Louisiana Administrative Code
Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS
Part XCI - Drug and Device Distributors
Chapter 13 - Wholesale Distributors
Section XCI-1311 - Verification Requirements
Universal Citation: LA Admin Code XCI-1311
Current through Register Vol. 50, No. 9, September 20, 2024
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.
AUTHORITY NOTE: Promulgated in accordance with R.S. 37:3461-3482.
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