How to Find a Compounding Pharmacy for Peptides

The peptide compounding landscape in the United States has changed dramatically since 2024. The FDA shut down compounding of semaglutide and tirzepatide after declaring drug shortages resolved, issued more than 50 warning letters to GLP-1 compounders in September 2025, and moved most popular research peptides — including BPC-157, CJC-1295, ipamorelin, and TB-500 — onto restricted lists that effectively ban their compounding. Federal agents raided and shut down at least one major peptide vendor entirely.

If you are looking for a compounding pharmacy that can legally prepare peptide medications, the choices are narrower than they were two years ago. But legitimate options still exist for peptides that remain legally compoundable. Finding the right pharmacy requires understanding the regulatory framework, knowing what to look for, and asking the right questions.

503A vs. 503B: Two Types of Compounding Pharmacies
What Peptides Can Still Be Compounded?
What Peptides Can No Longer Be Compounded?
The Post-FDA Crackdown Landscape
PCAB Accreditation: The Gold Standard
How to Find a Compounding Pharmacy
Questions to Ask Before You Choose a Pharmacy
Red Flags When Evaluating a Compounding Pharmacy
Working With Your Prescriber
What to Expect: Cost and Process
The Bottom Line
References

503A vs. 503B: Two Types of Compounding Pharmacies

Federal law creates two distinct categories of compounding pharmacies, each with different rules, oversight, and capabilities. Understanding this distinction is the first step in finding the right pharmacy.

503A Pharmacies (Traditional Compounding)

Section 503A of the Federal Food, Drug, and Cosmetic Act covers traditional compounding pharmacies. These are the pharmacies most people picture when they think of compounding — a licensed pharmacist preparing a custom medication for a specific patient based on a prescription.

Key characteristics of 503A pharmacies:

Require a patient-specific prescription. Every compounded preparation must be tied to an individual patient and a prescriber's order.
Cannot produce large batches. Unlike drug manufacturers, 503A pharmacies compound in small quantities as needed.
Regulated primarily by state boards of pharmacy. Each state sets its own standards, which creates variation in oversight quality.
Must comply with USP compounding standards adopted by their state, including USP <795> for non-sterile compounding and USP <797> for sterile compounding.
Limited to dispensing for home use. They ship directly to patients, not to clinics or hospitals for office administration.

503B Pharmacies (Outsourcing Facilities)

Section 503B, created by the Drug Quality and Security Act of 2013, established a category called "outsourcing facilities." These are large-scale compounding operations that function more like small pharmaceutical manufacturers.

Key characteristics of 503B pharmacies:

Can produce larger batches with or without patient-specific prescriptions.
Can sell to healthcare facilities for office use — meaning a clinic can stock compounded peptides and administer them directly.
Subject to federal FDA oversight, not just state regulation.
Must follow Current Good Manufacturing Practice (CGMP) requirements, the same standards that apply to drug manufacturers.
Must validate every compounding process and submit batches for testing and stability studies before bringing a new product to market.

Which Type Should You Use?

For most patients receiving peptide therapy through a physician, the practical difference comes down to this:

Factor	503A	503B
Requires prescription	Yes	Can compound without one (for facility use)
Federal FDA oversight	Limited	Yes, direct oversight
Manufacturing standards	USP standards (state-enforced)	CGMP (federally enforced)
Batch testing requirements	Less rigorous	Must validate processes and test batches
Can ship to patients	Yes	Yes
Can supply clinics for office use	No	Yes

If your prescriber works with a 503B outsourcing facility, you are generally getting a product manufactured under stricter federal quality controls. But a well-run 503A pharmacy with PCAB accreditation (more on this below) can also deliver high-quality compounded peptides.

What Peptides Can Still Be Compounded?

