The regulator says it does not plan to object to certain facilities generally regulated by state boards of pharmacy making copies of certain painkillers and muscle relaxants used to treat patients with COVID-19.
By Alec Gaffney
How things work now
The FDA defines drug compounding as the practice of a licensed professional combining, mixing or altering ingredients of a drug to create a medication tailored to the needs of an individual patient. Compounded drugs are intended to be used by individual patients for which there is special need not otherwise met by a manufactured drug product. For example, a patient with an allergy might require a specific medication without a certain dye, or a patient with trouble swallowing might need a liquid formulation of a drug only manufactured as a tablet. Typically, providers write individual prescriptions for patients that need a compounded drug, which is filled in a pharmacy.
Compounded drugs are not individually approved by the FDA. The FDA does not verify the safety, effectiveness or quality of individual compounded drugs. As a result, compounded drug products generally lack the same safety, quality and effectiveness assurances as approved drugs.
In addition, the FDA generally does not regulate certain types of compounding facilities, known as 503A facilities. Those facilities are overseen by state boards of pharmacy. They are not permitted to manufacture drugs in bulk or ship their products across state lines, unlike 503B “outsourcing” facilities. Further, the FDA generally requires 503A facilities to only compound products for an individual patient after the receipt of a valid prescription for that patient.
Ordinarily, the FDA prohibits compounding pharmacies from making “copies” of FDA-approved drugs. While compounded versions can be different with respect to their physical form or other attributes, regulators don’t want companies to be making versions that are essentially the same.
But under a new guidance document released this week, the FDA said it will permit 503A facilities to compound drugs that a “essentially a copy of a commercially available drug,” and will also permit that compounder to produce products without first obtaining a patient-specific prescription.
However, 503A facilities will need to meet some conditions to be able to do so. The compounded drug product will need to be provided directly to a hospital treating patients with COVID-19, and that hospital would have needed to exhaust other attempts to procure a drug (including from a 503B facility) before ordering the compounded version.
The compounding pharmacy will also need to keep records of orders received and the patient to whom the compounded drugs were administered. State boards of pharmacy would also need to “inform the pharmacy that they do not object to the pharmacy providing the drug product to the hospital without first obtaining a patient-specific prescription.” The compounded product would also need to be labeled with a beyond-use-date (BUD).
Critically, the policy would only apply to thirteen drugs: Cisatracurium besylate (a muscle relaxant), Dexmedetomidine hydrochloride (a sedative), Etomidate (a short-acting anesthetic), Fentanyl citrate (a painkiller), Furosemide (a diuretic), Hydromorphone hydrochloride (a painkiller), Ketamine hydrochloride (an anesthetic), Lorazepam (anti-anxiety), Midazolam hydrochloride (anti-anxiety, sedative), Norepinephrine bitartrate (blood pressure), Rocuronium bromide (muscle relaxant), Vancomycin hydrochloride (antibiotic), and Vecuronium bromide (muscle relaxant).
The relative complexity of the FDA’s policy makes it likely that the policy will have relatively minor impact. A hospital would first need to identify difficulty ordering a drug, then be unable to find the product available for sale at an outsourcing facility, then directly order the product from a 503A facility that is also cleared by a state board of pharmacy.
That process is time intensive and administratively difficult. While it may help some hospitals obtain supplies of needed drugs, it is just as likely that a lack of product availability is due to a shortage of its active pharmaceutical ingredients.
Finally, it’s not clear to what extent hospitals may be willing to share the names of those patients for whom they have procedure the compounded drugs, or how the FDA would even validate if these activities were occurring. The FDA does not conduct facility inspections of 503A facilities, leaving much of the oversight of its policies to state regulatory agencies.
To contact the editor and author of this analysis, email Alec Gaffney.