The compounding rulebook, cited.
Know what the rules require of every lot you compound, and whether your paperwork proves it, before an inspector or a rule change finds the gap for you.
Cosmetica maps the federal and state rules that govern what you compound, from 503A and 503B to FDA warning letters, USP chapters and state boards, and checks each API lot’s paperwork against them. A clear picture, not a consultant.
For 503B outsourcing facilities · 503A sterile pharmacies · their telehealth partners
- Form: base peptide, matches the CoA
- Manufacturer: FDA-registered establishment
- Import Alert 66-80: maker on the green list
- CoA has no country of manufacture, which Indiana requires
Findings cite the instrument, never a summary of it
Where the rules stand
The ground moved under compounded GLP-1s.
Two shortages ended, a court upheld FDA, and the enforcement letters kept coming. Each entry here links to its source. This is what the rulebook tracks for every API you compound, not just these three.
As of September 23, 2026 · summaries for orientation, not legal advice
Oct 2, 2024
FDA determines the tirzepatide shortage is resolved, and reaffirms it on December 19. Source
Feb 21, 2025
FDA determines the semaglutide shortage is resolved. Enforcement discretion ends for 503A pharmacies on April 24, when a district court rules, and for 503B facilities on May 22. Source
May 1, 2026
FDA proposes that semaglutide, tirzepatide and liraglutide not be placed on the 503B bulks list. Source
Jun 15, 2026
FDA publishes what telehealth companies must know when they promote compounded drugs. Source
Aug 27, 2026
The Fifth Circuit upholds FDA's removal of both drugs from the shortage list. Source
Sep 18, 2026
An FDA warning letter questions prescriber justifications that repeat across records as a basis for compounding copies. Source
Sep 21, 2026
FDA revises Import Alert 66-80: foreign GLP-1 API is detained unless the maker is on FDA's green list. Source
What the pilot delivers
Rules on one side, your evidence on the other.
The same engine that checks cosmetic formulas against more than 15 markets, pointed at the compounding rulebook. It reads your documents, matches each API to the rules that govern it, and shows the gap, continuously rather than the week before an inspection. Pilot facilities get it first, with us running the checks alongside them while the compounding rulebook is built out.
Your evidence, checked against the rules
Every certificate of analysis and supplier document, read line by line and checked against the rules: whether the API maker is FDA-registered, base form or salt, import-alert green-list status, research-grade or veterinary-grade wording, and the fields your states require on a CoA.
The rulebook, kept current for you
Shortage-list decisions, bulks-list rulings, import-alert revisions and new state rules. When a rule changes, the lots and products it touches are checked again and flagged. Nobody reads the Federal Register on a Friday afternoon.
The FDA paperwork, prepared
For outsourcing facilities, the June and December product reports come out of the data already in the system, in the SPL format FDA requires.
Every finding cited
Each finding shows the rule, the instrument and date behind it, the evidence from your document and what is missing. Export it for your quality file or an inspector.
Lot by lot
Every vial has a paper trail. We read all of it.
Why not what you already use
Every tool you have knows one side. Cosmetica connects them.
| Today | Built for | Where the gap is |
|---|---|---|
| Compliance consultants | Gap assessments, inspection prep and 483 responses, billed by the hour or the engagement | Episodic: they see your paperwork when there is a problem, not every lot |
| Pharmacy and batch-record software | Running the pharmacy: prescriptions, formulas, batch records, inventory | Records what you did; checking each CoA against FDA and state board requirements is left to you |
| Quality-management software | Storing SOPs, deviations, CAPAs and training records | Holds your documents; mapping them to FDA and state board requirements is left to you |
| Regulatory news and alerts | Telling you what FDA or a state board changed | Tells you what changed, not which of your lots it affects |
| Cosmetica | Connecting the rules to your evidence: every lot checked, every finding cited, re-checked when a rule changes | Works alongside them. It doesn’t run your pharmacy or your quality system, and it doesn’t replace testing |
Who it’s for
Built for the people who answer to the inspector.
503B outsourcing facilities
- CGMP and semiannual product reports
- Bulk-substance eligibility, by API
- API sourcing evidence before an inspection
503A sterile pharmacies
- Patient-specific compounding rules
- State API and CoA requirements, where you ship
- Which USP ‹797› version each state enforces
Telehealth platforms and their partners
- What your pharmacy partners compound against
- FDA's June 2026 rules on promoting compounded drugs
- Which pharmacy compounds each product, stated plainly
What we don’t do
A clear picture, not a consultant.
We don't write prescriber justifications.
Whether a compounded drug makes a significant difference for a patient is the prescriber's call. FDA's September 2026 warning letter questioned justifications that repeat across records.
We don't certify you compliant.
We show the rule, the evidence and the gap. Your pharmacist-in-charge and quality unit decide.
We don't replace testing.
Reading a certificate of analysis is not identity, potency or sterility testing. CGMP still requires them.
We're not your lawyer.
Findings are regulatory information with citations, not legal advice.
Questions
Before you ask.
Yes. Semaglutide, tirzepatide and liraglutide are tracked for both 503A pharmacies and 503B outsourcing facilities: shortage-list status, bulk-substance lists, import-alert status for API makers and FDA's letters on copies. The rulebook is organised by API and facility type, so peptides, hormones and the other APIs you compound are covered the same way.
No. Every finding is regulatory information with a citation: the rule, where it comes from, and the evidence from your own documents. Your pharmacist-in-charge, quality unit and counsel make the call. We deliberately do not tell you that you may or may not compound something.
Federal: FDCA sections 503A and 503B, 21 CFR Parts 210 and 211 for outsourcing facilities, FDA guidance and warning letters, the drug shortage list, the bulk drug substance lists and categories, and import alerts. USP chapters 795, 797 and 800. State boards of pharmacy are added state by state, starting with the states you ship to.
No. Whether a compounded drug makes a clinically significant difference for a patient is the prescriber's determination. FDA's September 2026 warning letter questioned justifications that repeat verbatim across records, and software that generates them is exactly that. We show the rules that apply; we do not supply the reasons.
Three recent certificates of analysis and, for an outsourcing facility, your last product report. We run them through the check and walk you through every finding, with the rule and the source behind each one.
Pilot facilities get founding pricing on an annual plan. Tell us your facility type and roughly how many APIs you compound, and we will quote it.
Pilot program
Send us three CoAs. See what the check finds.
We’re onboarding a small number of 503B and 503A facilities. Each finding comes with the rule and the source behind it.
Photos: Chidera Faustina Okeke and Navy Medicine on Unsplash · Vial illustration: Cosmetica