General Information
Each registered organization is permitted to have up to four dispensing facilities. Registered organizations must manufacture medical marijuana products in an enclosed, indoor facility that is secure.
The registered organizations may only manufacture medical products in forms that are approved by the commissioner of health. Currently, the following forms are approved: metered liquid or oil preparations; solid and semisolid preparations (capsules, chewable and effervescent tablets, lozenges); metered ground plant preparations; topical forms and transdermal patches.
Registered organizations can produce their own brand of medical marijuana products if they have the prior approval of the department. At least one product in this brand must have low THC and high CBD. Also, at least one product must have approximately equal amounts of THC and CBD.
Books and records of the registered organization must be made available to the department upon request. Should any deficiencies be found, the registered organization must submit a plan of correction within 15 calendar days of the issue date of the statement of findings. Once the department approves the plan, the registered organization is to implement the plan.
The registered organization must have a system in place to notify the department within 24 hours of any adverse events, theft, diversion of medical marijuana products, suspected security breach, known security breach, anything that may compromise health or safety, and medical marijuana transport vehicle accidents.
Dispensing
Medical marijuana products may only be handled and dispensed by individuals with New York State pharmacist licenses. Medical marijuana products cannot be vaporized or consumed on the dispensing facility premises.
Dispensing facilities may only dispense approved medical marijuana products to certified patients and designated caregivers. Dispensing facilities may not dispense more than a 30 day supply and may only dispense more when the patient has exhausted all but a seven day supply. Dispensing facility staff may not open the medical marijuana product packaging. The dispensing facility must be able to provide a patient specific log to the patient, the patient's designated caregiver, or the patient's practitioner upon request which includes the brand, administration form, dosage, dates dispensed, and any return of product. The dispensing facility must consult the prescription monitoring program registry prior to any sales or dispensing medical marijuana products.
The registered organization is responsible for maintaining the confidentiality of patients and the security of the facility. Additionally, access to medical marijuana storage areas within the dispensing facility, where security equipment and recordings are stored, must be restricted to registered employees, employees and authorized representatives of the department, emergency personnel responding to an emergency, and other persons authorized by a manager of the facility only to maintain the operations of the facility. All other person who enter the facility must be entered into the visitor log. This log must be made available to the department during all operating hours and upon request.
The dispensing facility must affix to the approved medical marijuana product package a patient specific bidpensing label approved by the department. This must include specific information:
- the dosing and administration instructions;
- the dispensing facility name, address, and phone number;
- the certifying practitioner's name;
- the quantity and date dispensed;
- the name and registry number of the certified patient and designated caregiver, if any;
- any recommendation or limitation by the practitioner as to the use of the medical marijuana; and
- the expiration date of the product once opened
The dispensing facility must also place the approved medical marijuana product in a plain outer package when dispensing. The dispensing facility must ensure that the patient receives approved marijuana product from no more than two distinct lots of any 30-day supply that is dispensed. The dispensing facility must also include a department approved package safety insert with each product package dispensed to a patient. This information shall include, but is not limited to
- the medical marijuana product and brand;
- a list of any excipients used;
- a warning if there is any potential for allergens in the medical marijuana product;
- contraindications;
- more specific dosage directions and instructions for administration;
- warning of adverse effects and/or any potential dangers stemming from the use of medical marijuana;
- instructions for reporting adverse effects as may be determined by the department;
- a warning about driving, operation of mechanical equipment, child care or making important decisions while under the influence of medical marijuana;
- information on tolerance, dependence and withdrawal and substance abuse, how to recognize what may be problematic usage of medical marijuana and obtain appropriate services or treatment;
- advice on how to keep the medical marijuana product secure;
- language stating that the certified patient may not distribute any medical marijuana product to anyone else;
- language stating that unwanted, excess, or contaminated medical marihuana product must be disposed of according to section 1004.20 of this Part; and
- language stating that “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.”
The dispensing facility must store the medical marijuana product to ensure that there is no contamination or deterioration of the medical marijuana product of its packaging.
If a Medical Marijuana Product is Returned to the Facility
If a medical marijuana product is returned to the facility, it must be disposed of. Until the time when it can be disposed it must be securely stored. This storage location must be separate from working inventory while the product awaits disposal. Additionally, the following information must be provided to the department:
- the name and registry identification number of the certified patient for whom the product was dispensed;
- the date of the return;
- the reason for return;
- the quantity/weight returned;
- the brand and form being returned;
- the name of the dispensing facility employee accepting the return