The Precision Peptide Company Inc. (CSE: BPC) (OTCQB: PNGAF) has commented on a U.S. Department of Health and Human Services draft Enforcement Discretion Policy that recognises non-injectable administration routes for six peptides, including BPC-157, under the 503A compounding pathway. The policy, published in the Federal Register on October 30, 2026, lists oral, topical, and intranasal forms alongside injection for select peptides. The company states the development aligns with its existing needle-free delivery strategy and its 16-therapy U.S. prescription telehealth formulary announced on October 29, 2026.

Key Points

  • The Precision Peptide Company Inc. (CSE: BPC) (OTCQB: PNGAF)
  • HHS published a draft Enforcement Discretion Policy on October 30, 2026 covering six peptides — BPC-157, Epitalon, KPV, MOTS-c, Semax, and TB-500 — under the 503A compounding framework
  • BPC-157 is recognised for subcutaneous, intramuscular, oral, and topical forms; the company holds an existing agreement with a U.S.-based 503A sterile compounding pharmacy
  • Investors may be watching how the company's evaluation with its compounding partner progresses and whether the draft policy is finalised by HHS and the FDA

HHS Draft Policy Outlines 503A Compounding Path for Six Peptides

HHS published the Enforcement Discretion Policy in the Federal Register on October 30, 2026, under Docket No. HHS-OASH-2026-0496. The policy describes an interim enforcement approach while the FDA develops its 503A bulk drug substances list, following a July 2026 meeting of FDA's Pharmacy Compounding Advisory Committee, which voted to recommend the same six peptides. Under the policy, HHS states it does not intend to take enforcement action against qualifying state-licensed pharmacies, federal facilities, or licensed physicians compounding from these peptides, provided defined conditions are met, including single-ingredient products, FDA-registered sourcing, lot-level certificates of analysis, valid patient-specific prescriptions, and adverse event reporting.

Needle-Free Routes for BPC-157 Align With BPC's Existing Delivery Strategy

The draft policy recognises oral and topical forms for BPC-157 and KPV, and intranasal use for Semax — routes the company states have been central to its approach since inception. The Precision Peptide Company currently offers needle-free patches, oral and topical formulations, and clinician-prescribed therapies under one brand. CEO Pratap Sandhu stated that the HHS framework, led by BPC-157, builds in verified sourcing, lot-level testing, and safety reporting, and that recognising oral, topical, and intranasal routes alongside injection reflects the company's needle-free first positioning from the outset.

Compounding Agreement and 16-Therapy Formulary Provide Existing Infrastructure

The company notes it holds a compounding agreement with a U.S.-based 503A sterile compounding pharmacy, supported by prescription and telehealth infrastructure established through prior announcements dating to June 2026. Its U.S. telehealth formulary reached 16 prescription therapies across seven therapy areas as of October 29, 2026, with all prescriptions issued by U.S.-licensed clinicians and compounded in the United States. The company states it is evaluating with its 503A compounding partner how the draft policy may apply to its formulary. Importantly, the policy remains a draft and is not binding; it may be revised or withdrawn.