Alerts

FDA and Pharmacy Weekly Digest - April 29

Alerts / April 29, 2019

FDA Issues Draft Guidance to Aid Companies in Initiating Voluntary Recalls – The FDA issued a draft guidance aimed at all regulated industries to help “ready their facilities and staff for possible recall situations.” The draft guidance, titled “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C,” recommends training, record keeping and enhanced procedures to ensure recall readiness.

Food/Dietary Supplements

Intentional Adulteration Inspections to Begin in March 2020 – The FDA announced that routine inspections to ensure compliance with the Intentional Adulteration rule are set to begin in March 2020.

Drugs/Biologics

FDA Reiterates Effectiveness of MMR Vaccine – The FDA issued a press release stating its concern about recent cases of measles in the U.S. The FDA states, “We do not take lightly our responsibility to ensure the safety and effectiveness of vaccines, and work diligently to assess [the] safety and effectiveness of all licensed vaccines for their intended uses. The MMR vaccine is very effective at protecting people against measles, mumps, and rubella. It also prevents complications caused by these diseases. And we have nearly 50 years of experience and evidence supporting that fact. In fact, according to the CDC, two doses of the MMR vaccine beginning at 12 months of age (the recommended dosing schedule) are 97% effective against measles, 88% effective against mumps, and 97% effective for rubella.”

FDA Seeks to Educate the Public About Safe Opioid Removal – The FDA launched an education plan to inform consumers about safe removal of opioids from their homes. The “Remove the Risk” campaign focuses on females aged 35-64 “who are most likely to oversee household health care decisions and often serve as the gatekeepers to opioids and other prescription medications in the home.”

FDA Addresses Stockpiles of Doxycycline Tablets and Capsules – The FDA published a guidance titled “Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles Guidance for Government Public Health and Emergency Response Stakeholders.” It is intended to give “guidance to government stakeholders on testing to extend the expiration date – under section 564A(b) of the Federal Food, Drug, and Cosmetic (FD&C) Act – of stockpiled doxycycline tablets and capsules for public health emergency preparedness and response purposes for an anthrax emergency.”

Medical Devices

FDA Issues Guidance on Surgical Staplers – As part of its continuing efforts to address postmarketing device issues, the FDA issued a guidance titled “Surgical Staplers and Staples for Internal Use – Labeling Recommendations.” The guidance is intended to “help manufacturers ensure their labeling provides adequate information for use, including relevant hazards, contraindications, and other information under which practitioners can use the device safely and for its intended purpose.”

FDA Releases “Immediately in Effect” Guidance for Combination Products – The FDA issued a guidance titled “Compliance Policy for Combination Product Postmarketing Safety Reporting,” which is immediately in effect for the FDA staff. The guidance is “intended to assist Combination Product Applicants who are subject to the Combination Product Postmarketing Safety Reporting Final Rule (…“combination product PMSR final rule,” “final rule,” or “rule”), issued on December 20, 2016 (81 FR 92603), and codified in 21 CFR Part 4, Subpart B.”

FDA Publishes Convenience Kit Guidance – The FDA released a guidance titled “Unique Device Identification: Convenience Kits.” This guidance discusses the FDA interpretation of the term “convenience kit” for purposes of the Unique Device Identification requirements.

Pharmacy

Alaska to License Nonresident Facilities Starting July 2019 – In July 2019, the Alaska Board of Pharmacy will begin licensing nonresident wholesalers, third-party logistics providers and outsourcing facilities.

Iowa to Require VAWD for Wholesalers and 3PLs – Iowa’s Board of Pharmacy is requiring VAWD accreditation for all current wholesalers and third-party logistics providers starting with 2020 renewals. In addition, “[a]ll new wholesale distributors and 3PLs seeking initial licensure in Iowa must provide proof of VAWD accreditation prior to a license being issued by the Board.”

Authorship Credit: Lindsay P. Holmes

Baker & Hostetler LLP publications are intended to inform our clients and other friends of the firm about current legal developments of general interest. They should not be construed as legal advice, and readers should not act upon the information contained in these publications without professional counsel. The hiring of a lawyer is an important decision that should not be based solely upon advertisements. Before you decide, ask us to send you written information about our qualifications and experience.