Hawaii Administrative Rules
Title 11 - DEPARTMENT OF HEALTH
Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS
Chapter 850 - MEDICAL CANNABIS DISPENSARIES
Subchapter 9 - LABORATORY CERTIFICATION, ANALYSIS, AND STANDARDS
Section 11-850-131 - Laboratory analysis required; batch size limits; representative samples; reserve samples

Universal Citation: HI Admin Rules 11-850-131

Current through February, 2024

(a) A dispensary licensee shall not dispense cannabis or manufactured cannabis products unless a laboratory certified by the department pursuant to this chapter has analyzed a representative sample of the cannabis or manufactured cannabis products and the samples meet the requirements set out in this subchapter.

(b) All samples submitted for laboratory analysis or held as reserve samples shall meet the requirements in subsection (f) for cannabis and subsection (g) for manufactured cannabis products.

(c) Collection of samples used to complete the analyses required by section 11-850-135 must take place after the batch of cannabis or manufactured cannabis product has completed all required production steps as outlined in the dispensary's standard operating procedures, except packaging and labeling, and is in its final form.

(d) A dispensary licensee shall maintain two reserve samples from each batch:

(1) In the same packaging in which the cannabis or manufactured cannabis product is dispensed;

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

(3) Until the use by date.

(e) A dispensary shall make reserve samples available for analysis or request laboratory analysis of reserve samples as directed by the department.

(f) Cannabis batch samples shall meet the following requirements:

(1) The sampler shall obtain a representative sample from each batch. The representative sample must weigh at least 0.35 per cent of the total batch weight. A sampler may collect a representative sample greater than 0.35 per cent of the total batch weight if necessary to perform the required testing or to ensure that the samples obtained are representative.

(2) The batch from which a sample is obtained shall weigh no more than 50.0 pounds. Laboratory analyses of a sample collected from a batch weighing more than 50.0 pounds shall be deemed invalid and the batch from which the sample was obtained shall not be released for retail sale.

(3) When the sampler obtains a representative sample from a batch, the sampler shall do all the following:
(A) Collect at least the number of sample increments relative to the batch size as listed in Table 1. The sampler may collect a greater number of sample increments if necessary to perform the required testing or to ensure that the samples obtained are representative;

(B) Obtain sample increments from random and varying locations of the batch, both vertically and horizontally. To the extent practicable, the sample increments obtained from a batch shall be of equal weight; and

(C) To the extent practicable, collect an equal number of sample increments from each container if the batch is stored in multiple containers.

Table 1

Cannabis batch size (pounds)

Minimum number of increments per sample

[LESS THAN EQUAL TO] 10.0

8

10.1 - 20.0

16

20.1 - 30.0

23

30.1 - 40.0

29

40.1 - 50.0

34

(g) Manufactured cannabis product batch samples shall meet the following requirements:

(1) The sampler shall obtain a representative sample from each manufactured cannabis product batch.

(2) The batch from which a sample is obtained shall contain no more than 150,000 units. Laboratory analyses of a sample collected from a batch containing more than 150,000 units shall be deemed invalid and the batch from which the sample was obtained shall not be released for retail sale.

(3) The sampler shall obtain a representative sample of a manufactured cannabis product batch by collecting at least the number of sample increments relative to the batch size as listed in Table 2. Each sample increment consists of one packaged unit or an equivalent amount of product in its final form. The sampler may collect a greater number of sample increments if necessary to perform the required testing or to ensure that the samples obtained are representative.

Table 2

Manufactured cannabis product batch size (units)

Minimum number of increments (units) per sample

[LESS THAN EQUAL TO] 50

2

51 - 150

3

151 - 500

5

501 - 1,200

8

1,201 - 3,200

13

3,201 - 10,000

20

10,001 - 35,000

32

35,001 - 150,000

50

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