Pharmacy compounding has been getting media attention recently for unsanitary conditions and poor inspection procedures even after the FDA revised its documents regarding regulations for compounding. The fault lies with the compounding pharmacies not the FDA. To better understand and improve on the perceived problems surrounding compounding pharmacies, we’ll dive into FDA jurisdiction, lack of appropriate oversight, and the recommended reforms.
Compounded drug products serve an important role for patients whose clinical needs cannot be met by an FDA-approved drug product. Whether they need a hypoallergenic version of their medication or an easier form to ingest, compounding helps people who need custom medication.
The states are the principal regulators of pharmacy practice, including compounding. State Boards of Pharmacy rely on U.S. Pharmacopeia Chapter 797 for guidance on sterile compounding practices. Recent complaints and inspections have led to the FDA requesting greater jurisdiction over compounding, especially intravenous or ophthalmic sterile drugs. In the Drug Safety and Quality Act of 2013, Congress did not mandate that compounding pharmacies register with the FDA, meaning that registration is voluntary.
To ensure your safety, and the safety of your animal patients, choose a compounding pharmacy that is registered with the FDA.
Lack of Appropriate Oversight
The FDA is having difficulty properly inspecting and grading compounding pharmacies because the law does not require compounding pharmacies to track and report adverse events or to provide complete labels on drugs – although this may be required by state law. According to the 2016 PEW Charitable Trust survey of multiple states’ board of pharmacies on oversight of compounding pharmacies – 28 of the 43 states that responded reported that they do not mandate specific expectations for specialized training in sterile compounding. Furthermore, 60% of states said that their states did not require pharmacies to report serious adverse events and reactions to sterile compounding.
In many of the 43 states who responded to the survey, the qualifications required of compounding pharmacies during inspection are lacking:
- Only 70% of states required a pharmacist license
- Only 60% required prior experience in a pharmacy
- Only 58% required training on applicable USP standards
There are many steps that federal and state level oversight can take to help level the playing field and make compounding pharmacies safer for public use. Legislation that makes compounding pharmacies register with the FDA will ensure that every pharmacy is required to keep up to FDA standards of excellence. Being required to report adverse events to the FDA and provide complete labels on their medications will help keep patients and practitioners safe and standardize the use of certain harmful medications.
Ideally, state pharmacy licensing boards should require that all compounding pharmacies are accredited by the Pharmacy Compounding Accreditation Board (PCAB). However, only 2.9% of compounding pharmacies are PCAB accredited! This should be made a nationwide mandate, otherwise pharmacies that operate below the required level of efficiency and sterility will not be punished or incentivized to do better.
Mandatory APhA (American Pharmacy Association) certification in sterile compounding for all pharmacy students, practicing pharmacists, and inspectors of compounding pharmacies should be put into place. There is no other way to properly supervise compounding pharmacies to ensure that the public is receiving safe, sterile medications.
There are a large number of unchecked compounders functioning as distribution centers rather than just providers of products customized to patient needs. Compounding pharmacies provide critically important services to patients, however, the lack of oversight is causing significant safety problems.
Only use accredited and FDA registered compounding pharmacies to assure the safety of your patients and to avoid fraudulent business practices. Contact EPC for more information on how to avoid disreputable compounding pharmacies.