reglab/statecodes huggingface dataset:
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3415.1. Delivery of medical devices on behalf of a medical equipment supplier

A. A permitted manufacturer, wholesale distributor, warehouser, nonresident warehouser, third-party logistics provider, or nonresident third-party logistics provider or registered nonresident manufacturer or nonresident wholesale distributor may deliver Schedule VI prescription devices directly to an ultimate user or consumer on behalf of a medical equipment supplier, provided that (i) such delivery occurs at the direction of a medical equipment supplier that has received a valid order from a prescriber authorizing the dispensing of such prescription device to the ultimate user or consumer and (ii) the manufacturer, nonresident manufacturer, wholesale distributor, nonresident wholesale distributor, warehouser, nonresident warehouser, third-party logistics provider, or nonresident third-party logistics provider has entered into an agreement with the medical equipment supplier for such delivery.
B. A permitted manufacturer, wholesale distributor, warehouser, nonresident warehouser, third-party logistics provider, or nonresident third-party logistics provider, or registered nonresident manufacturer or nonresident wholesale distributor may deliver Schedule VI prescription devices directly to an ultimate user's or consumer's residence to be administered by persons authorized to administer such devices, provided that (i) such delivery is made on behalf of a medical director of a home health agency, nursing home, assisted living facility, or hospice who has requested the distribution of the Schedule VI prescription device and directs the delivery of such device to the ultimate user's or consumer's residence and (ii) the medical director on whose behalf such Schedule VI prescription device is being delivered has entered into an agreement with the manufacturer, nonresident manufacturer, wholesale distributor, nonresident wholesale distributor, warehouser, nonresident warehouser, third-party logistics provider, or nonresident third-party logistics provider for such delivery.
2018, cc. 241, 242.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 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.
1970, c. 650, § 54-524.75; 1972, c. 798; 1988, c. 765.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 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.
1970, c. 650, § 54-524.61; 1976, c. 406; 1988, c. 765.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 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.
Code 1950, § 54-496; 1956, c. 225; 1970, c. 650, § 54-524.62; 1988, c. 765.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 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.
1984, c. 724, § 54-524.58:2; 1988, c. 765.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3420.1. Identification required for filling prescriptions

A. Before dispensing any drug listed on Schedules III through V, a pharmacist may require proof of identity from any patient presenting a prescription or requesting a refill of a prescription.
B. A pharmacist, or his agent, shall require proof of identity at the time of delivery from any person seeking to take delivery of any drug listed on Schedule II pursuant to a valid prescription, unless such person is known to the pharmacist or to his agent. If the person seeking to take delivery of a drug listed on Schedule II pursuant to a valid prescription is not the patient for whom the drug is prescribed, and the person is not known to the pharmacist or his agent, the pharmacist or his agent shall either make a photocopy or electronic copy of such person's identification or record the full name and address of such person. The pharmacist shall keep records of the names and addresses or copies of proof of identity of persons taking delivery of drugs as required by this subsection for a period of at least one month. For the purposes of this subsection, "proof of identity" means a driver's license, government-issued identification card, or other photo identification along with documentation of the person's current address.
C. Whenever any pharmacist permitted to operate in the Commonwealth or nonresident pharmacist registered to conduct business in the Commonwealth delivers a prescription drug order for any drug listed on Schedule II by mail, common carrier, or delivery service to a Virginia address, the method of delivery employed shall require the signature of the recipient as confirmation of receipt.
1988, c. 400, § 54-524.67:4; 2010, c. 193; 2011, cc. 262, 318.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3420.3. Prohibition on refusing to fill prescription from telemedicine provider

A. A pharmacy shall not implement or enforce a policy that prevents a pharmacist from dispensing a prescription solely on the basis of the prescriber's use of a telemedicine platform to provide services.
B. A pharmacist shall not prioritize dispensing a prescription from a prescriber who does not use telemedicine over dispensing a prescription from a prescriber who does use telemedicine solely on the basis of the prescriber's use of a telemedicine platform to provide services.
2023, c. 368.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3421. New drugs

