Here comes a national database of drug wholesalers and 3PLs

FDA issues guidance for filings from such organizations under the Drug Supply Chain Security Act (DSCSA)

The process by which FDA will build, and then monitor, a database of drug distributors and third-party logistics providers (3PLs) is gathering momentum. On Dec. 8, the agency issued new draft guidance for annual reporting requirements—a feature of the Drug Supply Chain Security Act passed in late 2013. FDA has probably had interactions with many wholesalers because they have a variety of existing reporting requirements themselves; but for many 3PLs, it’s a new world.

The guidance requires both wholesalers and 3PLs to file state licensure information (if it exists for 3PLs) by March 31, 2015. Wholesalers are to begin filing after Jan. 1; 3PLs are to begin essentially now. Each facility address is also required information. Wholesalers are to provide the name of a contact person for FDA; this is recommended but not required for 3PLs. All these data are to be updated annually.

FDA is also requesting voluntary submission of additional information: license expiration information; and a “unique facility identifier” (FDA had issued previous guidance that the DUNS number, a free service provided by Dunn & Bradstreet, is the preferred identifier; however, the GS1 organization is pushing, with some success, for organizations in healthcare products supply chains use its Global Location Number [GLN].) Another voluntary submission is information on “significant” state disciplinary actions, such as license revocations or consent decrees.

Only a few states currently license 3PLs for healthcare products, so the new regulations will be bringing a host of 3PLs into the FDA scope. Also, it’s not widely recognized, but usually when a pharma manufacturer buys finished drug products from another manufacturer, it is acting as a wholesaler. Further, many wholesalers also act as 3PLs, and FDA is instructing them to file under both categories. (The FDA definition of a 3PL is an entity that “provides or coordinates warehousing, or other logistics services of a product in interstate commerce on behalf of a manufacturer, wholesale distributor, or dispenser of a product, but does not take ownership of the product, nor have responsibility to direct the sale or disposition of the product.”)

FDA’s goal, as specified in DSCSA, is to “make a database of authorized wholesale distributors available to the public on FDA’s website [and] to make information about 3PLs available … because having the license status of 3PLs in one publicly available database would be helpful for FDA, trading partners, and other stakeholders.”