Iowa Admin. Code r. 653-13.1 - Standards of practice-packaging, labeling and records of prescription drugs dispensed by a physician
(1) A
physician shall dispense a prescription drug only in a container which meets
the requirements of the Poison Prevention Packaging Act of 1970, 15 U.S.C. ss. 1471- 1476 (2001), unless otherwise requested by the patient, and of Section
502G of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. ss. 301 et seq.
(2001).
(2) A label shall be
affixed to a container in which a prescription drug is dispensed by a physician
which shall include:
1. The name and address
of the physician .
2. The name of
the patient.
3. The date
dispensed.
4. The directions for
administering the prescription drug and any cautionary statement deemed
appropriate by the physician .
5.
The name and strength of the prescription drug in the container.
(3) The provisions of subrules
13.1(1) and 13.1(2) shall not apply to packaged drug samples.
(4) A physician shall keep a record of all
prescription drugs dispensed by the physician to a patient which shall contain
the information required by subrule 13.1(2) to be included on the label. Noting
such information on the patient's chart or record maintained by the physician
is sufficient.
This
Notes
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