La. Admin. Code tit. 46 § XCI-309

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

Section XCI-309 - Storage and Handling Requirements

A. The following are required for the storage and handling of drugs or devices, and for the establishment and maintenance of drug or device distribution records by drug or device distributors and their officers, agents, representatives, and employees.

1. Facility. A facility at which drugs or devices are stored, warehoused, handled, held, offered, marketed or displayed shall:

a. be of suitable size and construction to facilitate cleaning, maintenance, and proper operations;

b. have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security conditions;

c. have a designed and clearly identified quarantine area for storage of drugs or devices that are outdated, damaged, deteriorated, misbranded, or adulterated, or that are in immediate or sealed, secondary containers that have been opened;

d. be maintained in a clean and orderly condition; and

e. be free from infestation by insects, rodents, birds, or vermin of any kind.

2. Security

a. A facility used for drug or device distribution shall be secure from unauthorized entry.

i. Access from outside the premises shall be kept to a minimum and be well-controlled.

ii. The outside perimeter of the premises shall be well-lighted.

iii. Entry into areas where drugs or devices are held shall be limited to authorized personnel.

b. A facility, with the exception of a facility distributing medical gases only, shall be equipped with a monitored alarm system to detect entry after hours.

c. A distributor that distributes medical gases only shall store a medical gas under lock and key if the medical gas is stored inside a board-approved storage facility that is not equipped with a monitored alarm system to detect entry after hours.

d. A distributor that distributes medical gases only who stores the medical gas on an open dock shall be equipped with a monitored alarm system to detect entry after hours.

e. A facility shall be equipped with a security system that will provide suitable protection against theft or diversion and provide protection against theft or diversion that is facilitated or hidden by tampering with computers or electronic records.

3. Storage. Drugs or devices shall be stored at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of such drugs or devices or in compliance with applicable requirements in the current edition of an official compendium.

a. If no storage requirements are established for a drug or device, the drug or device may be held at room temperature, as defined in an official compendium of pharmacology and drug formulation, to help ensure that its identity, strength, quality, and purity are not adversely affected.

b. Appropriate electromechanical or electronic temperature recording equipment, devices, and logs approved by the board shall be utilized to document proper storage of drugs or devices. Spring-loaded or mercury driven temperature monitoring devices are not approved by the board for use in monitoring and recording product temperature.

c. The recordkeeping requirement in §311 shall be followed for all stored drugs or devices.

4. Examination of Materials

a. Upon receipt, each outside shipping container shall be visually examined for identity and to prevent the acceptance of contaminated or adulterated drugs or devices, or drugs or devices that are otherwise unfit for distribution or considered contraband or counterfeit. This examination shall be adequate to reveal exterior container damage that would suggest possible contamination or other damage to the contents.

b. Each outgoing shipment shall be carefully inspected for identity of the drug or device and to ensure that there is no delivery of drugs or devices that have been damaged in storage or held under improper conditions.

c. The recordkeeping requirements in §311 shall be followed for all incoming and/or outgoing drugs or devices.

d. Brokers, freight forwarders, agents, or representatives of a principal that receives at their place of business licensed by the board shipments of drugs or devices that are to be forwarded to their clients may not open the shipment packages. These packages are to be unopened and free of tampering when forwarded by carrier to the client.

5. Returned, Damaged, and Outdated Drugs or Devices

a. Drugs or devices that are outdated, damaged, deteriorated, misbranded, contaminated, adulterated, misbranded, counterfeit, or contraband shall be quarantined and physically separated in a clearly identified area from other drugs or devices until they are destroyed or returned to their supplier.

b. Any drugs or devices whose immediate or sealed outer or sealed secondary containers have been opened or used shall be identified as such, and shall be quarantined and physically separated in a clearly identified area from other drugs or devices until they are either destroyed or returned to the supplier.

c. If the conditions under which a drug or device has been returned cast doubt on the drug or device's safety, identity, strength, quality, or purity, then the drug or device shall be destroyed or returned to the supplier, unless examination, testing or other investigation proves that the drug or device meets appropriate standards for safety, identity, strength, quality, and purity. In determining whether the conditions under which a drug or device has been returned cast doubt on the drug or device's safety, identity, strength, quality, or purity, the drug or device distributor shall consider, among other things, the conditions under which the drug or device has been held, stored, or shipped before or during its return and the condition of the drug or device and its container, carton, or labeling, as a result of storage or shipping.

d. The recordkeeping requirements in §311 shall be followed for all outdated, damaged, deteriorate, misbranded, contaminated, adulterated, counterfeit, or contraband drugs or devices.

La. Admin. Code tit. 46, § XCI-309

Promulgated by the Department of Health and Hospitals, Board of Wholesale Drug Distributors, LR 18:382 (April 1992), amended LR 29:1480 (August 2003), LR 32:398 (March 2006), LR 34:875 (May 2008), Amended by the Department of Health, Board of Drug and Device Distributors, LR 422185 (12/1/2016).

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