FDA and Pharmacy Weekly Digest - May 19

Alerts / May 19, 2020

FDA Seeks Comment on the Proposed Collection of Information on Reportable Food – Reportable food is an article of food (other than infant formula) for which there is a reasonable probability that the use of or exposure to such article of food will cause serious adverse health consequences or death to humans or animals. The FDA is required to establish a Reportable Food Registry by which instances of reportable food must be submitted to the FDA by responsible parties and may be submitted by public health officials. The FDA seeks comment on ways to enhance the quality, utility and clarity of the information to be collected and on ways to minimize the burden of the collection of information on respondents.

Medical Devices

FDA Nixed Plan for Devices Referencing Drugs – In September 2017, the FDA announced a public hearing on a potential approach for device sponsors that seek to obtain marketing authorization for their products that are labeled for a new use with an approved, marketed drug when the sponsor for the approved drug does not wish to pursue or collaborate on the new use. After receiving comments, the FDA announced that it does not plan to follow the proposed approach.


FDA Updated Resources to Assist With Submission of Premarket Review Applications – The FDA compiled information and resources to assist tobacco product manufacturers in complying with tobacco regulations. The compilation provides tobacco product manufacturers with guidance and applicable compliance information in one organized resource.


FDA Announced Availability of MOU Addressing Compounded Drug Products – The standard memorandum of understanding (MOU) between the FDA and the states has been made available for public viewing. The FDA developed the MOU in consultation with the National Association of Boards of Pharmacy. For states that sign the MOU, information-sharing between the FDA and the state is triggered when 503A compounding pharmacies distribute more than 50% of their total compounded products between states. For states that do not sign the MOU, interstate distribution of compounded drug products will be limited to 5% of a 503A pharmacy's total compounded products distributed or dispensed annually. 503B outsourcing facilities and compounded veterinarian drugs are exempt from the limitations on interstate distribution.

NIOSH Published Draft Update to List of Hazardous Drugs –The draft List of Hazardous Drugs in Healthcare Settings is available for public viewing. Public comments are due by June 30. NIOSH also published the procedures for developing the NIOSH List of Hazardous Drugs in Healthcare Settings and information for healthcare settings on managing hazardous drug exposures.

FDA Released Updates to the Purple Book – The Purple Book contains information on all FDA-licensed biological products regulated by the Center for Drug Evaluation and Research (CDER) and FDA-licensed biological products regulated by the Center for Biologics Evaluation and Research (CBER), including licensed biosimilar and interchangeable products, and their reference products. The FDA added products approved in new drug applications (NDAs) that were deemed to be licenses under Section 351 of the Public Health Service Act on March 23, 2020.

Report on Topical Compounded Pain Creams Released – The National Academies of Sciences, Engineering, and Medicine (NASEM) released the report after reviewing scientific data on the safety and effectiveness of ingredients commonly used in compounded topical creams. NASEM concluded that there is inadequate data on topical compounded pain creams. The report also includes recommendations for state and federal regulators regarding oversight of compounded drugs and for healthcare professionals treating patients with compounded topical pain creams.

CMS To Release Annual IPPS Proposed Rule – The Centers for Medicare & Medicaid Services proposed rule on inpatient prospective payment systems is scheduled to be published on May 29. The proposed rule spans more than 1,500 pages. One notable proposal is to require hospitals to publish median negotiated reimbursement amounts by payor.

Maryland Bill Provides Protection to Pharmacies – Maryland HB1273 passed both chambers. The legislation requires a pharmacy benefits manager to allow a pharmacy or pharmacist to withdraw and resubmit a claim after an audit.

Authorship Credit: Marc Wagner

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