In line with the U.S. Food and Drug Administration’s (FDA) Drug Supply Chain Security Act (DSCSA) reporting requirements, the FDA has made that data available through a public database.
From Nov. 27, 2014, to March 31, 2015, 3PLs must report licensure (state licensure included if applicable) information for each facility and provide the name/address of each facility to the FDA. After the first year, the reporting requirement must be done on an annual basis, from Jan. 1 to March 31. See a recap of the reporting guidance.
According to the guidance: “Section 584 requires that any facility of a 3PL, as defined in section 581(22) of the FD&C Act, as amended by DSCSA, must report. 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.”
The database, which is updated on a daily basis, contains all of the licensing information related to a particular facility, not company. The information is self-reported by the 3PL or distributor.
In other news, the Nevada Board of Pharmacy is holding a public hearing on Oct. 15 to receive comments on new regulations that require licensure of 3PLs by the state. These changes also require those transporting pharmaceutical products within the state to become licensed by Nevada and expands licensure for “poisons, drugs, chemicals, devices or appliances.”
Other states such as California, Oregon, and Louisiana have also proposed or adopted state licensing requirements directed at 3PLs. Stay tuned for updates.