Final answer:
A pedigree is a document or electronic file that records each wholesale distribution of a prescription-only drug from sale by a manufacturer to its final sale, ensuring drug safety and efficacy.
Step-by-step explanation:
The term you're referring to is a pedigree. A pedigree is a document or electronic file that tracks the distribution journey of a prescription-only drug from the manufacturer, through various wholesalers and repackagers, to the final point of sale at a pharmacy or other medical facility. Pharmaceutical traceability is crucial to ensure that drugs remain safe and effective throughout their distribution. The Drug Supply Chain Security Act (DSCSA) mandates such record-keeping to prevent the introduction of counterfeit, stolen, or otherwise harmful drugs into the supply chain.
This requirement helps maintain the integrity of prescription medications. The FDA's role in requiring and checking pedigrees is part of a broader regulatory framework to ensure that prescription drugs, whether new, generic, or over-the-counter (OTC), meet strict safety and efficacy standards before being approved for the market. These regulations protect patients from potential health risks associated with unverified medications.