Verbatim response from Perplexity
The FDA has ended the grace period for compounding semaglutide and tirzepatide after declaring their national shortages resolved, meaning pharmacies can no longer legally produce bulk or mass-compounded versions that are "essentially copies" of FDA-approved GLP-1 drugs like Ozempic, Wegovy, Mounjaro, or Zepbound[2][3]. The agency clarified in late April 2025 that compounding is now only permitted under strict Section 503A conditions: for patients with a documented medical need where the FDA-approved dosage or form is not commercially available, or for unique individual indications[1][2].
Who is still operating legally:
- State-licensed pharmacies and physicians performing individualized compounding for specific patients who cannot be treated with commercially available FDA-approved drugs (e.g., requiring non-standard doses, forms, or having allergies to fillers) remain legal under Section 503A, provided they do not mass-produce or sell essentially copies recklessly[1][3].
- Outsourcing facilities (Section 503B) are restricted from regularly compounding essentially copies; they may still compound only if they fill four or fewer such prescriptions per calendar month for a specific drug product[3].
- Companies like Hims & Hers and other telehealth/compounding chains that mass-market compounded GLP-1s as generic alternatives to FDA-approved drugs are now facing FDA enforcement actions, warning letters, and potential seizure because they violate guidelines against misleading claims and bulk production[5][6].
Key restrictions:
- Bulk manufacturing of compounded GLP-1s at commercially available doses is no longer permitted[1].
- Fraudulent compounded products (with fake labels or non-existent pharmacies) and APIs from non-compliant manufacturers are under import alerts and enforcement scrutiny[4][5].
- Retatrutide and cagrilintide cannot be used in compounding under federal law, as they are not in FDA-approved drugs and lack safety/efficacy data[4].
In short, only patient-specific, individualized compounding with documented medical necessity continues legally; mass-market telehealth compounding is being shut down.