Highlights
All six peptides covered by the new HHS policy being added: BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500 are being added to the Company's prescription platform, with availability to patients expected in November 2026
Underway within a week of publication: the Company began adding all six peptides within a week of the policy's publication in the Federal Register on October 30, 2026
Built to the policy's standards: each peptide will be prescribed as a single-ingredient compounded product, prepared from bulk drug substance supplied with a lot-specific certificate of analysis, in the dosage forms set out in the policy
Clinician-prescribed and U.S.-compounded: every prescription is issued by a U.S.-licensed clinician following a clinical review and compounded in the United States by a licensed 503A pharmacy
Builds on a growing prescription platform: follows the Company's expansion of its U.S. telehealth formulary to 16 prescription therapies across seven therapy areas, announced October 29, 2026
Vancouver, British Columbia--(Newsfile Corp. - November 5, 2026) - The Precision Peptide Company Inc. (CSE: BPC) (OTCQB: PNGAF) (the "Company" or "BPC"), a publicly traded wellness company focused on advanced peptide formulations and delivery systems, today announced that it is adding all six peptides covered by the U.S. Department of Health and Human Services' ("HHS") interim enforcement policy, titled "Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances" (the "Policy") to its prescription platform, a process it began within a week of the Policy's publication in the Federal Register. The six peptides are expected to be available to patients in November 2026.
The six peptides are BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500.
Moving early on a new federal Policy
HHS published the Policy in the Federal Register on October 30, 2026 under Docket No. HHS-OASH-2026-0496. While the U.S. Food and Drug Administration ("FDA") develops, through rulemaking, the list of bulk drug substances that may be used in compounding under section 503A of the Federal Food, Drug, and Cosmetic Act (the "503A bulks list"), HHS has stated that it does not intend to take enforcement action against State-licensed pharmacies, Federal facilities or licensed physicians compounding products from these six peptides, provided the conditions outlined in the Policy are met. The Policy follows the July 2026 meeting of FDA's Pharmacy Compounding Advisory Committee, which voted to recommend the same six peptides for the 503A bulks list.
The Company commented on the Policy and its relevance to the Company's U.S. prescription platform on November 3, 2026. Two days later, all six peptides are being added to that platform, with availability to patients expected in November 2026.
How it works
Patients complete a secure online health assessment, which is reviewed by a U.S.-licensed clinician to determine whether a therapy is clinically appropriate. Approved prescriptions are compounded in the United States by a licensed 503A pharmacy through the Company's prescription and compounding partners, and shipped directly to patients.
Each of the six peptides will be prepared in line with the Policy's conditions:
- Single active ingredient: each product will contain only one active pharmaceutical ingredient, a peptide listed in the Policy;
- Verified sourcing: bulk drug substance from an FDA-registered manufacturer operating under current good manufacturing practice, supplied with a valid lot-specific certificate of analysis;
- Dosage forms set out in the Policy: each peptide will be prepared only in the dosage forms specified in the Policy;
- Patient-specific prescriptions: every product will be dispensed against a valid prescription from a licensed clinician; and
- Safety reporting: serious adverse events and product quality issues will be reported to FDA.
Pratap Sandhu, CEO of The Precision Peptide Company, commented:
"When HHS published this policy, we did not wait. We spent the past year building a U.S. prescription platform, with licensed clinicians, U.S. compounding and the infrastructure to serve patients nationwide, so that when the framework arrived we could move. Within a week of publication, we are adding all six covered peptides to our platform, prepared to the standards HHS has set out, and we expect patients to have access this month. This is what being ready looks like."
About The Precision Peptide Company
The Precision Peptide Company (CSE: BPC) (OTCQB: PNGAF) is a publicly traded wellness company building a next-generation platform for high-quality peptide formulations. By combining scientific formulation and innovative delivery technologies, the Company creates products at the intersection of biotechnology and scalable consumer wellness. Products are manufactured in an approved U.S. facility and distributed across North America. For more information, visit: www.precisionpeptidecompany.com.
Important Information
The Policy is an interim enforcement policy. It is not binding on HHS or the public, and may be revised or withdrawn, including if a safety signal or product quality issue arises. It applies only to compounded drug products prepared under section 503A and does not constitute FDA approval of any peptide. Whether any of the six peptides is added to the 503A bulks list will be determined through future FDA rulemaking.
The prescription therapies described in this news release are compounded medications. Compounded medications are not FDA-approved and have not been evaluated by the FDA for safety, effectiveness or quality. They are not equivalent to, or substitutes for, any FDA-approved product. They are available only by prescription from a licensed clinician following a clinical review, and may not be appropriate for all individuals. Availability of individual therapies is subject to applicable law and pharmacy supply. Nothing in this news release constitutes medical advice.
Forward-Looking Information
This news release contains forward-looking statements and forward-looking information within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward-looking statements or information. Forward-looking information includes, without limitation, statements regarding the addition of BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500 to the Company's U.S. prescription platform and their expected availability to patients in November 2026; the anticipated application of the Policy to those therapies and the Company's prescription and compounding arrangements; future FDA rulemaking and decisions regarding the inclusion of any of the six peptides on the 503A bulks list; the continued availability of the Company's prescription therapies; and the Company's development of its prescription, telehealth and peptide wellness platform.
The forward-looking statements and forward-looking information are based on assumptions management considers reasonable, including assumptions regarding the regulatory framework applicable to 503A compounding or future FDA decisions; that the Policy remain available on terms that permit the compounding and dispensing of the six peptides; that the Company can complete the addition of all six peptides in November 2026; the Company's and its partners' ability to satisfy applicable conditions under the Policy; the Company's ability to maintain its prescription and telehealth infrastructure and third-party arrangements; and continued customer demand for the Company's products and services. Although management of the Company believes that the expectations and assumptions on which such forward-looking statements and information are based are reasonable, undue reliance should not be placed on the forward-looking statements and information since no assurance can be given that they will prove to be correct.
Forward-looking statements and information are provided for the purpose of providing information about the current expectations and plans of management of the Company relating to the future. Readers are cautioned that reliance on such statements and information may not be appropriate for other purposes, such as making investment decisions. Since forward-looking statements and information address future events and conditions, by their very nature they involve inherent risks and uncertainties. Actual results could differ materially from those currently anticipated due to a number of factors and risks. Risk factors include, but are not limited to, delays in completing the addition of any or all of the six peptides to the Company's prescription; the risk that the Policy may may be revised or withdrawn; uncertainty regarding the timing and outcome of future FDA rulemaking t; changes in laws, regulations, regulatory guidance or enforcement priorities affecting 503A compounding, telehealth, prescribing or the sale and distribution of the Company's products; reliance on third-party prescribing, pharmacy and fulfillment partners and their ability to maintain required licences and comply with applicable requirements; disruptions to the telehealth platform or delivery of therapies to patients; risks relating to the safety, effectiveness and quality of compounded medications; the risk that customer demand may not meet expectations; and general economic and market conditions. Additional risk factors are described in the Company's continuous disclosure filings available on SEDAR+ at www.sedarplus.ca.
The Canadian Securities Exchange has not reviewed, approved or disapproved the contents of this news release.

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