Service — — Quality & Compliance
Quality & Compliance USP Standards, COAs & Testing
Every compounding pharmacy says it is high quality. These are the specific, verifiable things that distinguish one — and what to ask for before you send a prescription.
The USP Chapters That Govern Compounding
These are referenced in federal law and adopted by state boards, which makes compliance enforceable rather than aspirational.
| Chapter | Governs | Why it matters to you |
|---|---|---|
| USP 795 | Non-sterile compounding | Capsules, creams, troches, oral liquids — facilities, training, beyond-use dating |
| USP 797 | Sterile compounding | Anything injectable. Clean-room classification, air quality, personnel validation, sterility testing |
| USP 800 | Hazardous drug handling | Protects personnel and prevents cross-contamination; relevant to certain hormones |
USP 797 Is Not Optional for Injectables
If a pharmacy compounds sterile preparations without USP 797 compliance, it is producing something that should not be injected. This is the single most important verification for any peptide or injectable hormone preparation, and it is a reasonable thing to ask about directly.
What to Verify Before You Prescribe
All of these are answerable. A pharmacy that deflects on any of them is telling you something.
- Active licensure in your state, and non-resident licensure for the patient's state
- USP 797 compliance for any sterile preparation
- Third-party potency testing — and which laboratory performs it
- Sterility and endotoxin testing on injectable lots
- Willingness to provide a certificate of analysis on request
- PCAB accreditation status and when it was last renewed
- Environmental monitoring between validations, not just at certification
- Cold-chain shipping with temperature indicators for sensitive preparations
- FDA inspection history — warning letters, recalls, 483 observations
Why Endotoxin Testing Is Separate From Sterility
Sterility testing confirms no viable organisms. Endotoxin testing looks for bacterial cell-wall fragments, which are pyrogenic and survive sterilisation — a preparation can be sterile and still cause a febrile reaction.
For injectable preparations, both are necessary. A pharmacy that reports only sterility is reporting half the picture.
PCAB Accreditation, and Why Voluntary Matters
PCAB — part of ACHC — audits against compounding-specific standards. No pharmacy is required to hold it.
That is precisely what makes it informative. A pharmacy that has invited an outside audit it never had to pass has made a choice about how it operates. It is not a guarantee, and its absence is not disqualifying, but it is one of the few signals in this industry that costs something to obtain.
Regulatory Status Is Not Static
Peptide compounding status moves as the FDA evaluates bulk drug substances for 503A use. A compound available when you last prescribed it may not be now. Our FDA peptide status tracker is maintained for this, and a partner pharmacy should raise a change before filling rather than after.
FAQ
Common questions
What is USP 797 and why does it matter?
USP 797 governs sterile compounding — clean-room classification, air quality, environmental monitoring, personnel garbing and validation, and sterility testing. It is the essential standard for any injectable preparation.
What should a certificate of analysis show?
Identity, potency, and purity for the specific lot, and for injectables also sterility and bacterial endotoxin results. It should name the testing laboratory. A pharmacy unwilling to provide one on request is worth questioning.
Is PCAB accreditation required?
No, it is voluntary third-party accreditation against compounding-specific standards. Because it is optional, choosing to obtain and maintain it is a meaningful quality signal.
What is the difference between sterility and endotoxin testing?
Sterility testing confirms no viable organisms are present. Endotoxin testing detects bacterial cell-wall fragments that survive sterilisation and can cause fever. Injectable preparations need both.
How do I check a pharmacy's regulatory record?
State board of pharmacy license lookups are public, and FDA warning letters and inspection observations are published in the FDA's databases. Both are searchable by pharmacy name.
Provider Resources
Keep reading
Getting Started
What onboarding actually involves, in order, with the documents you'll need and the parts that typically hold things up.
Read more
Prescribing Guide
A compounded prescription carries more detail than a commercial one, because the pharmacy is making the preparation rather than pulling it from stock.
Read more
Clinical Protocols
Reference material for prescribers, organized by specialty.
Read more
Get In Touch
We Would Love To Hear From You
Send a message and our team will get back to you, typically within one business day. Clients may also call or email us directly.
- 866-206-1806
- customercare@newtropin.com
- 1615 S. Congress Ave, Delray Beach, FL 33445
Send us a message
For full contact form options, visit our contact page.