| Compound ↕ | Category ↕ | Brand / Alt. Name ↕ | Status & Regulatory Notes | 503A ↕ |
|---|
⚖️ Understanding Regulatory Categories
✓ FDA-Approved Drug
NDA/BLA-approved compounds listed in the FDA Orange Book. Require valid prescription. Off-label physician use permitted under professional supervision. Any compounding of essentially identical copies requires documented clinical justification per 503A.
⏳ Investigational (IND)
Compounds with active FDA-registered IND status in Phase 1–3 clinical trials. Not approved for commercial sale or general prescribing. Access restricted to authorized clinical trial participants. May carry FDA Orphan Drug or Fast Track designations.
🔬 Research Use Only (RUO)
Unapproved compounds available for laboratory and pre-clinical research. Cannot be marketed with drug claims or human-use intent. FDA considers RUO labeling fraudulent if evidence shows human administration is intended. Not eligible for standard 503A/B compounding.
💄 Cosmetic Ingredient
INCI-listed or accepted cosmetic actives for topical appearance applications. No FDA pre-market approval required provided claims remain appearance-based only. Any structure/function or disease claim reclassifies as an unapproved drug. Injectable forms remain RUO or require NDA.
💊 Dietary Supplement
DSHEA-compliant ingredients meeting the definition of dietary ingredients: vitamins, minerals, herbs, amino acids, or food constituents. GRAS recognition, NDI notification acceptance, or pre-1994 marketing history required. Disease treatment claims not permitted.
⚕️ Physician-Grade Formulation
Multi-ingredient clinician-directed products combining compounds from multiple regulatory categories. Classification determined at the individual ingredient level. Dispensed under physician supervision with appropriate structure-function labeling. Informed consent and patient monitoring recommended.
📰 April 1, 2026 — Critical Regulatory Update: GLP-1 Compounding Restrictions & Orforglipron FDA Approval
Orforglipron (Foundayo™) FDA Approved: The FDA approved Orforglipron as Foundayo™ (Eli Lilly) on April 1, 2026 — the first oral non-peptide small-molecule GLP-1 receptor agonist and the fastest new molecular entity (NME) approval since 2002, under the FDA Commissioner's National Priority Voucher (CNPV) pilot program. Approved for chronic weight management in adults with obesity or overweight with ≥1 weight-related comorbidity. This approval immediately subjects orforglipron to compounding restrictions under 503A "essentially a copy" rules. FDA Press Release →
Semaglutide Compounding Restrictions (Effective April 22–May 22, 2025): FDA declared the semaglutide injection shortage resolved on February 21, 2025. 503A enforcement discretion ended April 22, 2025 for state-licensed pharmacies. 503B enforcement discretion ended May 22, 2025 for outsourcing facilities. As of April 1, 2026, semaglutide does not appear on the 503B Bulks List or FDA Drug Shortage List. Compounding essentially identical copies is prohibited. Under 503A, limited compounding (≤4 Rx/month) requires prescriber documentation of a clinically significant difference for an individual patient.
Tirzepatide Compounding Restrictions (Effective February 18–March 19, 2025): FDA declared the tirzepatide shortage resolved December 19, 2024. 503A enforcement discretion ended February 18, 2025. 503B ended March 19, 2025. Same narrow 503A conditions apply. Combined formulations (e.g., semaglutide + B12) are also considered "essentially copies" if same API, strength (±10%), and route of administration match commercially available products. FDA April 1, 2026 Guidance →