Iowa Admin. Code r. 657-6.10 - Prescription label requirements

(1) Required information. The label affixed to or on the dispensing container of any prescription drug or device dispensed by a pharmacy pursuant to a prescription drug order shall bear the following:

a. Serial number (a unique identification number of the prescription);

b. The name, telephone number, and address of the pharmacy;

c. The name of the patient or, if such drug is prescribed for an animal, the species of the animal and the name of its owner, except as provided in 657-subrule 8.19(7) for epinephrine auto-injectors, 657-subrule 8.19(8) for opioid antagonists, 657-subrule 8.19(9) for expedited partner therapy, or 657-subrule 8.19(10) for bronchodilator canisters or bronchodilator canisters and spacers.

d. The name of the prescribing practitioner;

e. The date the prescription is dispensed;

f. The directions or instructions for use, including precautions to be observed;

g. Unless otherwise directed by the prescriber, the label shall bear the name, strength, and quantity of the drug dispensed.

(1) If a pharmacist selects an equivalent drug product for a brand name drug product prescribed by a practitioner, the prescription container label shall identify the generic drug and may identify the brand name drug for which the selection is made, such as "(generic name) Generic for (brand name product)";

(2) If a pharmacist selects a brand name drug product for a generic drug product prescribed by a practitioner, the prescription container label shall identify the brand name drug product dispensed and may identify the generic drug product ordered by the prescriber, such as "(brand name product) for (generic name)";

(3) If a pharmacist selects an interchangeable biological product for the biological product prescribed by a practitioner, the prescription container label shall identify the interchangeable biological product dispensed and may identify the biological product prescribed by the practitioner, such as "(interchangeable biological product) for (biological product)";

h. The initials or other unique identification of the dispensing pharmacist, unless the identification of the pharmacist involved in each step of the prescription filling process is electronically documented and retrievable.

(2) Exceptions. The requirements of subrule 6.10(1) do not apply to unit dose dispensing systems, 657-22.1 (155A), and patient med paks, 657-22.5 (126,155A).

Notes

Iowa Admin. Code r. 657-6.10

Amended by IAB October 14, 2015/Volume XXXVIII, Number 08, effective 11/18/2015 Amended by IAB February 17, 2016/Volume XXXVIII, Number 17, effective 3/23/2016 Amended by IAB February 14, 2018/Volume XL, Number 17, effective 3/21/2018 Amended by IAB February 12, 2020/Volume XLII, Number 17, effective 3/18/2020 Amended by IAB March 22, 2023/Volume XLV, Number 19, effective 4/26/2023