dcrodriguez/Code-of-Virginia huggingface dataset:
Code of Virginia — Title 54.1 (Professions and Occupations), Chapter 34 (DRUG CONTROL ACT)
§ 54.1-3425. Repealed.
Repealed by Acts 2009, c. 149, cl. 2, effective March 6, 2009, and c. 169, cl. 2, effective March 23, 2009.

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.

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.

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.

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.

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.
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.

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.

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.
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.
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.

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

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.
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.
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.

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.
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.

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.

Code of Virginia — Title 54.1 (Professions and Occupations), Chapter 34 (DRUG CONTROL ACT)
§ 54.1-3435.5. Repealed.
Repealed by Acts 2007, c. 662, cl. 2.

Code of Virginia — Title 54.1 (Professions and Occupations), Chapter 34 (DRUG CONTROL ACT)
§ 54.1-3436. Repealed.
Repealed by Acts 1992, c. 737.
Code of Virginia — Title 54.1 (Professions and Occupations), Chapter 34 (DRUG CONTROL ACT)
§ 54.1-3436.1. Prescription drug price transparency.
A. As used in this section:

"Brand-name drug" means a prescription drug approved under 21 U.S.C. § 355(b) or 42 U.S.C. § 262.

"Generic drug" means a prescription drug approved under 21 U.S.C. § 355(j).

"Nonprofit data services organization" has the same meaning as set forth in § 32.1-23.4.

"Pharmacy benefits manager" has the same meaning as set forth in § 38.2-3407.15:4.

"Wholesale acquisition cost" has the same meaning as set forth in 42 U.S.C. § 1395w-3a(c)(6)(B).

B. To ensure data that is useful, relevant, and not duplicative, the Department of Health may request wholesale distributors to report to the nonprofit organization with which the Department of Health has entered into a contract or agreement pursuant to § 32.1-23.4 the following information on the 25 costliest drugs in the Commonwealth upon a determination by the Department of Health that data received from health carriers, pharmacy benefits managers, and manufacturers is insufficient:

1. The wholesale acquisition cost that the wholesale distributor has negotiated directly with the manufacturer in the last calendar year, related to the 25 costliest drugs dispensed in the Commonwealth;

2. The wholesale acquisition cost that the wholesale distributor has negotiated directly with the manufacturer in the current calendar year for the 25 costliest drugs dispensed in the Commonwealth;

3. Aggregate total rebates, discounts, and price concessions negotiated directly with the manufacturer for the 25 costliest drugs dispensed in the Commonwealth in the last calendar year, for business in the Commonwealth, in total; and

4. Aggregate total discounts, dispensing fees, and other fees negotiated in the last calendar year with pharmacies, for the 25 costliest drugs dispensed in the Commonwealth, in total.

C. A report submitted by a wholesale distributor pursuant to subsection B shall not disclose the identity of a specific wholesale distributor, the price charged for a specific prescription drug or class of prescription drugs, or the amount of any price concession, rebate, or fee provided for a specific prescription drug or class of prescription drugs.

2021, Sp. Sess. I, c. 304.
Code of Virginia — Title 54.1 (Professions and Occupations), Chapter 34 (DRUG CONTROL ACT)
§ 54.1-3437. Permit to manufacture drugs.
It shall be lawful to manufacture, make, produce, pack, package, repackage, relabel or prepare any drug not controlled by Schedule I after first obtaining the appropriate permit from the Board. Such permits shall be subject to the Board's regulations on sanitation, equipment, and safeguards against diversion, and shall allow the distribution of the drug manufactured, made, produced, packed, packaged, repackaged, relabeled, or prepared to anyone other than the end user without the need to obtain a wholesale distributor permit. This provision shall not apply to manufacturers or packers of medicated feeds who manufacture or package no other drugs.

Code 1950, § 54-448; 1958, c. 551; 1970, c. 650, § 54-524.36; 1988, c. 765; 1996, cc. 37, 407; 2016, c. 221.

Code of Virginia — Title 54.1 (Professions and Occupations), Chapter 34 (DRUG CONTROL ACT)
§ 54.1-3437.1. Limited permit for repackaging drugs.
The Board may issue a limited manufacturing permit for the purpose of repackaging drugs, upon such terms and conditions approved by the Board, to the pharmacy directly operated by the Department of Behavioral Health and Developmental Services and which serves clients of the community services boards.

1997, c. 218; 2009, cc. 813, 840.

Code of Virginia — Title 54.1 (Professions and Occupations), Chapter 34 (DRUG CONTROL ACT)
§ 54.1-3438. Manufacturing, etc., of drugs or proprietary medicines, to be supervised by pharmacist.
No drugs or proprietary medicines shall be manufactured, made, produced, packed, packaged, repackaged, relabeled or prepared within this Commonwealth, except under the personal and immediate supervision of a pharmacist or such other person as may be approved by the Board of Pharmacy after an investigation and a determination by the Board that they are qualified by scientific or technical training to perform such duties or supervision as may be necessary to protect the public health and safety. This provision shall not apply to manufacturers or packers of medicated feeds who manufacture or pack no other drugs. Medicated feeds are hereby defined as products obtained by mixing a commercial feed and a drug.

Code 1950, § 54-447; 1958, c. 551; 1970, c. 650, § 54-524.37; 1976, c. 614; 1988, c. 765; 1996, cc. 37, 407.

