Pharmacy compounding or drug manufacturing? FDA's enforcement policy

Pharmacy compounding or drug manufacturing?

On June 15, 2012, the FDA reemphasized its long standing enforcement policies concerning pharmacy compounding in a press release discussing its analysis of compounded hydroxyprogestrerone caproate products. Even though the analysis of limited samples of compounded hydroxyprogestrone caproate did not raise major safety problems, the Agency indicated that compounding of any drug, including hydroxyprogesterone caproate, should not exceed the scope of traditional pharmacy compounding. The FDA generally views the process of reformulating or modifying the drugs already approved by FDA, to fall under traditional pharmacy compounding and within the State’s authority. Such activities are recognized to be analogous to the combining or altering of ingredients by a pharmacist, in response to a licensed practitioner’s prescription, in order to tailor a drug or treatment plan to an individual patient’s special medical needs.
However, should any such activities amount to large-scale compounding production to effectively bypass the New Drug approval provisions of the Federal Food, Drug and Cosmetic Act (“FDCA”), the FDA can exercise its jurisdiction to seek enforcement action against any such practices. The FDA Compliance Policy Guide for Staff and Industry issued in May 2002 provided a list of factors to be considered for a proper determination of whether a pharmacy is engaged in compounding or manufacturing. For example, evidence of receiving and using large quantities of bulk drug substances to prepare large quantities of unapproved drug product in advance of receiving a valid prescription or compounding formulations that are essentially copies of products already approved by the FDA may deem to be a violation of FDCA, and consequently, invite a regulatory action. Historically, the FDA prioritized its enforcement actions related to compounded drugs by assessing the risk-based approach, giving the highest enforcement priority to pharmacies that compound products that are causing harm or that amount to health fraud. To avoid facing an allegation of FDCA violation, early analysis of a given scenario is advisable. The press release is provided in the link below:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm308546.htm