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doi: 10.1002/hep.20280 44

The FDA Category 2 Framework and the July 2026 PCAC Meeting In 2023, the FDA created a list of 19 peptides classified as Category 2: substances that do not currently fit the five legal compounding categories but have enough clinical interest and accumulated safety data to warrant regulatory review

In addition, the applicant noted that there are differences in the FDA indications, applicable CPT codes, and APC assignments for the nominated device and the original (lumbar-specific) aprevo device

Cignarella A, Mioni R, Sabbadin C, et al

Front Endocrinol

At 2 to 8C, protected from light, in the original vial