I wanna hold your hand (sanitizer)...
Did you ever imagine something as mundane as hand sanitizer could become such a big deal? It's been an eventful week or so in terms of compounders' ability to meet demand in the current hand sanitizer shortage. Here's a run-down:
- Last week, with the help of Congressman Buddy Carter (GA-1), APC reached out to FDA urging them to allow pharmacy compounders to prepare hand sanitizers to meet demand in the current shortage.
- Saturday morning, FDA released a guidance document doing just that, and we alerted you.
- Within hours, we began hearing this from APC members:
- So on Monday, we urged our members not to let a good crisis go to waste, and offered a suggestion for engaging news media - plus a few caveats - on the hand sanitizer ingredient shortage issue.
- APC's CEO Scott Brunner also emailed FDA's Dr. Gail Bormel on Monday to alert her about the need for additional clarity and flexibility in what FDA would allow related to compounding of hand sanitizers. Despite FDA's March 14 guidance, he wrote, "challenges remain which, if not addressed timely by FDA, will limit the effectiveness of FDA's temporary guidance and pharmacy compounders' ability to be helpful in COVID-19 prevention efforts."
- That same day, FDA created an email address for compounders to submit questions regarding prep of hand sanitizers: email@example.com.
- On Wednesday, APC and its partners, the American Pharmacists Association, the National Community Pharmacists Association, and the National Alliance of State Pharmacy Associations sent a joint letter to FDA requesting clarification and flexibilty related to compounding hand sanitizers and anticipating additional health emergency needs that compounders can fill.
- On Wednesday, in response to FDA's March 14 guidance on alcohol-based gels, USP's Compounding Expert Committee issued advice to boards to use risk-based enforcement discretion on USP standards. It also issued instructions on how sanitizer can be compounded safely, as well as guidance on PPE shortages:
(Yes, USP's guidance on hand sanitizers is confusing. Section 503A of the Drug Quality & Security Act only allows USP/NF grade for API, and the March 14 FDA guidance allowing compounders to prepare hand sanitizers requires all ingredients to be USP grade and does not permit deviations. That means USP's formula #3 in its guidance does not comply with the March 14 FDA guidance. So what to do? Speculated one APC member: "I really don't see anyone coming after pharmacy for making hand sanitizer as long as it is an effective hand sanitizer. FDA has a lot bigger issues right now than me making hand sanitizer." That's just a quote, not advice, mind you.)
We're currently awaiting a response from FDA to our Monday and Wednesday communications.