PDSA Letter Re: Authorized Trading Partner Status Q&A
Source: PDSA
PDSA respectfully asks that the FDA provide further direction and clarity with regard to, and consistent with, the following additional question and answer: If an entity constitutes a “manufacturer” under the DSCSA but is not required to be registered under Section 510 of the FFDCA, (a) are trading partners exempt from the restriction against doing business with them because they do not have “authorized trading partner” status, and (b) if not, how does the manufacturer satisfy the requirement to be an authorized trading partner?