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21 C.F.R. § 216.23

Section 216.23 - Bulk drug substances that can be used to compound drug products in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act
Section 216.23 - Bulk drug substances that can be used to compound drug products in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act

3 Analyses of this regulation by attorneys

  1. FDA Giveth and Taketh Away as It Publishes Its Second Proposed Rule Concerning the Section 503A Bulk Substances List

    Hyman, Phelps & McNamara, P.C.Karla L. PalmerSeptember 11, 2019

    On September 5, 2019, FDA published its proposal to amend its Section 503A bulk substances regulation, 21 C.F.R. § 216.23, to add five bulk drug substances that FDA considered to the Section 503A Bulks List, and not to add 26 substances. Prior to this latest proposed rule, FDA has only finalized via the final rulemaking process its Section 503A Bulks List for ten substances (as blogged about here).

  2. FDA and Pharmacy Weekly Digest - May 2019 #1

    BakerHostetlerMay 8, 2019

    ” With respect to the opioid crisis, Amin indicated that the FDA was working to curb illicit internet sales of opioids and secure the drug supply chain.Citizen Petition Filed to Address a Bulk Drug Substance – An organization submitted a Citizen Petition requesting that the FDA amend 21 C.F.R. § 216.23 to include oxitriptan on the 503A Bulks List.

  3. FDA and Pharmacy Weekly Digest - May 7

    BakerHostetlerLindsay P. HolmesMay 7, 2019

    ” With respect to the opioid crisis, Amin indicated that the FDA was working to curb illicit internet sales of opioids and secure the drug supply chain.Citizen Petition Filed to Address a Bulk Drug Substance – An organization submitted a Citizen Petition requesting that the FDA amend 21 C.F.R. § 216.23 to include oxitriptan on the 503A Bulks List.Authorship Credit: Lindsay P. Holmes