Code of Virginia

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Code of Virginia
Title 54.1. Professions and Occupations
Chapter 33. Pharmacy
6/15/2021

Article 2. Board of Pharmacy.

§ 54.1-3305. Board; membership; terms; meetings; quorum; officers.

The Board of Pharmacy shall consist of ten members, as follows: eight licensed pharmacists who are graduates of an approved school or college of pharmacy and two citizen members. The terms of office of the members shall be four years.

The Board shall meet at least annually at such times and places, and upon such notice as the Board may determine and as its business may require. A majority of the members of the Board shall constitute a quorum for the transaction of business.

The Board shall annually elect from its members a chairman.

There shall be an executive director for the Board of Pharmacy who shall be licensed or eligible for licensure in the Commonwealth as a pharmacist.

Code 1950, §§ 54-404, 54-405, 54-410, 54-412; 1958, c. 551; 1970, c. 650, §§ 54-524.5, 54-524.11; 1976, c. 614, § 54-524.13; 1986, c. 464, § 54-524.6; 1988, cc. 42, 765; 1994, c. 283; 2005, c. 70.

§ 54.1-3306. Nominations.

Nominations may be made for each professional vacancy from a list of at least three names submitted to the Governor by the Virginia Pharmaceutical Association. The Governor may notify the Association of any professional vacancy other than by expiration. In no case shall the Governor be bound to make any appointment from among the nominees of the Association.

Code 1950, § 54-406; 1958, c. 551; 1970, c. 650, § 54-524.7; 1986, c. 464; 1988, c. 765.

§ 54.1-3307. Specific powers and duties of Board.

A. The Board shall regulate the practice of pharmacy and the manufacturing, dispensing, selling, distributing, processing, compounding, or disposal of drugs and devices. The Board shall also control the character and standard of all drugs, cosmetics, and devices within the Commonwealth, investigate all complaints as to the quality and strength of all drugs, cosmetics, and devices, and take such action as may be necessary to prevent the manufacturing, dispensing, selling, distributing, processing, compounding, and disposal of such drugs, cosmetics, and devices that do not conform to the requirements of law.

The Board's regulations shall include criteria for:

1. Maintenance of the quality, quantity, integrity, safety, and efficacy of drugs or devices distributed, dispensed, or administered.

2. Compliance with the prescriber's instructions regarding the drug and its quantity, quality, and directions for use.

3. Controls and safeguards against diversion of drugs or devices.

4. Maintenance of the integrity of, and public confidence in, the profession and improving the delivery of quality pharmaceutical services to the citizens of Virginia.

5. Maintenance of complete records of the nature, quantity, or quality of drugs or substances distributed or dispensed and of all transactions involving controlled substances or drugs or devices so as to provide adequate information to the patient, the practitioner, or the Board.

6. Control of factors contributing to abuse of legitimately obtained drugs, devices, or controlled substances.

7. Promotion of scientific or technical advances in the practice of pharmacy and the manufacture and distribution of controlled drugs, devices, or substances.

8. Impact on costs to the public and within the health care industry through the modification of mandatory practices and procedures not essential to meeting the criteria set out in subdivisions 1 through 7.

9. Such other factors as may be relevant to, and consistent with, the public health and safety and the cost of rendering pharmacy services.

B. The Board may collect and examine specimens of drugs, devices, and cosmetics that are manufactured, distributed, stored, or dispensed in the Commonwealth.

C. The Board shall report annually by December 1 to the Chairmen of the Senate Committee on Education and Health and the House Committee on Health, Welfare and Institutions on (i) the number of outsourcing facilities permitted or registered by the Board that have entered into a contract with the Department of Corrections for the compounding of drugs necessary to carry out an execution by lethal injection pursuant to § 53.1-234 and (ii) the name of any such outsourcing facilities that received disciplinary action for a violation of law or regulation related to compounding.

Code 1950, §§ 54-415, 54-416.1; 1954, c. 396; 1958, c. 551, § 54-524.16; 1970, c. 650, § 54-524.18; 1972, c. 798; 1980, c. 288; 1988, c. 765; 1995, c. 529; 1996, cc. 37, 407; 2005, c. 777; 2006, c. 632; 2016, c. 221; 2020, c. 1166.

§ 54.1-3307.1. Repealed.

Repealed by Acts 1997, c. 206.

§ 54.1-3307.2. Approval of innovative programs.

A. Any person who proposes to use a process or procedure related to the dispensing of drugs or devices or to the practice of pharmacy not specifically authorized by Chapter 33 (§ 54.1-3300 et seq.) of this title or by a regulation of the Board of Pharmacy may apply to the Board for approval to use such process or procedure. The application under this section may only include new processes or procedures, within the current scope of the practice of pharmacy, that relate to the form or format of prescriptions, the manner of transmitting prescriptions or prescription information, the manner of required recordkeeping, the use of unlicensed ancillary personnel in the dispensing process, and the use of new technologies in the dispensing process. The authority granted the Board under this section shall not authorize expansion of the current scope of practice for pharmacists and shall not interfere with the requirement that pharmacists only dispense drugs in accordance with instructions from a prescriber, as defined in § 54.1-3401.

