Drugs

The deadline for discontinuing distribution of certain alcohol-based hand sanitizers produced under temporary policies during the COVID-19 public health emergency (PHE) is March 31, 2022. On this date, manufacturers must also cease usage of ethanol prepared under COVID-19 PHE policies to manufacture a finished alcohol-based hand sanitizer.

The U.S. Food and Drug Administration (FDA) instituted the March 31 deadline when it withdrew three guidance documents outlining temporary policies for manufacturing alcohol-based hand sanitizer products during the COVID-19 PHE. The policies previously allowed for flexibility regarding FDA regulations for certain hand sanitizers in response to increased demand for these products during the COVID-19 PHE.

Keep reading to learn why FDA is transitioning out of COVID-19 policies for hand sanitizer and how to continue marketing your hand sanitizer product.

COVID-19 Policies for Manufacturing Hand Sanitizer

In March 2020, FDA published three guidances detailing temporary policies for manufacturers to produce certain alcohol-based hand sanitizer and alcohol for use in hand sanitizers during the COVID-19 PHE.

FDA regulates hand sanitizers as over-the-counter (OTC) drug products. These guidances enabled firms that were not drug manufacturers at the time to manufacture and distribute certain hand sanitizers to meet high demand during the COVID-19 PHE. Manufacturers needed to follow the policies outlined in the guidances to manufacture and distribute hand sanitizers that did not meet FDA’s applicable regulations.

Since the temporary policies’ inception, traditional manufacturers that were producing alcohol-based hand sanitizer before the COVID-19 PHE have increased their supply while public demand for these products has decreased. Because consumers and health care facilities no longer face challenges obtaining alcohol-based hand sanitizer, FDA has concluded that temporary policies helping to increase supply are no longer necessary.

FDA collected surveys from various hospitals and assessed results to reach this conclusion. According to the survey data, hospitals are no longer experiencing a disruption in hand sanitizer supply and the majority do not anticipate experiencing another shortage. The survey also revealed that traditional manufacturers currently supply most of the surveyed hospitals’ hand sanitizer.

Deadlines for Hand Sanitizers Manufacturers

In October 2021, FDA announced it was withdrawing the three guidances and called for companies manufacturing alcohol-based hand sanitizers under the temporary policies to cease production of these products by December 31, 2021 and stop selling and distributing such products by March 31, 2022.

Manufacturers that intend to continue producing hand sanitizer must now comply with the tentative final monograph for over-the-counter topical antiseptics and comply with all applicable requirements, including Current Good Manufacturing Practice requirements.

Manufacturers that do not intend to continue producing these products should deregister and delist their hand sanitizer products.

On March 14, 2022, the U.S. Food and Drug Administration (FDA) announced new fees for the Over-the-Counter (OTC) Monograph Drug User Fees (OMUFA) program for fiscal year (FY) 2022. Facility fees for FY 2022 are due June 1, 2022.

In 2021, FDA began collecting annual facility fees from covered OTC drug facilities under the OMUFA program, which was established by the passage of the March 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act. FDA states that OMUFA facility fees are used to help fund regulatory activities that allow FDA to adhere to submission review timelines, with the goal of improving the public’s access to OTC drugs.

How have 2022 OMUFA fees changed from 2021? Keep reading for details about increased fees.

2022 OMUFA Facility Fees

FDA requires facilities that manufacture or process a finished dosage form of an OTC monograph drug to pay an annual monograph drug facility (MDF) fee. The MDF fee for FY 2022 is $24,178.

Contract manufacturing organizations (CMOs) are OTC monograph drug facilities where neither the owner nor affiliates sells the drug produced at such facility directly to wholesalers, retailers, or consumers. CMOs are required to pay two-thirds of the regular MDF fee. The CMO fee for FY 2022 is $16,119.

Both the MDF and CMO fees for 2022 increased 19% from 2021. FDA largely attributes the increase in fees to a decreased number of fee-liable facilities, a decrease in the MDF to CMO ratio, and adjustments for inflation. FDA also increased fees to cover operating reserves needed to sustain the program through FY 2023.

FDA stated that hand sanitizer manufacturers that distributed hand sanitizer products under the COVID-19 public health emergency (PHE) will remain exempt from OMUFA facility fees: “FDA will not assess OMUFA facility fees upon those firms that first registered with FDA on or after the January 27, 2020 declaration of the COVID-19 public health emergency (PHE) solely for purposes of manufacturing OTC hand sanitizer products during the PHE.”

The OMUFA fees also do not apply to facilities that only manufacture active pharmaceutical ingredients (APIs), produce clinical research supplies, conduct testing, or place outer packaging on already packaged products for use in a kit. Additionally, as only human drugs are subject to OMUFA fees, facilities that only manufacture animal drugs are exempt.

The drug industry is raising concerns about the timeframe of the U.S. Food and Drug Administration’s (FDA) new drug reporting requirements. The requirements, created as part of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), call for FDA-registered drug establishments to submit annual reports to FDA of the amount of each listed drug that the company manufactured, prepared, propagated, compounded, or processed for commercial distribution. FDA wants companies to submit calendar year (CY) 2020 reports by February 15, 2022, and CY 2021 reports by May 16, 2022.

