N.J. Admin. Code § 17:30-19.5

Current through Register Vol. 56, No. 21, November 4, 2024

Section 17:30-19.5 - Retention samples and stability testing

(a) A cannabis business shall properly store the retention sample from each batch or lot released for distribution for personal use:

1. By using the same container in which the usable cannabis or cannabis product is distributed;

2. Under conditions consistent with the storage conditions recommended on the product label or, if no storage conditions are recommended on the label, under ordinary storage conditions; and

3. Undisturbed at the designated storage temperature for the appropriate time interval.

(b) At six months and 12 months after the release of the batch or lot, the cannabis business shall provide the testing laboratory with a portion of the retention sample for stability testing.

(c) The testing laboratory shall perform stability testing of the retention sample of usable cannabis and cannabis products for the cannabinoid content pursuant to the cannabinoid and terpene potency subsections of the Cannabis Regulatory Commission's Testing Guidance to:

1. Ensure product potency and purity; and

2. Support or debunk the listed expiration date of the batch or lot.

(d) If the stability testing debunks the listed expiration date of the batch or lot, the cannabis business shall amend its standard operating procedure on choosing an expiration date for a batch or lot and base its amended standard operating procedure on the results of stability testing.

(e) The testing laboratory shall perform stability testing of the retention sample of usable cannabis and cannabis products for:

1. Microbial contamination, pursuant to the microbial contamination subsection of the Cannabis Regulatory Commission's Testing Guidance; and

2. Water activity, pursuant to the water activity subsection of the Cannabis Regulatory Commission's Testing Guidance.

(f) The testing laboratory shall perform stability testing of the retention sample of vaporized formulation in an electronic smoking device for heavy metals, pursuant to the heavy metals subsection of the Cannabis Regulatory Commission's Testing Guidance.

(g) The cannabis business shall report the findings of the stability testing to the Commission, to ensure that usable cannabis and cannabis product purity and potency are maintained throughout the storage process without the stored products falling out of specification.

(h) If the sample falls out of specification, the cannabis business shall amend its standard operating procedure for packaging and storage and base its amended standard operating procedure on the results of the stability testing.

(i) In the case of an adverse event reported to the cannabis business or the Commission related to cannabis or cannabis products from the batch or lot pursuant to N.J.A.C. 17:30-9.16, the cannabis business shall provide the testing laboratory with a portion of the retention sample for confirmatory testing by the testing laboratory.

(j) A cannabis business shall destroy the remains of the retention sample, if any, rendering it unrecoverable and unrecognizable, six months after the expiration of the batch or lot.

N.J. Admin. Code § 17:30-19.5

Recodified from 17:30-16.5 by 55 N.J.R. 402(a), effective 3/6/2023