RULES AND REGULATIONS
DEPARTMENT OF HEALTH
[ 28 PA. CODE CH. 1161 ]
Medical Marijuana; Dispensaries; Amendments to Temporary Regulations
[47 Pa.B. 217]
[Saturday, January 14, 2017]
The Department of Health (Department) is publishing amendments to the temporary regulations in Chapter 1161 (relating to dispensaries) to read as set forth in Annex A. The temporary regulations are published under the Medical Marijuana Act (act) (35 P.S. §§ 10231.101—10231.2110). Section 1107 of the act (35 P.S. § 10231.1107) specifically provides that, to facilitate the prompt implementation of the act, the Department may promulgate temporary regulations that are not subject to sections 201—205 of the act of July 31, 1968 (P.L. 769, No. 240) (45 P.S. §§ 1201—1205), known as the Commonwealth Documents Law, the Regulatory Review Act (71 P.S. §§ 745.1—745.14) and sections 204(b) and 301(10) of the Commonwealth Attorneys Act (71 P.S. §§ 732-204(b) and 732-301(10)).
To implement the Medical Marijuana Program, the Department will be periodically publishing temporary regulations regarding various sections of the act. Chapter 1161 pertains to dispensaries that will dispense medical marijuana to patients and caregivers in accordance with the act. The amendments to the temporary regulations in Annex A will expire on January 14, 2019.
Interested persons are invited to submit written comments, suggestions or objections regarding the amendments to the temporary regulations to John J. Collins, Office of Medical Marijuana, Department of Health, Room 628, Health and Welfare Building, 625 Forster Street, Harrisburg, PA 17120, (717) 787-4366, RA-DHMedMarijuana@pa.gov. Persons with a disability who wish to submit comments, suggestions or objections regarding the temporary regulations may do so by using the previous contact information. Speech and/or hearing impaired persons may use V/TT (717) 783-6514 or the Pennsylvania AT&T Relay Service at (800) 654-5984 (TT). Persons who require an alternative format of this document may contact John J. Collins so that necessary arrangements may be made.
KAREN M. MURPHY, PhD, RN,
Fiscal Note: 10-201. No fiscal impact; (8) recommends adoption.
TITLE 28. HEALTH AND SAFETY
PART IX. MEDICAL MARIJUANA
CHAPTER 1161. DISPENSARIES
§ 1161.24. Limitations on dispensing.
(a) A dispensary may not dispense to a patient or caregiver:
(1) A quantity of medical marijuana that is greater than the amount indicated on the patient's certification, if any.
(2) A form or dosage of medical marijuana that is listed as a restriction or limitation on the patient certification.
(3) A form of medical marijuana not permitted by the act or this part, unless otherwise provided in regulations adopted by the Department under section 1202 of the act (35 P.S. § 10231.1202).
(b) A dispensary may not 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 patient certification currently on file with the Department.
§ 1161.25. Licensed medical professionals at facility.
(a) Except as provided in subsection (b), a dispensary shall ensure that a physician or a pharmacist is present at the facility at all times during the hours the facility is open to dispense or to offer to dispense medical marijuana to patients and caregivers.
(b) If a dispensary is authorized to operate more than one facility under its permit, a physician assistant or a certified registered nurse practitioner may be present onsite at each of the other locations instead of a physician or pharmacist.
(c) As required under the act, a physician, a pharmacist, a physician assistant or a certified registered nurse practitioner shall, prior to assuming any duties at a facility, successfully complete a 4-hour training course developed by the Department. The course must provide instruction in the latest scientific research on medical marijuana, including the risks and benefits of medical marijuana, and other information deemed necessary by the Department.
(d) Successful completion of the course required under subsection (c) shall be approved as continuing education credits as determined by:
(1) The State Board of Medicine and the State Board of Osteopathic Medicine.
(2) The State Board of Pharmacy.
(3) The State Board of Nursing.
(e) A practitioner or a physician, while at the facility, may not issue a patient certification to a patient.
§ 1161.28. Labels and safety inserts.
(a) Medical marijuana products dispensed by a dispensary must only be identified by the name of the grower/processor, the name of the dispensary, the form and species of medical marijuana, the percentage of THC and CBD contained in the medical marijuana product, and any other labeling required by the Department.
(b) A dispensary shall dispense medical marijuana to a patient or caregiver in a sealed and properly labeled package.
(c) The dispensary shall inspect the label to ensure that the label:
(1) Is easily readable.
(2) Is conspicuously placed on the package.
(3) Includes the name, address and permit number of the grower/processor.
(4) Lists the form and quantity of medical marijuana.
(5) Contains the following warning stating:This product is for medicinal use only. Women should not consume during pregnancy or while breastfeeding except on the advice of the practitioner who issued the certification and, in the case of breastfeeding, the infant's pediatrician. This product might impair the ability to drive or operate heavy machinery. Keep out of reach of children.
