Introduction

This chapter addresses recent compliance issues affecting pharmacies. With the enactment of a new federal law specific to pharmacy compounding, it is important for pharmacies to remain apprised of new requirements that may be applicable to them. This chapter also addresses several other pharmacy compliance issues and covers enforcement actions the US Food and Drug Administration (FDA) may take if pharmacies fail to comply with applicable statutes and regulations.

The FDA’s New Focus on the Pharmacy Industry

Typically, the pharmaceutical practice is regulated by the states. This remains true for some aspects of pharmacy; however, with the enactment of the Drug Quality and Security Act of 2013 (DQSA),¹ the FDA has increased its focus on particular areas of pharmacy, including compounding. Title I of the DQSA requires certain pharmacies that compound products that are not pursuant to a patient prescription to register as “outsourcing facilities.” Outsourcing facilities must engage in certain FDA reporting and must follow current good manufacturing practices (cGMPs), while statelicensed pharmacies are required to follow US Pharmacopeia (USP) standards (i.e., USP 797) for the compounding of sterile products. The FDA has issued a number of draft guidance documents regarding what types of entities should register as outsourcing facilities, cGMPs applicable to outsourcing facilities, and standards applicable to outsourcing facilities that repackage human drugs and biologics. The FDA has also issued a draft memorandum of understanding for states that addresses state and FDA oversight responsibilities regarding those entities that remain state-licensed pharmacies (compounding only based on patient-specific prescriptions). In addition to implementing compounding regulations, Title II of the DQSA put forth supply chain security requirements, more commonly known as track-and-trace—specifically, pedigree and documentation standards for pharmacies, which will begin to take effect over the next couple of years. Track-and-trace requirements will help ensure that proper documentation is kept and transferred when one entity purchases a prescription drug product from another, such as a pharmacy purchase of a product from a wholesaler, or a wholesaler purchase from a manufacturer. It will also help identify “suspect” products in the market and ensure that proper quarantine, investigation, and reporting procedures are implemented and followed.

Safety concerns related to pharmacy compounding are the major driver for the DQSA’s implementation. These concerns largely stem from the meningitis outbreak caused by an injectable drug compounded by New England Compounding Center in 2012. Approximately 17,000 vials of contaminated sterile injectable were shipped for administration to patients across the country. Based on Center for Disease Control data, the injections led to sixty-four deaths and infection in nearly 700 people. This tragedy shed new light on the oversight responsibilities of state pharmacy boards with respect to compounding pharmacies. It also raised a number of questions about the FDA’s responsibility in oversight and its authority to oversee and enforce against state-licensed compounding pharmacies. The enactment and implementation of the DQSA is aimed at clarifying some of those responsibilities. In addition, the emergence of the gray market and drug shortages have recently increased the demand for pedigree requirements. The industries most affected by these issues are pharmacies, manufacturers, and wholesalers.

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