New Department of Health Regulations Provide Additional Direction on Medical Marijuana Dispensary Operations in Pennsylvania; 28 Pa. Code §§1161 et seq.

December 13, 2016
By David L. Pollack
Posted in Litigation

by David L. Pollack, Of Counsel[1]

 NOTHING IN THIS DOCUMENT IS INTENDED OR SHALL BE CONSTRUED AS ADVICE TO PARTICIPATE IN, OR COUNSEL WITH RESPECT TO, CRIMINAL OR FRAUDULENT ACTIVITIES. POSSESSION, DISTRIBUTION AND SALE OF MARIJUANA IS A SERIOUS CRIME UNDER FEDERAL LAW, AND ENGAGING IN THOSE ACTIVITIES WITHOUT REGISTRATION UNDER THE PENNSYLVANIA MEDICAL MARIJUANA ACT, 35 P.S. §§ 10231.106 ET SEQ., IS A SERIOUS CRIME UNDER PENNSYLVANIA LAW. NOTHING HEREIN SHALL BE CONSTRUED AS ADVICE TO VIOLATE ANY SUCH LAW.

On December 10, 2016 the Pennsylvania Department of Health (the “Department”) published temporary regulations[2] (the “Regulations”) under the Pennsylvania Medical Marijuana Act[3] (the “Act”), which specify certain operating requirements for holders  of medical marijuana dispensary[4] permits under the Act. These regulations supplement the Department’s October 29, 2016 Temporary Regulations[5] covering the permit application process. In particular, these new regulations specify requirements for dispensary security (including security requirements for the security system), inventory control, sanitation and medical marijuana transport that are relevant to the planning of dispensary facilities. Persons who are contemplating entering this business should be advised of the following:

I.  The Department of Health continues to strongly regulate the actual handover of Medical Marijuana

How are the dispensaries expected to distribute medical marijuana?

 A dispensary will only be permitted to dispense medical marijuana to a patient or caregiver who presents a valid identification card to an employee who is authorized to dispense medical marijuana at the facility. The dispensary must also verify the validity of the patient or caregiver identification card using a prescribed electronic tracking system to access the Department’s database.

Additionally, relating to the facility itself, the dispensary may only dispense medical marijuana to a patient or caregiver in an indoor, enclosed, secure facility as approved by the Department. The dispensary must not be located within 1,000 feet of any property line of a school or day-care center.

A dispensary may not be located at the same site used for growing and processing medical marijuana.

What records must a medical marijuana dispensary keep when it dispenses medical marijuana?

Medical marijuana dispensaries are required to log the following information into the Department’s electronic tracking system:

  1. The name, address and any permit number assignment to the dispensary by the Department;
  2. The name and address of the patient and, if applicable, the patient’s caregiver;
  3. The date the medical marijuana was dispensed;
  4. Any requirement or limitation noted on the patient’s certification as to the form of medical marijuana that the patient should use; and
  5. The form and quantity of the medical marijuana dispensed.

Medical marijuana dispensaries are also required to provide the aforementioned information to the patient or caregiver in the form of a receipt.

Dispensaries are required to destroy and erase any copies of a patient’s certificate after generating the receipt.

Will patients be able to self-administer medical marijuana at the facility at which they acquire medical marijuana?

Generally, patients will not be permitted to self-administer medical marijuana at the facility where they acquire medical marijuana. However, it is at the facility’s discretion whether they permit their own employees, who are also patients, to self-administer medical marijuana while at the facility.

What are the limitations on dispensing medical marijuana?

A dispensary is not permitted to dispense an amount of medical marijuana greater than a 30-day supply to a patient or caregiver until the patient has exhausted all but a 7-day supply provided pursuant to the certification currently on file with the Department. A dispensary is also not permitted to provide a quantity or form of medical marijuana that is different than indicated on the patient’s certification.

As a dispensary permit holder, am I allowed to advertise medical marijuana at a discounted rate or as part of a giveaway?

No, a dispensary may not advertise medical marijuana as a promotional item, as a part of a giveaway, or as part of a coupon program. A dispensary is also not permitted to offer medical marijuana to a patient or caregiver free of cost unless the patient is approved for financial assistance by the Department. Additionally, a dispensary is not permitted to offer the delivery of or deliver medical marijuana to a patient’s or caregiver’s home or any other location.

II.  Medical marijuana dispensary operations will require certain expensive items and/or relationships as detailed in the regulations.

 What type of licensed medical professionals are required to work at the dispensary facility?

 Either a physician or a pharmacist must be present at a dispensary facility at all times during the hours the facility is open to dispense medical marijuana to patients and caregivers. If a dispensary is authorized to operate more than one facility under its permit, a physician assistant or a certified nurse practitioner may be present onsite at each of the other locations instead of a physician or pharmacist. As provided by the Act, each of the health professionals shall, prior to assuming any duties at the facility, successfully complete a 4-hour training course developed by the Department.

 What types of security and surveillance are required for a medical marijuana dispensary permit holder?

