Policy for Compounding of Certain Alcohol-Based Hand Sanitizer Products Through April 30, 2020; Immediately in Effect Guidance for Industry

See, attached .PDF for full comments. Because we understand that FDA staff is in emergency response mode, we provide the following immediate, specific concerns and requests: 1.We are grateful for FDA's March 14 "Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency," providing enforcement discretion for pharmacy compounders who prepare alcohol-based hand sanitizers for consumer use during the COVID-19 public health emergency. However, under that guidance, pharmacists are required to utilize USP-grade alcohol, which many compounders are unable to source at present, thereby undermining the effect of the FDA action and the ability of compounders to meet consumer need. At the same time, FDA has issued additional guidance, "Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)," allowing certain "manufacturing firms" to prepare hand sanitizers using food-grade alcohol. The result is a double standard, a situation in which, because of materials shortages, those with technical training and expertise are unable to meet the current need for hand sanitizers, while others who may have limited expertise are allowed to prepare them using materials prohibited to pharmacists. Accordingly, we ask FDA to immediately amend the "Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency," guidance to allow licensed pharmacists to utilize the same materials (i.e., food-grade alcohol) in preparing hand sanitizers as those allowed by FDA for non-pharmacy manufacturing firms during this public health emergency. 2.We anticipate potential shortages of critical OTC products used by COVID-19 patients. Some of these products, such as pain relievers, zinc and vitamin C supplements, cough medications, and saline solutions for nebulizers, can be safely compounded by pharmacists. We also anticipate potential shortages of critical FDA-approved prescription drugs, including drugs dispensed pursuant to a patient-specific prescription, as well as those distributed to hospitals, clinics and doctors to administer to patients in a clinical setting. 503A compounding pharmacies can help meet the increased demands for these products to prevent and mitigate shortages. We ask FDA to immediately issue guidance providing enforcement discretion for pharmacists to compound products that are "essentially a copy" of an FDA-approved drug that FDA identifies may be or is anticipated to be, in shortage during this public health emergency. a.We recommend that FDA identify classes of drug products or specific drug products that patients rely on for treatment and prevention of symptoms related to COVID-19, influenza, strep, and other related conditions for compounding under this guidance. b.We recommend that the guidance clarify that pharmacists may compound them immediately or for office use, pursuant to a drug order from a licensed prescriber. c.On March 23, 2020, FDA added hydroxychloroquine sulfate to category 1 under the "Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act." The FDA stated that it does not intend to object to registered outsourcing facilities using hydroxychloroquine (or chloroquine phosphate, which was already on category 1), to compound human drugs provided the drugs meet other conditions and requirements in the Federal Food, Drug, and Cosmetic Act. (FD&C Act). Compounding pharmacies that compound pursuant to section 503A of the FD&C Act are fully capable to compound these products from bulk as well to meet the market demand to prevent and mitigate a shortage. The enforcement discretion we seek would enable 503A compounding pharmacies to fill the urgent public health need along with 503B outsourcing facilities and other sources. Sincerely, Alliance for Pharmacy Compounding American Pharmacis…

Greetings: Attached, pls. find joint comments from the American Pharmacists Association, Alliance for Pharmacy Compounding, National Alliance of State Pharmacy Associations and National Community Pharmacists Association. See, attached .PDF for full comments. Our nation's compounding pharmacists are thankful for the opportunity afforded by the FDA to prepare alcohol-based hand sanitizers for consumer use for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020 because of the public health emergency posed by the coronavirus (COVID-19). As compounders who do this every day for our nation's patients, we are offering to serve as a resource to FDA for consultation prior to issuance of future emergency guidance documents to ensure that the formulas and information provided are sufficient to meet public need. Challenges yet remain with the guidance, which if not addressed by FDA in a timely manner, will limit the effectiveness of FDA's guidance and pharmacy compounders' ability to be helpful in COVID-19 prevention efforts. Compounding pharmacists at our organizations have already contacted FDA's compounding team with inquiries at compounding@fda.hhs.gov. In order to receive a consistent response from FDA, our organizations have compiled a number of pertinent questions on the guidance. Our organizations thank FDA's compounding team for your quick actions issuing this guidance to respond to this crisis. If these issues can be addressed promptly, the aim of FDA's March 14 guidance can be achieved much more quickly, and FDA's and pharmacy compounders' role in COVID-19 prevention will have immediate and substantive impact in communities across America. Our organizations welcome the opportunity to meet with FDA for regular productive and proactive dialogue with our nation's compounders as this crisis continues. We all want to help get ahead of this current public health emergency and address potential patient needs. Compounding pharmacists are trained, prepared, and stand ready to help in the event certain FDA-approved products go into shortage. We recognize that the current situation limits an in-person meeting, however, we are happy to meet with FDA through virtual meeting technologies. We look forward to hearing from you soon to clarify this guidance and continuing to work with you on the ongoing issues required to prevent the spread of COVID-19.