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DEFINITIONS

Dangerous drug or device: unsafe for self-use in humans or animals; and

  1. Any drug that bears the legend: "Caution: federal law prohibits dispensing without prescription," "Rx only," or other phrases with similar meaning.

  2. Any device that bears the statement: "Caution: federal law restricts this device to sale by or on the order of a …," "Rx only," or other statement with similar meaning.

(Business & Professional Code § 4022)

Dispense: The furnishing (i.e. supplying, selling, etc.) of drugs/devices upon a prescription from a prescriber (i.e. physician, dentist, podiatrist, etc.) acting within the scope of his or her practice.

(Business & Professional Code § 4024)

Electronic Transmission Prescription: includes both image and data prescription. An electronic image transmission prescription is any prescription order for which a facsimile of the order is received by a pharmacy from a prescriber. An electronic data transmission prescription (e-script) is any prescription order, other than an electronic image transmission prescription, that is electronically transmitted from a prescriber to a pharmacy.

(Business & Professional Code § 4040)

Epinephrine auto-injector: A disposable delivery device designed for automatic injection of a premeasured dose of epinephrine into the person to prevent or treat a life threatening allergic reaction.

(Business & Professional Code § 4119.4)

Interchangeable: A biological product that has been determined to therapeutically equivalent by the federal Food and Drug Administration as set forth in the latest addition or supplement of the Approved Drug Products with Therapeutic Equivalence Evaluations.

(Business & Professional Code § 4073.5)

Manufacturer:

  • Any person who prepares, derives, produces, compounds, or repackages any drug or devices.

  • Holder(s) of an approved New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), or a Biologics License Application (BLA).

  • A manufacturer's third-party logistics provider.

  • A private label distributor.

Manufacturer does not include a pharmacy that (1) compounds a drug for parenteral therapy pursuant to a prescription, delivering to another pharmacy for the purpose of administering the drug to the intended patient, or (2) that, at a patient's request, repackages a drug previously dispensed to the patient, pursuant to a prescription.

(Business & Professional Code § 4033)

Pharmacy: An area or place where the practice of pharmacy occurs and prescriptions are compounded. At the pharmacy, controlled substances, dangerous drugs/devices are stored, possessed, prepared, manufactured, derived, compounded, repackaged, sold, or dispensed.

(Business & Professional Code § 4037)

Pre-printed multiple checkoff prescription blank: Any form listing more than one dangerous drug with the intend that if a mark is checked next to the name of the drug, that indicates a prescription order for that drug.

(California Code of Regulations § 1717.3)

Prescription: An oral, written, or ...

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