La. Admin. Code tit. 46 § XXXIV-1311

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

Section XXXIV-1311 - Verification Requirements

A. A wholesale distributor shall have systems in place to enable the wholesale distributor to comply with the following requirements.

1. Upon making a determination that a product in possession or control of a wholesale distributor is a suspect product, or upon receiving a request for verification from the appropriate federal official that has made a determination that a product within the possession of a wholesale distributor is a suspect product, a wholesale distribution shall:

a. quarantine the suspect product from product intended for distribution until the suspect product is cleared or dispositioned; and

b. promptly conduct an investigation to determine whether the suspect product is an illegitimate product, which shall includes validating any applicable transaction history and transaction information in the possession of the wholesale distributor and otherwise investigating to determine whether the product is an illegitimate product.

2. If the wholesale distributor determines that a suspect product is not an illegitimate product, the wholesale distributor shall promptly notify the appropriate federal or state official of such determination and such product may be further distributed.

3. A wholesale distributor shall keep records of the investigation of a suspect product for not less than six years after the conclusion of the investigation.

B. In a manner consistent with the systems and processes of the wholesale distributor, the wholesale distributor shall:

1. upon determining that a product in the possession or control of a wholesale distributor is an illegitimate product:

a. quarantine the illegitimate product from product intended for distribution until the illegitimate product is dispositioned;

b. disposition the illegitimate product that is in the possession or control of the wholesale distributor;

c. take reasonable and appropriate steps to assist trading partners in the disposition of the illegitimate product that is not in the possession or control of the wholesale distributor; and

d. retain a sample of the illegitimate product for further physical examination or laboratory analysis of the product as necessary and appropriate;

2. upon determining that a product is an illegitimate product, the wholesale distributor shall notify the appropriate federal or state officials and all immediate trading partners that there is reason to believe the wholesale distributor may have received an illegitimate product no later than 24 hours after making such determination;

3. upon the receipt of a notification from the appropriate federal or state official or a trading partner that a determination has been made that a product is an illegitimate product, a wholesale distributor shall identity all illegitimate product subject to the notification that is in the possession or control of the wholesale distributor, including any product that is subsequently received, and shall perform the activities described in Subsection A of this Section;

4. upon making a determination, in consultation with the appropriate federal official, that a notification is no longer necessary, a wholesale distributor shall promptly notify immediate trading partners that such notification has been terminated;

5. a wholesale distributor shall keep records of the disposition of an illegitimate product for not less than six years after the conclusion of the disposition.

C. A wholesale distributor may satisfy the requirements of this Section by developing a secure electronic database or utilizing a secure electronic database developed or operated by another entity.

La. Admin. Code tit. 46, § XXXIV-1311

Promulgated by the Department of Health, Board of Drug and Device Distributors, LR 42:2187 (December 2016).

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:3461-3482.