California-Pharmacist-Winter-2024 - Flipbook - Page 46
laws & regulations
Dispensing Compounded GLP-1 Injectables
Sourced From 503A/B Facilities
Tony J. Park
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Question:
Answer 1:
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Answer 2:
CAVEAT:
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44
vol. 71, no. 4 | California Pharmacist
References
1. i.e., ensure “LSC” or “NSC" licensure of the
source by verifying their licensure with the California State Board of Pharmacy: https://www.
pharmacy.ca.gov/about/verify_lic.shtml
2. See FDA website, “FD&C Act Provisions that
Apply to Human Drug Compounding” at https://
www.fda.gov/drugs/human-drug-compounding/
fdc-act-provisions-apply-human-drug-compounding
3.
California Business and Professions Code §
4123 (2024).
4. See FDA guidance, “Pharmacy Compounding
of Human Drug Products Under Section 503A
of the Federal Food, Drug, and Cosmetic Act” at
https://www.fda.gov/media/94393/download
5. The drug [MUST] appear on
California Code of Regulations
§ 1735.2(d)(3) (2024).
