Amidst reports that alcohol-based hand sanitizer is increasingly difficult to find, the FDA says it will temporarily allow compounding pharmacies to make and sell the products. The change in policy follows concerns that people were making their own ineffective versions of hand sanitizer.
How Things Work Now
Patients may sometimes need access to a drug that is not commercially available. For example, a patient may have difficulty swallowing, and may need a liquid formation of a drug, or the patient may be allergic to an ingredient used in a mass-produced drug and need a version of that drug without that ingredient. To create those products, facilities known as “compounding pharmacies” may create a customized version of that drug for that single patient.
There are differences in how pharmaceutical compounders are regulated compared to traditional manufacturers. Most small-scale compounding pharmacies are regulated by state boards of pharmacy, and are only allowed to compound drugs for individual patients after receipt of a valid prescription. Large-scale compounders may be registered as “outsourcing facilities” and are regulated by the FDA, allowing them to compound products in advance of receipt of a valid prescription and at a larger scale.
Hand sanitizer is an over-the-counter (OTC) product, which is regulated by the FDA under the OTC monograph system. Under a final rule issued in April 2019 (Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for OTC Human Use), the FDA
The FDA’s OTC Drug Review process for hand sanitizers, or “the Consumer Antiseptic Rub Rule,” was finalized in April 2019. The rule 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.
With the outbreak of the novel coronavirus, 2019-nCoV, and the associated illness COVID-19, staples like hand sanitizer and cleaning solutions have become difficult to find for both consumers and health care providers alike.
In response, new—and potentially unsafe—solutions are popping up online. For example, former TV chef turned talk show host Rachel Ray recently had a segment on her program entitled “How To Make Your Own Hand Sanitizer,” while other online lifestyle brands, such as “Wholefully,” “The Spruce,” and “Wellness Mama” are all offering free tutorials on home brewing hand sanitizing products in the home.
On March 14, the FDA issued a final guidance, effective immediately, stating that it intends to allow compounders to make alcohol-based hand sanitizers for the duration of the declared public health emergency. Due to the emergency nature of the ongoing outbreak, the FDA is implementing the guidance without public comment, although comment may be submitted on the public docket.
Under federal law, compounders are ordinarily not permitted to compound anything that is “essentially a copy” of a legally marketed product. Hand sanitizer is legally marketed under an OTC monograph. However, the FDA said it will exercise enforcement discretion—or not take action against compounders that make and sell hand sanitizers, due to increased demand and concerns that “some consumers are producing hand sanitizer for personal use.” The FDA said it will not enforce its existing prohibitions for as long as the public health emergency remains in effect. According to the agency, “compounders, relative to untrained consumers, are more familiar with standards and methods” for producing these types of products.
The FDA will allow compounders, including both compounding pharmacies and outsourcing facilities, to make and sell hand sanitizer under the following conditions:
- The compounder uses US Pharmacopoeia-grade ingredients that are consistent with the World Health Organization’s recommendations on formulating alcohol-based hand sanitizer products (i.e., either 80% ethanol alcohol by volume or 75% isopropyl alcohol by volume, 1.45% glycerol by volume, 0.125% hydrogen peroxide by volume, and the use of sterile distilled or cold-boiled water);
- The compounder may not use other active or inactive ingredients, and ensures that all ingredients are correct;
- The hand sanitizer is prepared using the same standards used to compound similar nonsterile drugs; and
- The hand sanitizer is labelled correctly (labelling for ethyl alcohol formulation or isopropyl alcohol formulation, as appropriate).
Under the policy, the FDA will not take action against state-licensed compounding pharmacies and outsourcing facilities for violations of general manufacturing standards, adulteration or misbranding requirements, labelling requirements, or section 505 of the Federal Food, Drug, and Cosmetic (FD&C) Act, which sets approval and clearance requirements for legally marketed drug and medical device products. In addition, the FDA will not enforce section 582 of FD&C Act, requiring trading partners to notify the FDA of illegitimate products, for outsourcing facilities.
For the duration of the outbreak of COVID19, certain OTC medical supplies—such as hand sanitizer, cold and flu products (e.g., cough drops) may remain difficult to find from traditional retailers. Compounding pharmacies may be able to help expand availability of some products, but will require additional leniency from the FDA. At present, only hand sanitizer is covered by the approach. As additional products enter shortage situations, this policy could be expanded.
While the policy could help to ensure that more alcohol-based hand sanitizers are generally available to the public, it’s unclear to what extent it could improve the overall supply of the product, and to what extent product availability may help.