21 USC 356d - Coordination; task force and strategic plan

U.S Code last checked for updates: May 05, 2024

§ 356d.

Coordination; task force and strategic plan

(a)

Task force and strategic plan

(1)

In general

(A)

Task force

(B)

Strategic plan

The strategic plan described in subparagraph (A) shall include—

(i)

plans for enhanced interagency and intra-agency coordination, communication, and decisionmaking;

(ii)

plans for ensuring that drug shortages are considered when the Secretary initiates a regulatory action that could precipitate a drug shortage or exacerbate an existing drug shortage;

(iii)

plans for effective communication with outside stakeholders, including who the Secretary should alert about potential or actual drug shortages, how the communication should occur, and what types of information should be shared;

(iv)

plans for considering the impact of drug shortages on research and clinical trials; and

(v)

an examination of whether to establish a “qualified manufacturing partner program”, as described in subparagraph (C).

(C)

Description of program

In conducting the examination of a “qualified manufacturing partner program” under subparagraph (B)(v), the Secretary—

(i)

shall take into account that—

(I)

a “qualified manufacturer”, for purposes of such program, would need to have the capability and capacity to supply products determined or anticipated to be in shortage; and

(II)

in examining the capability and capacity to supply products in shortage, the “qualified manufacturer” could have a site that manufactures a drug listed under section 356e of this title or have the capacity to produce drugs in response to a shortage within a rapid timeframe; and

(ii)

shall examine whether incentives are necessary to encourage the participation of “qualified manufacturers” in such a program.

(D)

Consultation

(2)

Timing

Not later than 1 year after July 9, 2012, the task force shall—

(A)

publish the strategic plan described in paragraph (1); and

(B)

submit such plan to Congress.

(b)

Communication

(c)

Action

(d)

Reporting by other entities

(e)

Review and construction

No determination, finding, action, or omission of the Secretary under this section shall—

(1)

be subject to judicial review; or

(2)

be construed to establish a defense to an enforcement action by the Secretary.

(f)

Temporary sunset

(g)

Coordination

The Secretary shall ensure timely and effective internal coordination and alignment among the field investigators of the Food and Drug Administration and the staff of the Center for Drug Evaluation and Research’s Office of Compliance and Drug Shortage Program regarding—

(1)

the reviews of reports shared pursuant to section 374(b)(2) of this title; and

(2)

any feedback or corrective or preventive actions in response to such reports.

(June 25, 1938, ch. 675, § 506D, as added Pub. L. 112–144, title X, § 1003, July 9, 2012, 126 Stat. 1103; amended Pub. L. 117–328, div. FF, title III, § 3616(a), Dec. 29, 2022, 136 Stat. 5874.)

cite as: 21 USC 356d