reglab/statecodes huggingface dataset:
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1151a - GROWERS/PROCESSORS › Section 1151a.21 - Growers/processors generally

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The
				qualifications that a grower/processor shall meet to receive a permit are
				continuing qualifications to maintain the permit.
(b) In addition to any other requirements in
				the act or this part, a grower/processor shall comply with the following:
(1) A grower/processor may not engage in the
				business of growing, processing, possessing, selling or offering to sell seeds,
				immature medical marijuana plants, medical marijuana plants, medical marijuana
				or medical marijuana products to another medical marijuana organization without
				first being issued a permit by the Department and without first being
				determined operational by the Department as required under §
										1141a.42 (relating to failure to
				be operational).
(2) A
				grower/processor may not employ an individual at its facility who is under 18
				years of age.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1151a - GROWERS/PROCESSORS › Section 1151a.22 - Plans of operation

Current through Register Vol. 54, No. 28, July 13, 2024
(a) At the time
				the Department determines a grower/ processor to be operational, the
				grower/processor shall provide the Department with a full and complete plan of
				operation for review that includes the following:
(1) Employment policies and
				procedures.
(2) Security policies
				and protocols including:
(i) Staff
				identification measures.
(ii)
				Monitoring of attendance of staff and individuals requiring access to the
				facility.
(iii) Alarm
				systems.
(iv) Video
				surveillance.
(v) Monitoring and
				tracking inventory.
(vi) Personal
				security.
(3) A process
				for growing, receiving, processing, packaging, labeling, handling, tracking,
				transporting, storing, disposing and recalling of seeds, immature medical
				marijuana plants, medical marijuana plants, medical marijuana or medical
				marijuana products, and a process for handling, tracking, transporting, storing
				and disposing of medical marijuana waste in accordance with applicable laws,
				rules and regulations.
(4)
				Workplace safety, including conducting necessary safety checks prior to
				starting the growing and processing of seeds, immature medical marijuana
				plants, medical marijuana plants, medical marijuana or medical marijuana
				products.
(5) Contamination
				protocols.
(6) Maintenance,
				cleaning and sanitation of equipment in the facility or on-site, or
				both.
(7) Maintenance and
				sanitation of the site or the facility, or both.
(8) Proper handling and storage of any
				solvent, gas or other chemical used in growing or processing seeds, immature
				medical marijuana plants, medical marijuana plants, medical marijuana or
				medical marijuana products in accordance with this part and other applicable
				laws, rules and regulations.
(9)
				Quality control, including regulation of the amount of THC in each process lot,
				proper labeling and minimization of contamination of medical marijuana or
				medical marijuana products.
(10)
				Inventory maintenance and reporting procedures.
(11) The investigation of complaints and
				potential adverse events from other medical marijuana organizations, patients,
				caregivers or practitioners regarding the operation of the
				grower/processor.
(12) A recall
				plan meeting the requirements of §
										1151a.42(d)
				(relating to complaints about or recall of medical marijuana
				products).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1151a - GROWERS/PROCESSORS › Section 1151a.23 - Grower/processor facilities

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A
				grower/processor may only grow, store, harvest or process seeds, immature
				medical marijuana plants, medical marijuana plants, medical marijuana or
				medical marijuana products in an indoor, enclosed, secure facility that has
				been inspected and deemed operational.
(b) The following areas of a facility must be
				clearly marked with proper signage:
(1)
				Growing and processing areas. These areas shall be easily observed by the
				Department and its authorized agents and by law enforcement.
(2) Nongrowing and nonprocessing
				areas.
(3) Limited access areas.
				Areas of ingress and egress to a limited access area must be clearly identified
				by the posting of a sign which must be not less than 12 inches wide and 12
				inches long, composed of letters not less than 1/2 inch in height, which must
				state: Do Not Enter- Limited Access Area-Access Limited to Authorized Personnel
				and Escorted Individuals.
(4) Areas
				that include business offices and reception rooms.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1151a - GROWERS/PROCESSORS › Section 1151a.24 - Growing and processing inventory

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A
				grower/processor may obtain and transport seeds or immature medical marijuana
				plants from outside of this Commonwealth for the purpose of securing its
				start-up inventory. Seeds or immature medical marijuana plants obtained from
				outside of this Commonwealth shall be obtained within 30 days from the date
				that the Department determines that the grower/processor is operational;
				between December 1 and December 30 annually; or within any 30-day window
				established by the Department under the following process:
(1) A grower/processor may make a written
				request to the Department to open an additional 30-day window for the
				importation of seeds and immature medical marijuana plants.
(2) The written request must provide a
				justification for the importation of additional seeds or immature medical
				marijuana plants including, but not limited to, the need to refresh or improve
				genetics, patient demand, and the need to ensure ample supply of
				product.
(3) The written request
				must state the starting and ending date being requested.
(4) The request must be submitted at least 60
				days in advance of the proposed start date.
(5) The Department will provide written
				notice to the grower/processor, no later than 30 days prior to the proposed
				start date, approving or denying the request based on sufficiency of the
				justification presented.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1151a - GROWERS/PROCESSORS › Section 1151a.25 - Access to grower/processor facilities

