How to offer BPC-157 to your business
Learn how to add BPC-157 to your business under HHS's interim 503A compounding policy, from pharmacy sourcing and clinical protocols to state compliance.
Disclaimer: This content is intended for general informational purposes only and should not be construed as legal advice. For guidance on your specific situation, consult a licensed attorney.
The interim enforcement discretion policy from the U.S. Department of Health and Human Services (HHS) now covers BPC-157 acetate for 503A compounding when specific conditions are met.
Interest in peptides is growing. If you’re looking at how to add BPC-157 to your business, start with the policy’s boundaries. Then consider how the offering would fit your services, which clinicians and pharmacy partners you need, and how you’ll manage the patient experience.
Here’s what to know before you build a program.
What is BPC-157 acetate?
What is BPC-157?
BPC-157 is a synthetic 15-amino-acid peptide.
What the research shows
Most published research comes from laboratory and animal studies, including studies of gastrointestinal, tendon, ligament, and muscle injury models. A 2025 systematic review described the research as promising in animals and limited in humans.¹
In July 2026, FDA reviewed BPC-157 for ulcerative colitis. FDA staff concluded that evidence was lacking to determine whether it is effective for that condition. FDA also reported adverse event case reports involving compounded BPC-157 products, although it noted that the information available did not show whether BPC-157 caused the events, and it raised immunogenicity concerns for certain routes of administration.2,3
However, HHS gives three reasons for including BPC-157 under Appendix B in the interim policy:
- Use history. Historical use is now documented and quantified, including multiple human studies.
- Quality evidence. A lot-specific certificate of analysis from an FDA-registered facility now covers the identity, impurity, endotoxin, microbial, and residual solvent results that FDA’s Center for Drug Evaluation and Research (CDER) previously found lacking.
- Built-in safeguards. The policy’s conditions address remaining risks through lot-level testing, single-ingredient products, and MedWatch reporting.
Why are businesses wanting to add BPC-157?
Grand View Research estimates that the global peptide therapeutics market was worth $140.86 billion in 2025 and projects it will reach $294.58 billion by 2033. That estimate covers the broader peptide therapeutics market, not BPC-157 specifically. However, BPC-157 alone receives roughly 300,000 monthly searches in the U.S. broadly (Google Keyword Trends, Jun 2025–May 2026).
Is BPC-157 legal to prescribe?
BPC-157 falls under HHS’s nonbinding interim enforcement discretion policy for 503A compounding. It is not on the 503A Bulks List or Category 1, and the policy does not mean it is FDA-approved or creates a safe harbor. HHS can narrow or withdraw the policy, and state requirements still apply. As stated in the draft policy, the HHS will not take enforcement action on compounded BPC-157 as long as all specified requirements are met.
What forms of BPC-157 does the policy cover?
The policy covers BPC-157 acetate only. Other salt forms, including free base, fall outside the policy. The policy permits four routes of administration:
- Subcutaneous injection
- Intramuscular injection
- Oral
- Topical
For oral formulations, the compounder must document that the specific formulation achieves adequate human oral bioavailability. Each compounded product may contain only one covered peptide. Combinations in a single vial such as BPC-157 with TB-500 fall outside the policy.
How to add BPC-157 to your business
If you want to offer BPC-157, it’s important to prioritize building a compliant, clinician-led, and patient-first infrastructure that aligns the requirements laid out by the interim policy.
Step 1: Decide where BPC-157 fits
Start with your existing services and patient population. Does a BPC-157 offering fit your focus? Are your patients already asking for it?
Consider three things:
- Patient demand: Is there a clear audience for this service?
- Clinical capacity: Do you have access to licensed clinicians who can evaluate patients, determine whether prescribing is appropriate, and oversee care?
- Brand fit: Can you explain the service accurately without making claims about outcomes?
If you’re planning to offer multiple peptide therapies, you’ll also need to consider how each fits your clinical services, prescribing workflows, pharmacy relationships, and patient care processes.
Step 2: Choose your care delivery model
In-person vs. Hybrid vs. Virtual
Decide whether the service will be in person, virtual, or hybrid. Your model affects how patients access consultations, prescriptions, administration, and follow-up.
It also determines certain regulatory restrictions. For instance, multi-state virtual care requires a provider in each state and alignment to that state’s compounding policies. Also, certain states may have different compounding laws and regulations.
Ensure the delivery model works with your clinical team, pharmacy partner, and applicable state requirements.
Step 3: Build the clinical and regulatory foundation
Before accepting patients, establish who is responsible for clinical decisions and how the program will operate.
