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503Pharma Weekly Compounding Pharmacy Roundup

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

Group Lab Testing Program — We Need Your Numbers

503Pharma is negotiating group pricing for contract lab testing — potency, sterility, endotoxin, and stability studies. More pharmacies in means better rates for everyone.

PCAC meets July 23–24 on BPC-157, TB-500, KPV, and MOTS-C. Pharmacies with testing infrastructure in place will be ahead of the curve.

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This Week's Headlines

GLP-1 SUPPLY

Lupin Recalls 217,621 Liraglutide Pens for Particulate Matter

Lupin Pharmaceuticals is recalling 217,621 liraglutide injection pens (18 mg/3 mL) after a white thread-like structure was found in cartridges — recall D-0541-2026, Class II, multiple lots. Liraglutide is the one GLP-1 still on the shortage list, and shortage status is the statutory hinge for 503B bulk compounding. A six-figure pen recall on that molecule is a supply-side disruption 18 days before the comment window on FDA's proposed 503B bulks exclusion closes June 29.

HRT RECALL

ANI Estradiol Gel Recalled for Defective Containers

ANI Pharmaceuticals is recalling 3,964 cartons of Estradiol Gel 0.1% after packets were found empty or partially full — recall D-0543-2026, Class II. A dose-delivery failure on a branded estradiol product while patches remain backordered with no resolution date and progesterone sits on the shortage database across capsules, injection, and vaginal inserts.

PEPTIDE MARKET

Precision Peptide Begins BPC-157 Compounding

The Precision Peptide Company (CSE: BPC) announced June 2 it signed a compounding agreement with an undisclosed 503A pharmacy to prepare BPC-157, with compounding beginning immediately and claimed capacity of 25,000 scripts/day. A publicly traded company is commercializing seven weeks before the advisory committee meets; the 503A partner's name is withheld “for competitive reasons.”

Intel Briefs

DEADLINES

Three Dates in Three Weeks

June 29 — GLP-1 503B bulks exclusion comment closes.

June 30 — PCAC oral presentation requests due.

July 9 — written comments to Docket FDA-2025-N-6895 that will reach committee before the July 23–24 meeting.

NEW: 503Pharma Formula Library

We just launched a formula library for compounding pharmacies — 100+ ready-to-use formulations, now live in the members area at app.503pharma.com.

Every formula is built for real compounding workflows: USP 795/797-compliant, sterile and non-sterile coverage, beyond-use dating included, and updated as guidance evolves. No starting from scratch, no hunting through scattered references.

app.503pharma.com

What's inside:

  • 100+ formulations across sterile and non-sterile categories

  • BUD assignments aligned to USP 795/797

  • Custom formulation requests

  • Regularly updated as FDA and USP guidance changes

The members area is free to join. Formula access is a paid feature.

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