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503Pharma Weekly Compounding Pharmacy Roundup
Your trusted source for compounding pharmacy education, news and insights.
503Pharma .
August 07, 2026
STABILITY STUDY CONSORTIUM — FOUNDING MEMBER SPOTS
The 503Pharma Group Stability Study Consortium launches with 20 founding seats at $4,000/year — three Category 3 stability studies, extended BUD data you can reference. A single solo study costs more than this entire membership.
Full details and FAQs here. Key points:
- $4,000/year for at least 3 studies
- Limited to 20 founding members
- This is the lowest price this program will ever be
If interested, reply to this email and we’ll send you the enrollment details.
This Week’s Headlines
FDA Withdraws 2021 Synthetic-Peptide Guidance, Replaces It with 17 Product-Specific Drafts
On July 28, FDA published 17 revised draft product-specific guidances for generic peptide drug products and simultaneously withdrew its May 2021 general guidance on generic applications for highly purified synthetic peptides, stating it “no longer reflects the Agency’s current scientific thinking.” The revised guidances cover products including liraglutide, semaglutide, teriparatide, octreotide, and leuprolide, among others. The comment period closes September 28, 2026.
The five analytical areas the new guidances concentrate on:
Peptide-product submission requirements
Innate-immune-response (immunogenic impurity) testing
Impurity identification and thresholds
Higher-order-structure characterization
Biological-activity assessment
State Regulation
Louisiana’s Peptide Compounding Law Is Now in Effect
On August 1, Louisiana’s Act 374 (SB 253) took effect. The law prohibits state licensing boards from blocking a pharmacy from compounding peptides, provided the peptide is not on FDA’s Category 2 list and the API is obtained from an FDA-registered manufacturer. If you hold a Louisiana resident or nonresident permit and compound peptides, this is law you are operating under today.
Meanwhile, an NPR analysis published August 3 reports that attorneys expect FDA to skip formal rule-making in favor of an interim Category 1 listing.
Sterile Enforcement
Austin Pharmacy Recalls Glutathione Nationwide — Endotoxin culprit
On August 5, Victory Medical Center Pharmacy (Austin, TX) recalled three lots of Compounded Glutathione 200 mg/mL multi-dose vials (lots 1980571, 1981940, 1984345; August 27 expiration) after its own testing found elevated endotoxin. Product reached TX, FL, and NY. Adverse events reported: fever, chills, severe headache, nausea, vomiting, tachycardia.
503B Operations
FDA Raises FY2027 Outsourcing-Facility Fees
FDA published its FY2027 fee schedule on July 30. Registration period: October 1 – December 31, 2026. FDA invoices after determining registration is complete; do not pay before receiving that invoice.
Fee Type | FY2026 | FY2027 | Change |
|---|---|---|---|
Small-business establishment | $6,829 | $7,142 | +$313 |
Non-small-business establishment | $20,726 | $22,074 | +$1,348 |
Re-inspection | $20,486 | $21,427 | +$941 |
State & Federal Legislative Tracker
Where the bills and cases stand. Updated weekly.
Measure | Status | What It Does |
|---|---|---|
Louisiana Act 374 (SB 253) | Effective August 1 | Permits peptide compounding if the peptide is off the FDA Category 2 list and API is from an FDA-registered manufacturer. |
California AB 1990 | Before the CA Senate | Requires compounded-med ads to carry FDA-approved risk language. APC opposes the labeling provision. APC → |
Virginia HB 917 | In committee | Restricts compounding from bulk drug substances; compounding records to Board within 48 hours of request. Track → |
Colorado SB 66 | Postponed indefinitely | GLP-1 labeling and sourcing requirements, fines up to $1,000/dose. Dead for now; a copyable template. Bill text → |
Tennessee FAIR Rx Act (Pub. Ch. 1111) | Enacted | Amends Title 63 with new standards for registered pharmacies. |
SAFE Drugs Act (S. 3794) | Reported to full Senate July 22; awaiting floor vote | Caps “essentially a copy” compounding at 20/month, adds out-of-state reporting, 503B pre-inspection. |
GLP-1 503B Exclusion | Comment closed July 30; awaiting final rule | Would permanently exclude semaglutide, tirzepatide, and liraglutide from the 503B Bulks List. |
✉ That's your 503Pharma weekly digest. Our mission is to keep compounding professionals informed, prepared, and ahead of the curve.