Compounders Ask FDA for More Guidance on Hand Sanitizer, Launch Donation Campaign

As pharmacists continue to report hand sanitizer shortages due to the coronavirus disease 2019 (COVID-19) pandemic, several organizations have written to the FDA asking for further guidance.¹ In an effort to stem the shortage, several organizations have also launched the #CompoundingHandoff campaign to encourage donations from compounding pharmacists.²

The letter was issued by the American Pharmacists Association, the Alliance for Pharmacy Compounding (APC), the National Community Pharmacists Association (NCPA), and the National Alliance of State Pharmacy Associations. The organizations said they wrote the letter together in order to receive a single consistent response from the FDA.¹

Although the FDA has announced that it will take no action against compounders preparing alcohol-based hand sanitizer, the guidance fails to address several key concerns, including shortages of the 75% isopropyl alcohol (IPA) required in the FDA’s specifications.¹

“[The] FDA should consider allowing compounders further flexibility to meet the consumer need,” the letter said. “For example, allowing pharmacists to exercise professional judgment with the use of food-grade products for compounding hand sanitizers, as well as allowing flexibility in formulas as long as the final concentration of alcohol is >60%.”¹

In addition to shortages of isopropyl alcohol, the letter said pharmacists are struggling to obtain 99% IPA and ethyl alcohol from suppliers. Members have reported finding ethyl alcohol from liquor stores, but it is not USP grade, according to the letter. Therefore, the organizations requested an acceptable formula using 70% IPA or a formula for other hand sanitizers with antiseptic properties, such as benzalkonium chloride.¹

The letter also noted that the FDA’s guidance does not preempt state laws and some state boards of pharmacy have not issued emergency orders allowing pharmacists to compound certain alcohol gels. In an effort to unify all states, the letter asked the FDA to provide clarification to the state boards of pharmacy with the goal of aligning their state-specific order with the FDA guidance.¹

Other requests in the letter include:¹

• Addressing shipping, reselling, and distribution regulations for the compounded hand sanitizers.
• Clarifying how long water should be boiled in order to meet the guidance requirements.
• Clarifying the labeling of the products, which the guidance currently says to label “purified water USP,” although that is not one of the required ingredients.
• Clarifying the default beyond use expiration dates and providing guidance on how to extend them.
• Addressing standard cleaning and disinfecting practices while some agents are increasingly unavailable.

Finally, the letter asked the FDA to consider extending the applicability beyond the current crisis to allow pharmacists to meet ongoing hygiene challenges and prevent future pandemics.¹

“Compounding pharmacists are trained, prepared, and stand ready to help in the event certain FDA-approved products go into shortage,” the letter said.¹

Several organizations have also launched a campaign to drive hand sanitizer donations from compounding pharmacists in order to aid first responders. The organizers include the Professional Compounding Centers of America (PCCA), NCPA, and APC.²

“Dubbed the ‘#CompoundingHandoff,’ the initiative provides compounding pharmacists with a plan of action to help their communities,” said a statement from the organizers.²

PCCA has developed their own formulas for pharmaceutical-grade, alcohol-based hand sanitizers based on FDA-approved guidelines and reported that more than 1600 pharmacies have already downloaded them.² The hashtag campaign unites pharmacists’ efforts, links them with first responders who need the hand sanitizer, and encourages other to become involved. The press release noted that some pharmacies have also provided hand sanitizers at no cost to at-risk community members, such as the elderly and immunocompromised.²

“Independent pharmacies are on the front lines of this crisis, and in many places they are the only accessible health care providers,” said NCPA Chief Executive Officer Doug Hoey, RPh, MBA, in the statement. “Ensuring their patients and local first responders have sanitizer is a key part of the national effort to fight COVID-19, and independent pharmacies are willing and proud to meet that need.”²

REFERENCES

• RE: Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency Immediately in Effect Guidance for Industry. APA, APC, NASPA, NCPA; March 20, 2020. https://a4pc.org/Common/Uploaded%20files/Advocacy/Joint%20Compounding%20Sanitizer%20Comments%20Final%20031820.pdf. Accessed March 27, 2020.
• PCCA, NCPA, and APC Launch #CompoundingHandoff Campaign to Drive Hand Sanitizer Donations [news release]. PCCA; March 26, 2020. https://www.pccarx.com/pccanews/CCANCPAandAPCLaunchCompoundingHandoffCampaigntoDriveHandSanitizerDonations. Accessed March 26, 2020.