October 20, 2026 | FDA & Healthcare Regulatory Update
The FDA is taking steps toward potentially expanding access to certain compounded peptides, including BPC-157. On October 14, 2026, the agency submitted a proposed policy titled “Interim Access Policy for Compounding Using Certain Peptides” to the White House Office of Information and Regulatory Affairs (OIRA) for review.
Although the policy has not yet been published, reporting from The Washington Post and Associated Press indicates that the administration intends to temporarily permit certain peptides to be compounded under an FDA enforcement-discretion policy.
For compounding pharmacies, telehealth companies, and medical practices, this development could create significant new business opportunities. However, the scope of the proposed policy, its implementation timeline, and the conditions for participation remain uncertain.
Here is what we know and what healthcare businesses should be considering now.
What Is FDA Planning to Change?
On October 7, 2026, The Washington Post reported that the administration was developing a temporary policy allowing compounding pharmacies to dispense certain previously restricted peptides while FDA considers longer-term regulatory changes.
On October 15, Associated Press reported that two people familiar with the proposal confirmed the anticipated policy would permit temporary compounding of certain peptides, specifically identifying BPC-157.
The proposed mechanism is enforcement discretion.
Rather than immediately changing federal compounding regulations, FDA could announce that it does not intend to pursue certain enforcement actions against pharmacies that compound specified peptides under defined conditions.
This approach could provide an interim pathway for qualifying pharmacies while FDA evaluates whether to formally add those substances to its authorized bulk drug substances list.
However, FDA has not publicly released the draft policy, and the information reported by these publications has not been independently confirmed through the actual policy text.
Which Peptides Could Be Covered?
In July 2026, FDA's Pharmacy Compounding Advisory Committee reviewed seven peptides for potential inclusion on the Section 503A bulk drug substances list.
According to the Alliance for Pharmacy Compounding (APC), the committee recommended six peptides for inclusion:
- BPC-157
- TB-500
- KPV
- MOTS-c
- Semax
- Epitalon
The committee did not recommend the seventh substance, emideltide (DSIP).
These recommendations are significant because FDA's scientific reviewers previously expressed concerns regarding the available evidence of safety and effectiveness.
The committee's recommendations are advisory, however, and do not themselves change the law.
The full list of peptides covered by the proposed interim access policy remains unknown. Although BPC-157 has been specifically identified in media reporting, there is no confirmation that FDA will include all six peptides recommended by the committee.
The final policy may also distinguish among different chemical forms, routes of administration, or formulations of the same peptide.
What About BPC-157's Previous Category 2 Classification?
There is an important regulatory distinction that businesses should understand.
FDA previously classified BPC-157 as a Category 2 bulk drug substance based on identified potential safety risks.
However, FDA's April 2026 updates removed BPC-157 from Category 2 because the relevant nominations had been withdrawn. FDA subsequently considered BPC-157-related substances through its July advisory committee process.
Removal from Category 2 did not automatically make BPC-157 eligible for compounding.
A substance's removal from a safety-risk category, its nomination for the 503A bulks list, and its legal eligibility for compounding are separate regulatory issues.
The proposed interim access policy could provide greater clarity, but the specific conditions will not be known until publication.
When Will the New FDA Peptide Policy Take Effect?
The policy could potentially be released before the end of 2026, but FDA has not announced an effective date.
The policy was submitted to OIRA on October 14, 2026, and remains listed as “Pending Review.”
An OIRA meeting concerning the policy is scheduled for October 21, 2026, at the request of the American Academy of Peptide Medicine. This stakeholder meeting does not constitute policy approval or establish a publication or effective date.
Under Executive Order 12866, OIRA generally has 90 calendar days to complete review of many covered regulatory actions. Certain preliminary actions are subject to shorter review periods, and extensions are permitted.
If the ordinary 90-day period applied to this submission, the corresponding date would be approximately January 12, 2027.
However, the official OIRA filing identifies no legal deadline, and the public record does not establish which review period governs this particular Notice. January 12 should therefore not be interpreted as an anticipated effective date or mandatory deadline.
A release during the remaining months of 2026 is possible, but review and implementation could also extend into 2027.
Importantly, completion of White House review is not necessarily the same as implementation. FDA must still publicly issue the policy, which may specify when its provisions become operative.
If FDA adopts an enforcement-discretion policy effective upon issuance, eligible pharmacies may be able to begin operating under its terms without waiting for formal rulemaking. Alternatively, the agency could establish additional conditions or a later implementation date.
For businesses planning peptide programs, the appropriate strategy is to prepare for a possible regulatory change while avoiding commitments to a launch date that FDA has not confirmed.
Will the New Policy Make Peptide Compounding Legal?
Not automatically.
Section 503A of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 353a, establishes conditions under which qualifying compounded drugs are exempt from certain federal requirements.
