FDA and Pharmacy Weekly Digest - October 30

Alerts / October 30, 2020

FDA Released Retail Food Employee Health Handbook – The FDA published the Employee Health and Personal Hygiene Handbook to help food employees avoid spreading viruses and bacteria to food. Food establishment management and food employees can use the question-and-answer format of the handbook to prevent the spread of disease.

FDA Warned Companies Selling Dietary Supplement Containing Cesium Chloride – The FDA issued warning letters letters to companies labeling cesium chloride as a dietary supplement. According to the FDA, the “FDA is not aware of any information demonstrating that cesium chloride was lawfully marketed as a dietary ingredient in the United States before October 15, 1994.” Firms must provide certain safety-related information about the ingredient to the FDA before including it in a dietary supplement.


FDA to Hold Virtual Meeting on the Reauthorization of the Biosimilar User Fee Act (BsUFA) – The BsUFA authorizes the FDA to collect user fees to support the review of biosimilar biological products. Interested stakeholders may register for the Nov. 19 meeting.

FDA Extends Delayed Enforcement Under Track and Trace – The Drug Supply Chain Security Act (DSCSA) established product tracing, product identifier, authorized trading partner and verification requirements for manufacturers, wholesale distributors, repackagers and dispensers. Under the act, wholesale distributors must verify saleable returned product. Under updated guidance, the FDA does not intend to take action against wholesale distributors that do not, prior to Nov. 27, 2023, verify a product identifier before further distributing returned product as required under the DSCSA. Additionally, the FDA does not intend to take action against dispensers that do not, prior to Nov. 27, 2023, verify the product identifier for suspect or illegitimate product in the dispenser’s possession or control.

FDA Finalizes Guidance on Referencing Approved Drug Products in Abbreviated New Drug Applications (ANDAs) – This guidance describes how to identify a Reference Listed Drug (RLD) and reference standard in an ANDA. Additionally, the guidance clarifies references to approved drug products that appear on the “Discontinued Drug Product List” and the FDA’s identification of certain reference standards as RLDs in the printed and electronic versions of the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book).

Medical Devices

FDA Announces Priority CDRH Guidance Lists – The FDA’s Center for Devices and Radiological Health (CDRH) published an A-list and a B-list. The A-list is the list of prioritized guidance documents that the CDRH intends to publish, including final guidance on clinical-decision support software and draft guidance on medical device shortages, contents of premarket submissions for software contained in medical devices, and the Transition Plan for Medical Devices Distributed Under Enforcement Policies or Emergency Use Authorization During the COVID-19 Public Health Emergency. The B-list contains guidance documents that the CDRH intends to publish if resources permit, including final guidance on the Unique Device Identification System: Form and Content of the Unique Device Identifier and draft guidance on the Risk Categorization for Software as a Medical Device.


FDA Updates Guidance on Deeming Certain Tobacco Products – The revised guidance reflects recent court decisions regarding the FDA’s enforcement of premarket requirements for premium cigars, as well as health warning and labeling requirements for cigars and pipe tobacco. Recent court rulings involving premium cigars as well as health warning and labeling requirements for cigars and pipe tobacco prompted this revision. The FDA will not seek to enforce the applicable warning and labeling requirements for cigars and pipe tobacco at this time.

FDA Issues Draft Guidance for Tobacco Products– The Center for Tobacco Products issued draft guidance for industry on “Principles for Designing and Conducting Tobacco Product Perception and Intention Studies.” The guidance is intended to help applicants design and conduct tobacco product perception and intention studies that may be submitted as part of a modified risk tobacco product application, a premarket tobacco product application, or a substantial equivalence report.


Vermont Enacts Law to Expand Pharmacy Services – The Vermont law allows pharmacists to enter into collaborative practice agreements, under which pharmacists may prescribe. Additionally, pharmacists may prescribe, order and/or administer under state protocol the following: opioid antagonists, epinephrine auto-injectors, tobacco cessation products, hormonal contraceptives, dietary fluoride and influenza vaccines.

FDA Clarified Revisions to Labeling for Insulin Pens – The FDA recently advised healthcare professionals and patients about insulin pen packaging and dispensing. In November 2019, the FDA approved revisions to the labeling for insulin pens to emphasize the recommendation for dispensing insulin pens in original sealed cartons. Pharmacists typically break cartons for patient needs or insurance purposes. The FDA strongly encourages dispensing insulin pens with FDA-approved labeling and has encouraged manufacturers of insulin pens to develop smaller carton sizes.

FDA Announced Compounding Memorandum of Understanding (MOU) – The FDA released the final “Memorandum of Understanding: Certain Distributions of Compounded Human Drug Products Between the State Board of Pharmacy or Other Appropriate State Agency and the Food and Drug Administration.” Pharmacies or physicians located in a state that has not entered into the MOU will be limited to distributing no more than 5 percent of compounded drug products interstate. Drug products intended for veterinary use, repackaged drug products, biological products subject to licensure through a biologics license application under Section 351 of the Public Health Service Act (42 U.S.C. 262), and drug products compounded by outsourcing facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act are not subject to the 5 percent limit or any provisions of the MOU.


COVID-19 Vaccine Developers Do Not Require Inspection – According to reporting following a meeting of the FDA advisers for COVID-19 vaccine standards, the FDA will not pre-inspect facilities. Typically, a manufacturing facility must be inspected prior to a new drug approval. The FDA inspections do not require pre-approval inspections for products seeking emergency use.

Medicare and Medicaid Expected to Pay for COVID-19 Vaccine – Reports indicate that the Centers for Medicare and Medicaid is expected to issue a rule which would allow beneficiaries to receive a vaccine under emergency authorization at no cost.

Pharmacy Interns and Pharmacy Technicians May Administer Childhood and COVID-19 Vaccines – The Department of Health and Human Services issued guidance on expanding access to childhood and COVID-19 vaccines. According to HHS, this authorization preempts any state and local law that prohibits or effectively prohibits those who satisfy these requirements from administering COVID-19 or routine childhood vaccines. The guidance outlines several requirements for pharmacy interns and pharmacy technicians to be eligible to administer vaccines.

Authorship Credit: Mac Wagner

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.

Related Services