Alerts

FDA and Pharmacy Weekly Digest - June 3

Alerts / June 3, 2019
Food/Dietary Supplements

Acting FDA Commissioner Remarks on Cannabis-Derived Ingredients in Food – Last week, the FDA held a public hearing titled “Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds.” At the hearing, Acting Commissioner Sharpless remarked, “While we don’t generally require foods to be approved by FDA before coming to market, we do require that a new food additive be approved as safe by FDA before being put in the food supply, unless the substance is generally recognized as safe, or GRAS. This requirement applies to cannabis-derived ingredients, just as it does to any other substance. Americans deserve to know that substances being added to their foods are safe, regardless of the source. I will note that several cannabis-derived substances have already come to market through the GRAS pathway. In December, FDA announced that we completed our evaluation of GRAS notices for three hemp seed ingredients and had no objection to their being marketed in human foods for certain uses without approval, provided they comply with all other requirements.”

FDA Announces Partnership With the American Chemical Society (ACS) – The FDA announced its partnership with the ACS to provide a training series on chemical science as it relates to food safety. The first session, “Frontiers in Flavor Chemistry,” will be held on June 4.

Drugs/Biologics

FDA Issues Untitled Letter to Stem Cell Company – The FDA sent an untitled letter to a company for offering “unapproved stem cell products to treat a variety of diseases and conditions, such as Lyme disease, diabetes, Parkinson’s disease, stroke, kidney failure and amyotrophic lateral sclerosis (ALS).” The letter notes that the company’s products appear to be drug and biological products, and the FDA encouraged the company to “engage with the FDA about regulatory oversight of this field and work with the agency for appropriate development, including designing clinical trials, to explore the safety and potential benefits of these products.”

FDA Requests Feedback on Opioid Product Packaging – The FDA issued a Federal Register Notice soliciting feedback on “potential modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) to require that certain solid, oral dosage forms of immediate-release (IR) opioid analgesics commonly prescribed for treatment of acute pain be made available in fixed-quantity unit-of-use blister packaging for outpatient dispensing.” In a press release, the FDA stated this is one step toward its goal “to promote more rational prescribing practices of opioids and reduce the rate of new addiction while maintaining appropriate access for patients who need these drugs.”

FDA Releases Dispute Resolution Guidance – The FDA published a guidance titled “Formal Dispute Resolution: Sponsor Appeals Above the Division Level Guidance for Industry and Review Staff.” The guidance is intended to assist industry and staff “resolving scientific and/or medical disputes between CDER or CBER and sponsors that cannot be resolved at the division level.”

Medical Devices

FDA Seeks Test Plan Participants – The FDA issued a statement that it would seek “test cases from software organizations planning to submit a De Novo Request or 510(k) submission for software as a medical device (SaMD) in 2019 or shortly thereafter” per its 2019 Test Plan.

Pharmacy

United States Pharmacopeia (USP) Releases New Chapter <800> Date – The USP announced its “intent to postpone the official date of General Chapter <800> Hazardous Drugs – Handling in Healthcare Settings.” The new date is now Dec. 1.

States Continue Activity Related to PBM Regulation – Four states have recent PBM legislation. Tennessee’s governor signed into law a PBM reform bill, HB 786. In addition, legislatures in Alabama, Illinois and Louisiana have also advanced PBM-related legislation.

Authorship Credit: Lindsay P. Holmes

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