Update – Enhanced Drug Distribution Security Requirements Under Section 582

FDA is issuing this guidance for immediate implementation in accordance with 21 CFR 10.115(g)(2). Submit one set of either electronic or written comments on this guidance at any time. Submit electronic comments to https://www.regulations.gov. Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You should identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register.

Link to FDA site article: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enhanced-drug-distribution-security-requirements-under-section-582g1-federal-food-drug-and-cosmetic?inf_contact_key=c9c38ac30cb989cc25562ca9dfc29aa8680f8914173f9191b1c0223e68310bb1