New Louisiana Peptide Protections
The popularity of peptides, such as BPC-157, sermorelin, and TB-500 have exploded in the last few years. And recently an FDA advisory council recommended that six popular peptides be placed on a list more favorable to compounding. However, many of the popular peptides do not yet have approved indications from the Federal Food and Drug Administration (FDA), leading to uncertainty surrounding the rules for compounding and prescribing these medications. While some states such as Indiana have enacted laws seeking to control the compounding of these medications, few states have laws or guidance supporting their use.
A new law in Louisiana, known as SB 253, recently went into effect that provides specific protections to prescribers and entities who compound and prescribe peptides while still deferring to federal rules. The new law requires that occupational licensing boards such as the medical board, nursing board or pharmacy board allow licensees with prescriptive authority to provide patients with peptides. The peptides must be shipped from an FDA registered 503B outsourcing facility or 503A compounding pharmacy that is in compliance with applicable federal rules. The boards are also required to allow licensed pharmacists to compound or dispense peptides provided they are working in a state licensed pharmacy that is in compliance with the United States Pharmacopeia.
Neither of these provisions expand access to peptides directly nor do they expand anyone’s scope of practice. However, they do prevent prescribers and pharmacists from being blocked by their state licensing boards as long as their practices comply with federal rules and the applicable standard of care. As with any new law, there are uncertainties in how it will be implemented. If you are a Louisiana practitioner planning to add peptides to your practice it is advisable to speak with your attorney to ensure that you are in compliance with these requirements.
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