Iowa Admin. Code r. 645-327.7 - Supplying-requirements for containers, labeling, and records
Current through Register Vol. 44, No. 6, September 22, 2021
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645—327.7(147) Supplying—requirements for containers, labeling, and records.
327.7(1) Containers. A prescription drug shall be supplied in a container which meets the requirements of the Poison Prevention Packaging Act of 1970, 15 U.S.C. §§1471-1476 (1976), which relate to childproof closure, unless otherwise requested by the patient. The containers must also meet the requirements of Section 502G of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §§301 et seq. (1976), which pertain to light resistance and moisture resistance needs of the drug supplied.
327.7(2) Labeling. A label bearing the following information shall be affixed to a container in which a prescription drug is supplied:
a. The name and practice address of the supervising physician and physician assistant.
b. The name of the patient.
c. The date supplied.
d. The directions for administering the prescription drug and any cautionary statement deemed appropriate by the physician assistant.
e. The name, strength and quantity of the prescription drug in the container.
f. When supplying Schedule II, III, or IV controlled substances, the federal transfer warning statement must appear on the label as follows: “Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.”
327.7(3) Samples. Prescription sample drugs will be provided without additional charge to the patient. Prescription sample drugs supplied in the original container or package shall be deemed to conform to labeling and packaging requirements.
327.7(4) Records. A record of prescription drugs supplied by the physician assistant to a patient shall be kept which contains the label information required by paragraphs 327.7(2)“b” to “e.” Noting such information on the patient’s chart or record is sufficient.