A. No person shall sell, deliver, offer for sale, hold for sale or give away any new drug unless an application with respect to the drug has been approved and the approval has not been withdrawn under § 505 of the federal Food, Drug, and Cosmetic Act (21 U.S.C. § 355).
B. This section shall not 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 with the U.S. Food and Drug Administration in accordance with 21 C.F.R. Part 312.
1970, c. 650, § 54-524.95; 1988, c. 765; 2000, c. 135.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3422. Controlled substances registration certificate required in addition to other requirements; exemptions

A. Every person who manufactures, distributes or dispenses any substance that 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, those persons who are licensed physician assistants, and those persons who are licensed practitioners of medicine, osteopathy, podiatry, dentistry, optometry, nursing, 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, perform laboratory analysis, 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 listed on Schedules I through VI:
1. An agent or employee of any holder of a controlled substance registration certificate or of any practitioner listed in subsection A of this section as exempt from the requirement for registration, if such agent or employee 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.
1972, c. 798, § 54-524.47:2; 1988, c. 765; 1996, cc. 408, 468, 496; 1998, c. 490; 2001, cc. 243, 465; 2020, c. 941.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 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 (15 U.S.C. § 1471 et seq.). 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.
1978, c. 833, § 54-524.67:1; 1988, c. 765; 1996, c. 408.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 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.
1978, c. 839, § 54-524.67:2; 1988, c. 765.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 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.
1970, c. 650, § 54-524.100; 1988, c. 765.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 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.
1970, c. 650, § 54-524.46; 1988, c. 765.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 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.
Code 1950, §§ 54-449, 54-450; 1970, c. 650, § 54-524.38; 1976, c. 614, § 54-524.39; 1988, c. 765.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 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 Department of Forensic Science or authorized by such Department 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.
Code 1950, § 54-524.77; 1970, c. 650; 1972, cc. 741, 798, § 54-524.77:1; 1973, c. 479; 1977, c. 633; 1988, c. 765; 1990, c. 825; 2005, cc. 868, 881.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3432. Supervision by pharmacist

Every pharmacy shall be under the personal supervision of a pharmacist on the premises of the pharmacy.
Code 1950, § 54-478; 1958, c. 551; 1970, c. 650, § 54-524.51; 1988, c. 765.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 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. Upon consultation with the Department of Historic Resources, the Board may grant an exception from this section for such signage on an historic building that formerly housed a drugstore or pharmacy if that building is individually listed as a Virginia Historic Landmark, a contributing property in a Virginia Historic Landmark District, or determined to be eligible for listing by the Department of Historic Resources, provided that the signage relates to the historic character of the building.
Code 1950, § 54-477; 1970, c. 650, § 54-524.49; 1988, c. 765; 2005, c. 97.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3434.01. Notice of pharmacy closing; change of ownership; penalty

A. Prior to the closing of a pharmacy for more than one week, the owner shall either (i) post a conspicuous notice at least thirty days prior to the anticipated closing or (ii) mail a notice, at least fourteen 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 and other required prescription dispensing records and individual patient records will be transferred unless patients indicate their preference to the contrary. The Board of Pharmacy shall promulgate regulations providing for a definition of "closing of a pharmacy" and exceptions to the requirements of this section.
B. Upon any change of ownership of a pharmacy, regardless of how such change may be effectuated, the prescription dispensing records and other patient records for at least two years immediately prior to the change of ownership, shall be transferred, in accordance with Board regulations, to the new owner in a manner to ensure the confidentiality, integrity, and security of the pharmacy's prescription dispensing records and other patient records and the continuity of pharmacy services at substantially the same level as that offered by the previous owner.
Refusing to process a request for the prescription dispensing records and other patient records tendered in accordance with law or regulation shall constitute a closing and the requirements of this section shall apply. Such refusal may constitute a violation of § 54.1-111 A 9, depending on the circumstance.
1992, c. 667; 1994, c. 668; 1998, c. 470.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3434.03. Continuous quality improvement program