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A grower/processor facility may not be
				open to the general public. When an individual who is not approved to enter the
				facility requires access to the facility for purposes regarding the growing,
				processing or testing of seeds, immature medical marijuana plants, medical
				marijuana plants, medical marijuana or medical marijuana products, or for
				potential investment or employment, a grower/processor shall require the
				individual to sign a log, detailing the need for entry, and to wear a temporary
				identification badge that is visible to others at all times while onsite and in
				the facility.
(b) A
				grower/processor shall require an individual to present government-issued
				identification that contains a photo to gain access to the site and
				facility.
(c) No one under 18 years
				of age is permitted to enter a grower/processor site or facility.
(d) A grower/processor shall post a sign in a
				conspicuous location at each entrance of a site and a facility that states:
THESE PREMISES ARE UNDER CONSTANT VIDEO SURVEILLANCE. NO ONE
				  UNDER THE AGE OF 18 IS PERMITTED TO ENTER.
(e) A grower/processor shall do the following
				when admitting an individual to a site or facility:
(1) Require the individual to sign a log and
				detail the need for entry upon entering and to sign the log when leaving the
				facility.
(2) Check the
				individual's government-issued identification to verify that the name on the
				identification provided matches the name in the log. A photocopy of the
				identification must be retained with the log.
(3) Issue a temporary identification badge
				with the individual's name and company, if applicable, and a badge
				number.
(4) Escort the individual
				while the individual remains in the facility or onsite.
(5) Ensure that the individual does not touch
				seeds, immature medical marijuana plants, medical marijuana plants, medical
				marijuana or medical marijuana products located in a limited access
				area.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1151a - GROWERS/PROCESSORS › Section 1151a.26 - Security and surveillance

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A
				grower/processor shall have security and surveillance systems, utilizing
				commercial-grade equipment, to prevent unauthorized entry and to prevent and
				detect an adverse loss. The security and surveillance systems must include all
				of the following:
(1) A
				professionally-monitored security alarm system that includes the following:
(i) Coverage of all facility entrances and
				exits; rooms with exterior windows, exterior walls, roof hatches or skylights;
				storage rooms, including those that contain seeds, immature medical marijuana
				plants, medical marijuana plants, medical marijuana or medical marijuana
				products and safes; and the perimeter of the facility.
(ii) A silent security alarm system signal,
				known as a duress alarm, generated by the entry of a designated code into an
				arming station to signal that the alarm user is being forced to turn off the
				system.
(iii) An audible security
				alarm system signal, known as a panic alarm, generated by the manual activation
				of a device intended to signal a life-threatening or emergency situation
				requiring law enforcement response.
(iv) A silent alarm signal, known as a holdup
				alarm, generated by the manual activation of a device intended to signal a
				robbery in progress.
(v) An
				electrical, electronic, mechanical or other device capable of being programmed
				to send a prerecorded voice message requesting dispatch, when activated, over a
				telephone line, radio or other communication system to a law enforcement,
				public safety or emergency services agency.
(vi) 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, e-mail or text
				message an alert to a designated security person within the facility within 5
				minutes after the failure.
(vii)
				Smoke and fire alarms.
(viii)
				Auxiliary power sufficient to maintain operation of specified growing and
				processing areas identified in the grower/processor's plan of operation for no
				less than 48 hours following a power outage.
(ix) The ability to ensure all access doors
				are not solely controlled by an electronic access panel to prevent locks from
				becoming released during a power outage.
(x) Motion detectors.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1151a - GROWERS/PROCESSORS › Section 1151a.27 - Requirements for growing and processing medical marijuana

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A grower/processor may use a pesticide
				that is registered by the Department of Agriculture under the Pennsylvania
				Pesticide Control Act of 1973 (3 P.S. §§
										111.21-112), and designated by the Secretary
				of Agriculture in consultation with the secretary for use by a
				grower/processor. The following apply:
(1) The
				Secretary of Agriculture will publish the list of approved pesticides by notice
				in the
Pennsylvania Bulletin
.
(2) The list shall be posted on the
				Department's publicly accessible Internet web site and shall be reviewed and
				updated by the Secretary of Agriculture, in consultation with the secretary, at
				least once annually and transmitted to the Legislative Reference Bureau for
				publication in the
Pennsylvania Bulletin
.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1151a - GROWERS/PROCESSORS › Section 1151a.28 - Forms of medical marijuana

