FDA Clarifies: You Cannot Compound Approved Drugs 
[Posted on: Thursday, July 14, 2016]

Last year, during the drug pricing debate triggered by Turing Pharma’s Martin Shkreli, a San Diego compounding pharmacy Imprimis Pharmaceuticals announced that it would offer a cheap compounded version of the expensive FDA-approved drug. At that time, we criticized Imprimis based on our belief that such a practice will jeopardize all approved drugs. This week FDA confirmed our concern and took measures to stop such activities by compounding pharmacies. Two new guidance documents from FDA confirm that FDA does not allow creating compounded versions of approved prescription drugs or OTC drugs. The only conditions in which an approved drug can be compounded are if there is a shortage of the drug, of if the FDA-approved version has been discontinued or is no longer marketed. FDA guidance documents go at length describing the risks associated with the quality of compounded drugs, the preference of the FDA-approved version over the compounded version due to the detailed review an FDA approval entails, and the negative effect of compounding drugs that are essentially copies of FDA-approved drug products on the development of generic and 505(b)(2) products. FDA extended the above rules to OTC products. OTC products do not require a pre-approval by FDA but need to strictly follow the drug monographs and must be manufactured at cGMP-compliant facilities; both of these conditions cannot be met by most compounding pharmacies. Compounding has been suggested as an option to create cheaper version of expensive FDA-approved drug products but as FDA points out, it raises several concerns. FDA has been enforcing good quality practices at compounding pharmacies over the last 3 years since the passing of the Drug Quality and Security Act (DQSA) of 2013. The DQSA defines specific requirements to prevent contamination and spread of infections via compounded drugs, but does not require compounding pharmacies to be compliant with cGMP requirements for drug manufacturing. However, many of the FDA auditors have been making observations about non-compliance to cGMP rather than DQSA. This week FDA announced that FDA auditors will no longer list cGMP violations in FDA 483s issued at the end of an audit of a compounding pharmacy provided the facility compounds only drugs that meet DQSA requirements. However, if the facility is found to compound drugs not permitted under DQSA, the cGMP requirements will become effective and appropriate regulatory action for non-compliance to cGMP will be taken. In effect, FDA defined the specific differences between a compounding pharmacy and a drug manufacturing facility from a regulatory perspective. Taken together this week FDA took concrete steps to block all efforts to use compounding pharmacies to fight the drug prices. Drug pricing debate should now move away from compounding pharmacies and towards and more appropriate political process. There should not be any doubts about the regulatory process anymore.