When comparing compounded GLP-1 providers, you'll occasionally see "PCAB Accredited" mentioned as a trust signal. But what exactly does this mean? PCAB accreditation represents the highest voluntary standard for compounding pharmacy quality—and only about 8% of compounding pharmacies have earned it.
What is PCAB?
PCAB stands for the Pharmacy Compounding Accreditation Board, a subsidiary of the Accreditation Commission for Health Care (ACHC). Founded in 2007, PCAB was created to establish and enforce quality standards specifically for compounding pharmacies.
Unlike basic state licensing (which all pharmacies must have), PCAB accreditation is entirely voluntary. Pharmacies choose to pursue it—and pay for the rigorous inspection process—because they want to demonstrate a commitment to quality that goes beyond minimum legal requirements.
Key Fact
Only approximately 8% of the 7,500+ compounding pharmacies in the United States hold PCAB accreditation. This selectivity makes it a meaningful differentiator when evaluating providers.
What PCAB Accreditation Evaluates
To earn PCAB accreditation, a pharmacy must pass a comprehensive evaluation covering multiple domains:
1. Quality Management Systems
- • Written policies and procedures for all compounding activities
- • Documentation and record-keeping standards
- • Error reporting and corrective action processes
- • Regular internal audits and quality reviews
2. Personnel Qualifications
- • Staff training requirements and competency assessments
- • Continuing education programs
- • Proper supervision and delegation protocols
- • Personnel health and hygiene standards
3. Facilities and Equipment
- • Proper cleanroom classifications and design
- • Environmental monitoring (air quality, temperature, humidity)
- • Equipment calibration and maintenance
- • Appropriate laminar flow hoods and isolators
4. Compounding Processes
- • Master formulation records and documentation
- • Proper aseptic technique for sterile compounding
- • Ingredient verification and sourcing
- • Beyond-use dating protocols
5. Quality Testing
- • Potency testing requirements
- • Sterility testing for injectable preparations
- • Endotoxin testing
- • Stability testing and documentation
PCAB vs. Other Certifications
Understanding how PCAB compares to other pharmacy designations helps put its value in context:
| Certification | What It Means | Required? |
|---|---|---|
| State License | Minimum legal requirement to operate | Yes |
| 503A Registration | State-regulated, patient-specific compounding | Yes (for 503A) |
| 503B Registration | FDA-registered outsourcing facility | Yes (for 503B) |
| PCAB Accreditation | Highest voluntary quality standard | No (voluntary) |
| LegitScript | Verifies telehealth platform legitimacy | No (voluntary) |
Why PCAB Matters for GLP-1 Medications
Compounded GLP-1 medications like semaglutide and tirzepatide are injectable sterile preparations. This is the highest-risk category of compounding because contamination or potency errors can directly harm patients.
Sterility Concerns
Injectable medications bypass the body's natural barriers. If a compounded injectable is contaminated with bacteria, fungi, or endotoxins, it goes directly into your body. PCAB-accredited pharmacies must demonstrate rigorous sterility testing and environmental controls.
Potency Consistency
The FDA has found compounded semaglutide with potency ranging from 42% to 170% of labeled strength. PCAB accreditation requires potency testing protocols that help ensure you receive the dose stated on your vial.
Beyond-Use Dating
Compounded medications have shorter shelf lives than manufactured drugs. PCAB standards require pharmacies to establish appropriate beyond-use dates based on stability testing, reducing the risk of degraded medication.
Important Context
PCAB accreditation doesn't make a compounded drug FDA-approved. It simply means the pharmacy has demonstrated adherence to higher quality standards than legally required. Compounded medications still carry risks that FDA-approved medications don't.
How to Verify PCAB Accreditation
If a telehealth provider claims to use a PCAB-accredited pharmacy, you can verify this yourself:
-
1
Ask the provider for the specific name of their compounding pharmacy partner.
-
2
Visit the ACHC website at achc.org (ACHC administers PCAB)
-
3
Search their accreditation directory for the pharmacy name
-
4
Verify accreditation is current and hasn't expired or been revoked
If a provider won't disclose their pharmacy partner or you can't verify the accreditation claim, treat that as a yellow flag.
Why Don't More Pharmacies Get PCAB Accredited?
Given its value as a trust signal, why do only 8% of compounding pharmacies hold PCAB accreditation?
PCAB vs. 503B: Which is Better?
This is a common question. Both represent quality signals, but they're different things:
503B Outsourcing Facilities
- • Registered with FDA
- • Subject to cGMP requirements
- • Regular FDA inspections
- • Can compound without individual prescriptions
- • Federal oversight
PCAB Accreditation
- • Third-party accreditation
- • Rigorous quality standards
- • Comprehensive evaluation process
- • Can apply to 503A or 503B pharmacies
- • Voluntary commitment to excellence
A 503B pharmacy with PCAB accreditation represents the highest combination of regulatory oversight and voluntary quality commitment. However, a PCAB-accredited 503A pharmacy may still provide excellent quality—it just operates under different regulatory frameworks.
The Bottom Line
PCAB accreditation is the gold standard for compounding pharmacy quality. When a pharmacy invests in this voluntary certification, it demonstrates a commitment to safety and quality that exceeds legal requirements.
For compounded GLP-1 medications—which are injectable sterile preparations—pharmacy quality matters significantly. While PCAB accreditation doesn't guarantee perfect outcomes, it provides meaningful assurance that the pharmacy follows rigorous protocols for sterility, potency, and overall quality management.
Find PCAB-Certified Providers
Compare GLP-1 providers and filter by pharmacy certification type. See which use PCAB-accredited or 503B pharmacies.
Compare Providers →