 A dispensary must have security systems that utilize commercial-grade equipment to prevent unauthorized entry and to prevent and detect an adverse loss. The security and surveillance systems must include a professionally monitored security alarm system that includes:

  1. Coverage of all facility entrances and exits; rooms with exterior and exits; rooms with exterior windows, exterior walls, roof hatches or skylights; storage rooms, including those that contain medical marijuana and safes; and the perimeter of the facility.
  2. A silent alarm system signal, known as a duress alarm, generated by the entry of a designated code into an arming station in order to signal that the alarm user is being forced to turn off the system.
  3. An audible security alarm signal, known as a panic alarm, generated by the manual activation of a device intended to a signal a life-threatening or emergency situation requiring law enforcement response.
  4. A silent alarm signal, known as a holdup alarm, generated by the annual activation of a device intended to signal a robbery in progress.
  5. An electrical, electronic, mechanical or other device capable of being programmed to end a prerecorded voice message requesting dispatch, when activated, over a telephone line, radio or other communication system to law enforcement, public safety or emergency services agency.
  6. A failure notification system that provides an audible, text or visual notification of any failure in the systems. The failure notification system must provide by telephone, email, or text message an alert to a designed security person within 5 minutes after the failure.
  7. Smoke and fire alarms.
  8. Auxiliary power sufficient to maintain security and surveillance systems for at least 48 hours following the power outage.
  9. Motion detectors.

Dispensaries are also required to have a professionally-monitored security and surveillance system that is operational 24 hours a day, 7 days a week and records all activity in images capable of clearly revealing facial detail. The security and surveillance system must be equipped with fixed camera placement that allows for a clear image of all individuals and activities in and around the following:

  1. Any area of the facility where medical marijuana is loaded or unloaded into or from transport vehicles.
  2. Entrances to and exits from the facility. Entrances and exits must be recorded from both indoor and outdoor vantage points.
  3. Rooms with exterior windows, exterior walls, roof hatches or skylights and storage rooms, including those that may contain medical marijuana and safes.
  4. Five feet from exterior of the perimeter of the facility.
  5. All limited access areas

The cameras in the medical marijuana dispensary facilities must also be able to take clear and still photographs and be able to display the correct date and time. The dispensaries must also be able to record all images captured by each surveillance camera for a minimum for 4 years. The recordings must be stored in a secure place and protected with a separate security system.

The temporary regulations further explains that medical marijuana dispensaries must designate an employee to continuously monitor the security and surveillance systems of the facility.

Medical marijuana dispensaries are also required to install commercial-grade, nonresidential doors and door locks on each external door of the facility.

What sanitation and safety requirements are required by the Department for a medical marijuana dispensary facility?

A dispensary shall provide its employees and visitors with adequate and convenient handwashing facilities furnished with running water at a temperature that is suitable for sanitizing hands. The following apply:

  1. Hand-washing facilities must be located where good sanitary practices require employees to wash and sanitize their hands.
  2. Effective nontoxic sanitizing cleansers and sanitary towel service or suitable hand drying devices shall be provided.
  3. A dispensary must provide its employees and visitors with adequate, readily accessible bathrooms that are that are maintained in a sanitary condition and in good repair.
  4. A dispensary shall comply with all other applicable State and local building code requirements.

What are requirements surrounding the transportation of medical marijuana?

Medical marijuana may be transported and delivered by a dispensary to a medical marijuana organization in the following circumstances:

  1. A dispensary may deliver medical marijuana to a medical marijuana organization only between 7:00am and 9:00pm for the purposes of transferring medical marijuana among the permitee’s dispensary locations and returning medical marijuana to a grower/processor.
  2. A dispensary may contract with a third-party contractor for delivery so long as the contractor complies with the regulations set forth in 28 Pa. Code §§1161 et seq.

Dispensaries will are not permitted to transport medical marijuana to any location outside of Pennsylvania. The dispensary must use a global positioning system to ensure safe, efficient delivery of the medical marijuana to a medical marijuana organization.

Vehicles permitted to transport medical marijuana must:

  1. Be equipped with a secure lockbox or locking cargo area.
  2. Have no markings that would either identify or indicate that the vehicle is being used to transport medical marijuana.
  3. Be capable of being temperature controlled for perishable medical marijuana, as appropriate.
  4. Be insured in an amount that is commercially reasonable and appropriate.

Each transport vehicle must be staffed with a delivery team consisting of at least two individuals. The dispensary is also required to notify the Department daily of its delivery schedule, including routes and delivery times.

How will the Department know whether I am in compliance with all these requirements?

At the time the Department determines a dispensary to be operational, the dispensary is required provide the Department with a full and complete plan of operation consistent with regulatory requirements for a review that includes the following:

  1. Employment policies and procedures;
  2. Security policies and protocols;
  3. A process for receiving, packaging, labeling, handling, tracking, transporting, storing, disposing, returning and recalling products containing medical marijuana in accordance with all applicable laws, rules and regulations;
  4. Workplace safety;
  5. Maintenance, cleaning and sanitation of the site or facility, or both;
  6. Inventory maintenance and reporting procedures;
  7. The investigation of complaints and potential adverse events from other medical marijuana organizations, patients, caregivers or practitioners; and
  8. The use of the electronic tracking system prescribed by the Department.

SMGG intends to stay at the forefront of legal developments in this area.  For questions, please contact Erica L. Laughlin or David L. Pollack of Strassburger McKenna Gutnick & Gefsky at elaughlin@smgglaw.com; dpollack@smgglaw.com or (412) 281-5423.

[1] The author would like to recognize the significant contributions of John Scialabba, University of Pittsburgh Law School class of 2017, to this post.

[2] Codified at 28 Pa. Code §§1161 et seq.

[3] Codified at 35 P.S. §§ 10231.106 et seq.

[4] The new rules and regulations define a dispensary as a person who holds a permit issued by the Department to dispense medical marijuana.

[5] As described in SMGG’s November 3 Blog.