Md. Code Regs. 10.34.22.06

Current through Register Vol. 51, No. 25, December 13, 2024

Section 10.34.22.06 - Minimum Requirements for the Storage and Handling of Prescription Drugs or Devices

A. Facilities. Facilities at which prescription drugs or devices are stored, warehoused, handled, held, offered, marketed, or displayed shall:

(1) Be of suitable size and construction to facilitate:

(a) Cleaning;

(b) Maintenance; and

(c) Proper operations;

(2) Have storage areas designed to provide adequate:

(a) Equipment;

(b) Humidity control;

(c) Lighting;

(d) Sanitation;

(e) Security conditions;

(f) Space;

(g) Temperature; and

(h) Ventilation;

(3) Have a quarantine area for storage of prescription drugs or devices that are:

(a) Adulterated;

(b) Damaged;

(c) Deteriorated;

(d) In immediate or sealed secondary containers that have been opened;

(e) Misbranded; or

(f) Outdated;

(4) Be maintained in a clean and orderly condition; and

(5) Be free from infestation by insects, rodents, birds, or vermin.

B. Security. A facility:

(1) Used for wholesale distribution shall be secure from unauthorized entry as follows:

(a) Access from outside the premises shall be:

(i) Kept to a minimum; and

(ii) Well controlled;

(b) The outside perimeter of the premises shall be well lit; and

(c) Entry into areas where prescription drugs or devices are held shall be limited to authorized personnel;

(2) Shall be equipped with:

(a) An alarm system to detect entry after hours;

(b) A security system that provides protection against theft and diversion;

(c) Appropriate software to facilitate the identification of evidence of tampering with computers or electronic records;

(d) An inventory management and control system that protects against, detects, and documents any instances of theft, diversion, or counterfeiting;

(e) A security system to protect the integrity and confidentiality of data and documents;

(f) Video monitoring of all entrances and exits, or alternate acceptable security; and

(g) A means to make the data and documentation required under this section readily available to the Board, an agent of the Board, or federal and other State law enforcement officials.

C. Storage.

(1) A wholesale distributor shall store a prescription drug or device at appropriate temperatures and under appropriate conditions in accordance with requirements:

(a) If any, of the labeling of the drug or device; or

(b) Set forth in the current edition of an official compendium, such as the United States Pharmacopeia/National Formulary (USP/NF), under 21 CFR § 205.50(c), as amended.

(2) If no storage requirements are established for a prescription drug or device, the drug or device shall be held at a controlled room temperature, as defined in an official compendium as set forth in §C(1)(b) of this regulation to help assure that its identity, strength, quality, and purity are not adversely affected.

(3) A wholesale distributor shall use appropriate manual, electromechanical, or electronic temperature and humidity recording equipment, devices, and logs to document proper storage of prescription drugs or devices.

(4) A wholesale distributor shall follow the record-keeping requirements in Regulation .07 of this chapter for stored prescription drugs or devices.

D. Examination of Materials.

(1) Upon receipt, a wholesale distributor shall visually examine each outside shipping container for identity and to prevent the acceptance of:

(a) Contaminated prescription drugs or devices; or

(b) Prescription drugs or devices that are otherwise unfit for distribution.

(2) The examination required under §D(1) of this regulation shall be adequate to reveal container damage that would suggest possible contamination or other damage to the contents.

(3) A wholesale distributor shall carefully inspect each outgoing shipment:

(a) For identity of the prescription drug or device product; and

(b) To ensure that there is no delivery of a prescription drug or device that has been damaged in storage or held under improper conditions.

(4) A wholesale distributor shall follow the record-keeping requirements in Regulation .07 of this chapter for incoming and outgoing prescription drugs or devices.

E. Returned, Damaged, and Outdated Prescription Drugs or Devices.

(1) A wholesale distributor shall quarantine and physically separate prescription drugs or devices that are outdated, damaged, deteriorated, misbranded, or adulterated from other prescription drugs or devices until the quarantined and separated drugs or devices are destroyed or returned to their supplier for proper disposal.

(2) The wholesale distributor shall identify, mark, quarantine, and physically separate from other prescription drugs or devices those prescription drugs or devices whose immediate or sealed outer or sealed secondary containers have been opened or used, until the drugs or devices are either destroyed or returned to their supplier for proper disposal.

(3) Prescription Drugs.

(a) If the conditions under which a prescription drug has been returned cast doubt on the prescription drug's safety, identity, strength, quality, or purity, then the wholesale distributor shall destroy or return the prescription drug to the supplier, unless examination, testing, or other investigation proves that the prescription drug meets appropriate standards of safety, identity, strength, quality, and purity.

(b) In determining whether the conditions under which a prescription drug has been returned cast doubt on the prescription drug's safety, identity, strength, quality, or purity, the wholesale distributor shall consider, at a minimum, the:

(i) Conditions under which the prescription drug has been held, stored, or shipped before or during its return; and

(ii) Condition of the prescription drug and its container, carton, or labeling, as a result of storage or shipping.

(4) Prescription Devices.

(a) If the conditions under which a prescription device has been returned cast doubt on the prescription device's safety, identity, or quality, then the wholesale distributor shall destroy or return the prescription device to the supplier, unless examination, testing, or other investigation proves that the prescription device meets appropriate standards of safety, identity, strength, and quality.

(b) In determining whether the conditions under which a prescription device has been returned cast doubt on the prescription device's safety, identity, or quality, the wholesale distributor shall consider, among other things, the:

(i) Conditions under which the prescription device has been held, stored, or shipped before or during its return; and

(ii) Condition of the prescription device and its container, carton, or labeling, as a result of storage or shipping.

(5) A wholesale distributor shall follow the record-keeping requirements in Regulation .07 of this chapter for outdated, damaged, deteriorated, misbranded, or adulterated prescription drugs or devices.

Md. Code Regs. 10.34.22.06

Regulations .06 adopted effective March 28, 2005 (32:6 Md. R. 636)
Regulations .06 adopted effective April 7, 2008 (35:7 Md. R. 748)