Compounding Pharmacy Evaluation Rubric
Vendor-neutral framework for evaluating any compounding pharmacy sourcing peptides for clinical practice. Grounded in federal DQSA provisions and USP standards.
Draft — requires medical AND pharmacist reviewer signoff
This rubric is a draft requiring licensed-physician and pharmacist review before clinical application.
503A vs 503B Distinction
Under the Drug Quality and Security Act (DQSA, 2013):
| Attribute | 503A Compounding Pharmacy | 503B Outsourcing Facility |
|---|---|---|
| Who may purchase | Individual patients with Rx | Healthcare facilities (office stock) |
| FDA registration | Not required (state-licensed) | Mandatory; voluntary FDA inspection |
| State pharmacy licensure | Required per ship-to state | Required; plus FDA |
| cGMP compliance | USP chapters; not full cGMP | Full cGMP (21 CFR 210/211) |
| Drug substance | FDA Bulk Drug Substances list, USP/NF, or FDA-approved component | 503B Bulks List or FDA-approved component |
| Batch size | Patient-specific, limited anticipatory | Large batch, office use |
USP <797> and <800> Compliance
- <797> — Sterile compounding; category 1/2/3 risk tiers; ISO Class 5 cleanroom; environmental monitoring; media-fill testing.
- <800> — Hazardous drugs handling.
Questions to ask:
- Which USP <797> category and resulting BUD?
- Sterility / endotoxin testing per batch or periodic?
- Media-fill testing frequency?
Certificate of Analysis (CoA) Requirements
| Element | Good | Red flag |
|---|---|---|
| Identity | HPLC/MS confirming peptide | Appearance check only |
| Assay | ≥98% | <95% or not tested |
| Water content | <10% for lyophilized | >15% |
| Sterility | USP <71> no growth | Not tested |
| Endotoxin | Peptide-specific limit met | Not tested on injectable |
| HPLC purity | Single dominant peak | "Purity >90%" with no chromatogram |
| Heavy metals | USP <232>/<233> or spec | Not tested |
Red Flags
- Will not provide full CoA
- API "bulk from overseas" without FDA-registered supplier disclosure
- No state pharmacy licensure in ship-to states
- Pricing substantially below compliant 503A market
- Ships to non-practitioner buyers
- Claims compounded product is "the same as" FDA-approved branded drug when molecular entities differ
Summary Decision Aid
Acceptable if all of:
- ✓ Appropriate 503A/503B registration
- ✓ Current state licensure in all ship-to states
- ✓ Complete CoA with HPLC data per batch
- ✓ FDA-registered API supplier with disclosed country of origin
- ✓ USP <797> program with environmental monitoring
- ✓ BUD rationale supported by stability testing
- ✓ Transparent responses to due-diligence questions
- ✓ Returns honored on CoA failures
If any is "no" or "unknown," source elsewhere.
Related Peptides
Regulatory References
- USP <797> Pharmaceutical Compounding — Sterile Preparations (2024)
- USP <800> Hazardous Drugs — Handling in Healthcare Settings (2024)
- FDA Drug Quality and Security Act (DQSA) 2013
- FDA Drug Shortages Database
Referenced in: Module 5 Lesson 5.4