21 U.S.C. § 355d — Internal committee for review of pedi-

Page 260 TITLE 21—FOOD AND DRUGS § 355d reports, including recommendations therein, regarding the topics addressed in the reports under this section, including with respect to— ‘‘(A) improving public access to information from pediatric studies conducted under such sections 355a and 355c of this title; and ‘‘(B) improving the timeliness of pediatric studies and pediatric study planning under such sections 355a and 355c of this title.’’ Statutory Notes and Related Subsidiaries RULE OF CONSTRUCTION Nothing in amendment by Pub. L. 115–52 to limit the authority of the Secretary of Health and Human Serv- ices to issue written requests under section 355a of this title or section 262(m) of Title 42, The Public Health and Welfare, or to negotiate or implement amendments to such requests proposed by applicants, see section 504(e) of Pub. L. 115–52, set out as a note under section 355c of this title. DEFINITION OF ‘‘SECRETARY’’ The term ‘‘Secretary’’ as used in this section means the Secretary of Health and Human Services, see sec- tion 503 of Pub. L. 112–144, set out as a note under sec- tion 355a of this title. § 355d. Internal committee for review of pedi- atric plans, assessments, deferrals, deferral extensions, and waivers The Secretary shall establish an internal com- mittee within the Food and Drug Administra- tion to carry out the activities as described in sections 355a(f) and 355c(f) of this title. Such in- ternal committee shall include employees of the Food and Drug Administration, with expertise in pediatrics (including representation from the Office of Pediatric Therapeutics), biopharma- cology, statistics, chemistry, legal issues, pedi- atric ethics, neonatology, and the appropriate expertise pertaining to the pediatric product under review, such as expertise in child and ado- lescent psychiatry or pediatric rare diseases, and other individuals designated by the Sec- retary. (June 25, 1938, ch. 675, § 505C, as added Pub. L. 110–85, title IV, § 403, Sept. 27, 2007, 121 Stat. 875; amended Pub. L. 112–144, title V, § 509(c), July 9, 2012, 126 Stat. 1049; Pub. L. 115–52, title V, § 505(f), Aug. 18, 2017, 131 Stat. 1047.) Editorial Notes AMENDMENTS 2017—Pub. L. 115–52 inserted ‘‘or pediatric rare dis- eases’’ after ‘‘psychiatry’’. 2012—Pub. L. 112–144 inserted ‘‘deferral extensions,’’ after ‘‘deferrals,’’ in section catchline and ‘‘neonatology,’’ after ‘‘pediatric ethics,’’ in text. § 355e. Pharmaceutical security (a) In general The Secretary shall develop standards and identify and validate effective technologies for the purpose of securing the drug supply chain against counterfeit, diverted, subpotent, sub- standard, adulterated, misbranded, or expired drugs. (b) Standards development (1) In general The Secretary shall, in consultation with the agencies specified in paragraph (4), manu- facturers, distributors, pharmacies, and other supply chain stakeholders, prioritize and de- velop standards for the identification, valida- tion, authentication, and tracking and tracing of prescription drugs. (2) Standardized numeral identifier Not later than 30 months after September 27, 2007, the Secretary shall develop a standard- ized numerical identifier (which, to the extent practicable, shall be harmonized with inter- national consensus standards for such an iden- tifier) to be applied to a prescription drug at the point of manufacturing and repackaging (in which case the numerical identifier shall be linked to the numerical identifier applied at the point of manufacturing) at the package or pallet level, sufficient to facilitate the iden- tification, validation, authentication, and tracking and tracing of the prescription drug. (3) Promising technologies The standards developed under this sub- section shall address promising technologies, which may include— (A) radio frequency identification tech- nology; (B) nanotechnology; (C) encryption technologies; and (D) other track-and-trace or authentica- tion technologies. (4) Interagency collaboration In carrying out this subsection, the Sec- retary shall consult with Federal health and security agencies, including— (A) the Department of Justice; (B) the Department of Homeland Security; (C) the Department of Commerce; and (D) other appropriate Federal and State agencies. (c) Inspection and enforcement (1) In general The Secretary shall expand and enhance the resources and facilities of agency components of the Food and Drug Administration involved with regulatory and criminal enforcement of this chapter to secure the drug supply chain against counterfeit, diverted, subpotent, sub- standard, adulterated, misbranded, or expired drugs including biological products and active pharmaceutical ingredients from domestic and foreign sources. (2) Activities The Secretary shall undertake enhanced and joint enforcement activities with other Fed- eral and State agencies, and establish regional capacities for the validation of prescription drugs and the inspection of the prescription drug supply chain. (d) Definition In this section, the term ‘‘prescription drug’’ means a drug subject to section 353(b)(1) of this title. (June 25, 1938, ch. 675, § 505D, as added Pub. L. 110–85, title IX, § 913, Sept. 27, 2007, 121 Stat. 952.) § 355f. Extension of exclusivity period for new qualified infectious disease products (a) Extension If the Secretary approves an application pur- suant to section 355 of this title for a drug that