For bulk drug substances that lack an applicable USP or NF monograph and are not components of FDA-approved drugs, Section 503A(b)(1)(A)(i)(III) requires substances:
"that appear on a list developed by the Secretary through regulations issued by the Secretary under subsection (c);"
Section 503B establishes a separate framework for outsourcing facilities, including its own bulk drug substance requirements involving FDA's clinical-need list and the drug shortage list.
FDA already maintains separate interim enforcement policies under Sections 503A and 503B.
The forthcoming peptide policy may modify the agency's enforcement approach for one or both categories, but its coverage has not been disclosed.
An enforcement-discretion policy also would not constitute FDA approval of the affected peptides or amend the statutory requirements for compounding.
This distinction has several practical consequences.
First, FDA's decision not to pursue certain enforcement actions would not necessarily prevent state pharmacy boards or other regulators from enforcing independently applicable requirements.
Second, an interim policy would not establish that a particular peptide is safe or effective for any intended treatment.
Third, permission to compound a drug does not automatically resolve the legal requirements governing its prescribing, dispensing, administration, or marketing.
Telehealth companies and medical practices must independently consider applicable state medical practice laws, prescribing requirements, clinical oversight obligations, advertising restrictions, and healthcare business structure requirements.
What Safeguards Could FDA Require?
The Alliance for Pharmacy Compounding has been advocating for a temporary enforcement-discretion pathway, subject to patient-safety protections.
Its publicly available proposal recommends validated active pharmaceutical ingredient sourcing, prescriber oversight, enhanced patient disclosures, adverse-event reporting, and collection of de-identified dispensing information.
APC has also proposed continued enforcement against businesses unlawfully marketing research-use-only peptides for human consumption.
These recommendations provide insight into the type of regulatory framework that might emerge.
However, they remain industry proposals, not confirmed FDA requirements.
The final policy could adopt some, all, or none of these recommendations, or establish different conditions altogether.
What Should Compounding Pharmacies and Telehealth Companies Do Now?
Businesses considering entering or expanding in the peptide market may benefit from evaluating their compliance infrastructure before FDA's policy is released.
For compounding pharmacies, preparation may include reviewing bulk ingredient sourcing, compounding procedures, pharmacy licensing, applicable USP standards, patient disclosures, and compliance with existing FDA guidance.
For telehealth companies and medical practices, relevant considerations include clinical protocols, prescriber licensing, physician supervision or collaboration, patient consent, pharmacy partnerships, and interstate telehealth requirements.
For businesses developing integrated peptide programs, particular attention should be given to the allocation of regulatory and clinical responsibility among the telehealth platform, medical practice, and dispensing pharmacy.
These arrangements may also raise corporate practice of medicine, fee-splitting, anti-kickback, and advertising compliance considerations.
Importantly, companies should avoid launching new peptide programs based solely on the expectation of a favorable FDA policy.
Advance preparation may reduce the time required to launch a compliant program once the policy is issued, but the legal framework must be evaluated before implementation.
What Happens Next?
The immediate next step is completion of OIRA's review and publication of the FDA policy.
The final document should clarify which peptides are covered, which pharmacies or outsourcing facilities may qualify, the scope of FDA's enforcement discretion, and any additional safeguards or implementation requirements.
The October 14 submission represents a meaningful development for the peptide industry. Combined with FDA's July advisory committee proceedings and publicly reported administration plans, it provides evidence that a new regulatory pathway is under active consideration.
However, the actual policy remains the decisive document.
For pharmacies, telehealth companies, and medical practices, the key question is not simply whether FDA will expand peptide access, but how businesses can structure their operations to comply with the new policy and existing federal and state laws.
Legal Guidance for Peptide Compounding and Telehealth Businesses
Our healthcare regulatory practice advises compounding pharmacies, telehealth companies, medical practices, and healthcare businesses on FDA compliance, pharmacy regulations, corporate practice of medicine restrictions, healthcare transactions, and telemedicine operations.
Businesses considering launching or expanding peptide programs should evaluate their pharmacy relationships, business structures, clinical arrangements, and regulatory obligations before implementation.
Contact our healthcare regulatory attorneys to discuss a pre-launch compliance review or the legal requirements applicable to your peptide business.
Sources
- FDA Interim Peptide Access Policy — Official OIRA Review Record
- FDA Pharmacy Compounding Advisory Committee — July 23–24, 2026
- FDA — Bulk Drug Substances Nominated Under Section 503A
- FDA — Interim Policy on Compounding Under Section 503A
- Alliance for Pharmacy Compounding — Peptide Regulatory Proposals
- 21 U.S.C. § 353a — Pharmacy Compounding
- 21 U.S.C. § 353b — Outsourcing Facilities
- Executive Order 12866 — Regulatory Planning and Review
- The Washington Post — October 7, 2026 Reporting
- Associated Press — October 15, 2026 Reporting
This article provides general legal and regulatory information and does not constitute legal advice.
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