(a) (1) âManufacturerâ means and includes every person who prepares, derives, produces, compounds, or repackages any drug or device except a pharmacy that manufactures on the immediate premises where the drug or device is sold to the ultimate consumer. (2) Notwithstanding paragraph (1), âmanufacturerâ shall not mean a pharmacy compounding a drug for parenteral therapy, pursuant to a prescription, for delivery to another pharmacy for the purpose of delivering or administering the drug to the patient or patients named in the prescription, provided that neither the components for the drug nor the drug are compounded, fabricated, packaged, or otherwise prepared prior to receipt of the prescription. (3) Notwithstanding paragraph (1), âmanufacturerâ shall not mean a pharmacy that, at a patientâs request, repackages a drug previously dispensed to the patient, or to the patientâs agent, pursuant to a prescription. (b) Notwithstanding subdivision (a), âmanufacturerâ also means a person who prepares, derives, manufactures, produces, or repackages a dangerous drug, as defined in Section 4022, device, or cosmetic. Manufacturer also means the holder or holders of a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), or a Biologics License Application (BLA), provided that such application has been approved; a private label distributor (including colicensed partners) for whom the private label distributorâs prescription drugs are originally manufactured and labeled for the distributor and have not been repackaged; or the distributor agent for the manufacturer, contract manufacturer, or private label distributor, whether the establishment is a member of the manufacturerâs affiliated group (regardless of whether the member takes title to the drug) or is a contract distributor site.
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