(6) Lists the amount of individual doses contained within the package and the species and percentage of THC and CBD.
(7) Contains a warning that the medical marijuana must be kept in the original container in which it was dispensed.
(8) Contains a warning that unauthorized use is unlawful and will subject the purchaser or user to criminal penalties.
(9) Includes the name and address of the dispensary.
(10) Lists a use by or expiration date.
(11) Lists the packaging date.
(12) Includes instructions for proper storage of the medical marijuana in the package.
(13) Contains any other information required by the Department.
(d) The dispensary shall inspect the label to ensure that the label does not bear:
(1) Any resemblance to the trademarked, characteristic or product-specialized packaging of any commercially available food or beverage product.
(2) Any statement, artwork or design that could reasonably lead an individual to believe that the package contains anything other than medical marijuana.
(3) Any seal, flag, crest, coat of arms or other insignia that could reasonably mislead an individual to believe that the product has been endorsed, manufactured or approved for use by any state, county or municipality or any agency thereof.
(4) Any cartoon, color scheme, image, graphic or feature that might make the package attractive to children.
(e) When a dispensary dispenses medical marijuana to a patient or caregiver, the dispensary shall also provide the patient or caregiver with a safety insert developed and approved by the Department that includes the following information:
(1) The method or methods for administering individual doses of medical marijuana.
(2) Any potential dangers stemming from the use of medical marijuana.
(3) How to recognize what may be problematic usage of medical marijuana and how to obtain appropriate services or treatment for problematic usage.
(4) The side effects and contraindications associated with medical marijuana, if any, which may cause harm to the patient.
(5) How to prevent or deter the misuse of medical marijuana by an individual under 18 years of age or others.
(6) Any other information determined by the Department to be relevant to enhance patient safety.
§ 1161.32. Inventory data.
(a) A dispensary shall maintain the following inventory data in its electronic tracking system:
(1) Medical marijuana received from a grower/processor.
(2) Medical marijuana dispensed to a patient or caregiver.
(3) Damaged, defective, expired or contaminated medical marijuana awaiting return to a grower/processor or awaiting disposal.
(b) A dispensary shall establish inventory controls and procedures to conduct monthly inventory reviews and annual comprehensive inventories of medical marijuana at its facility.
(c) A written or electronic record shall be created and maintained of each inventory which includes the date of the inventory, a summary of the inventory findings, and the employee identification numbers and titles or positions of the individuals who conducted the inventory.
§ 1161.33. Storage requirements.
(a) A dispensary shall have separate locked limited access areas for storage of medical marijuana that is expired, damaged, deteriorated, mislabeled, contaminated, recalled, or whose containers or packaging have been opened or breached until the medical marijuana is returned to a grower/processor, destroyed or otherwise disposed of as required under § 1151.40 (relating to management and disposal of medical marijuana waste).
(b) A dispensary shall maintain all storage areas in a clean and orderly condition and free from infestation by insects, rodents, birds and pests.
§ 1161.35. Transportation of medical marijuana.
(a) A dispensary may transport and deliver medical marijuana to a medical marijuana organization in this Commonwealth in accordance with this section. The following apply:
(1) A dispensary may deliver medical marijuana to a medical marijuana organization only between 7 a.m. and 9 p.m. for the purposes of transferring medical marijuana among the permittee'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 this section.
(3) A dispensary may not transport medical marijuana to any location outside of this Commonwealth.
(4) A dispensary shall use a global positioning system to ensure safe, efficient delivery of the medical marijuana to a medical marijuana organization.
(b) 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) Display current State inspection stickers and maintain a current State vehicle registration.
(5) Be insured in an amount that is commercially reasonable and appropriate.
(c) A transport vehicle shall be staffed with a delivery team consisting of at least two individuals and comply with the following:
(1) At least one delivery team member shall remain with the vehicle at all times that the vehicle contains medical marijuana.
(2) Each delivery team member shall have access to a secure form of communication with the dispensary, such as a cellular telephone, at all times that the vehicle contains medical marijuana.
(3) Each delivery team member shall carry an identification badge or card at all times and shall, upon demand, produce it to the Department or its authorized agents, law enforcement or other Federal, State or local government officials if necessary to perform the government officials' functions and duties.
(4) Each delivery team member shall have a valid driver's license.
(5) While on duty, a delivery team member may not wear any clothing or symbols that may indicate ownership or possession of medical marijuana.
(d) Medical marijuana stored inside the transport vehicle may not be visible from the outside of the transport vehicle.
(e) Except as provided in subsection (h), a delivery team shall proceed in a transport vehicle from the dispensary, where the medical marijuana is loaded, directly to the medical marijuana organization, where the medical marijuana is unloaded, without unnecessary delays. Notwithstanding the foregoing, a transport vehicle may make stops at multiple facilities, as appropriate, to deliver medical marijuana.
