensure the security of the drug, confidentiality of protected health information, and appropriate recordkeeping.
2. That an emergency exists and this act is in force from its passage.
3. That the Board of Pharmacy shall promulgate regulations to implement the provisions of this act to be effective within 280 days of its enactment.
