Which statement is true about compounding in relation to drug shortages?

• A. It is permissible if the medication is on the FDA Drug Shortage list
• B. It is permissible if the patient cannot reasonably make up the dose with commercially available options
• C. It is permissible if the drug is discontinued and no longer marketed
• D. All of the Above

Answer: (D)

When supplies are tight, compounding becomes a practical way to ensure patients still get needed therapy. A pharmacist can prepare a drug in a form, strength, or dosage that isn’t commercially available, as long as safety, quality, and regulatory requirements are met.

If a medication appears on the FDA Drug Shortages List, compounding can help bridge the gap for patients who rely on that medicine, particularly when there aren’t suitable commercially available alternatives. If the client cannot reasonably obtain the required dose with products that are commercially available, compounding is appropriate to tailor the therapy to the prescriber’s intent. If a drug has been discontinued and is no longer marketed, compounding may provide access to the needed medication for patients who would otherwise go without, again under proper regulatory oversight and quality controls.

All of these scenarios reflect legitimate, regulated reasons to use compounding to address drug shortages, so the best answer is that all of the above are permissible under appropriate standards and safeguards.