Average Wholesale Price
PharmacyA benchmark used in pricing prescription drugs, representing a published price suggesting what wholesalers charge pharmacies. Not actual transaction prices and often criticized as inflated. Being replaced by more transparent pricing benchmarks.
More Pharmacy Terms
340B Drug Pricing Program
A federal program requiring drug manufacturers to provide outpatient drugs at reduced prices to eligible healthcare organizations serving low-income and uninsured patients. Organizations can use savings to expand services but program has faced controversy over its scope and use.
503A Pharmacy
Traditional compounding pharmacy operating under state pharmacy board authority and section 503A of FDCA. Compounds patient-specific prescriptions using FDA-approved ingredients. Limited to preparing small quantities and cannot distribute across state lines like manufacturers.
503B Outsourcing Facility
Large-scale compounding facility registered with FDA under section 503B of FDCA. Can compound without patient-specific prescriptions and distribute across state lines. Subject to current good manufacturing practices and FDA oversight. Fills gap between compounding and manufacturing.
Biologic Drug
Medication made from living organism or its products. Examples include vaccines, gene therapies, blood products, antibodies. Larger and more complex than traditional small-molecule drugs. Cannot be exactly replicated (biosimilars are similar but not identical). Often require special storage and handling. Typically expensive. Growing segment of new drugs.
Biosimilar
A biological product highly similar to an already-approved biological product (reference product) with no clinically meaningful differences in safety, purity, or potency. Less expensive than the reference biologic but not identical like generic drugs are to brand drugs.
Black Box Warning
Strongest safety warning FDA can require on prescription drug labeling. Boxed in black border on package insert and prescribing information. Indicates serious or life-threatening risks. Does not prevent prescribing but alerts prescribers and patients. Examples include antidepressants and suicide risk, NSAIDs and cardiovascular risk. Also called boxed warning.
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