The American Peptide Access Act - American Legislative Exchange Council - American Legislative Exchange Council

The American Peptide Access Act

Prior to task force meetings, ALEC posts these legislative member-submitted draft model policies to our website. The draft model policies are then discussed, debated, and voted on by ALEC task force members. Policies that receive final approval by legislators on the ALEC Board of Directors become official ALEC model policy. Draft model policies that fail to become official ALEC model policy are removed from the website.

Summary

In recent years, peptides have surged in popularity among patients and clinicians seeking targeted therapies for wellness, recovery, and longevity. This proposed model bill provides regulatory certainty for healthcare providers, pharmacists, and state-licensed compounding pharmacies who are lawfully prescribing, compounding, and dispensing peptides, establishing a state-level safeguard that reinforces the FDA's ongoing effort to formally clarify the legal status of these compounds. This bill ensures that clinicians and patients have access to peptides that are compounded and dispensed in the United States by licensed pharmacists, providing enhanced accountability and protecting patients from the quality and sterility risks posed by unregulated, grey market overseas suppliers. Relative to peptides; to provide for the regulation of peptides by licensing boards; to provide requirements for providers and compounding pharmacies; and to provide for related matters.

Draft

The American Peptide Access Act

Be it enacted by the State of ______________:

Section 1: Peptides; Patient Right to Try.

(a) As used in this Section:
1. “Peptide” means an alpha amino acid polymer with a specific, defined sequence fewer than 40 amino acids in size, which may be used in compounded products in accordance with applicable state and federal law.
  - (i) “Peptide” includes, but is not limited to, BPC–157 (free base), BPC–157 acetate; KPV (free base), KPV acetate; TB–500 (free base), TB–500 acetate; MOTs-C (free base), MOTs-C acetate; Emideltide (free base), Emideltide acetate; Semax (free base), Semax acetate; and Epitalon (free base), Epitalon acetate.
(b) No professional or occupational licensing board shall prohibit or discipline a healthcare provider licensed in this state for prescribing or compounding a peptide.
(c) The prescribing healthcare provider shall either (i) compound the peptide or (ii) ensure any peptide prescribed pursuant to this Section is compounded by an FDA-registered 503B outsourcing facility or state-licensed pharmacy authorized to compound products.
(d) No professional or occupational licensing board shall prohibit or discipline a State-licensed pharmacy authorized to compound products for the act of compounding and dispensing a lawfully prescribed peptide.
(e) No professional or occupational licensing board shall prohibit a federally registered outsourcing facility from compounding or dispensing a peptide so long as the federally registered facility is in compliance with 21 U.S.C. 353b.
(f) No professional or occupational licensing board shall prohibit or discipline a licensed pharmacist for the act of compounding or dispensing a peptide that is lawfully prescribed.