La. Admin. Code tit. 51 § VI-105

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

Section VI-105 - Registration of Foods, Drugs, Cosmetics and Prophylactic Devices [formerly paragraph 6:008-1]

A. Registration Provisions. In accordance with the provisions of R.S. 40:627, all processed foods, proprietary or patent medicines, prophylactic devices and cosmetics, in package form, must be registered annually with the Louisiana Food and Drug Unit of the OPH/DHH. Application for registration may be accomplished by using the appropriate form supplied by the Food and Drug Unit.

B. [formerly paragraph 6:008-2] Application for Registration, Firm Name. Application for registration shall be made in the name of the firm appearing on the labels.

C. [formerly paragraph 6:008-3] Safety and Efficacy. Products containing new ingredients cannot be registered unless the application for registration includes sufficient evidence to prove that they have been properly tested and found to be safe and effective for use.

D. [formerly paragraph 6:008-4] Seizure. Foods, drugs, prophylactic devices and cosmetics not meeting the provisions of R.S. 40:601 et seq., shall be seized.

E. [formerly paragraph 6:008-5] Penalty. All firms shall apply for annual registration of their products. These certificates of registration expire 12 months from the date of issuance. Any applications received in the Food and Drug Control Unit Office more than 45 days after expiration of the previous certificate shall be assessed a late registration fee as stipulated in R.S. 40:627(D).

F. Product registration fees shall be assessed according to the following schedule:

1. for out-of-state soft drinks, according to the provisions of R.S. 40:716;

2. for all other products subject to registration requirements, a per product per dba per product category fee, up to the maximum allowed for under R.S. 40:628(B) per dba per product category.

G. For registration renewals, the provisions of Subsection F will be effective beginning with registrations having an expiration date of June 30, 2016.

La. Admin. Code tit. 51, § VI-105

Promulgated by the Department of Health and Hospitals, Office of Public Health, LR 28:1231 (June 2002), amended LR 401943 (10/1/2014).

AUTHORITY NOTE: Promulgated in accordance with R.S. 40:4(A)(1)(a), R.S. 40:5(2)(3)(5)(8)(15)(17)(19)(21), R.S. 40:628 and R.S. 40:716.