Each pharmacy shall implement a program for continuous quality improvement, according to regulations of the Board. Such program shall provide for a systematic, ongoing process of analysis of dispensing errors that uses findings to formulate an appropriate response and to develop or improve pharmacy systems and workflow processes designed to prevent or reduce future errors. The Board shall promulgate regulations to further define the required elements of such program.
Any pharmacy that actively reports to a patient safety organization that has as its primary mission continuous quality improvement under the Patient Safety and Quality Improvement Act of 2005 (P.L. 109-41), shall be deemed in compliance with this section.
2011, c. 124.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3434.04. Automatic review of certain case decisions

The Board of Pharmacy shall, in cases in which a monetary fine may be imposed for a violation of the provisions of Article 2 (§ 54.1-3432 et seq.) of the Drug Control Act relating to the practice of pharmacy and the pharmacy subject to the fine is affiliated with a free clinic that receives state or local funds, ascertain the factual basis for its decisions of such cases through informal conference or consultation proceedings in accordance with § 2.2-4019, unless the named party and the Board agree to resolve the matter through a consent order or the named party consents to waive such a conference or proceeding to go directly to a formal hearing.
2014, c. 345.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3434.05. Permit to act as an outsourcing facility

A. No person shall act as an outsourcing facility without first obtaining a permit from the Board.
B. Applications for a permit to act as an outsourcing facility 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 outsourcing facility and who will be fully engaged in the compounding performed at the location designated on the application. Such application shall be accompanied by a fee determined by the Board in regulation. All permits shall expire annually on a date determined by the Board in regulation. No permit shall be issued or renewed for an outsourcing facility unless the facility can demonstrate compliance with all applicable federal and state laws and regulations governing outsourcing facilities.
C. As a prerequisite to obtaining or renewing a permit from the Board, the outsourcing facility shall (i) register as an outsourcing facility with the U.S. Secretary of Health and Human Services in accordance with 21 U.S.C. § 353b and (ii) submit a copy of a current inspection report resulting from an inspection conducted by the U.S. Food and Drug Administration that indicates compliance with the requirements of state and federal law and regulations, including all applicable guidance documents and Current Good Manufacturing Practices published by the U.S. Food and Drug Administration.
The inspection report required pursuant to clause (ii) shall be deemed current for the purposes of this section if the inspection was conducted (a) no more than one year prior to the date of submission of an application for a permit to the Board or (b) no more than two years prior to the date of submission of an application for renewal of a permit to the Board. However, if the outsourcing facility has not been inspected by the U.S. Food and Drug Administration within the required period, the Board may accept an inspection report or other documentation from another entity that is satisfactory to the Board, or the Board may cause an inspection to be conducted by its duly authorized agent and may charge an inspection fee in an amount sufficient to cover the costs of the inspection.
D. Every outsourcing facility shall compound in compliance with the requirements of state and federal law and regulations except § 54.1-3410.2, to include all applicable guidance documents and Current Good Manufacturing Practices published by the U.S. Food and Drug Administration.
E. An outsourcing facility shall not engage in compounding of drug products to be dispensed pursuant to a valid prescription for a specific patient without first obtaining a permit to operate a pharmacy.
2015, c. 300.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3434.2. Permit to be issued

The Board shall only register nonresident pharmacies that maintain a current unrestricted license, certificate, permit, or registration as a pharmacy in a jurisdiction within the United States, or within another jurisdiction that may lawfully deliver prescription drugs directly or indirectly to consumers within the United States.
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 a date determined by the Board in regulation. Renewal is contingent upon the nonresident pharmacy providing documentation of a current inspection report in accordance with subdivision A 3 of § 54.1-3434.1; continuing current, unrestricted licensure in the resident jurisdiction; and continuing certification if required in subdivision A 4 of § 54.1-3434.1.
1990, c. 270; 2005, c. 115; 2008, cc. 79, 320, 618; 2013, c. 765.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3434.4. Prohibited acts

