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503Pharma Weekly Compounding Pharmacy Roundup

Your trusted source for compounding pharmacy education, news and insights.

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503Pharma .
October 02, 2025

🚨 FDA Warning on Fraudulent Compounded GLP-1 Products

The FDA issued an alert about fraudulent compounded semaglutide and tirzepatide being sold under pharmacy labels that never actually produced them. At least one adverse event has been reported.

  • Risks: dosing errors, mislabeled salt forms, unsafe frequency of use.

  • Action for Pharmacies: Educate patients on verifying product legitimacy, reinforce documentation, and maintain strict supply-chain traceability.

📎 FDA Alert

🏛️ Legislative Spotlight: H.R. 5316 — Drug Shortage Compounding Patient Access Act

The Alliance for Pharmacy Compounding (APC) is backing new legislation introduced in Congress that could reshape compounding during drug shortages.

  • Allows 503A pharmacies to prepare shortage drugs for urgent clinical use.

  • Creates a 60-day transition period after a drug exits shortage.

  • Streamlines FDA’s bulk drug substance list updates.

Why it matters: This bill could give compounders clearer legal footing when filling critical shortage gaps.

⚖️ California Finalizes Compounding Regulations (Effective Oct 2025)

The California Board of Pharmacy approved new compounding rules:

  • Applies only to pharmacy licensees, not physician practices.

  • Requires pharmacists to justify when a compounded product is an “essentially a copy” of a commercial drug (unless it’s on FDA/ASHP shortage lists).

Insight: Expect other states to watch California’s move closely. Documentation requirements may tighten nationwide.

📈 Market Outlook

A recent market report projects the U.S. compounding pharmacy market will grow from $6.3B in 2024 to $10.7B by 2033 (CAGR 6.1%).
Drivers: demand for personalized medicine, sterile injectables, and growing reliance on compounding amid drug shortages.

Featured Compounding Formula of the Week

Ipamorelin Injection Formulation - 503Pharma

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Access free compounding formulas, pharmacy directories, and specialized resources for 503A and 503B facilities. 503Pharma provides the tools compounding pharmacies need—no subscription required.

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✉️ That’s your 503Pharma weekly digest. Our mission is to keep compounding professionals informed, prepared, and ahead of the curve.