Md. Code Regs. 14.17.14.02

Current through Register Vol. 51, No. 24, December 2, 2024

Section 14.17.14.02 - Records

A. A licensee shall maintain, independent of the seed-to-sale tracking system, a searchable, secure, tamper-evident record of each distribution that contains:

(1) If applicable, the name and address of the patient;

(2) The quantity delivered; and

(3) The product name, strength, batch number, and lot number.

B. A licensee shall maintain:

(1) To ensure uniformity, for each batch and lot:

(a) Records of production and distribution; and

(b) Daily checklists;

(2) A record of test methods and test results for each batch and lot, including graphs, charts, or spectra from laboratory instrumentation;

(3) A log of individuals visiting each premises; and

(4) A duplicate set of all records at a secure, off-site location.

F. Unless otherwise specified, a licensee, or a certifying provider shall retain a record for a period of 2 years.

Md. Code Regs. 14.17.14.02

Regulation .02 adopted effective 50:14 Md. R. 559, eff. 7/1/2023 (EMERGENCY); adopted effective 51:14 Md. R. 676, eff. 6/7/2024, exp. 8/31/2024 (Emergency); adopted effective 51:14 Md. R. 678, eff. 7/22/2024.