A. It is unlawful for any person or entity which is not registered under this article to (i) conduct the business of shipping, mailing, or otherwise delivering Schedule II through VI controlled substances into Virginia or (ii) advertise the availability for purchase of any Schedule II through VI controlled substances by any citizen of the Commonwealth. Further, it shall be unlawful for any person who is a resident of Virginia to advertise the pharmacy services of a nonresident pharmacy or compounding services of an outsourcing facility that 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 or outsourcing facility to obtain controlled substances.
B. Any controlled substance that is ordered or shipped in violation of any provision of this chapter, shall be considered as contraband and may be seized by any law-enforcement officer or any agent of the Board of Pharmacy.
1990, c. 270; 2005, c. 115; 2008, cc. 79, 618; 2015, c. 300.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3434.5. Nonresident outsourcing facilities to register with the Board

A. Any outsourcing facility located outside the Commonwealth that ships, mails, or delivers in any manner Schedule II through VI drugs or devices into the Commonwealth shall be considered a nonresident outsourcing facility and shall be registered with the Board.
B. Applications for registration to act as a non-resident outsourcing facility shall be made on a form provided by the Board and signed by a pharmacist who is licensed as a pharmacist in Virginia and who is in full and actual charge of the outsourcing facility, is fully engaged in the compounding performed at the location stated on the application, and is fully responsible for the outsourcing facility's compliance with state and federal law and regulations. Such application shall be accompanied by a fee determined by the Board in regulation. All registrations shall expire annually on a date determined by the Board in regulation.
C. As a prerequisite to registering or renewing a registration with the Board, the outsourcing facility shall (i) register as an outsourcing facility with the U.S. Secretary of Health and Human Services in accordance with 21 U.S.C. § 353b and (ii) submit a copy of a current inspection report resulting from an inspection conducted by the U.S. Food and Drug Administration that indicates compliance with the requirements of state and federal law and regulations, including all applicable guidance documents and Current Good Manufacturing Practices published by the U.S. Food and Drug Administration.
The inspection report required pursuant to clause (ii) shall be deemed current for the purposes of this section if the inspection was conducted (a) no more than one year prior to the date of submission of an application for registration with the Board or (b) no more than two years prior to the date of submission of an application for renewal of a registration with the Board. However, if the outsourcing facility has not been inspected by the U.S. Food and Drug Administration within the required period, the Board may accept an inspection report or other documentation from another entity that is satisfactory to the Board, or the Board may cause an inspection to be conducted by its duly authorized agent and may charge an inspection fee in an amount sufficient to cover the costs of the inspection.
D. A nonresident outsourcing facility shall not engage in compounding of drug products to be dispensed pursuant to a valid prescription for a specific patient without first obtaining a registration to operate a nonresident pharmacy. The nonresident pharmacy shall comply with all state and federal laws, regulations, and requirements except § 54.1-3410.2.
2015, c. 300.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3435. License to act as wholesale distributor; renewal; fee

A. It shall be unlawful for any person to engage in the wholesale distribution of prescription drugs in the 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 the 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 a date determined by the Board in regulation; notify the Board within 30 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.
B. A wholesale distributor that ceases distribution of Schedule II through V drugs to a pharmacy, licensed physician dispenser, or licensed physician dispensing facility located in the Commonwealth due to suspicious orders of controlled substances shall notify the Board within five days of the cessation. For the purposes of this section, "suspicious orders of controlled substances" means, relative to the pharmacy's, licensed physician dispenser's, or licensed physician dispensing facility's order history and the order history of similarly situated pharmacies, licensed physician dispensers, or licensed physician dispensing facilities, (i) orders of unusual size, (ii) orders deviating substantially from a normal pattern, and (iii) orders of unusual frequency.
C. A wholesale distributor shall be immune from civil liability for giving notice in accordance with subsection B unless the notice was given in bad faith or with malicious intent.
D. The Board shall not impose any disciplinary or enforcement action against any licensee or permit holder solely on the basis of a notice received from a wholesale distributor pursuant to subsection B.
E. 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.
F. Every wholesale distributor shall comply with federal requirements for an electronic, interoperable system to identify, trace, and verify prescription drugs as they are distributed.
1970, c. 650, § 54-524.44; 1976, c. 614; 1980, c. 288; 1988, c. 765; 1992, c. 737; 2008, c. 320; 2015, c. 299; 2016, c. 221.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3435.01. Registration of nonresident wholesale distributors; renewal; fee