(f) A dispensary shall immediately report to the Department, either through a designated phone line established by the Department or by electronic communication with the Department in a manner prescribed by the Department, any vehicle accidents, diversions, losses or other reportable events that occur during transport of medical marijuana.
(g) A dispensary shall notify the Department daily of its delivery schedule, including routes and delivery times, either through a designated phone line established by the Department or by electronic communication with the Department in a manner prescribed by the Department.
(h) A transport vehicle is subject to inspection by the Department or its authorized agents, law enforcement, or other Federal, State or local government officials if necessary to perform the government officials' functions and duties. A transport vehicle may be stopped and inspected along its delivery route or at any medical marijuana organization.
§ 1161.36. Transport manifest.
(a) A dispensary shall generate a printed or electronic transport manifest that accompanies every transport vehicle and contains the following information:
(1) The name, address and permit number of the dispensary, and the name of and contact information for a representative of the dispensary who has direct knowledge of the transport.
(2) The name, address and permit number of the medical marijuana organization receiving the delivery, and the name of and contact information for a representative of the medical marijuana organization.
(3) The quantity, by weight or unit, of each medical marijuana harvest batch, harvest lot or process lot contained in the transport, along with the identification number for each harvest batch, harvest lot or process lot.
(4) The date and approximate time of departure.
(5) The date and approximate time of arrival.
(6) The transport vehicle's make and model and license plate number.
(7) The identification number of each member of the delivery team accompanying the transport.
(b) When a delivery team delivers medical marijuana to multiple medical marijuana organizations, the transport manifest must correctly reflect the specific medical marijuana in transit. Each recipient shall provide the dispensary with a printed receipt for the medical marijuana received.
(c) All medical marijuana being transported shall be packaged in shipping containers and labeled in accordance with §§ 1151.34 and 1161.28 (relating to packaging and labeling of medical marijuana; and labels and safety inserts).
(d) A dispensary shall provide a copy of the transport manifest to the recipient receiving the medical marijuana described in the transport manifest. To maintain confidentiality, a dispensary may prepare separate manifests for each recipient.
(e) A dispensary shall, if requested, provide a copy of the printed transport manifest, and any printed receipts for medical marijuana being transported, to the Department or its authorized agents, law enforcement, or other Federal, State or local government officials if necessary to perform the government officials' functions and duties.
§ 1161.37. Evidence of adverse loss during transport.
(a) If a dispensary receiving a delivery of medical marijuana or medical marijuana products from a medical marijuana organization discovers a discrepancy in the transport manifest upon delivery, the dispensary shall refuse acceptance of the delivery and immediately report the discrepancy to the Department either through a designated phone line established by the Department or by electronic communication with the Department in a manner prescribed by the Department, and to the appropriate law enforcement authorities.
(b) If a dispensary discovers evidence of, or reasonably suspects, a theft or diversion of medical marijuana or medical marijuana products during transport, the dispensary shall immediately report its findings or suspicions to the Department either through a designated phone line established by the Department or by electronic communication with the Department in a manner prescribed by the Department, and to law enforcement.
(c) If a dispensary discovers a discrepancy in the transport manifest, the dispensary shall:
(1) Conduct an investigation.
(2) Amend the dispensary's standard plan of operation, if necessary, to prevent future discrepancies between the quantity or description of inventory listed in the transport manifest and the quantity or description of inventory delivered.
(3) Submit a report of the investigation to the Department. The following apply:
(i) A written preliminary report of the investigation shall be submitted to the Department within 7 days of discovering the discrepancy.
(ii) A final written report of the investigation shall be submitted to the Department within 30 days of discovering the discrepancy.
§ 1161.40. Application for additional dispensary locations.
(a) An applicant for a dispensary permit shall include a primary dispensary facility location, and may include up to two additional dispensary facility locations, in its initial permit application. A permittee may file an application under this section for additional dispensary facility locations at a later date.
(b) A dispensary shall submit an application for additional dispensary locations on a form prescribed by the Department.
(c) A dispensary submitting an application for additional dispensary locations shall include with the application the following fees:
(1) An application fee of $5,000, which is nonrefundable.
(2) A permit fee of $30,000 for each dispensary location being proposed. The permit fee shall be submitted with the application for additional dispensary locations and will be refunded if the application is not granted.
(d) A dispensary may not begin operations at an additional location until the Department approves the application for additional dispensary locations, in writing, under this section.
(e) A dispensary submitting an application for additional dispensary locations shall follow the requirements in § 1141.29 (relating to initial permit application) and this part.
[Pa.B. Doc. No. 17-61. Filed for public inspection January 13, 2017, 9:00 a.m.]
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