21 USC 814 - Removal of exemption of certain drugs

U.S Code last checked for updates: Nov 25, 2024

§ 814.

Removal of exemption of certain drugs

(a)

Removal of exemption

(b)

Factors to be considered

In removing a drug or group of drugs from exemption under subsection (a), the Attorney General shall consider, with respect to a drug or group of drugs that is proposed to be removed from exemption—

(1)

the scope, duration, and significance of the diversion;

(2)

whether the drug or group of drugs is formulated in such a way that it cannot be easily used in the illicit production of a controlled substance; and

(3)

whether the listed chemical can be readily recovered from the drug or group of drugs.

(c)

Specificity of designation

(d)

Reinstatement of exemption with respect to particular drug products

(1)

Reinstatement

(2)

Factors to be considered

In deciding whether to reinstate the exemption with respect to a particular drug product under paragraph (1), the Attorney General shall consider—

(A)

the package sizes and manner of packaging of the drug product;

(B)

the manner of distribution and advertising of the drug product;

(C)

evidence of diversion of the drug product;

(D)

any actions taken by the manufacturer to prevent diversion of the drug product; and

(E)

such other factors as are relevant to and consistent with the public health and safety, including the factors described in subsection (b) as applied to the drug product.

(3)

Status pending application for reinstatement

A transaction involving a particular drug product that is the subject of a bona fide pending application for reinstatement of exemption filed with the Attorney General not later than 60 days after a regulation removing the exemption is issued pursuant to subsection (a) shall not be considered to be a regulated transaction if the transaction occurs during the pendency of the application and, if the Attorney General denies the application, during the period of 60 days following the date on which the Attorney General denies the application, unless—

(A)

the Attorney General has evidence that, applying the factors described in subsection (b) to the drug product, the drug product is being diverted; and

(B)

the Attorney General so notifies the applicant.

(4)

Amendment and modification

A regulation reinstating an exemption under paragraph (1) may be modified or revoked with respect to a particular drug product upon a finding that—

(A)

applying the factors described in subsection (b) to the drug product, the drug product is being diverted; or

(B)

there is a significant change in the data that led to the issuance of the regulation.

(Pub. L. 91–513, title II, § 204, as added Pub. L. 103–200, § 2(b)(1), Dec. 17, 1993, 107 Stat. 2334; amended Pub. L. 104–237, title IV, § 401(c), Oct. 3, 1996, 110 Stat. 3108; Pub. L. 109–177, title VII, § 712(a)(2), Mar. 9, 2006, 120 Stat. 263.)

cite as: 21 USC 814