Code of Virginia

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Code of Virginia
Title 54.1. Professions and Occupations
Chapter 34. Drug Control Act
9/17/2021

Article 4. Permitting of Manufacturers.

§ 54.1-3437. Permit to manufacture drugs.

It shall be lawful to manufacture, make, produce, pack, package, repackage, relabel or prepare any drug not controlled by Schedule I after first obtaining the appropriate permit from the Board. Such permits shall be subject to the Board's regulations on sanitation, equipment, and safeguards against diversion, 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.

§ 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.

§ 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.

§ 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.

§ 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.

§ 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.

§ 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.

§ 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.

§ 54.1-3442.02. (Effective January 1, 2022) Prescription drug price transparency.

A. As used in this section:

"Biosimilar" means a drug that is produced or distributed pursuant to a biologics license application approved under 42 U.S.C. § 262(k)(3).

"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) or 42 U.S.C. 262(k).

"New prescription drug" means a drug or biological product receiving initial approval under an original new drug application pursuant to 21 U.S.C. § 355(b) or under a biologics license application under 42 U.S.C. § 262.

"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. Every manufacturer shall report annually by April 1 to the nonprofit organization with which the Department of Health has entered into a contract or agreement pursuant to § 32.1-23.4, for each (i) brand-name drug and biologic other than a biosimilar with a wholesale acquisition cost of $100 or more for a 30-day supply or a single course of treatment and any increase of 15 percent or more in the wholesale acquisition cost of such brand-name drug or biologic over the preceding calendar year; (ii) biosimilar with an initial wholesale acquisition cost that is not at least 15 percent less than the wholesale acquisition cost of the referenced brand biologic at the time the biosimilar is launched; and (iii) generic drug with a price increase that results in an increase in the wholesale acquisition cost of such generic drug that is equal to 200 percent or more during the preceding 12-month period, when the wholesale acquisition cost of such generic drug is equal to or greater than $100, annually adjusted by the Consumer Price Index for All Urban Consumers, for a 30-day supply, with such increase defined as the difference between the wholesale acquisition cost of the generic drug after such increase and the average wholesale acquisition cost of such generic drug during the previous 12 months, the following information:

1. The name of the prescription drug;

2. Whether the drug is a brand name or generic;

3. The effective date of the change in wholesale acquisition cost;

4. Aggregate, company-level research and development costs for the most recent year for which final audit data is available;

5. The name of each of the manufacturer's new prescription drugs approved by the U.S. Food and Drug Administration within the previous three calendar years;

6. The name of each of the manufacturer's prescription drugs that, within the previous three calendar years, became subject to generic competition and for which there is a therapeutically equivalent generic version; and

7. A concise statement regarding the factor or factors that caused the increase in wholesale acquisition cost.

C. A manufacturer's obligations pursuant to this section shall be fully satisfied by the submission to the nonprofit data services organization with which the Department of Health has entered into a contract pursuant to § 32.1-23.4 of information and data that a manufacturer includes in the manufacturer's annual consolidation report on Securities and Exchange Commission Form 10-K or any other public disclosure.

2021, Sp. Sess. I, c. 304.