Biologics Distribution for Miami Medspas and Dermatology Practices

Where SB 1768 does and does not apply

Florida's SB 1768 addresses physician use of certain non-FDA-approved stem cell therapies in orthopedics, wound care and pain management; it does not extend to aesthetic or cosmetic dermatology use. Miami medspas and dermatology practices should not assume the statute covers aesthetic procedures and should confirm general requirements with the Florida Board of Medicine and their own counsel.

Precision Biologics does not provide clinical or legal advice on how any state or federal rule applies to a specific practice.

Account verification for medspas and dermatology practices

Because products are sold only to licensed clinics, physician-supervised medspas and physicians, account setup confirms a supervising physician's license and NPI number for medspas, or the practice's own NPI number for dermatology and plastic surgery practices.

Documentation and shipment handling

Verified accounts can request a certificate of analysis, donor eligibility summary and lot release record for a specific lot, plus full ingredient disclosure for lyophilized exosome formats.

Cryopreserved formats ship overnight on dry ice in validated containers for -80 degree Celsius storage; lyophilized formats are shelf-stable and arrive with a product insert describing storage and reconstitution. Practices should log the lot number at receipt.

FDA has stated there are no FDA-approved exosome products. Exosome products are generally regulated as biologic drugs under section 351 of the Public Health Service Act, not as 361 HCT/Ps. Purchase and clinical use decisions belong to the physician with their own regulatory counsel.

These products are not FDA approved or licensed for any disease or condition. Information is for licensed healthcare professionals and is not medical or legal advice.