Compounding pharmacies serve a great need within our communities, as evidenced by the thousands of compounding pharmacies throughout the country. While these pharmacies serve their patients’ needs by creating, preparing, mixing, and packaging (compounding) drugs for the individual needs of their patients, there have been some concerns over the safety of compounded drugs.
Because of an outbreak of fungal meningitis in 2012 caused by a compounding pharmacy, Congress and the Food and Drug Administration (FDA) were prompted to pass the Drug Quality and Security Act (DQSA) in November 2013. What happened was a compounding pharmacy failed to adequately sterilize needles, which were then shipped throughout the country, resulting in over 750 cases of illness and 60 deaths.
The FDA already had plans to step in to protect the public from improperly compounded drugs and to set guidelines to hopefully prevent a similar situation from occurring in the future. For that reason, new guidelines have been created, which apply specifically to compounding pharmacies.
New FDA Guidelines for Compounding Pharmacies
Although compounded drugs are technically on the FDA’s list of unapproved drugs, even government agencies, such as hospitals, participate in the process of compounding drugs. The following are some very general guidelines that compound pharmacies can follow.
- Accreditation – It is now possible for a compound pharmacy to receive a nationally recognized accreditation, which had not been offered before.
- Facility and Equipment – Any facility in which drugs are being compounded should be kept clean and organized. The space should be open with plenty of room for storage, cleaning, and maintenance. All equipment should be in good working order and properly maintained.
- Personnel – Just like any other healthcare setting, only properly authorized individuals should be handling the compounded drugs. Anyone that is ill or could somehow compromise the quality of the drugs being compounded should not be allowed to prepare the drugs. All health concerns should be reported to the pharmacist.
- Packaging and Storage – The chemicals and ingredients should be stored according to their manufacturer’s recommendations. Temperature requirements should always be met. Labeling should be handled in accordance with state and federal regulations.
- Quality Improvement – Like most businesses, improvements should continue to be made to improve the quality of the ingredients and chemicals used in the compounded drugs. Procedures should be put in place to ensure the calculations are always correct, and that all measurements are performed with functioning equipment.
- Records – Pharmacists should be maintaining records of compounding, equipment maintenance records, ingredient records, and formulation records.
Are You Looking for a Compounding Pharmacy Near You?
Compounding pharmacies absolutely serve the medical needs of their prospective communities and we need them to continue to operate. New guidelines are helpful in protecting the public from safety issues. Hopefully these guidelines will be helpful but not so restrictive as to make compounding pharmacies unable to continue their work.
For more in-depth information on the new guidelines or if you’re looking for a pharmacy try this compounding pharmacy in NYC.