United States Regulatory Updates

This is a compilation of the recent regulatory updates for the United States. Every week, we post an update of what's new, which you can view here.

2020

• October 4: The US Department of Health and Human Services (HHS) and the US Food and Drug Administration (FDA) released a "Safe Importation Action Plan," which provides baseline rules for the safe importation of certain drugs originally intended for foreign markets. The rules state that medicines imported from Canada, which were not originally targeted for the US, must be relabeled to meet US requirements. Manufacturers can also import versions of FDA-approved drug products sold in foreign countries that are the same as the US versions, provided they use a new National Drug Code (NDC) for those products.
• August 23: The Healthcare Distribution Alliance (HDA) Verification Router Service (VRS) Task Force is meeting this week to discuss policies for exception management. The Task Force will also present at the upcoming US Food and Drug Administration (FDA) industry listening session on August 31, 2020.
• August 16: The US Food and Drug Administration (FDA) is holding an industry listening session on August 31, 2020. Issues related to the upcoming deadlines for saleable returns and dispenser requirements under the US Drug Supply Chain Security Act (DSCSA) will be discussed.
• May 10: The US Food and Drug Administration (FDA) published new guidance for medical device manufacturers to follow during the COVID-19 public health emergency. Manufacturers are required to notify the FDA about interruptions in the manufacturing of certain devices that may lead to a shortage. The new guidance is designed to help manufacturers provide the FDA with timely notifications that include the correct information.
• May 3: The US Food and Drug Administration (FDA) published new guidance that seeks to clarify the scope of temporary exemptions and exclusions from DSCSA for the duration of the COVID-19 public health emergency. The guidance is focused on products used to diagnose, treat, or cure COVID-19.
• March 29: AA $2 trillion federal coronavirus relief bill has been signed into law in the United States. In addition to providing economic stimulus and helping those affected by the pandemic, the CARES Act contains several provisions related to drug and medical device shortages and healthcare industry risk management planning.
• March 15: The US Congress may consider multiple new bills aimed at improving the overall visibility and readiness reporting for the U.S drug supply. The bills are primarily focused on reporting of production sites and raw materials. While the bills have significant support, there is still uncertainty as to whether they will be formally taken up by lawmakers.

2019

• November 24: The US Office of Management and Budget is reviewing a proposed rule from the US Food and Drug Administration (FDA) that would allow certain medicines to be imported from Canada and other countries as a cost-saving measure. It’s still unclear whether new DSCSA requirements will arise if the rule is adopted.
• November 3: A new report from the US Food and Drug Administration (FDA) Drug Shortages Task Force outlines the major causes of drug shortages and recommends steps the FDA and the pharmaceutical industry can take to combat this growing problem. The root causes of shortages often involve economic factors driven by both private and public-sector policies, according to the report.
• October 27: The state of New York passed a new pharmaceutical recalls law that aims to increase patient safety. The law requires pharmacies to alert affected patients within three days of a Class 1 recall notification.
• March 31: The Pharmaceutical Distribution Security Alliance (PDSA) published a white paper that highlights their plan for US DSCSA governance, which includes both 2019 VRS and 2023 unit-level tracing. For further information, the PDSA will be holding a webinar the week of April 1 and an open meeting the week of May 1 in Washington, DC.
• February 10: The Food and Drug Administration (FDA) officially launched their Pilot Program for DSCSA 2023, which is intended to assist members of the pharmaceutical distribution supply chain in the development of an electronic, interoperable system that will identify and trace certain prescription drugs as they are distributed within the United States.

2018

• November 25: Major industry associations have published their comments on the FDA product identifier Q&A guidance.
• October 28: The FDA published new draft guidance for verification under DSCSA.
• September 30: The FDA published a new decision tree for determining if a product should have a product identifier under the Drug Supply Chain Security Act (DSCSA).
• September 23: The FDA finalized three DSCSA-related guidance documents: A compliance policy for serialized products; a grandfathering policy for non-serialized product; and a general question and answer document along with key questions related to serialized product.
• August 26: The FDA announced an initiative to revise the National Drug Code (NDC). The initial announcement was made for the program along with an invitation for a first public meeting at the FDA, which will be held on 11/5.
• May 13: The FDA published guidance on waivers, exceptions, and exemptions this week for DSCSA compliance.
• April 1: The FDA released the Office of Inspector General report on pharmacy dispenser status with DSCSA compliance.
• March 4: The FDA published two new draft guidance documents for DSCSA on 2/28/18. The internal summary for these documents was prepared and circulated on 3/3/18.
• January 28: The FDA published their 2018 planned guidances for DSCSA.
• January 28: Medical Device: The FDA has published a letter postponing the implementation of UDI requirements for Class 1 by 2 years. The implementation is now slated for 2020 for phase 1 and 2022 for phase 2, which is direct marking.
• January 28: The USAID organization published new standards (requirements, implementation guidelines, and technical guidelines) that support the use of GS1 standards and require the supply of master data via a GDSN provider by the end of 2019. USAID provides these standards as part of its work with developing countries and their governments in enhancing medicine supply chains.