§1060.12. Legend drug imprint

A. No legend drug in solid dosage form may be manufactured or distributed for sale in this state unless there is clearly marked or imprinted on the dosage form a code imprint identifying the drug and the manufacturer or distributor of the drug. The Louisiana Department of Health, upon application by a manufacturer or distributor, may exempt a particular drug product from the requirement to be imprinted on the grounds that imprinting is not feasible because of said drug product's size, texture, or other unique characteristics.

B. On or before January 1, 1984, manufacturers or distributors of legend drugs shall provide to the Louisiana Department of Health a list of their legend drugs and the description of the code imprint each bears. The department shall provide for the distribution of the information required to be submitted under this Part to all poison control centers in the state. The department shall provide to any licensed health care provider, upon request, lists of legend drugs and code imprints provided to the department under this Section, but may charge a reasonable fee to cover copying and postage costs. Manufacturers and distributors shall provide updated lists to the department annually or as changes or revisions occur.

C. A legend drug that does not meet the above requirements shall be deemed misbranded.

D. Whoever manufactures or distributes for sale or otherwise provides to any other person for dispensing any legend drug in solid dosage form that fails to comply with this Section shall be fined twenty-five thousand dollars, or imprisoned for five years, or both.

E. The provisions of Subsections A, B, C, and D of this Section shall not apply to any of the following:

(1) Drugs purchased by a pharmacy, pharmacist, or licensed wholesaler prior to January 1, 1984, and held in stock for resale.

(2) Drugs which are manufactured by or upon the order of a practitioner licensed by law to prescribe or administer drugs and which are to be used solely by the patient for whom prescribed.

Added by Acts 1982, No. 872, §1, eff. Jan. 1, 1984; Redesignated from R.S. 40:1238 by HCR 84 of 2015 R.S.