Drug companies submitted public comments in response to FDA’s guidance detailing these requirements. Many companies are concerned that they can not gather the required information by the February 15 deadline. These establishments are asking FDA to extend the deadline, allowing companies more time to work out the logistical challenges of gathering and preparing the required information.

What are the drug industry’s thoughts about FDA’s drug reporting requirements? Read on to get the specifics.

Not Enough Time

In its comments, generic drug company Viatris noted the complex nature of the information to be included in the CARES Act reports. Because all reports must correspond to a National Drug Code (NDC) number, large companies with an extensive inventory containing multiple NDC numbers per product will need to submit a substantial number of reports.

Viatris stated that, to supply the information requested, the industry would need to “compile, format, and submit over 3.3 million data points to the Agency in less than four months after issuance of the draft guidance.”

Along with other companies, Viatris is asking FDA to consider extending the February 15 deadline. Although establishments have suggested varying dates, most have proposed the deadline to submit CY 2020 reports be moved to April 2022 or later.

Not Enough Staff

Commenting parties also explained their current staff can not feasibly adopt the additional workload necessary to submit the detailed CARES Act reporting. Because companies did not already have people and processes in place to meet the requirement, many are not likely to currently have staff to devote to the complex reporting. Some establishments will need to collect that data from multiple facilities scattered across the globe.

Association for Accessible Medicine (AAM) commented that fulfilling the reporting requirements could take “14 full-time employees working on the reporting project full-time for a seven week period”, estimating that this additional staffing could cost the company up to $100,000. AAM also noted that, in addition to increased staffing, some establishments will need to invest in new or updated software, as compliance with these requirements “is not an instantaneous process that can be readily achieved based on existing systems and processes”.

In 2021, the U.S. Food and Drug Administration (FDA) took enforcement actions against multiple establishments listing Cannabidiol (CBD) as an inactive ingredient in over-the-counter (OTC) drugs. FDA has not formally approved any cannabis-derived compound as an active ingredient for OTC drug use, and has not evaluated CBD under the agency’s OTC Drug Review, the process by which many OTC drugs are reviewed and permitted to be marketed.

Keep reading to see how FDA’s increased enforcement might affect your products that contain CBD.

Products Containing CBD Growing in Popularity

The 2018 “Farm Bill” signed into law on December 20, 2018 removed hemp from the Controlled Substances Act. Cannabis plants and derivatives that contain no more than 0.3 percent tetrahydrocannabinol (THC) on a dry weight basis are no longer controlled substances under federal law. The bill preserves FDA authority to regulate products containing cannabis and cannabis-derived compounds, regardless of whether or not they are classified as hemp. As a result, companies have pounced on this interest, marketing a variety of products with CBD as an ingredient including beverages, supplements, and OTC drugs.

Regulations of Inactive Ingredients

Within the last year, FDA has published statements related to the use of CBD in OTC drugs, but as an inactive ingredient. According to FDA regulation, an active ingredient is “any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans.” An inactive ingredient is “any component of a drug other than an active ingredient.”

FDA expects that substances named as inactive ingredients have a suitable physical or technical function such as preservatives, flavors, propellants, ointment bases and pH control agents. Moreover, FDA has long held that prominence being given to an inactive ingredient in a manner that creates an impression of therapeutic value is inappropriate and may cause the product to be deemed misbranded.

FDA Enforcement Actions

In March 2021, FDA issued warning letters to two companies for selling products that contained CBD as an inactive ingredient. Their products were branded as unapproved drugs “regardless of whether the CBD is represented on the labeling as an active ingredient or an inactive ingredient.” FDA’s cited reason was that the products would not meet the general requirement of safety and suitability of inactive ingredients under the regulation 21 CFR 330.1(e). FDA further explained that “CBD has no known functional role as an inactive ingredient in a finished drug product… CBD, however, has known pharmacological activity with demonstrated risks.” Both companies were also cited for highlighting the presence of CBD on their product labels, implying that CBD was functioning as an active ingredient. They were given 15 working days to respond or risk legal action, including seizure and injunction.

In December 2021, FDA contacted companies directly, appearing to target those with products listed with the agency that had CBD as an inactive ingredient. In their email, FDA stated:

You have listed one or more unapproved cannabidiol (CBD)-containing nonprescription drug product(s) with the U.S. Food and Drug Administration (FDA).   

Currently, however, no nonprescription drug products containing CBD as an active ingredient have been determined to be generally recognized as safe and effective and not a new drug, or otherwise able to be legally marketed without an approved new drug application.  Even if CBD could be considered an inactive ingredient in a nonprescription drug product, such product would still need an approved new drug application to be legally marketed, because the product would not meet the general requirements for nonprescription drug products under section 505G of the Federal Food, Drug, and Cosmetic Act (FD&C Act). In particular, such product would not meet the general requirement with respect to the safety and suitability of inactive ingredients under 21 CFR 330.1(e)…

It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations, including listing drug products with FDA.  Any information you would like to send regarding your listed drug products should be sent to [email protected], by replying to this email. A firm should discontinue its drug listing in eDRLS after no longer selling the product.  We will continue to regularly monitor the marketplace to ensure compliance with the FD&C Act. 

The email was generated from the FDA’s Office of Unapproved Drugs and Labeling Compliance (OUDLC).

Accordingly, companies marketing OTC drug products in the U.S. would be prudent to review their formulations to determine if this situation applies.