As of early 2026, the peptides that can legally be compounded must meet at least one of these criteria:

The peptide is the active ingredient in an FDA-approved drug
It has a USP (United States Pharmacopeia) monograph
It appears on the FDA's Category 1 list of bulk drug substances approved for compounding

Peptides that currently meet these criteria include:

Sermorelin — a growth hormone-releasing hormone analog with a USP monograph
NAD+ — available for compounding under current guidelines
Gonadorelin — a GnRH analog with established compounding status
Oxytocin — FDA-approved with a well-established compounding history

For FDA-approved peptide medications like semaglutide or tirzepatide, compounding is only permitted during FDA-declared drug shortages, which ended in 2025 for both drugs.

What Peptides Can No Longer Be Compounded?

The FDA's Pharmacy Compounding Advisory Committee (PCAC) reviewed numerous peptides for potential inclusion on the 503A Bulks List. All of the following were rejected and remain prohibited for compounding:

BPC-157
Thymosin Alpha 1
TB-500 (Thymosin Beta 4)
CJC-1295 (with or without DAC)
Ipamorelin
AOD-9604
GHK-Cu (injectable form)
Melanotan II
KPV
Selank
Semax
GHRP-2 and GHRP-6

If a compounding pharmacy offers to prepare any of these peptides, they are either operating outside current FDA guidelines or have not updated their practices. Either way, it is a significant red flag.

The Post-FDA Crackdown Landscape

The regulatory environment shifted rapidly between 2024 and 2025. Here is what happened:

October 2024: The FDA removed tirzepatide from its drug shortage list, triggering a 60-day wind-down period for 503A compounders and a 90-day period for 503B facilities.

February 2025: The FDA declared the semaglutide shortage resolved, setting similar wind-down deadlines — April 22 for 503A pharmacies, May 22 for 503B facilities.

March 2025: The Outsourcing Facilities Association filed lawsuits challenging the FDA's shortage determinations. A U.S. district court denied their motions for preliminary injunctions in both the tirzepatide and semaglutide cases.

September 2025: The FDA issued more than 50 warning letters to companies compounding or manufacturing GLP-1 medications, targeting claims that compounded products are "generic versions" or contain the "same active ingredient" as FDA-approved drugs.

State-level enforcement: State attorneys general began independent enforcement actions. Connecticut, for example, shut down a vendor selling raw semaglutide and tirzepatide powders directly to consumers as "research-grade" chemicals with self-injection instructions.

The practical result: if a pharmacy is still advertising compounded semaglutide or tirzepatide in 2026, they are likely not operating within the current regulatory framework.

PCAB Accreditation: The Gold Standard

The Pharmacy Compounding Accreditation Board (PCAB) represents the highest voluntary quality standard for compounding pharmacies in the United States. As of recent data, only about 68 pharmacies nationwide have achieved PCAB accreditation.

What PCAB Accreditation Means

PCAB accreditation means the pharmacy has:

Submitted to the profession's most rigorous independent review and inspection process
Demonstrated compliance with USP <795> (non-sterile compounding), USP <797> (sterile compounding), and USP <800> (hazardous drug handling) standards
Opened their facility to physical inspection by third-party experts
Agreed to annual verification and ongoing compliance monitoring
Documented proof that they meet nationally accepted quality assurance, quality control, and quality improvement standards

PCAB was established in 2007 by eight leading pharmacy organizations, including the American Pharmacists Association, the National Association of Boards of Pharmacy, and the United States Pharmacopeia. It is now administered by the Accreditation Commission for Health Care (ACHC).

How to Verify PCAB Accreditation

Look for the PCAB seal on the pharmacy's website or physical location
Visit the ACHC website at achc.org/pcab to confirm accreditation status
Call ACHC directly at (855) 937-2242, ext. 458, or email customerservice@achc.org

How to Find a Compounding Pharmacy

Online Directories

Alliance for Pharmacy Compounding (APC) Locator: The APC maintains a searchable directory at a4pc.org/find-a-compounder where you can search for compounding pharmacies by location and specialty.

