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  • Pete Ganze

NYS DOH Hemp Rules and Regulations - Changes for 2021

New York’s NYS DOH “Hemp Rules and Regulations” (Oct. 26, 2020) are the first Rules and Regulations to be adopted in

the nation and will significantly change how the HEMP Processor, Manufacturer and Grower must function going forth.

PROCESSOR License Requirements (which now can include the new MANUFACTURE License): (overview)

1. PROCESSOR Licenses (incl MANUFACTURE) – two year term issued NYS DOH (or NYS Office of Cannabis - new)

2. MANUFACTURE License is NOW required - bottling, labeling, or distribution; also requires cGMP certification

3. PROCESSOR Licenses issued 2018, 2019 and 2020 - not grandfathered in; New Processor licenses are required

4. PROCESSOR Licenses NOW require licensee to be cGMP certified, e.g. Food Grade Sanitary

a. cGMP Facilities: Certified and Compliant Facilities include:

i. “white processing rooms” – clean, epoxy floors, floor drains, sanitary standards, yearly audits,

hygienic junctures when entering work area, secure access (keylocks) to work area

ii. Designated personnel changing areas; special clothing used in work areas

iii. Process Areas: Heating/Air Conditioned - 70 o F incl high air changes per hour

b. cGMP Paperwork: SOP’s, Tracking and Tracing:

i. Product tracking, QA/QC testing - receiving, processing, and shipment

ii. Written “Standard Operating Procedures” SOP - processes, personnel and equipment

c. NYS DOH: Testing of Biomass and processed oils. Must use an accredited Lab to do testing. Tests now

required for CBD, THC, Heavy Metals, Mold, Pesticides (three addl pesticides), Residual Solvents (new)

MANUFACTURER License Requirements – new license category – license not previously required (overview)

1. MANUFACTURER License required to package, label, and sell CBD products – Also Requires cGMP

2. MANUFACTURER License is a separate license, but also available as PROCESSOR/MANUFACTURER license.

OUT OF STATE PROCESSOR AND MANUFACTURER doing business in NYS in the future:

1. ANY products coming to NYS must meet the criteria set forth in NYS “Rules and Regulations” to be sold in NYS.

According to the New York Cannabis Growers and Producers Association, these new “Rules” result in fewer processors

qualifying for the new PROCESSOR and MANUFACTURE license, or a shortage of Processor(s). NorthEast Extracts LLC is

here to service your drying and extraction needs with high quality CO2 extracted CBD products.

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