B. The application to the Board shall address safety to the public regarding the new process or procedure, any potential benefit to the public, promotion of scientific or technical advances in the practice of pharmacy, compliance with prescriber's instructions for any drug dispensed, any impact the new process may have on the potential for diversion of drugs, maintenance in the integrity of and public confidence in the profession of pharmacy and of the drugs dispensed, impact on cost to the public and within the health care industry, means of monitoring the new process or procedure for any negative outcomes or other problems, and the reporting of such outcomes to the Board.

C. An informal conference committee, composed of not less than two members of the Board and in accordance with § 2.2-4019, shall receive and review the application and any investigative report requested by the committee. The committee shall have the authority to grant or deny approval of the request. The committee may grant approval of the request unconditionally or may impose conditions on the approval as follows:

1. The committee may grant approval for a finite period of time, after which time the applicant must provide additional information as requested by the committee in order to continue the approval;

2. The committee may require that ongoing reports concerning performance and problems be submitted; or

3. The committee may impose such other conditions as it deems necessary to provide assurance of public health and safety and accountability for controlled substances.

D. If an applicant does not agree with the decision of the committee, the applicant may request a hearing before the Board or a panel of the Board, in accordance with § 2.2-4020.

E. Application under this section shall be on a form provided by the Board and shall be accompanied by a fee determined by the Board.

2000, c. 876.

§ 54.1-3307.3. Waiver of requirements; declared disaster or state of emergency.

When the Governor has declared a disaster or a state of emergency pursuant to Chapter 3.2 (§ 44-146.13 et seq.) of Title 44 and it is necessary to permit the provision of needed drugs, devices, and pharmacy services to the citizens of the Commonwealth, the Board may waive the requirements of this chapter, the Drug Control Act (§ 54.1-3400 et seq.), and the Board's regulations governing the practice of pharmacy (18VAC110-20-10 et seq.). However, the Board shall not authorize the administering or dispensing of controlled substances by persons whose scope of practice does not include such authority.

2003, c. 794.

§ 54.1-3308. Power of inspection.

The members of the Board and their duly authorized agents shall have the power to inspect in a lawful manner the drugs, cosmetics and devices which are manufactured, stored or dispensed in the Commonwealth. For this purpose the Board shall have the right to enter and inspect during business hours any pharmacy, or any other place in Virginia where drugs, cosmetics or devices are manufactured, stored or dispensed. The Board shall report any evidence of violation of the provisions of this chapter or Chapter 34 (§ 54.1-3400 et seq.) of this title by practitioners for action to the appropriate licensing board. The report shall constitute a pending complaint upon which the appropriate licensing board shall initiate action within thirty days.

Code 1950, § 54-417; 1958, c. 551; 1968, c. 582, § 54-524.19; 1970, c. 650; 1972, c. 798; 1976, c. 614; 1988, c. 765.

§ 54.1-3309. Enforcement.

A. The Board or its agents are authorized upon presenting appropriate credentials and a written notice as to the purpose of the inspection to the owner, operator or agent in charge to enter at reasonable times any factory, warehouse or establishment in which drugs, devices or cosmetics are manufactured, processed, packed or held for introduction into commerce or to enter any vehicle being used to transport or hold such drugs, devices or cosmetics.

The Board or its agents are authorized to inspect such factory, warehouse, establishment or vehicle and all pertinent equipment, materials, containers and labeling.

In the case of any factory, warehouse, establishment or consulting laboratory in which prescription drugs are manufactured, processed, packed or held, the inspection shall extend to all things, including records, files, papers, processes, controls and facilities, bearing on compliance with Chapter 34 (§ 54.1-3400 et seq.) of this title.

No inspection authorized for prescription drugs shall extend to financial data, sales data other than shipment data, pricing data, personnel data, other than data as to qualifications of technical and professional personnel performing functions subject to this chapter, and research data.

Each inspection shall be commenced and completed with reasonable promptness. The Board or its agents shall have access to copy all records of carriers in commerce showing the movement in commerce of any drug, device, or cosmetic and the quantity, shipper and consignee. The evidence obtained under this section shall not be used in a criminal prosecution of the person from whom obtained; and carriers shall not be subject to the provisions of Chapter 34 by reason of their receipt, carriage, holding, or delivery of food, drugs, devices, or cosmetics in the usual course of business.

B. If the authorized agent inspecting a factory, warehouse or other establishment has obtained any sample in the course of the inspection, upon completion of the inspection and prior to leaving the premises, he shall give to the owner, operator, or agent in charge a receipt describing the samples.

1970, c. 650, § 54-524.99; 1988, c. 765.