PCCA Member Pharmacies: The Professional Compounding Centers of America (PCCA) is a membership organization that provides compounding pharmacies with training, quality ingredients, and support. PCCA membership, combined with PCAB accreditation, signals that a facility is serious about quality.

State Board of Pharmacy: Your state's board of pharmacy maintains a list of licensed pharmacies, including their compounding designations. This is the most authoritative source for confirming a pharmacy is legally licensed to compound in your state.

Through Your Healthcare Provider

The most reliable path to a legitimate compounding pharmacy is through a physician or nurse practitioner who prescribes peptide therapy. Prescribers who regularly work with compounded peptides typically have established relationships with pharmacies they have vetted. Ask your provider:

Which compounding pharmacy do they use?
Why did they choose that pharmacy?
What quality checks does the pharmacy perform?
Is the pharmacy a 503A or 503B facility?

Through Specialty Clinics

Clinics that focus on hormone optimization, anti-aging medicine, or functional medicine often have relationships with specific compounding pharmacies. While this does not guarantee quality on its own, clinics that stake their reputation on outcomes tend to work with pharmacies that deliver consistent products.

Questions to Ask Before You Choose a Pharmacy

Before filling a compounded peptide prescription, ask the pharmacy these questions:

Licensing and Accreditation

Are you a 503A or 503B compounding pharmacy? Either can be legitimate, but you should know which regulatory framework applies.
Are you PCAB accredited? If not, what third-party quality assessments have you undergone?
In which states are you licensed to compound and ship? A pharmacy must be licensed in both its home state and the state where the patient resides.

Quality Control

Do you test every batch, or only periodic batches? Batch-specific testing is the standard you want.
What tests do you perform? Look for HPLC purity, mass spectrometry identity confirmation, endotoxin testing, and sterility testing at minimum.
Can you provide a batch-specific Certificate of Analysis for my prescription? If the answer is no, that is a problem.
Where do you source your active pharmaceutical ingredients (APIs)? APIs must come from FDA-registered suppliers, not "research use only" sources.

Sterile Compounding Specifics

Do you compound sterile preparations in an ISO-classified clean room? USP <797> requires specific environmental controls for sterile compounding.
What is your beyond-use dating for reconstituted peptides? This tells you how long the pharmacy has validated their product to remain stable and sterile.
How do you ship temperature-sensitive peptides? Proper cold-chain shipping with insulated packaging and cold packs is standard for peptide medications.

Red Flags When Evaluating a Compounding Pharmacy

Walk away if you encounter any of these:

The pharmacy offers to compound peptides that are on the FDA's restricted list (BPC-157, CJC-1295, TB-500, etc.)
No prescription is required for compounded peptide products
They advertise compounded semaglutide or tirzepatide despite the shortage period having ended
They cannot or will not provide batch-specific testing documentation
APIs are sourced from "research use only" suppliers rather than FDA-registered manufacturers
The pharmacy has no identifiable physical address or state licensure information
Prices are dramatically lower than other compounding pharmacies — quality sterile compounding has a cost floor
They market products with health claims ("guaranteed fat loss," "muscle-building," etc.) that legitimate pharmacies would not make

Working With Your Prescriber

A compounding pharmacy requires a prescription from a licensed healthcare provider. Here is how to make that relationship work effectively:

Start with the prescriber, not the pharmacy. Find a physician, nurse practitioner, or physician assistant who has experience with peptide therapy. They will guide you toward appropriate pharmacies.

Discuss which peptides are legally available. Your prescriber should be current on which peptides can and cannot be compounded under today's regulations. If they are recommending peptides that are on the FDA's restricted list, that raises questions about their regulatory awareness.

Ask about monitoring. Legitimate peptide therapy includes baseline lab work and follow-up testing. A provider who prescribes a peptide without any monitoring plan may not be providing adequate care.

