Regulatory Updates

The practice of compounding medicines can provide important public health opportunities.  The FDA’s compounding program – including implementation of the compounding provisions of the law – is a priority for the agency. We recognize that in delivering on implementation commitments, we must balance the need to preserve access to appropriately compounded drugs for patients who have a medical need for these products with the need to help protect patients from poor quality compounded drugs that could cause harm.”

Scott Gottlieb, MD, FDA Commissioner, September 7, 2018

A stack of what binders representing regulations affecting compounding medicine

The compounding pharmacy plays a vital role in Personalized Medicine, offering the ability to provide individualized, custom tailored therapies for patients quickly, and safely.  In efforts to raise standards of quality, new and more stringent regulatory requirements are being proffered from various sectors of the industry. 

On September 7th, 2018, FDA Commissioner, Dr. Scott Gottlieb, released a statement outlining how the FDA will work with both the National Boards of Pharmacy and State level agencies to ensure compounding pharmacies are operating at the highest standard of quality and abiding by all regulatory requirements to produce the safest formulations for their patients. Unfortunately, some compounding pharmacies are not operating at these basic standards making the FDA’s prioritization of this issue even more important. 

This proposed draft memorandum of understanding (MOU) is aiming to increase collaboration and standardization of regulatory requirements between the FDA and State Boards of Pharmacy.  The MOU describes the process for investigation, by the appropriate State agency, of complaints relating to compounded drug products that are distributed outside of that State.  The FDA is defining what constitutes an inordinate amount of compounded drug products sold interstate is greater than 50%, and submission of disclosure information – notably volume of compounded products distributed interstate. 

Dr. Gottlieb’s statement emphasizes the importance of working with the best in class compounding pharmacies that adhere to high standards of quality as set by many governmental agencies. He elaborated on the risks associated with compounded drugs such as a lack of quality, adverse events, and contamination when compounding pharmacies did not adhere to these standards. 

In January 2018, the FDA released the 2018 Compounding Policy Priorities Plan which includes quality assurance aspects of the compounding space and the laws that pharmacies must abide by. These include guidelines around what types of products the compounding pharmacy may produce, raw material regulation, and other compliance measures.  

At the same time, there is currently a review process ongoing in Congress of the Preserving Patient Access to Compounded Medications Act of 2017 (H.R.2871), introduced by U.S. Congressmen Morgan Griffith (VA) and Henry Cuellar (TX) on June 12, 2017,  which would NOT require compounding pharmacies to register with the FDA as drug manufacturers. Neither would it impose any limitations on 503(a) compounding pharmacy’s dispensing of medications across state lines. H.R. 2871 would help to clarify the Drug Quality & Security Act (DQSA) in a way that will better align the statute with congressional intent and better balance public safety and patient access. 

Lastly, there is the prospect that 503(a) compounding pharmacies will be required to be compliant with USP 800 standards by December of 2019. USP 800 describes requirements including responsibilities of personnel handling hazardous drugs; facility and engineering controls; procedures for deactivating, decontaminating and cleaning; spill control; and documentation.  

Choosing a pharmacy without any background information or knowledge of their compounding standards could pose a great risk for patients. Personalized Medicine has arrived, but it is imperative that it is accessed under the highest standards of quality to assure safety, efficacy, and an overall great patient experience that positively impacts public health. Your compounding pharmacy partner is critical in achieving these goals and assuring that you only work with the best in class compounding pharmacies. 

Is your compounding pharmacy ready for compliance in this ever-changing landscape?   

You can read the full text of the FDA Announcement here. H.R. 2871 here, and USP 800 here.