You've heard the saying, "Don't let a good crisis go to waste."

With FDA's announcement this past weekend that it will take no enforcement action against compounders who prepare alcohol-based hand sanitizers, the current public health emergency presents an opportunity for you to demonstrate in your community the extraordinary value of pharmacy compounding in COVID-19 prevention and treatment efforts.
Saturday's announcement empowers pharmacy compounders to help meet consumer demand during the current shortage of FDA-approved hand sanitizers.
Because the hand sanitizer shortage is showing up daily in headlines and television reports, the fact that your pharmacy can compound hand sanitizers - if you can access the required 75% isopropyl alcohol - may well be newsworthy in your media market. (And if you can't access the proper ingredients, that's likely newsworthy, too.)

Reach out this week to local news media - television, print, and online - to tell them how you and your fellow compounders have now been authorized by FDA to provide hand sanitizers during the shortage.   Invite them into your pharmacy and explain how FDA's guidance is welcomed, but:
  • Does not preempt state law, and some state boards of pharmacy have yet to issue state-specific emergency orders allowing compounding of certain alcohol gels.
  • Does not address reported shortages of the 75% isopropyl alcohol required in the FDA specs, without which you are unable to compound as the FDA guidance intends.
  • FDA must consider allowing compounders further flexibility to meet the consumer need, including, for instance, allowing pharmacists to exercise professional judgment with the use of food-grade products for compounding sanitizers, as well as allowing flexibility in formulas as long as the final concentration of alcohol is >60%.
APC has responded to FDA this morning to ask for clarification and further guidance on these three issues.

If the media comes to your pharmacy, allow the reporter to observe the compounding process. Take that opportunity to tell them about other ways pharmacy compounding benefits patients and communities.
Remember that when it comes to compounding, many in the news media still associate it with the NECC tragedy of several years ago or with billing scandals that continue to tarnish the image of your profession. While we'd never have wished for this current public health emergency, it provides a timely opportunity to tell the real story about what pharmacy compounders do, the challenges you face, and the essential role you play in our nation's healthcare system.

Please share your media results and patient stories with us at or via social media @a4pcrx.
IMPORTANT -- Before you begin compounding hand sanitizers, be aware of these caveats:
  • FDA has confirmed to APC that a patient-specific prescription is not required while this temporary guidance is in effect, but the FDA guidance document does not address reselling/distribution of compounded hand sanitizers. APC is seeking further clarification on that.
  • Saturday's guidance from FDA does not preempt state law or regulation. Before compounding hand sanitizers without a patient-specific prescription, you should check with your state board of pharmacy to assure you're allowed to do so under state law, regulation, and/or special order. (At present, we're aware of emergency orders in several states that relate to compounding, garbing, etc., during this public health emergency. We're working with our partner, the National Alliance of State Pharmacy Associations, to develop a complete list, and we hope to share that soon.)
  • The FDA guidance explicitly states that compounders may prepare alcohol-based hand sanitizers only if certain circumstances are present. Read the FDA guidance document carefullyand if you are unable to comply fully with its conditions, do not attempt to compound hand sanitizers.
  • APC is reaching out to FDA to encourage the agency to grant permission for temporary compounding of certain other over-the-counter medications helpful in treatment of COVID-19 (pain relievers, saline for inhalers, etc.) in the event those medications experience shortages as a result of the current public health emergency. At present however, the FDA guidance pertains only to alcohol-based hand sanitizers.
Stay tuned for more information as it comes available. Thanks for all you're doing to combat the COVID-19 threat in your community.  

Scott Brunner, CAE
Chief Executive Officer
APC is the voice for pharmacy compounding, representing compounding pharmacists, technicians, educators, students, researchers and suppliers. Compounding exists for patients and animals who are not served by traditional pharmaceutical manufacturers. Every day, APC members play a critical, often life-or-death role in patients' lives, creating essential medications unavailable elsewhere for a range of issues, including autism, oncology, dermatology, ophthalmology, pediatrics, women's health, and others.  Learn more at