Understand that compounded does not mean inferior. Compounded medications fill real clinical needs — dose customization, alternative delivery forms, access to non-commercially-available combinations. The key is that the compounding is done by a qualified pharmacy under appropriate quality controls.

For more on what to expect from peptide therapy, see our guide on understanding peptide side effects and proper injection technique.

What to Expect: Cost and Process

Typical Costs

Compounded peptides are generally not covered by insurance (see our insurance coverage guide for details on which peptides may qualify). Expect to pay out of pocket for most compounded preparations.

Cost ranges vary widely depending on the peptide, dose, and pharmacy:

Cost Component	Typical Range
Compounded peptide vial (e.g., sermorelin)	$100-400 per month
Consultation with prescribing provider	$150-350 (initial), $75-200 (follow-up)
Lab work (baseline and monitoring)	$100-500 depending on panel
Supplies (syringes, alcohol swabs, sharps container)	$20-40 per month

The Process

Consultation with a licensed prescriber who evaluates whether peptide therapy is appropriate
Prescription sent to the compounding pharmacy
Pharmacy compounds the medication and performs quality testing
Medication shipped to you (or in some cases, to your provider's office) with cold-chain packaging
Ongoing monitoring with your prescriber through follow-up visits and lab work

The Bottom Line

Finding a legitimate compounding pharmacy for peptides in 2026 requires more diligence than it did even two years ago. The regulatory landscape has tightened significantly, which is actually good news for patient safety — it means the pharmacies still operating are more likely to be doing so within a proper quality framework.

Focus on these priorities: work with a knowledgeable prescriber, verify that the pharmacy holds appropriate licensure and ideally PCAB accreditation, confirm they follow USP compounding standards, ask for batch-specific testing documentation, and ensure their API sourcing is from FDA-registered suppliers. If a pharmacy can satisfy all of those requirements, you are in strong hands.

The peptides that remain legally compoundable are limited compared to what was available in 2023, but the ones that are available can be prepared safely and effectively by qualified pharmacies operating under proper oversight.

References

FDA. "Clinical Pharmacology Considerations for Peptide Drug Products." Guidance Document, 2025. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-pharmacology-considerations-peptide-drug-products
NCPA. "FDA Releases Guidance for Compounding Pharmacies." January 2025. https://ncpa.org/newsroom/qam/2025/01/13/fda-releases-guidance-compounding-pharmacies
Frier Levitt. "Regulatory Status of Peptide Compounding in 2025." https://www.frierlevitt.com/articles/regulatory-status-of-peptide-compounding-in-2025/
Wilson Sonsini. "FDA Sends Warning Letters to More Than 50 GLP-1 Compounders and Manufacturers." September 2025. https://www.wsgr.com/en/insights/fda-sends-warning-letters-to-more-than-50-glp-1-compounders-and-manufacturers.html
NCPA. "FDA Ends Compounding Discretion for Tirzepatide, Maintains Discretion for Semaglutide." March 2025. https://ncpa.org/newsroom/qam/2025/03/13/fda-ends-compounding-discretion-tirzepatide-maintains-discretion
CNN. "FDA Crackdown on Off-Brand Ozempic Products Set to Take Effect." May 2025. https://www.cnn.com/2025/05/21/health/fda-compounded-semaglutide-tirzepatide-crackdown
ACHC. "PCAB Accreditation for Compounding Pharmacies." https://achc.org/pcab-compounding-pharmacy/
Alliance for Pharmacy Compounding. "Find a Compounding Pharmacy." https://a4pc.org/find-a-compounder
The FDA Group. "503A vs. 503B: A Quick-Guide to Compounding Pharmacy Designations & Regulations." https://www.thefdagroup.com/blog/503a-vs-503b-compounding-pharmacies
SafeHG. "FDA's Overreach on Compounded Peptides: Legal Battles and How Clinics Can Push Back." 2025. https://www.safehg.com/fdas-overreach-on-compounded-peptides-legal-battles-and-how-clinics-can-push-back/

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