Code of Virginia — Title 54.1 (Professions and Occupations), Chapter 34 (DRUG CONTROL ACT)
§ 54.1-3439. Application for nonrestricted manufacturing permit; fee.
Every person desiring to manufacture any drug or proprietary medicines shall annually apply to the Board for a nonrestricted manufacturing permit. The application shall be accompanied by the required fee. Separate applications shall be made and separate permits issued for each specific place of manufacturing. Each such permit shall expire annually on a date determined by the Board in regulation.

1970, c. 650, § 54-524.40; 1972, c. 798; 1976, c. 614; 1980, c. 288; 1988, c. 765; 1996, cc. 37, 407; 2008, c. 320.
Code of Virginia — Title 54.1 (Professions and Occupations), Chapter 34 (DRUG CONTROL ACT)
§ 54.1-3440. Persons to whom nonrestricted permit is granted.
No person shall be granted a nonrestricted permit as a manufacturer unless he is of good moral character and properly equipped as to land, buildings, equipment and safeguards against diversion to carry out the functions of a manufacturer with due regard to the protection of the public safety.

1970, c. 650, § 54-524.41; 1976, c. 614; 1988, c. 765.

Code of Virginia — Title 54.1 (Professions and Occupations), Chapter 34 (DRUG CONTROL ACT)
§ 54.1-3441. Restricted manufacturing permit; application; fee; separate application and permit for each place of manufacturing.
Every person desiring to manufacture a proprietary medicine or to repackage medical gases shall apply to the Board for a restricted manufacturing permit. The application shall be accompanied by the required fee. Separate applications shall be made and separate permits issued for each separate place of manufacturing.

1976, c. 614, § 54-524.41:1; 1980, c. 288; 1988, c. 765; 1996, cc. 37, 407.

Code of Virginia — Title 54.1 (Professions and Occupations), Chapter 34 (DRUG CONTROL ACT)
§ 54.1-3442. When permit not to be granted; regulations.
No person shall be granted a restricted manufacturing permit as a manufacturer unless such person is properly equipped as to buildings and equipment to carry out the functions of a manufacturer with due regard to the protection of the public health. The Board shall promulgate regulations in order to carry out the provisions of this section.

1976, c. 614, § 54-524.41:2; 1988, c. 765.

Code of Virginia — Title 54.1 (Professions and Occupations), Chapter 34 (DRUG CONTROL ACT)
§ 54.1-3442.01. Registration of nonresident manufacturer; renewal.
A. Any manufacturer located outside the Commonwealth who ships prescription drugs into the Commonwealth shall be registered with the Board. The nonresident manufacturer shall renew such registration 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 previously submitted.

B. The nonresident manufacturer shall at all times maintain a valid, unexpired license, permit, or registration in the state in which it is located or current registration as a manufacturer or repackager with the federal Food and Drug Administration 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 shipments into other jurisdictions and shall be provided to the Board, its authorized agent, or any agent designated by the Superintendent of the Department of State Police upon request within seven days of receipt of such request.

2016, c. 221.
Code of Virginia — Title 54.1 (Professions and Occupations), Chapter 34 (DRUG CONTROL ACT)
§ 54.1-3442.1. Definitions.
As used in this article, unless the context requires a different meaning:

"Investigational drug, biological product, or device" means a drug, biological product, or device that has successfully completed Phase I of a clinical trial but has not been approved for general use by the U.S. Food and Drug Administration and remains under investigation in a clinical trial.

"Terminal condition" means a condition caused by injury, disease, or illness from which, to a reasonable degree of medical probability, a patient cannot recover and (i) the patient's death is imminent or (ii) the patient is in a persistent vegetative state.

"Treating physician" means a physician who is providing or has previously provided medical treatment or evaluation to and has or previously had an ongoing treatment relationship with the person.

2015, cc. 655, 656.
Code of Virginia — Title 54.1 (Professions and Occupations), Chapter 34 (DRUG CONTROL ACT)
§ 54.1-3442.3. Expanded access to investigational drugs, biological products, or devices; cost; insurance coverage.
A. A manufacturer of an investigational drug, biological product, or device may make such investigational drug, biological product, or device available to a person who meets the criteria set forth in subsection A of § 54.1-3442.2; however, nothing in this article shall require a manufacturer of an investigational drug, biological product, or device to make such investigational drug, biological product, or device available to such person.

B. A manufacturer that makes an investigational drug, biological product, or device available to a person who meets the criteria set forth in subsection A of § 54.1-3442.2 may provide the investigational drug, biological product, or device to the person free of charge or may require the person to pay the costs of, or the costs associated with, the manufacture of the investigational drug, biological product, or device.

C. An insurer proposing to issue individual or group accident and sickness insurance policies providing hospital, medical and surgical, or major medical coverage on an expense-incurred basis, a corporation providing individual or group accident and sickness subscription contracts, or a health maintenance organization providing a health care plan for health care services may provide coverage for costs related to treatment of a person's terminal condition with an investigational drug, biological product, or device; however, nothing in this article shall require an insurer proposing to issue individual or group accident and sickness insurance policies providing hospital, medical and surgical, or major medical coverage on an expense-incurred basis, a corporation providing individual or group accident and sickness subscription contracts, or a health maintenance organization providing a health care plan for health care services to provide coverage for costs related to treatment of a person's terminal condition with an investigational drug, biological product, or device.

2015, cc. 655, 656.