The drug supply chain safety law is close to implementation, and FDA issues exemption guidelines

Source: Zhilin May 22, 2018 After several meetings on the topic of the drug supply chain Safety Act (dscsa), and hearing the views of leading suppliers (both providing hardware and software), it takes a long time for the number of suppliers to increase After the industry is in a disadvantageous position in terms of obtaining equipment and comprehensive integration, as well as in terms of verification, the documents on Exemption seem to be coming out The draft guidance on industrial exemptions, exceptions, and exemptions under section 582 of the federal food, drug, and Cosmetic Act, issued on May 8, is an obvious product of addressing this confusing situation The draft guide explains who, what, where, when and how to implement the exemption process The final implementation of all aspects of dscsa will be sometime in 2023, about 10 years after the signing of dscsa, the exemption guide being issued now also addresses the concerns expressed by many suppliers and trading partners This guide provides draft guidance recommendations for trading partners (defined as manufacturers, repackers, wholesale distributors, and regulators) that must submit exemption requests It also outlines the basis of the three exemption requests to be accepted: the section 582 requirements identified in the exemption request are guaranteed, because compliance with the requirements will cause undue financial difficulties or the exceptions to the section 582 requirements on product identification for emergency medical reasons are guaranteed, because the product packaging containers identified in the request are too small, As a result, the products and / or transactions identified in section 582 of the label relief request that contain the information required to meet these requirements are suitable for the maintenance of public health In addition, the exemption request should include: the name, telephone number, and email address of the person FDA can contact about the proposed exemption, exception, or relief The identity of the trading partner covered by the proposed exemption, exception or relief the requirements of section 582 of the FD & C act applicable to the proposed exemption, exception or relief requested for the description of the exemption, exception or relief activities and / or products (including National Drug Codes) for which the proposed exemption, exception or relief is being sought Specify the reasons why FDA should approve the exemption, exception or relief, including supporting documents The document also states that "section 582 (a) (3) (a) (II) and (III) of FD & C act grants FDA the right to determine the exception or relief in accordance with the requirements of section 582 FDA intends to use this authority where necessary to address issues affecting a wide segment of the industry and / or multiple trading partners, affecting many activities or involving multiple products " We believe that this gives FDA the power to take a wide range of actions in the event of unforeseen events, which will have a significant impact, so they do not have to review the surge of exemption requests The document also sets out the confirmation requirements of 18 USC 1001, which will ensure that no material false, fictitious or fraudulent Disclaimer Statement is submitted to the government in the exemption request There is also further information on how to review these requests and how the FDA informs the applicant of its decision In the process of final implementation, there will certainly be some rough situations, and FDA seems ready to smooth them out if necessary.