New York Governing Body Information
2019 Marijuana Packaging Laws Update
Although lawmakers in New York have tried to pass a law that will legalize adult-use marijuana, lawmakers were not successful in passing the law due to disagreements about equity for social security and possible criminal record expungements. Accordingly, the information governing New York’s medical marijuana labeling and packaging requirements is very limited.
Similar to other states, common terms and spelling for marijuana used in New York include “marijuana” and “marihuana”.
Labeling and Packaging Requirements for Dispensaries
The following labeling requirements for dispensaries differ slightly to labeling requirements for manufacturing facilities.
In addition to maintaining a visitor log that must take note of the visitor’s name, date, time, and purpose of visit, dispensaries must follow the following labeling and packaging requirements:
- The name of the patient
- The registry identification number (RIN) of patient
- The designated caregiver (if applicable)
- The name of the certifying practitioner
- The dispensing facility’s name, address, and telephone number
- Doses and instructions for administration
- The quantity and date dispensed
- Any recommendations by the practitioner as to the use of medical marihuana
- Any limitations by the practitioner as to medical marihuana
- The total concentration of THC and/or CBD must be noted on the label in milligrams
In addition to the requirements above, labels must be easy to read and firmly attached to the package.
Safety Package Inserts
In addition to the actual marijuana in the package that the dispensary gives to the patient, dispensaries are also required to give safety inserts or manuals to the patient. Each product must come with a safety pamphlet or insert.
Safety inserts must include:
- The name and description of the medical marihuana product
- The medical marihuana brand
- A list of any inactive ingredients used in the marihuana
- A warning of potential allergens that may be in the marihuana
- A list of cautions on why the marihuana product should not be used or specific cautions that must be noted when taking the marihuana product
- A warning of adverse effects and potential dangers that come with using the marihuana product
- Instructions for reporting any adverse effects that the patient may endure, and as may be determined by the department of health
- Safety inserts must contain a warning about driving and operating heavy machinery or taking care of children while under the influence of medical marihuana
- Tolerance, dependency and withdrawal, and symptoms of withdrawal must be noted on the label. In addition to these cautions and warnings, the label should indicate that the patient should obtain appropriate treatment or contact a physician if they suspect withdrawal has occurred or will occur
- Information and advice on how to keep the medicinal marihuana product safe and secure
- A statement indicating that the certified patient shall not distribute the product to anyone else
- A statement indicating that any unwanted, excess, or contaminated marihuana should be disposed of properly (according to section 1004.20 of New York’s Marihuana Regulations)
- The following statement: “this product has not been analyzed by the FDA. There is limited information on the side effects of using this product and there may be associated health risks”
2018 Marijuana Packaging Laws Update
It’s been a long road for the legalization of cannabis in New York, with mayors and citizens alike calling for change all through the twentieth century. Just before legalization, in the later waves of decriminalization, New York City ceased minor possession arrests. Later that year, the Empire State passed legislation to permit cannabis for medical purposes. The New York Medical Marijuana Program as established by the Compassionate Care Act created their program.
Just like in most medical cannabis states, the possession of small amounts of cannabis is decriminalized. Possession of 25 grams (just under an ounce) all the way up to eight ounces only incurs a misdemeanor and a fine that increases with the amount. Possession of anything beyond that state mandated “personal use” amount, selling more than 25g, trafficking any amount, and are all classified as felonies.
Medical Cannabis Laws in New York
The New York Medical Marijuana Program oversees all the regulations for dispensaries, patients, providers, and caregivers in the Empire State. The law allows patients to hold a 30 day supply of cannabis-infused, non-smokable products if they suffer from a qualifying condition. Patients allowed to utilize medicinal marijuana are people suffering from chronic pain, epilepsy, HIV/AIDS, PTSD, multiple sclerosis and several others. Patients are not allowed to grow their own cannabis, but they are allowed to have up to two caregivers.
Retail Cannabis Business Rules in New York
In New York, registered businesses are allowed to distribute non-smokable cannabis products such as lotions, ointments, patches, chewables, tablets, and lozenges. Other non-smokable forms can be permissible for distribution as well. To apply to operate as a registered organization, one must submit an application and a nonrefundable application fee . For selling purposes, organizations can only extract from the leaves and flowers of female plants. Each product brand must have a specific concentration of THC and CBD and have a consistent cannabinoid profile.
2017 Marijuana Packaging Laws Update
The New York Medical Marijuana Program oversees all the regulations for dispensaries, patients, providers, and caregivers in the Empire State. They’ve set pretty thorough guidelines for packaging, including resealable, tamper evident, child resistant, and light proof features. The labeling regulations are pretty unique in that they require the NYMMP to approve all labels before they can be affixed to the marijuana product packaging. They also have detailed guidelines for the text and information that should be on the labels. Read on for some of the specific regulations, and check the link at the bottom of the quote for the full text of the law.
“(g) Approved medical marihuana products shall be limited to the following forms and routes of administration:
(1) liquid or oil preparations for metered oromucosal or sublingual administration or administration per tube;
(2) metered liquid or oil preparations for vaporization;
(3) capsules for oral administration; or
(4) any additional form and route of administration approved by the commissioner. Smoking is not an approved route of administration.
(5) approved medical marihuana products may not be incorporated into edible food products by the registered organization unless approved by the commissioner.
(h) The registered organization shall package the final form of the approved medical marihuana product at the manufacturing site. The original seal shall not be broken except for quality testing at an approved laboratory, for adverse event investigations, by the department, or by the certified patient or designated caregiver.
(i) The registered organization shall package the approved medical marihuana product such that it is child-resistant, tamper-proof/tamper-evident, light-resistant, and in a resealable package that minimizes oxygen exposure.
(j) The registered organization shall identify each lot of approved medical marihuana product with a lot unique identifier.
(k) Each approved medical marihuana product shall be affixed with a product label. Medical marihuana product labels shall be approved by the department prior to use. Each product label shall be applied at the manufacturing facility, be easily readable, firmly affixed and include:
(1) the name, address and registration number of the registered organization;
(2) the medical marihuana product form and brand designation;
(3) the single dose THC and CBD content for the product set forth in milligrams (mg);
(4) the medical marihuana product lot unique identifier (lot number or barcode);
(5) the quantity included in the package;
(6) the date packaged;
(7) the date of expiration of the product;
(8) the proper storage conditions;
(9) language stating:
(i) “Medical marihuana products must be kept in the original container in which they were dispensed and removed from the original container only when ready for use by the certified patient”;
(ii) “Keep secured at all times”;
(iii) “May not be resold or transferred to another person”;
(iv) “This product might impair the ability to drive”;
(v) “KEEP THIS PRODUCT AWAY FROM CHILDREN (unless medical marihuana product is being given to the child under a practitioner’s care”); and
(vi) “This product is for medicinal use only. Women should not consume during pregnancy or while breastfeeding except on the advice of the certifying practitioner, and in the case of breastfeeding mothers, including the infant’s pediatrician.”
The New York Medical Marijuana Program Regulations are the source for these packaging regulations, and they contain lots more useful information.