In response to the COVID-19 pandemic, the FDA and the Drug Enforcement Agency have temporarily altered some rules related to pharmacy practices.
The updated rules address potential drug shortages the pandemic may cause as well as shortages of equipment pharmacists need to compound sterile drugs.
Six pharmacy policy changes made by the FDA and DEA in response to the COVID-19 pandemic:
Editor's note: Policy changes are listed in chronological order, starting with the most recent.
- FDA allowing small compounding pharmacies to supply hospitals
The FDA is temporarily allowing small compounding pharmacies to supply hospitals that aren't able to buy drugs from their usual manufacturers. - FDA eases rules so compounders can make drugs for COVID-19 ventilator patients
The FDA is temporarily relaxing drug compounding rules in response to a shortage of drugs needed to put COVID-19 patients on ventilators. For as long as the pandemic lasts, the agency said it will not take action against compounding pharmacies that make a drug that is a copy of an approved drug, use bulk ingredients not on an approved list, or fail to meet good manufacturing requirements for stability. - DEA lifts 3 restrictions on hospitals, pharmacies during COVID-19 pandemic
The first exception allows DEA-registered hospitals and clinics to handle controlled substances at their satellite locations as long as certain conditions are met. The second exception allows narcotic treatment programs to accept deliveries of narcotics without having to provide a signature at the time of delivery so people don't have to come into contact as an effort to prevent the spread of COVID-19. The third exception allows DEA-registered dispensers, including hospitals, pharmacies and physicians, to distribute controlled substances beyond the 5 percent limit. - FDA allows pharmacists to use nonstandard PPE during pandemic
The FDA said it will allow pharmacists to use nonstandard personal protective equipment to compound drugs if standard protective gear can't be obtained by pharmacies during the COVID-19 pandemic. - FDA updates hospital pharmacy compounding rules to address potential shortages
The FDA released four updates of the rules hospital pharmacies must follow under the federal Food, Drug and Cosmetic Act when it comes to compounding drugs to address problems that may arise during the COVID-19 pandemic. - DEA eases production limits for some narcotics amid shortage during pandemic
The Drug Enforcement Administration has increased production limits for some controlled substances that have seen demand spike due to the COVID-19 pandemic.