Following reports that alcohol-based hand sanitizer is increasingly difficult to find, the FDA says it will temporarily allow other manufacturing entities—including distilleries—to make hand sanitizer.
How Things Work Now
In addition to prescription drug products, the FDA has been tasked with regulatory oversight over non-prescription, or over-the-counter (OTC) drugs since 1972.
The most common way that OTC products can come to market is through the monograph process. Under that pathway, the FDA establishes a monograph, or set of standards, that an OTC product should meet. If the product meets those standards, the sponsor doesn’t have to submit the product for review by the agency. However, if the product is novel or deviates from the standards as outlined in the monograph—or if the sponsor wants to switch the drug from nonprescription to prescription status—they could be required to submit a New Drug Application (NDA). In order to make an OTC product, a manufacturer must register with the FDA through its Drug Registration and Listing System, as it would with a prescription drug.
Hand sanitizer is an OTC product, which is regulated by the FDA under the OTC monograph system. The monograph for hand sanitizer products was finalized in April 2019 (Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for OTC Human Use). In the monograph, the FDA defines which ingredients may be used in antiseptic rubs, which may not, and which ingredients require additional study. There are 28 ingredients that are prohibited from being used in OTC antiseptic rubs, for example.
The ongoing COVID-19 outbreak has raised significant concerns among American consumers and medical professionals about the supply of basic sanitary gear—including hand sanitizer. As AgencyIQ has previously noted, several DIY hand sanitizer recipes have been popping up online, including one from TV personality Rachel Ray, raising concerns at the FDA about the safety and efficacy of home-brewed solutions.
On March 20, the FDA issued guidance that will allow non-drug manufacturers that register with the agency to manufacture and sell hand sanitizer without falling afoul of federal requirements. The policy states that the FDA will use “enforcement discretion” and not enforce its regulations against “firms that prepare alcohol-based hand sanitizers” during the public health emergency associated with the COVID-19 outbreak.
The new entities that can now make hand sanitizer legally include “certain entities that are not currently regulated by FDA as drug manufacturers.” This appears to include other types of manufacturers, such as distilleries. Some distilleries have already started to make hand sanitizer with the consent of regulators, according to some media reports.
Although still not regulated as drug manufacturers, under the new policy businesses will still have to register with the FDA in the FDA Drug Registration and Listing System (DRLS).
The agency does set a series of criteria that are acceptable—i.e., under which it will allow non-drug manufactures to make hand sanitizer—for the scope of the policy. Specifically, manufacturers must follow the World Health Organization’s (WHO) recipe for hand sanitizer and keep “a simple record should be used to document key steps and controls.” Additionally, firms should ensure that they are verifying the alcohol content in their hand sanitizer, and the hand sanitizer should be labeled according to the existing standards under the OTC monograph.
This guidance is the second policy this week that expands the types of entities that can make hand sanitizer.
The FDA issued guidance on Monday allowing drug compounders to make and sell hand sanitizer, stating that compounders would, at least, have the appropriate equipment and technical knowledge to effectively and safely manufacture topical antiseptic rubs. However, this new policy to allow new kinds entities that don’t necessarily have experience with making drug products—and reflects a growing concern about shortages.
The FDA stated in the guidance that it received “a number of queries from entities that are not currently licensed or registered drug manufacturers that would like to prepare alcohol-based hand sanitizer,” indicating that more than one entity had reached out with questions about potential enforcement activities if they began to make the product. However, it’s unclear to what extent the policies could improve the overall supply of the product.
As with the policy to allow drug compounders to make hand sanitizer, this guidance will be withdrawn upon the conclusion of the COVID-19 public health emergency.