Type of Posting: Notice of Intent to Revise
Posting Date: 31-Jul–2020
Targeted Official Date: To be Determined, Revision Bulletin
In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the responsible Expert Committee intends to revise the Alcohol and Dehydrated Alcohol monographs by including the Limit of Methanol test in the Identification (ID) section, consistent with a request documented in a letter from the U.S. Food and Drug Administration (FDA) (Ref. 1).
Recently, FDA alerted the public to a sharp increase in hand sanitizer products that are labeled to contain ethanol (also known as ethyl alcohol) but that have tested positive for methanol (Ref. 2-4). These recent reported incidents of products labeled as ethanol testing positive for methanol could create risks to public health beyond hand sanitizers since ethanol is extensively used in many other drug products. FDA's letter indicates that since Alcohol and Dehydrated Alcohol are widely used as pharmaceutical ingredients, the Agency is concerned that this critical contamination risk is poised to have a broad impact on the supply chain. To address this public health issue, FDA has requested that USP revise the Identification section of the USP Alcohol and Dehydrated Alcohol monographs by including Identification C Test for “Limit of Methanol”1. A similar approach previously has been used to address public health crises in several other cases, including glycerin products that tested positive for diethylene glycol (DEG) (Ref. 5).
USP proposes to begin the revision process by first adding the Limit of Methanol test in the ID section of the USP Alcohol and USP Dehydrated Alcohol monographs. The added Limit of Methanol test in the ID section will refer to the currently official Organic Impurities test in the USP Alcohol and USP Dehydrated Alcohol monographs.
USP is publishing this Notice of Intent to Revise (NITR) to inform stakeholders about the proposed upcoming revisions to the USP Alcohol and USP Dehydrated Alcohol monographs via the USP accelerated revision process and to prepare companies for operational and compliance implications associated with a rapid implementation timeframe. USP is planning to follow this NITR with a Revision Bulletin (RB) to become official on a specified date.
Both USP Alcohol monographs are currently harmonized through the Pharmacopeial Discussion Group (PDG) process (Ref. 6). However, based on public health concerns and informed by the request from FDA, USP plans to add the Limit of Methanol test as a local requirement in the ID section and inform PDG.
USP encourages stakeholders to provide feedback by August 13, 2020 on any impact that may result from this revision; please direct any such feedback to the email Methanol-ID@usp.org. As indicated in FDA's letter, manufacturers should evaluate their supply chain for this product and contact CDER Drug Shortage Staff at firstname.lastname@example.org if any access or potential drug shortage issues arise.
1USP has identified additional related monographs in the USP–NF and FCC, namely the USP Isopropyl Alcohol and USP Azeotropic Isopropyl Alcohol monographs, and the FCC Ethyl Alcohol and FCC Isopropyl monographs. USP will announce potential compendial revisions to these monographs at a later date.
- US Pharmacopeial Convention (USP) website, Letter from FDA to USP on July 30, 2020
- Accessed: 31Jul2020
- FDA Updates on Hand Sanitizers with Methanol
- Glycerin Frequently Asked Questions
- Pharmacopeial Discussion Group (PDG), at https://www.usp.org/harmonized-standards/pdg