As the compounding industry answered the call to create hand sanitizer during COVID-19, the FDA has been working to resolve questions surrounding the effort. They issued a guidance document on Friday, March 27 that aimed to clarify which materials could be used in creating the sanitizer, but after receiving even more questions, they requested a call with stakeholders to help clear up any misunderstandings. MEDISCA and partners participated on the call and came away with a few notes that we feel will help compounding pharmacies understand what the FDA is expecting. Please see below for general notes from the call, and be sure to review the latest guidance document for the official position of the FDA.
a. Alcohol/Ethanol: In the discussion, the FDA stated that the ethanol does not need to be USP nor ACS grade. Using consumable or distillery grade will work if it is produced in concentrations that are high enough that the finished product is 80% alcohol by volume. It is best to use 94.5% ethanol – similar to the USP standard. The FDA wants to ensure that during the production of the chemical, impurities were not introduced, which may happen when using lower grades.
b. Glycerin/Glycerol (humectants used for the final product to be kind on the hands): The FDA is requesting that only a USP or food grade can be used in formulating hand sanitizer. The FDA has stated that at this time glycerin cannot be substituted for propylene glycol. They recommend keeping it at 1.45%, although the FDA would not object to the lower amount listed in the guidance document in the footnote.
c. Isopropyl Alcohol: If using IPA as an active ingredient, it needs to follow the USP standard.
d. Water: The FDA was very clear in their statement that sterile water was to be used and that it can be sterilized by boiling, distilling or purification processes. The FDA strongly cautioned that once it is sterilized, it is to be used quickly so that it remains sterile. A question was asked to the FDA if an RO system can be used, and they said it could be used if the system is well maintained, properly designed, and is well documented.
a. The FDA was very insistent that the only denaturants to be used are the ones listed in the guidance document. Others might be considered in the future, but not at this moment. This is in line with the World Health Organization’s’ position. Both organizations feel that hand sanitizer could be attractive to small children. The FDA explained with the higher use of hand sanitizers, the curiosity of small children, and the extended time at home, poison control calls have increased by 50%. The FDA used the example that a child consuming of 1.5tsp could result in an ER visit.
b. It is important to note that the FDA specifically asked compounders not to use Acetone as a denaturant. They found that Acetone becomes harmful over weeks of topical use due to its toxicity.
3. PACKAGING LABEL
a. The FDA was also insistent that each bottle of hand sanitizer be labeled in accordance with the guidance document. They felt that this was another way to let parents know of what was in it, and hopefully avoid kids ingesting it.
b. Specifically, the FDA called out that they should all be labeled with “keep out of reach from children”.
a. The FDA suggested that each bottle receive an expiry date or BUD. These products are expected to be used soon after production, during the pandemic.
b. Once the situation is stable or back to normal, FDA stated that they will issue a statement to retract the guidance document authorizing the compounding of hand sanitizers. This means that when the retraction statement is issued, all hand sanitizers compounded can no longer be sold and must be destroyed immediately.