Labeling

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  1. (a)

    1. (1) The pharmacist filling a prescription for dispensing to an ultimate patient may affix to the container a label showing:

      1. (A) The pharmacy name, address, and telephone number;

      2. (B) The date of dispensing;

      3. (C) The serial number of the prescription;

      4. (D) The name of the patient;

      5. (E) The name of the prescribing practitioner;

      6. (F) Either:

        1. (i) The trade name of the drug product, if any, or the generic name and identity of the manufacturer of the dispensed drug product, if the drug product appears generically listed on the drug formulary list as established by this subchapter; or

        2. (ii) In the case of a biological product, the trade name of the biological product, if any, or the proper name of the biological product and identity of the manufacturer of the dispensed biological product;

      7. (G) The strength per unit dose of the medication;

      8. (H) The quantity of the medication; and

      9. (I) Directions for use.

    2. (2) If a pharmacist dispenses a generically equivalent product or interchangeable biological product, the person for whom the medication is prescribed shall be informed before dispensing or the label should appropriately indicate the substitution.

    3. (3) This subsection does not apply to the dispensing of medication to inpatients in hospitals.

    4. (4) In the case of dispensing a drug product or biological product, the prescribing practitioner may indicate that the name, manufacturer, and strength of the medication dispensed shall be deleted from the label.

  2. (b) An authorized person who fills a prescription for dispensing to an ultimate patient shall affix to the container a label showing:

    1. (1) The trade name of the medication or the generic name of the medication unless directed to the contrary by the prescribing practitioner; or

    2. (2) The trade name, if any, or the proper name of the biological product unless directed to the contrary by the prescribing practitioner.


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