Legal issues related to compounding pharmacies are a hot topic. In November 2017, a Florida compounding pharmacy owner pled guilty in federal court to conspiracy to commit a $100-million-dollar healthcare fraud. According to the US Department of Justice, the accused submitted false claims for compounded medicines to both private insurers and Medicare. The accused and his co-conspirators falsified billing codes and even submitted claims for ingredients they did not have.

Just last month, the Food and Drug Administration (FDA) released a statement regarding management of compounding substances used to treat patients. Compounding pharmacies provide “designer” drugs for patients for whom a needed drug is unavailable from FDA approved sources. Because compounded drugs are not approved by the FDA, they do not undergo the rigorous safety, effectiveness, and quality screenings that are the norm for FDA approved drugs. For this reason, there is a greater risk to the patient population when compounded drugs are used.

In 2012, there was a national outbreak of fungal meningitis stemming from the injection of a compounded drug that was believed to be sterile but was not. A pharmacist from the New England pharmacy involved in compounding the contaminated drug was acquitted late last year of murder charges for the deaths related to contamination. He was, however convicted of mail fraud and racketeering in related charges.

Following that case, Congress enacted steps to manage the problem in the Drug Quality and Security Act, which increases control of the safety and quality of compounded medications. In support of the Act, the FDA recently released a plan for compounding policy priorities which includes:

• Risk-based approach to manufacturing standards for outsourcing facilities;
• Restricting compounding of drugs that are essentially copies of FDA-approved drugs to avoid “workarounds” where drug companies do not utilize the approval process opting to compound instead;
• Regulating compounding of bulk drug substances;
• Solidifying FDA’s partnership with state regulatory authorities;
• Finalization of biological products guidance and clarifying other policies on activities that compounders undertake; and,
• Compliance

The complete document of the FDA’s plan can be viewed at: https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm592795.htm

If your case has issues related to compounding, call my office and let’s discuss them. I can help you understand the utilization of compounding drugs and the potential cause and effect of that use.

Terri Chabaud, RN, CLNC

References

Rasmussen, K. (2017). Florida compounding pharmacy owner’s guilty plea is latest example of increased fed scrutiny. Corporate Counsel (November 8, 2017). Retrieved from https://www.law.com/corpcounsel/sites/corpcounsel/2017/11/08/110817cc_compoundingplea/

U.S. Food & Drug Administration. (2018). 2018 compounding policy priorities plan. Retrieved from ttps://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm592795.htm