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21 U.S.C. § 353a–1 — Enhanced communication

Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 353a–1 — Enhanced communication

**(a) Submissions from State boards of pharmacy** In a manner specified by the Secretary of Health and Human Services (referred to in this section as the “Secretary”), the Secretary shall receive submissions from State boards of pharmacy— (1) describing actions taken against compounding pharmacies, as described in subsection (b); or (2) expressing concerns that a compounding pharmacy may be acting contrary to [section 353a of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section353a&num=0&edition=prelim). **(b) Content of submissions from State boards of pharmacy** An action referred to in subsection (a)(1) is, with respect to a pharmacy that compounds drugs, any of the following: (1) The issuance of a warning letter, or the imposition of sanctions or penalties, by a State for violations of a State’s pharmacy regulations pertaining to compounding. (2) The suspension or revocation of a State-issued pharmacy license or registration for violations of a State’s pharmacy regulations pertaining to compounding. (3) The recall of a compounded drug due to concerns relating to the quality or purity of such drug. **(c) Consultation** The Secretary shall implement subsection (a) in consultation with the National Association of Boards of Pharmacy. **(d) Notifying State boards of pharmacy** The Secretary shall immediately notify State boards of pharmacy when— (1) the Secretary receives a submission under subsection (a)(1); or (2) the Secretary makes a determination that a pharmacy is acting contrary to [section 353a of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section353a&num=0&edition=prelim).

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Source location: Title 21, Chapter 9, § 353a–1; chapter-009-federal-food-drug-and-cosmetic-act.md

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 353a — Pharmacy compounding

**(a) In general** Sections 351(a)(2)(B), 352(f)(1), and 355 of this title shall not apply to a drug product if the drug product is compounded for an identified individual patient based on the receipt of a valid prescription order or a notation, approved by the prescribing practitioner, on the prescription order that a compounded product is necessary for the identified patient, if the drug product meets the requirements of this section, and if the compounding— (1) is by— (A) a licensed pharmacist in a State licensed pharmacy or a Federal facility, or (B) a licensed physician, on the prescription order for such individual patient made by a licensed physician or other licensed practitioner authorized by State law to prescribe drugs; or (2) (A) is by a licensed pharmacist or licensed physician in limited quantities before the receipt of a valid prescription order for such individual patient; and (B) is based on a history of the licensed pharmacist or licensed physician receiving valid prescription orders for the compounding of the drug product, which orders have been generated solely within an established relationship between— (i) the licensed pharmacist or licensed physician; and (ii) (I) such individual patient for whom the prescription order will be provided; or (II) the physician or other licensed practitioner who will write such prescription order. **(b) Compounded drug** (1) **Licensed pharmacist and licensed physician** — A drug product may be compounded under subsection (a) if the licensed pharmacist or licensed physician— (A) compounds the drug product using bulk drug substances, as defined in regulations of the Secretary published at section 207.3(a)(4) of title 21 of the Code of Federal Regulations— (i) that—

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