Advocacy & Practice Updates — Advocacy & Practice

Compounding Pharmacies—What You Need to Know

Since 2001, more than two dozen patient deaths have been linked to a contaminated prescription from a compounding pharmacy. The FDA has sent dozens of warnings to various compounding pharmacies regarding their approach to sanitization. As well, demands have been made for tightening regulations on compounding pharmacies beginning in 2001, when the first known infection from a compounded drug was discovered in Los Angeles.

While FDA approved drugs go through a vigorous screening system, compounding pharmacies are overseen by the State Board of Pharmacy. In addition, FDA approved drugs are permitted to be mass produced; however, those mass produced in a compounding pharmacy are done so unlawfully.  Compounding pharmacies aren’t supposed to do large-scale productions of drugs like a drug-manufacturer; instead they must create on a per-prescription basis.

Unlike when a physician prescribes an FDA approved drug, prescriptions of compounded drugs leave the physician and compounding pharmacies liable and when it comes to adverse events. Physicians should take strong precautions when prescribing a compounded drug, which include [1]:

  • Making sure that there is no FDA approved equivalent available
  • Knowing whether the compounding firm being used is FDA registered
  • Where raw products come from and if it is of pharmaceutical grade for humans
  • How and when the product was compounded
  • Sterility
  • If equipment is free of contaminants or other drugs

Since the latest infection outbreak of meningitis from New England Compounding Center, health officials are pushing for tightening of regulation on compounding pharmacies.  

Learn more about compounding pharmacies.

Reference:

  1. Sellers S, Utian WH. Pharmacy compounding primer for physicians: prescriber beware [published online ahead of print October 7, 2012]. Drugs. doi: 10.2165/11640850-000000000-00000. 

Updated: October 13, 2012

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