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 that meets the
requirements of the Poison Prevention Packaging Act of 1970,
15 U.S.C. Sections
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.
Section 301 et seq. (2001).
(2) A label affixed to a container in which a
prescription drug is dispensed by a physician shall include:
a. The name and address of the
physician.
b. The name of the
patient.
c. The date
dispensed.
d. The directions for
administering the prescription drug and any cautionary statement deemed
appropriate by the physician.
e.
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) Physicians must document all prescription
drugs dispensed to patients, including required label information. Noting such
information on the patient's chart or record maintained by the physician is
sufficient.
Notes
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(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.
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