At the time of delivery of the drug, the dispensing container shall bear a label with at least the following information:

1. (1) unique identification number of the prescription;
2. (2) name, address, and phone number of the pharmacy;
3. (3) the name of the patient, or if such drug was prescribed for an animal, the species of the animal and the name of its owner;
4. (4) the name of the prescribing practitioner;
5. (5) the date the prescription is dispensed;
6. (6) name or initials of the dispensing pharmacist;
7. (7) instructions for use;
8. (8) quantity dispensed;
9. (9) appropriate ancillary instructions such as storage instructions or cautionary statements such as warnings of potential harmful effect of combining the drug product with any product containing alcohol;
10. (10) if the prescription drug order is for a Schedule II-IV controlled substance, the statement "Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.";
11. (11) if the pharmacist has selected a generically equivalent drug pursuant to the provisions of the Act, §40, the statement "Substituted for Brand Prescribed" or "Substituted for 'Brand Name'" where "Brand Name" is the actual name of the brand name product prescribed;
12. (12) the name of the registered nurse or physician assistant, if the prescription is carried out by a registered nurse or physician assistant in compliance with the Medical Practice Act, §3.06(d) (Texas Civil Statutes, Article 4495b); and

13. (13) unless otherwise directed by the prescribing practitioner, the name and strength of the actual drug product dispensed.

    1. (A) The name shall be either:

       1. (i) the brand name; or
       2. (ii) if no brand name, then the generic name and name of the manufacturer or distributor of such generic drug. (The name of the manufacturer or distributor may be reduced to an abbreviation or initials, provided the abbreviation or initials are sufficient to identify the manufacturer or distributor. For combination drug products or nonsterile compounded drug products having no brand name, the principal active ingredients shall be indicated on the label.)
    2. (B) Except as provided in paragraph (11) of this subsection, the brand name of the prescribed drug shall not appear on the prescription container unless it is the drug product actually dispensed.

Source Note:The provisions of this §309.5 adopted to be effective April 23, 1982, 7 TexReg 1479; amended to be effective October 22, 1985, 10 TexReg 3896; amended to be effective September 14, 1988, 13 TexReg 4327; amended to be effective February 1, 1989, 14 TexReg 453; amended to be effective September 5, 1990, 15 TexReg 4817; amended to be effective June 1, 1994, 19 TexReg 3929.