More on Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients

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. FDA is issuing these temporary policies for pharmacy compounding to meet urgent patient needs and we’ve prepared a summary of key takeaways for compounding pharmacies to take note of.

In A Nutshell

• 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.
• The document provides 503A compounding facilities with permission to compound certain drugs that appear on the FDA’s drug shortage list.
• During the COVID-19 emergency, compounding of these drugs will not be in violation to the FDA’s policies on compounding what are essentially copies of an FDA-approved drug.
• FDA does not consider drugs appearing on the drug shortage list to be “commercially available”
• Compounding pharmacies are still subject to the prescription requirement of section 503A of the Food, Drug, and Cosmetic Act (FD&C Act).

Certain Conditions Must Be Met

The policy allows compounding pharmacies to dispense certain compounded medications under particular conditions without first receiving a patient-specific prescription order. The FDA does not intend to take regulatory action against compounding facilities providing the medications to hospitals without obtaining a patient specific prescription as long as certain conditions are met.

Pharmacies Must Comply with Insanitary Conditions

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 the 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, 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 must mark 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 must document a request to the hospital that they 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 the 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 Conditions That Must Be Present Are:

• The drug compounded must be included on a list of drugs used for hospitalized patients with COVID-19 provided in Appendix A of the guidance document;
• The compounded drug can only contain one of the active ingredients found on the list provided in Appendix A;
• The hospital must inform the outsourcing facility that they are treating patients with COVID-19 and have made reasonable attempts to obtain an FDA-approved drug product;
• The bulk drug substances used must comply with USP monograph standards, be obtained from FDA-registered facilities, and be accompanied by a certificate of analysis;
• The expiration date assigned to the compounded drug must comply with Appendices B and C of the guidance document, with some exceptions.

The List of Drugs Which This Guidance Applies To:

The following are the medications being used to treat patients with COVID-19 that appear in Appendix A:

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>”. To learn more about Eagle’s Scan RDI rapid sterility testing method, which enables sterility results in as little as one business day, click {here}.

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.

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 status of this guidance document {Social media plug? Subscribe to Eagle’s… to stay current with these, and other ever-evolving guidelines}.

View the complete Guidance Document on the FDA website

References:

• The U.S Food and Drug Administration – https://www.fda.gov/regulatory-information/search-fda-guidance-documents/temporary-policy-compounding-certain-drugs-hospitalized-patients-outsourcing-facilities-during-covid. Accessed Thursday, April 16, 2020.

 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.