No Script Required but Conditions Apply
A Summary of FDA’s Guidance for 503A Compounding of COVID-19 Meds
On April 20, 2020, the FDA issued a guidance document outlining temporary policies to allow 503A compounding pharmacies to prepare certain compounded medications for hospitalized patients during the COVID-19 public health emergency. This comes after a similar guidance document was issued on April 16, 2020 for 503B outsourcing facilities. The FDA is issuing these temporary policies to enable compounding pharmacies to meet urgent patient needs, and we’ve prepared a summary of key takeaways for compounding pharmacies.
Compounding Shortage Drugs
The FDA has received numerous reports from hospitals regarding difficulty in sourcing commercially available drugs needed to treat patients hospitalized with COVID-19 due to increased demand and global supply chain interruptions. While some of the reports regard drug products appearing on the FDA’s drug shortage list, hospitals have also reported difficulty in sourcing drugs that do not yet appear on the shortage list due to regional disparities.
503A compounding pharmacies are permitted to compound drugs that appear on the FDA’s drug shortage list without violating the FDA’s policies on compounding what are essentially copies of an FDA-approved drug, as the FDA does not consider drugs appearing on the shortage list to be commercially available. However, compounding pharmacies are still subject to the prescription requirement of section 503A of the Food, Drug, and Cosmetic Act (FD&C Act).
In A Nutshell
- The temporary policies allow compounding pharmacies to dispense certain compounded medications to hospitals without first receiving a patient-specific prescription order.
- The temporary policies outlines certain conditions that compounding pharmacies must meet to dispense non-patient specific drugs without risking regulatory action.
- This temporary policy applies to state-licensed pharmacies, including hospital and health system pharmacies, and will remain in effect for the duration of the public health emergency or until the FDA updates or withdraws the guidance.
Pharmacies Must Comply with Section 503A of the FD&C Act
The compounding pharmacy must comply with all other requirements of section 503A of the FD&C Act with the exception of the requirement for receipt of a patient-specific prescription. The compounding pharmacy must also comply with section 501(a)(2)(A) of the FD&C Act, which states that drugs may not be packed, prepared, or held under insanitary conditions that may result in the drug becoming contaminated with filth or rendered injurious to health. Learn more about insanitary conditions at compounding facilities.
These Additional Conditions Apply:
- The drug compounded must be included on a list of drugs used for patients hospitalized with COVID-19 provided in Appendix A of the guidance document (see list below);
- The compounded drug can only contain one of the active ingredients found on the list provided in Appendix A;
- The hospital informs the compounding pharmacy that they are treating patients with COVID-19 and that they have not been able to obtain a drug product containing the same active ingredient and for the same route of administration from an FDA-approved source or a registered outsourcing facility;
- The compounded drug is labeled with a default beyond-use-date (BUD) in accordance with Appendix B of the guidance document, with some exceptions;
- The pharmacy marks the order with a notation documenting that the drug is provided to a hospital to treat patients during the COVID-19 public health emergency;
- The pharmacy documents that they requested the hospital to provide records identifying the patients to whom the drugs were administered within one month of dispensing the compounded drugs and;
- Before providing these compounded drugs to hospitals, the pharmacy must notify their state authorities of the intent to dispense non-patient specific medications, and the state authorities must inform the pharmacy that they do not object to this practice.
The List of Drugs Which This Guidance Applies To:
The following are the aqueous solutions for injection being used to treat patients with COVID-19 that appear in Appendix A:
- Cisatracurium besylate
- Dexmedetomidine hydrochloride
- Fentanyl citrate
- Hydromorphone hydrochloride
- Ketamine hydrochloride
- Midazolam hydrochloride
- Norepinephrine bitartrate
- Rocuronium bromide
- Vancomycin hydrochloride
- Vecuronium bromide
The Default BUDs for Labeling
The following are the default BUD’s listed in Appendix B:
|Processing Conditions||Storage Conditions|
|Controlled Room Temperature (20-25C)||Refrigerator
||4 days||6 days|
||10 days||12 days|
||20 days||22 days|
Shorter BUDs May Be Necessary
The pharmacy may need to label compounded medications with a shorter BUD if literature or scientific information indicates that the drug may not be physicochemically stable for the duration of the BUD. Additionally, if the pharmacy has not been able to obtain PPE that it typically uses to comply with the insanitary conditions provision of the FD&C Act, the pharmacy must assign a BUD of 24 hours for compounds stored at room temperature or 3 days for compounds stored under refrigerated conditions.
Use of Rapid Sterility Methods
The FDA states (emphasis added) that the default beyond-use dates “include the time necessary to complete a sterility test, which may include rapid sterility test methods as well as sterility testing described under US Pharmacopeia (USP) General Chapter <71>”. Learn more about Eagle’s ScanRDI rapid sterility testing method, which enables sterility results in as little as one business day.
Find out When the Policy is Updated
The FDA does advise that it “may withdraw or revise this guidance, at any time and without advance notice, based on the Agency’s consideration of patient needs, actual and potential benefits and risks to patients, and any other factors the Agency believes are appropriate”. As such, we encourage you to frequently check the Eagle Blog and subscribe to Eagle TV. We’re keeping compounders up to date with the latest in regulatory changes and making sure you get the news as soon as it’s published.
Have questions? Our experts are here to help. Fill our “Coronavirus Fact Check Form” for answers to this or any other subject related to COVID-19. Our scientific experts are committed to providing answers to help you in navigating these challenging times.
Who We Are
Eagle consultants and scientists are helping compounding facilities implement successful quality systems. Our team has over 200 years of combined experience in the FDA-regulated pharmaceutical industry and can provide guidance in establishing the systems and processes that will help facilities producing compounded medications meet and exceed regulatory expectations. Follow the link below to learn more about our consulting services.
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