A. Any person located outside the Commonwealth who engages in the wholesale distribution of prescription drugs into the 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 a date determined by the Board in regulation; notify the Board within 30 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 the 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 State Police upon request within seven days of receipt of such request.
D. A nonresident wholesale distributor that ceases distribution of Schedule II through V drugs to a pharmacy, licensed physician dispenser, or licensed physician dispensing facility located in the Commonwealth due to suspicious orders of controlled substances shall notify the Board within five days of the cessation. For the purposes of this section, "suspicious orders of controlled substances" means, relative to the pharmacy's, licensed physician dispenser's, or licensed physician dispensing facility's order history and the order history of similarly situated pharmacies, licensed physician dispensers, or licensed physician dispensing facilities, (i) orders of unusual size, (ii) orders deviating substantially from a normal pattern, and (iii) orders of unusual frequency.
E. A nonresident wholesale distributor shall be immune from civil liability for giving notice in accordance with subsection D unless the notice was given in bad faith or with malicious intent.
F. The Board shall not impose any disciplinary or enforcement action against any licensee or permit holder solely on the basis of a notice received from a nonresident wholesale distributor pursuant to subsection D.
G. This section shall not apply to persons who distribute prescription drugs directly to a licensed wholesale distributor located within the Commonwealth.
H. Every nonresident wholesale distributor shall comply with federal requirements for an electronic, interoperable system to identify, trace, and verify prescription drugs as they are distributed.
1994, c. 300; 2008, c. 320; 2015, c. 299; 2016, c. 221.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3435.02. Certain permitted pharmacies and medical equipment suppliers exempted

A. A permitted pharmacy may engage in wholesale distributions of small quantities of prescription drugs without being licensed as wholesale distributors when such wholesale distributions are in compliance with federal law as follows: such wholesale distributions of controlled substances do not exceed five percent of the gross annual sales of prescription drugs by the relevant permitted pharmacy or such wholesale distributions of Schedules II through V controlled substances do not exceed five percent of the total dosage units of the Schedule II through V controlled substances dispensed annually by the relevant permitted pharmacy.
B. A permitted medical equipment supplier may engage in wholesale distributions of small quantities of oxygen without being licensed as a wholesale distributor when such wholesale distributions are in compliance with federal law and such distributions do not exceed five percent of the gross annual sales of oxygen by the relevant permitted medical equipment supplier.
2003, c. 509; 2004, c. 854.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3435.1. Denial, revocation, and suspension of license, permit, or registration of certain entities

A. The Board may deny, revoke, suspend, or take other disciplinary actions against a wholesale distributor license, nonresident wholesale distributor registration, third-party logistics provider permit, nonresident third-party logistics provider registration, manufacturer permit, nonresident manufacturer permit, or nonresident warehouser registration as provided for in § 54.1-3316 or the following:
1. Any conviction of the applicant, licensee, or registrant under federal or state laws relating to controlled substances, including, but not limited to, drug samples and wholesale or retail prescription drug distribution;
2. Violations of licensing requirements under previously held licenses;
3. 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; or
4. 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 Drug Supply Chain Security Act of 2013, Title II of P. L. 113-54, and the requirements of Chapter 21 of the Code of Federal Regulations.
B. Wholesale drug distributors, nonresident wholesale drug distributors, third-party logistics providers, nonresident third-party logistics providers, manufacturers, nonresident manufacturers, and nonresident 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 wholesale drug distributors' premises and delivery vehicles.
1992, c. 737; 1994, c. 300; 2007, c. 662; 2016, c. 221; 2018, c. 96.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 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 a date determined by the Board in regulation; 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, solutions for peritoneal dialysis, and sterile water and saline for irrigation.
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.
1992, c. 737; 1996, c. 408; 1997, c. 677; 2008, c. 320; 2013, c. 504.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3435.3. Inspection and audit

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.
1992, c. 737; 2007, c. 662.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3435.3:1. Registration of nonresident medical equipment suppliers; renewal; fee

