3 Biggest Compounding Pharmacy Myths Debunked

Compounding pharmacies have been the subject of many articles in the press recently.

Pharmacy Times spoke with David G. Miller, RPh, executive vice president and CEO of the International Academy of Compounding Pharmacists, who noted there are often misconceptions or misinformation regarding compounders. Dr. Miller debunks what he thinks are the 3 biggest compounding pharmacy myths.

1. Only compounding pharmacists compound products.

Every pharmacy in the United States compounds in some way, Dr. Miller said in an exclusive interview with Pharmacy Times. Any time an IV drip is mixed in a hospital IV lab, or a community pharmacist mixes 2 creams together, that’s compounding.

Compounding is a long-standing tradition. During the 1930s and 1940s, the majority of prescriptions were compounded, according to the Professional Compounding Centers of America.

Since then, the industry has changed so that pharmacists may undergo advanced training on compounding beyond the education they receive in pharmacy school. They then apply those skills in a compounding pharmacy to create medications that are tailored to patients’ specific needs.

“I think it’s important to understand and recognize that compounding has always been a component of what we do as pharmacists and that we all do it in some manner and that the law, both on the federal and state level, applies to us,” Dr. Miller said.

Some members of the pharmacy community distance themselves from compounders and label them as bad, when in reality, compounding is a part of what they do, too.

“We’re all in the same boat,” he explained.

2. Compounding pharmacists “go rogue.”

Dr. Miller said there is a perception that some compounding pharmacists try to get around the law, and some individuals have described them as going rogue. However, no compounding pharmacist sends any medications into any hands without a prescription, he noted.

“This perception that compounding pharmacists are somehow skirting the laws ignores the simple fact that we have to have a prescription to do anything,” Dr. Miller said. “They fill prescriptions just like any other pharmacist. The only difference is that instead of pulling the bottle from the shelf behind us, we have to make it from scratch.”

3. Compounding pharmacists are not regulated.

This myth is of particular concern, according to Dr. Miller, who asserted that compounding pharmacies are heavily regulated.

Even without the Drug Quality Security Act, compounding pharmacies are required to meet standards and be subject to inspection by their boards of pharmacies. They also have to follow US Pharmacopeia (USP) standards.

More than likely, Dr. Miller noted that the average pharmacist in a community practice setting has probably not read USP <795> and the average hospital pharmacist working with IVs has probably not read USP <797> regarding sterile compounding. In other words, compounding pharmacies must meet significant practice standards in addition to following state and federal laws.

Following the 2012 fungal meningitis outbreak caused by tainted medications compounded at New England Compounding Center, the federal government and state governments passed new legislation to create more oversight. The FDA also invited pharmacy experts to join its Pharmacy Compounding Advisory Committee, which gives recommendations to companies that prepare compounded medications under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.