FDA regulatory

Route of administration

Definition

How a drug enters the body — oral, intravenous, subcutaneous, intramuscular, ophthalmic and so on.

Route is the main determinant of which CPT administration code applies, and of whether the drug is clinician-administered at all.

Dosage formThe physical form in which a drug is supplied — tablet, capsule, injection, solution, kit and so on.Definition CPT 96372Therapeutic, prophylactic or diagnostic injection given subcutaneously or intramuscularly.Definition Self-administered drugA drug that a patient can reasonably administer themselves, which therefore falls outside the medical benefit.Definition

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