FDA and Pharmacy Weekly Digest - October 8, 2020

Alerts / October 8, 2020

FDA Released Food Traceability Proposed Rule – The United States Food and Drug Administration (FDA) is proposing to establish additional traceability recordkeeping requirements for manufacturers, processors, packers or holders of foods that the FDA places on the Food Traceability List. These entities would have to establish and maintain records containing information on critical tracking events – such as growing, shipping, receiving, creating and transforming the foods – in the supply chain for these designated foods. The proposed traceability recordkeeping requirements would apply not only to foods specifically appearing on the Food Traceability List but also to foods that contain listed foods as ingredients. The FDA is accepting comments on both the proposed rule and the tentative Food Traceability List.

FDA Finalized Molluscan Shellfish Equivalence Determination – The finalized molluscan shellfish equivalence determination for Spain and the Netherlands will enable trade in shellfish to resume between the United States and the EU for the first time since 2010. This final equivalence determination will permit the importation of raw shellfish harvested from certain production areas in Spain and the Netherlands from establishments that are listed by the FDA on the Interstate Certified Shellfish Shippers List.

FDA and USDA Sign MOU – The United States Department of Agriculture (USDA) and the FDA signed a Memorandum of Understanding (MOU) related to the export of milk and milk products. The MOU is expected to facilitate U.S. dairy exports.

FDA and Mexican Regulators Strengthen Food Safety Partnership – The FDA and its regulatory counterparts in Mexico – the Federal Commission for the Protection from Sanitary Risks (COFEPRIS) and the National Service of Agro-Alimentary Health, Safety and Quality (SENASICA) – enhanced a partnership to work together on food safety through a Statement of Intent (SOI). The regulatory bodies’ SOI broadens and strengthens the scope of their existing partnership to include the safety of all human food regulated by the FDA. According to the FDA, about one-third of all food imported into the U.S. and 60% of all imported produce is from Mexico.

FDA Requests Information on Labeling Cell-Cultured Seafood – The FDA is requesting information pertaining to the labeling of foods comprised of or containing cultured seafood cells. The FDA invites comment on (1) names or statements of identity for foods comprised of or containing cultured seafood cells; (2) consumer understanding of terms that have been suggested for the names or statements of identity of foods comprised of or containing cultured seafood cells; and (3) how to assess material differences between the foods that are the subject of this document and conventionally produced foods.


FDA Reminds Industry of Drug Master File Pathway – The FDA held a webinar to encourage the use of Drug Master Files (DMFs) to support cannabis research. DMFs are submissions to the FDA used to provide confidential, detailed information about facilities, processes or articles used in the manufacturing, processing, packaging and storing of human drug products.

FDA Issues Final Rule on Drug Importation – The rule allows states, Indian tribes, pharmacists and wholesalers (in certain instances) to submit importation program proposals to the FDA for review and authorization. The rule is limited to drugs approved in Canada and requires that the FDA approve a proposal for importation. Eligible prescription drugs would have to be relabeled with the required U.S. labeling and undergo testing for authenticity and degradation and to ensure that the drugs meet established specifications and standards. Labeling and other requirements are described in FDA guidance.

Medical Devices

FDA Announces Digital Health Center of Excellence – Digital Health Center of Excellence aims to connect and build partnerships among stakeholders to accelerate digital health advancements, share knowledge and innovate regulatory approaches. Priorities for the Center of Excellence include cybersecurity, the software precertification pilot program, artificial intelligence and machine learning as a medical device, and wireless medical devices. The FDA is holding two upcoming virtual listening sessions for developers, healthcare providers and researchers to learn about the new initiative.


FDA Warns E-Cigarette and E-Liquid Product Marketers – FDA continues to issue warning letters to companies marketing electronic nicotine delivery system (ENDS) products. The letters focus on new tobacco products without required marketing authorization. These actions show FDA’s ongoing, aggressive enforcement in the tobacco space.


DEA Finally Implements Ryan Haight Online Pharmacy Consumer Protection Act – The Drug Enforcement Administration (DEA) adopted the interim final rule as a final rule without change apart from a minor technical amendment. The rule requires an in-person medical evaluation as a prerequisite to prescribing or otherwise dispensing controlled substances by means of the Internet, except in the case of practitioners engaged in the practice of telemedicine. Under the Ryan Haight Online Pharmacy Consumer Protection Act of 2008, a practitioner who has obtained from the DEA a special registration may be exempted from the in-person medical evaluation requirement. Healthcare providers and patients continue to wait on the DEA to issue a rule on this special telemedicine registration.

Ohio Expands Pharmacist Consult Agreements – House Bill 203 was signed into law in Ohio. The new law expands the list of healthcare providers with whom pharmacists may enter into consult agreements to now include clinical nurse specialists, certified nurse-midwives, certified nurse practitioners and physician assistants in addition to physicians. Under a consult agreement, a pharmacist may manage drug therapy by changing the duration of treatment for the current drug therapy; adjusting a drug’s strength, dose, dosage form, frequency of administration or route of administration; discontinuing the use of a drug; administering a drug; and ordering lab and diagnostic tests.

The Comment Period for Draft Guidance on Compounding Animal Drugs From Bulk Is Closing – The comment period closes on Oct. 15. When finalized, this guidance will describe the circumstances in which FDA does not intend to take action against drugs compounded from bulk drug substances. Under the draft guidance, only bulk drug substances on the List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals or Antidotes for Food-Producing Animals can be compounded into drugs for office stock or for antidotes for food-producing animals when no other medically appropriate treatment options exist.

Supreme Court Heard Oral Argument in PBM Case – On Oct. 6, the Court heard oral argument which had been delayed from the last term because of COVID-19. In Rutledge v. Pharmaceutical Care Management Association, the Court will decide whether Arkansas can regulate pharmacy benefit managers’ (PBMs) drug-reimbursement rates by statute. The outcome of this case will likely shape state regulation of PBMs.

OMB Receives Guidance to Review on Insanitary Conditions at Compounding Facilities – The “Insanitary Conditions at Compounding Facilities; Guidance for Industry” is at the Office of Management and Budget (OMB) pending regulatory review. The guidance is not available for public viewing but will likely be similar to the draft guidance issued in 2018.

Authorship Credit: Marc N. Wagner

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