La. Admin. Code tit. 49 § I-1189

Current through Register Vol. 50, No. 11, November 20, 2024

Section I-1189 - Labeling of Drugs or Devices-Exemptions from Requirements [Formerly 49:4.0480]

A. A shipment or other delivery of a drug or device shall be exempt from the requirements of §1187 A. 1, if it complies with all of the following conditions.

1. Such drug or device, because of its toxicity or other potentiality for harmful effect or the method of its use or the collateral measures necessary to its use or the collateral measures necessary to its use, is generally recognized by experts qualified by scientific training and experience to evaluate its safety and efficacy, as not safe and not efficacious for use except by or under the supervision of a physician, dentist, or veterinarian.

2. Such shipment or delivery is made for the purpose of exclusive use:

a. by physicians, dentists, or veterinarians in their professional practice; or

b. upon their prescriptions and under labeling bearing the directions for use specified in such prescriptions; or

c. in the manufacture of another drug or device.

3. Adequate directions for the use of such drug or device by physicians, dentists, or veterinarians, as the case may be, are readily available.

4. The label of such drug or device (other than surgical instruments and other devices to be used exclusively by physicians, dentists, or veterinarians in their professional practice) bears the statements: "Caution-To be dispensed only by a ..", the blank being filled in with one or more of the words "physician", "dentist", and "veterinarian", as the case may be.

5. No representation with respect to the conditions for which a drug or device is to be used and no statement of dosage or other direction for use appears in its labeling except representations or directions:

a. in printed matter supplied to a physician, dentist or veterinarian separately from such drug or device; and

b. specified in the prescription of a physician, dentist, or veterinarian upon which such drug or device was dispensed.

6. In the case of a drug which is not designated solely by a name recognized in an official compendium and which is fabricated from two or more ingredients, its label also bears a statement of the quantity or proportion of each active ingredient.

La. Admin. Code tit. 49, § I-1189

Adopted by the Department of Health and Human Resources, Office of Preventive and Public Health Services, September 1968.

AUTHORITY NOTE: Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as amended.