DRUG PRODUCT SUPPLY CHAIN INTEGRITY

To encourage the Food and Drug Administration (FDA) and relevant state authorities to take the steps necessary to ensure that (1) all drug products entering the supply chain are thoroughly inspected and tested to establish that they have not been adulterated or misbranded and (2) patients will not receive improperly labeled and packaged, deteriorated, outdated, counterfeit, adulterated, or unapproved drug products; further,

To encourage FDA and relevant state authorities to develop and implement regulations to (1) restrict or prohibit licensed drug distributors (drug wholesalers, repackagers, and manufacturers) from purchasing legend drugs from unlicensed entities and (2) ensure accurate documentation at any point in the distribution chain of the original source of drug products and chain of custody from the manufacturer to the pharmacy; further,

To advocate for the establishment of meaningful penalties for companies that violate current good manufacturing practices (cGMPs) intended to ensure the quality, identity, strength, and purity of their marketed drug product(s) and raw materials; further,

To advocate for improved transparency so that drug product labeling includes a readily available means to retrieve the name and location of the facility that manufactured the specific lot of the product and the country of origin of the active pharmaceutical ingredient; further,

To advocate that this readily retrievable manufacturing information be available prospectively to aid purchasers in determining the quality of a drug product and its raw materials; further,

To foster increased pharmacist and public awareness of drug product supply chain integrity; further,

To urge Congress and state legislatures to provide adequate funding, or authority to impose user fees, to accomplish these objectives.

Rationale

The aspect of drug product selection that is not transparent from the labeling is its quality. This information needs to be readily available so those who make the purchasing decision on behalf of hospitals and health systems can factor quality into the decision. Aspects of manufacture that affect quality include the production and compliance history of a manufacturer, the specific name and location of the manufacturing plant, and the source of raw materials, including active pharmaceutical ingredients. This information has been useful in responding to a recall, but it is also important as part of the procurement process. The FDA’s Strategic Plan for Preventing and Mitigating Drug Shortages recommends that purchasers of medications consider quality as a component of the purchasing decision. FDA publishes some quality information about manufacturers; however, in subcontracting and licensing situations, it is not always known who the actual manufacturer is, which specific plant location produced the product, and the country of origin of the active pharmaceutical ingredient.

Hospitals and health-system pharmacy leaders have years of experience in managing the demands and challenges of ensuring that drug supply chain safety and integrity is at the highest level possible. Unfortunately, there are many forces in the marketplace that seek to divert and introduce illicit products into the supply chain.

ASHP has supported efforts to improve the integrity of the drug product supply chain, which has included advocacy on track-and-trace legislation, collaboration with the United States Pharmacopeia (USP) in its efforts on supply chain integrity, leadership in dealing with the various issues arising from drug shortages, and a voice for patients and pharmacists on needed change (regulatory and practice-based) with pharmacy’s trading partners to enable pharmacists to secure legitimate drug products.

On November 27, 2013, the Drug Quality and Security Act (DQSA) was signed into law. Title II of the DQSA, the Drug Supply Chain Security Act (DSCSA) set forth new definitions and requirements related to drug product tracing. The DSCSA outlines critical steps to build an electronic, interoperable system which will identify and trace certain prescription drug products as they are distributed in the United States. Implementation of this new electronic, interoperable system will enhance FDA’s ability to help protect U.S. consumers by improving detection and removal of potentially dangerous products from the pharmaceutical distribution supply chain. Full implementation of the enhanced drug distribution security requirements was initially slated for November 27, 2023. However, the FDA has issued exemptions to eligible trading partners from drug distribution security requirements in the DSCSA. These exemptions beyond the stabilization period include a phased compliance timeline and vary depending on the eligible trading partners.