A. Any person located outside the Commonwealth other than a nonresident pharmacy registered pursuant to § 54.1-3434.1 that ships, mails, or delivers to a consumer in the Commonwealth any hypodermic syringes or needles, medicinal oxygen, Schedule VI controlled device, those Schedule VI controlled substances with no medicinal properties that are used for the operation and cleaning of medical equipment, sterile water and saline for irrigation, or solutions for peritoneal dialysis pursuant to a lawful order of a prescriber shall be registered with the Board as a nonresident medical equipment supplier. Registration as a nonresident medical equipment supplier shall be renewed by March 1 of each year. Applicants for registration or renewal of a registration shall submit a fee specified by the Board in regulations at the time of registration or renewal. A nonresident medical equipment supplier registered in accordance with this section shall notify the Board within 30 days of any substantive change in the information previously submitted to the Board.
B. The nonresident medical equipment supplier shall at all times maintain a valid, unexpired license, permit, or registration in the state in which it is located, if required by the resident state, and shall furnish proof of such license, permit, or registration upon application for registration or renewal. If the resident state does not require a license, permit, or registration to engage in direct consumer supply of the medical equipment described in subsection A, the applicant shall furnish proof that it meets the minimum statutory and regulatory requirements for medical equipment suppliers in the Commonwealth.
C. Records of distribution of medical equipment described in subsection A into the Commonwealth shall be maintained in such a manner that they are readily retrievable from records of distribution into other jurisdictions and shall be provided to the Board, its authorized agent, or any agent designated by the Superintendent of State Police upon request within seven days of receipt of such request.
2016, c. 88.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 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 a date determined by the Board in regulation; 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.
1992, c. 737; 2008, c. 320.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3435.4:01. Registration to act as a nonresident warehouser; regulations

A. Any warehouser located outside the Commonwealth that ships prescription drugs or devices into the Commonwealth shall be registered with the Board. Such nonresident warehouser shall renew such registration annually on a date determined by the Board and shall notify the Board within 30 days of any substantive change in the information previously submitted.
B. The Board may promulgate such regulations relating to the storage, handling, and distribution of prescription drugs and devices by nonresident warehousers as it deems necessary to implement this section, to prevent diversion of prescription drugs and devices, and to protect the public.
C. The nonresident warehouser shall at all times maintain a valid, unexpired license, permit, or registration in the state in which it is located that authorizes the possession and distribution of such prescription drugs and devices and shall furnish proof of such upon application and at each renewal.
D. Records of prescription drugs and devices distributed into the 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 State Police upon request within seven days of receipt of such request.
2018, c. 96.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3435.4:1. Permitting of third-party logistics provider; renewal

A. It shall be unlawful for any person to operate as a third-party logistics provider in the Commonwealth without a valid, unrevoked permit issued by the Board. The third-party logistics provider shall renew such permit annually on a date determined by the Board in regulation and shall notify the Board within 30 days of any substantive change in the information reported on the application form previously submitted.
B. The Board shall adopt such regulations relating to the requirements to operate as a third-party logistics provider, including the storage, handling, and distribution of prescription drugs by third-party logistics providers, as it deems necessary to prevent diversion of prescription drugs and to protect the public.
2016, c. 221.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3435.4:2. Registration of nonresident third-party logistics provider; renewal

A. Any third-party logistics provider located outside the Commonwealth that ships prescription drugs or devices into the Commonwealth shall be registered with the Board. Such nonresident third-party logistics provider shall renew such registration annually on a date determined by the Board and shall notify the Board within 30 days of any substantive change in the information previously submitted.
B. The Board may promulgate such regulations relating to the storage, handling, and distribution of prescription drugs and devices by nonresident third-party logistics providers as it deems necessary to implement this section, to prevent diversion of prescription drugs and devices, and to protect the public.
C. The nonresident third-party logistics provider shall at all times maintain a valid, unexpired license, permit, or registration in the state in which it is located or current licensure as a third-party logistics provider with the FDA and shall furnish proof of such upon application and at each renewal.
D. Records of prescription drugs and devices distributed into the 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 State Police upon request within seven days of receipt of such request.
2018, c. 96.