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The law › Title 21, Food and Drugs › Chapter 9

21 U.S.C. 353a: Pharmacy compounding

Created in 1997 by the Food and Drug Administration Modernization Act of 1997 (Public Law 105-115). Changed by 1 later law. No bill we track in this Congress changes it.

1 other section of the Code cite this one, including 21 U.S.C. 353a–1.

1 part of federal rules cite it as their authority, written by Food and Drug Administration, Department of Health and Human Services (1).

This Congress

No bill we track in the 119th Congress changes this section.

    How it got here

    2013

    • Pub. L. 113–54, §106(a)(1), struck out "unsolicited" before "receipt of a valid prescription" in introductory provisions. Law text · (a)
    • Pub. L. 113–54, §106(a)(4), substituted "subsection (c)" for "subsection (d)". Law text · (b)
    • Pub. L. 113–54, §106(a)(2), (3), redesignated subsecs. (d) to (f) as (c) to (e), respectively, and struck out former subsec. (c). Prior to amendment, subsec. (c) read as follows: "A drug may be compounded under subsection (a) of this section only if the pharmacy, licensed pharm… Law text · (c), (d), (e), (f)

    Text, outline and history from the official U.S. Code (2024 edition) on GovInfo, published by the Office of the Law Revision Counsel. Changes made after that edition appear under This Congress.