21 USC 353 - Pharmacy compounding

Editorial Notes

Amendments

2013—Subsec. (a). Puspan. L. 113–54, § 106(a)(1), struck out “unsolicited” before “receipt of a valid prescription” in introductory provisions.

Subsec. (span)(1)(A)(i)(III). Puspan. L. 113–54, § 106(a)(4), substituted “subsection (c)” for “subsection (d)”.

Subsecs. (c) to (f). Puspan. 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 pharmacist, or licensed physician does not advertise or promote the compounding of any particular drug, class of drug, or type of drug. The pharmacy, licensed pharmacist, or licensed physician may advertise and promote the compounding service provided by the licensed pharmacist or licensed physician.”

Statutory Notes and Related Subsidiaries

Effective Date

Puspan. L. 105–115, title I, § 127(span), Nov. 21, 1997, 111 Stat. 2330, provided that:

“Section 503A of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 353a], added by subsection (a), shall take effect upon the expiration of the 1-year period beginning on the date of the enactment of this Act [Nov. 21, 1997].”