US Consumers' Hand Sanitizer Resources Expand: FDA Allows Compounding During Pandemic

Agency says compounding pharmacies are more familiar with standards and methods for producing drug products than “untrained consumers.” It will allow operations that might otherwise get sanctioned for marketing adulterated drugs because their products likely are better than some remedies consumers are making. It is aware consumers are experiencing difficulties accessing alcohol-based hand sanitizers and are concocting their own hand sanitizers.

Coronavirus prevention medical surgical masks and hand sanitizer gel for hand hygiene corona virus protection.

The US Food and Drug Administration is not enforcing some prohibitions against pharmacy compounders preparing nonprescription ethyl and isopropyl alcohol-based hand sanitizers to combat a shortage of the products resulting from the Covid-19 pandemic.

The agency on 14 March announced it will allow operations that might otherwise get sanctioned for marketing adulterated drugs because...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on HBW Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Regulation

FDA Takes World Tour In Recent OTC Warnings

 

FDA Center for Drug Evaluation and Research Office of Manufacturing Quality, Office of Compliance and Office of Unapproved Drugs & Labeling Compliance recently advise Indian, Canadian and US firms about GMP problems.

FDA’s FY 2026 Budget Request Lacks New Policy Proposals

 
• By 

The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.

EU Pharma Reform: Council Proposes Rx Exemption For Topical Antimicrobials

 
• By 

The EU Council has introduced a key amendment to Article 51 (para 1, point e) of the new pharma directive: “A medicinal product shall be subject to medical prescription where it is an antimicrobial, unless intended for topical use.”

AESGP Annual Meeting: Commission Must ‘Think Carefully’ Before Reverse-Switching Antimicrobials

 
• By 

If the European Commission is serious about improving the competitiveness of the European Union, it should ditch the idea of making commonly used OTC antimicrobials like thrush treatments and cold sore creams prescription-only, warns Greek Medicines Agency president Evangelos Manolopoulos

More from Policy & Regulation

FDA Takes World Tour In Recent OTC Warnings

 

FDA Center for Drug Evaluation and Research Office of Manufacturing Quality, Office of Compliance and Office of Unapproved Drugs & Labeling Compliance recently advise Indian, Canadian and US firms about GMP problems.

German Associations Call For EU Green Claims Directive Trilogue Suspension

 
• By 

Pharma Deutschland is one of 21 German associations calling for trilogue negotiations in relation to the EU Green Claims Directive to be suspended while a “comprehensive and independent written impact assessment” is undertaken.

Over The Counter: EU Omnibus And ESG, What You Need To Know, With CEN Group’s Jasper Crone

 
• By 

HBW Insight catches up with sustainability expert Jasper Crone to find out what consumer health companies need to know about the European Commission's Omnibus simplification package.