Supply Chain Parties Must Report Disciplinary Actions to FDA, Guidance Says
Starting next year, pharmaceutical wholesale distributors must submit annual reports that include detailed contact and state licensure information as well as any significant disciplinary actions taken by state or federal officials, the FDA says.
Reports of significant disciplinary actions must identify the type and final date the action was taken, as well as if it resulted in a revoked or suspended license or limited the ability of the facility to conduct drug-related business, according to draft guidance on reporting requirements for wholesale distributors and third-party logistic providers.
Third-party logistics providers must submit similar contact and licensure information as wholesale distributors, but the reporting of significant disciplinary action is voluntary, according to the guidance that implements the 2013 Drug Supply Chain Security Act.
Initial reports are due between Jan. 1, 2015, and March 31, 2015, for wholesale distributors, and from now until March 31, 2015, for third-party logistics providers. Subsequent annual reports must be filed during the first three months of each year, while disciplinary actions should be submitted within 30 days of final action.
The DSCSA establishes national standards for the licensing of supply chain entities and should make reporting easier, said Dave DeJean, vice president of the Center of Excellence at the network vendor Systech.
The first round may be difficult because it involves a new process, he said. Before the federal law, the system was mandated by regional pharmacy boards of different states, with different reporting requirements and different information, DeJean said.
The guidance follows DSCSA draft guidance last month to assist manufacturers, re-packagers, wholesale distributors and dispensers to comply with the new product tracing requirements.
Establishing a Pharma Supplier Audit Program will show you how to build a manageable and defensible supplier auditing program, helping you with these new annual reports.