The voice for compounding pharmacy  |  October 4, 2019
Compounding peptides? Take care ...
We're hearing that some compounders are being asked by prescribers to compound peptides, especially those often prescribed by the anti-aging community of physicians.  While there is a body of clinical evidence that supports the use of these peptides,  most do not meet the statutory requirements found in DQSA, which allow compounding of a substance:  
  • For which there's an applicable USP/NF monograph; 
  • That is an active drug component of an FDA-approved product; 
  • Or is on FDA's List of Bulk Drug Substances That Can Be Used Under Section 503A;
  • Or on Category 1 of the list of substances nominated for the 503A list. 
We urge IACP members to consider the risks/benefits of compounding preparations with peptides that are not compliant with DQSA, which could lead to FDA or state board of pharmacy enforcement action.