Exploring the Impact of New Regulations: Where Are We Now Regarding Compounding Pharmacies?

As we have blogged for the past several years, the emergence of compounding pharmacies created an unexpected danger for consumers because there were practically no controls or standards governing the manufacturing of these medications. Compounding pharmacies came into existence to create personalized medication for patients.

The dangers of compounding pharmacies first became evident in 2012, when a large outbreak of fungal meningitis was discovered in the United States. The source was traced back to contaminated medications packaged by the New England Compounding Center, a large compounding pharmacy based in Massachusetts. The medications in question, methylprednisolone used in injections, eventually led to 64 confirmed deaths, over 700 injuries, and more than 400 lawsuits filed against the New England Compounding Center, resulting in over $100 million dollars in settlements.

Of greater importance for consumers, the outbreak prompted congressional leaders and federal health officials to review the regulations that govern compounding pharmacies. This review led to the passage of the Drug Quality and Security Act, designed to amend the Federal Food, Drug, and Cosmetic Act to provide new levels of FDA oversight regarding the operation of compounding pharmacies.

As explained by the FDA, “compounding is a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient.” Due to the rising cost of many injectable drugs such as methylprednisolone, many health providers are turning to non-traditional, large scale compounding pharmacies, which many argue transforms the process into large-batch manufacturing as opposed to individualized chemistry.

Although FDCA changes are intended to make medicine safer, most compounding pharmacies do not fall under the regulatory umbrella of the FDA, and rely on state-run boards for oversight. However, “Firms that register with FDA as “outsourcing facilities” under section 503B will be regulated by FDA and inspected by FDA according to a risk-based schedule.” This change was designed to prevent large non-traditional pharmacies from committing errors similar to those in 2012. Traditional compounding pharmacies continue to operate much as they had before 2012.

In addition, the Drug Quality and Security Act created a Pharmacy Compounding Advisory Committee, which “provides advice on scientific, technical, and medical issues concerning drug compounding under sections 503A and 503B. The committee advises, as required, on any other product for which the FDA has regulatory responsibility, and makes appropriate recommendations to the Commissioner of Food and Drugs.”

Congress has worked to help prevent tragedies arising from non-traditional compounding pharmacies, but consumers must still be aware of the risks of compounded drugs. Traditional compounding pharmacies often have no FDA oversight, and as the FDA cautions, “There can be health risks associated with compounded drugs that do not meet federal quality standards. Compounded drugs made using poor quality practices may be sub- or super‑potent, contaminated, or otherwise adulterated. Additional health risks include the possibility that patients will use ineffective compounded drugs instead of FDA-approved drugs that have been shown to be safe and effective.”

As consumers of any medication, we should make certain that we know all the details of any medication before beginning use, including having knowledge of the pharmacy which compounded the product, the expected side effects, and all of the ingredients and drugs contained.

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