Here’s the latest:

Hells Canyon Pharmacy is committed to compliance with all federal and state regulations governing the compounding of medications, including Section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA). We affirm that our practice of compounding semaglutide with vitamin B12 is lawful and does not violate any provisions outlined in Section 503A for the following reasons:

1.     Patient-Specific Prescriptions – Our pharmacy compounds semaglutide with B12 only upon receipt of valid, patient-specific prescriptions issued by licensed healthcare practitioners. As per Section 503A, compounded medications must be prepared based on individual patient needs, ensuring they are not produced in bulk for mass distribution.

2.     Use of Bulk Drug Substances – Section 503A permits the use of bulk drug substances in compounding as long as they comply with the U.S. Pharmacopeia (USP) or National Formulary (NF) standards, or appear on the FDA’s approved list. The semaglutide utilized in our formulations meets these standards, and our sources comply with all federal and state regulatory requirements.

3.     No Commercially Available Equivalent – Compounded semaglutide with B12 is intended to address specific patient needs, such as reducing nausea associated with semaglutide therapy. Section 503A allows compounding of medications that are not "essentially a copy" of a commercially available drug unless the compounded formulation provides a clinical difference for an individual patient as documented by the prescribing healthcare provider.

4.     Compliance with FDA and State Regulations – Our pharmacy strictly follows current good compounding practices (cGCPs) and all applicable regulatory guidelines. We do not compound medications that have been withdrawn or removed from the market due to safety concerns, and we ensure that our processes meet the highest quality standards.

5.     Interstate Distribution Limitations – We adhere to FDA-mandated limits on interstate distribution and comply with state-specific licensing and reporting requirements, further ensuring compliance with Section 503A.

Given these factors, our pharmacy remains in full compliance with Section 503A of the FDCA and will continue to safely and legally compound semaglutide with B12 to meet the individual needs of patients as prescribed by their healthcare providers.