Regulation .02 Records.
Regulation .02 Records.LinkCopy Citation
A.
A licensee shall maintain:
(1)
Independent of the seed-to-sale tracking system, a searchable, secure, tamper-evident record of each distribution that contains:
(a)
If applicable, the name and address of the patient;
(b)
The quantity delivered; and
(c)
The product name, strength, batch number, and lot number.
(2)
To ensure uniformity, for each batch and lot:
(a)
Records of production and distribution; and
(b)
Daily checklists;
(3)
A record of test methods and test results for each batch and lot;
(4)
A log of individuals visiting each premises; and
(5)
A duplicate set of all records at a secure, off-site location.
B.
Unless otherwise specified, a licensee, or a certifying provider shall retain a record for a period of 2 years.