United States: Bakerhostetler FDA And Pharmacy Weekly Digest - October 29, 2018

Food/Dietary Supplements

FDA Investigation Into Salmonella Outbreak – The Food and Drug Administration (FDA) announced that it is investigating a multistate outbreak of Salmonella enteritidis it believes is linked to shell eggs. There are 44 reported cases, and the Centers for Disease Control and Prevention has determined that the outbreak is over. A recall has been initiated as a result of this outbreak.

FDA Releases Produce Guidance – The FDA released a draft guidance focused on standards related to produce for human consumption. The guidance is to aid in implementation of the Produce Safety Rule. It reiterates the importance of preventive measures to reduce foodborne illness contamination of produce during its growing, harvesting, packing and holding. The FDA also announced that several public meetings will be held to discuss the guidance. Information on registration will be available on Oct. 31, 2018.

Food Recalls – Three food companies issued recalls. One recall notes elevated levels of lead in certain spices. The other recalls relate to the potential for undeclared allergens in the products, specifically peanuts and soy.


Opioid Bill Signed Into Law – President Trump signed H.R.6. into law. The SUPPORT for Patients and Communities Act is intended to be comprehensive legislation to combat opioid addiction. It includes a grant program for treatment and recovery centers, provides access to opioid addiction medications, broadens the naloxone program, encourages pain treatment education and awareness, and much more.

Consent Decree for OTC Products – A Tennessee company was ordered to cease the sale of certain over-the-counter (OTC) products. A Tennessee court entered a consent decree ordering a permanent injunction against the company based on current good manufacturing practices for its hair- and skin-care products. The company must stop operating until it takes corrective action.

DSCSA Guidance – The FDA released a draft guidance addressing the Drug Supply Chain Security Act (DSCSA) verification requirements applicable to manufacturers, wholesale distributors, dispensers and repackagers of drugs. This guidance covers systems to determine suspect products, quarantine and investigate suspect products, quarantine and dispose of illegitimate products, notify the FDA and trading partners, and respond to requests for verification.

Drug Shortages – On Oct. 19, 2018, the FDA announced that Leucovorin Calcium Lyophilized Powder for Injection (currently in short supply) was added to the drug shortage list. On Oct. 24, 2018, the FDA updated the drug shortage list to remove Penicillin G Benzathine and Penicillin G Procaine (Bicillin C-R) Injection and add Sacrosidase (Sucraid) Oral Solution.

Drug Recall – One organization issued a voluntary nationwide recall of an ophthalmic solution because a product was found to have an unidentified particulate in the solution.

Medical Devices

Medical Device Public Workshop – The FDA announced a public workshop and a white paper related to medical device servicing and remanufacturing activities. The workshop will be held on Dec. 10-11, 2018, to "publicly discuss the distinction between medical device servicing and remanufacturing activities to better inform the development of a future draft guidance."

FDA Modifies List of Recognized Standards – The FDA released a modified list of standards the FDA will recognize for use in premarket reviews. The publication is "intended to assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices." The modifications took effect on Oct. 22, 2018.

FDA Releases Cybersecurity Guidance – FDA published a draft guidance document to address medical device functionality and safety in the context of cybersecurity issues. The guidance contains recommendations for cybersecurity device design, labeling and information to be included in device premarket submissions related to cybersecurity.


FDA Holds Public Meeting on PMTA – On Oct. 22-23, 2018, the FDA held a public meeting on the tobacco product application review process. The public meeting focused on education about the premarket tobacco product application (PMTA) process and other application pathways. The meeting also solicited feedback on the FDA's policies and plans for submission and review of applications. The FDA indicated that it will make the webcast and the transcript of the meeting available in the near future. Prior to the meeting, FDA Commissioner Gottlieb released a statement that the FDA is "committed to developing new guidance and regulations – including the development of product standards – that will better spell out the rules of the road for industry and make the regulatory process for products such as electronic nicotine delivery system (ENDS) more efficient."

Recently Posted Warning Letters

The FDA posted a number of new warning letters. One letter was issued to an outsourcing facility whose products the FDA claims fail to meet the conditions of Section 503B, including use of bulk substances that do not appear on the 503B bulks list. Another was issued to a company for allegedly selling misbranded and unapproved new drugs, specifically opioids and HIV drugs. The FDA also issued a warning letter to a food facility whose product labels it claims do not comply with FDA hazard analysis and critical control points, and food labeling requirements, including "drug" claims on certain food product labels.


ESI Opens Its Mail-Order Network – Express Scripts (ESI) announced that it would "expand its network offerings to include networks designed for pharmacies predominantly engaged in mail order practice." This is a change from ESI's former policy, which focused on retail pharmacy networks.

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