At a minimum, define:
- Which licensed clinicians can evaluate patients and prescribe
- Do you have the provider capacity to support this program
- How the pharmacy receives a valid, patient-specific prescription
- How clinical rationale and prescribing decisions are documented
- Which supervision and practice requirements apply in each state
- How patient eligibility, consent, follow-up, and escalation are handled
Prescription of a peptide is always under the discretion and clinical judgment of the provider based on patient health and data.
Step 4: Vet your pharmacy partner
Work with a state-licensed 503A compounding pharmacy and confirm it can meet the policy’s specific requirements. Ask about:
- BPC-157 form: The pharmacy compounds BPC-157 acetate only, not free base or other forms.
- COA documentation: Each bulk substance has a valid, lot-specific COA with testing for identity, purity, potency, and harmful contaminants, including endotoxins, heavy metals, and microbial contamination.
- Supplier validation: If the pharmacy sources the substance through a repacker, relabeler, or reseller, that intermediary must document validation of the original manufacturer and its COA.
- Compounding standards: The pharmacy follows applicable USP standards, including USP Chapter 797 for sterile compounding, and maintains appropriate controls to prevent insanitary conditions.
- Product restrictions: Each compounded product contains only one active pharmaceutical ingredient (API). BPC-157 and TB-500 combinations, for example, fall outside the policy.
- Oral formulations: The pharmacy maintains documentation that the specific formulation achieves adequate oral bioavailability in humans.
- Delivery devices: Any device co-packaged with or containing the compounded product is an FDA 510(k)-cleared syringe.
- Reporting and labeling: The pharmacy reports compounded products, serious adverse events, and product quality issues to FDA and applicable state authorities. Patient labeling must include the statement “This is a compounded drug product. Not for resale.” and explain how to report adverse events and product quality issues.
- State requirements: Confirm the pharmacy has the required authority and licensure for the states where it compounds and dispenses, as applicable under state law.
The policy is intended to discourage continued widespread use of certain research-use-only peptides from foreign manufacturers that pose safety risks. The practical safeguard is to verify the source, manufacturer registration, and COA rather than rely on a supplier’s research-use-only or other marketing label.
If you’re evaluating potential partners, understanding how 503A compounding pharmacies work can help you ask more informed questions.
Step 5: Standardize the patient journey, with clinicians at the center
Map the experience from the first inquiry through follow-up. Patients should understand what the product is, what is known about the research, and what the limitations are.
Build a consistent process for:
- Intake and clinical evaluation
- Informed consent
- Prescription and dispensing coordination
- Patient instructions and follow-up
- Reporting and escalation if a patient experiences a side effect or has a product quality concern
Give patients clear instructions for contacting your team. Define who reviews a report, when the prescribing clinician gets involved, and how serious concerns are escalated.
Step 6: Set up the technology
Your systems should support intake, clinical documentation, secure patient messaging, pharmacy coordination, and follow-up. Decide where each part of the process lives and who is responsible for keeping records current.
Step 7: Plan for policy changes
This is an interim policy, not a permanent change to the 503A Bulks List. HHS may revise or withdraw its enforcement discretion, including in response to safety or product quality concerns.
Keep an eye on updates from HHS and the FDA, including formal action on the 503A Bulks List. Have a plan for communicating with patients and adjusting operations if the policy changes.
Work to add peptides to your business faster with OpenLoop
Building a peptide program takes more than finding a pharmacy. OpenLoop® offers infrastructure to help businesses develop and operate peptide services, including:
- 503A pharmacy partners where permitted by law
- Medically reviewed protocols
- A 50-state clinician network
- Compliance-aligned infrastructure
- 24/7/365 patient support
Contact OpenLoop to discuss your business and program needs.
Compounded drugs are not FDA-approved. FDA does not review compounded drugs for safety, effectiveness, or quality. The peptides discussed in this article have not been approved by FDA for recovery or performance. Compounded preparations require a prescription following an appropriate clinical evaluation, and no prescription is guaranteed. Availability varies based on clinical appropriateness, applicable federal and state laws, pharmacy availability, and other regulatory requirements. Not all peptide therapies are available in all states or through all pharmacies.
This content is for general informational purposes only. It is not medical or legal advice and does not create a clinician-patient or attorney-client relationship. For guidance on your specific situation, consult a licensed clinician or attorney.
References:
- Vasireddi N, et al. Emerging use of BPC-157 in orthopaedic sports medicine: a systematic review. 2025. PMID 40756949. https://pubmed.ncbi.nlm.nih.gov/40756949/
- U.S. Food and Drug Administration. Briefing Document: BPC-157-Related Bulk Drug Substances, Pharmacy Compounding Advisory Committee, July 23, 2026. https://www.fda.gov/media/193343/download
- Regulatory Affairs Professionals Society. FDA advisory committee backs two controversial peptides (July 23, 2026). https://www.raps.org/resource/fda-advisory-committee-backs-two-controversial-peptides.html