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A
				grower/processor may only process medical marijuana for dispensing to a patient
				or caregiver in the following forms:
(1)
				Pill.
(2) Oil.
(3) Topical forms, including gel, creams or
				ointments.
(4) A form medically
				appropriate for administration by vaporization or nebulization, including dry
				leaf or plant form for administration by vaporization.
(5) Tincture.
(6) Liquid.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1151a - GROWERS/PROCESSORS › Section 1151a.29 - Limit on medical marijuana processing

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
				In the form intended to be sold to another medical marijuana organization,
				medical marijuana or a medical marijuana product must have a specific
				concentration of total THC and total CBD and must have a consistent cannabinoid
				profile. The concentration of the following cannabinoids shall be reported to
				the Department by an approved laboratory and include the following on the label
				(CAS numbers need not be displayed on the label):
(1) THC.
(2) THCA, if greater than 0.0%.
(3) THCV, if greater than 0.0%.
(4) CBD.
(5) CBDA, if greater than 0.0%.
(6) CBDV, if greater than 0.0%.
(7) CBN, if greater than 0.0%.
(8) CBG, if greater than 0.0%.
(9) CBC, if greater than 0.0%.
(10) D8, if greater than 0.0%.
(11) Any other cannabinoid component at
				0.1%.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1151a - GROWERS/PROCESSORS › Section 1151a.30 - Inventory data

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A
				grower/processor shall maintain the following inventory data in its electronic
				tracking system which must include an accounting of and an identifying tracking
				number for:
(1) The number, weight and type
				of seeds.
(2) The number of
				immature medical marijuana plants.
(3) The number of medical marijuana
				plants.
(4) The number of medical
				marijuana products ready for sale.
(5) The number of damaged, defective, expired
				or contaminated seeds, immature medical marijuana plants, medical marijuana
				plants, medical marijuana and medical marijuana products awaiting
				disposal.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1151a - GROWERS/PROCESSORS › Section 1151a.31 - Storage requirements

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A
				grower/processor shall ensure that a facility has separate and locked limited
				access areas for storage of seeds, immature medical marijuana plants, medical
				marijuana plants, medical marijuana and medical marijuana products that are
				expired, damaged, deteriorated, mislabeled, contaminated, recalled or whose
				containers or packaging have been opened or breached until the seeds, immature
				medical marijuana plants, medical marijuana plants, medical marijuana and
				medical marijuana products are destroyed or otherwise disposed of as required
				under §
									1151a.40 (relating to management
				and disposal of medical marijuana waste).
(b) A grower/processor facility shall
				maintain all storage areas in a clean and orderly condition and free from
				infestation by insects, rodents, birds and pests.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1151a - GROWERS/PROCESSORS › Section 1151a.32 - Equipment, operation and maintenance

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A grower/processor shall ensure that a
				facility has a written process in place to maintain the sanitation and
				operation of equipment that comes into contact with seeds, immature medical
				marijuana plants, medical marijuana plants, medical marijuana or medical
				marijuana products to prevent contamination. The grower/processor shall provide
				a copy of the written process to the Department upon request.
(b) As part of the written process required
				under subsection (a), a grower/processor shall:
(1) Annually, or more frequently if
				recommended by the manufacturer, calibrate, check and inspect the following to
				ensure accuracy:
(i) Automatic, mechanical or
				electronic equipment.
(ii) Scales,
				balances or other measurement devices used in the grower/processor's
				operations.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1151a - GROWERS/PROCESSORS › Section 1151a.33 - Sanitation and safety in a facility

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A
				grower/processor shall maintain a facility in a sanitary condition to limit the
				potential for contamination or adulteration of the seeds, immature medical
				marijuana plants, medical marijuana plants, medical marijuana or medical
				marijuana products grown and processed in the facility and any medical
				marijuana product produced at a facility. The following requirements apply:
(1) Equipment and surfaces, including floors,
				counters, walls and ceilings, shall be cleaned and sanitized as frequently as
				necessary to protect against contamination, using a sanitizing agent registered
				by the United States Environmental Protection Agency, in accordance with the
				instructions printed on the label. Equipment and utensils shall be so designed
				and of such material and workmanship as to be capable of being adequately
				cleaned.
(2) Trash shall be
				properly removed.
(3) Floors, walls
				and ceilings shall be kept in good repair.
(4) Equipment, counters and surfaces for
				processing must be food grade quality and may not react adversely with any
				solvent being used.
(5) Adequate
				protection against pests shall be provided through the use of integrated pest
				management practices and techniques that identify and manage plant pathogens
				and pest problems, and the regular disposal of trash to prevent
				infestation.
(6) Toxic cleaning
				compounds, sanitizing agents, solvents used in the growing and processing of
				seeds, immature medical marijuana plants, medical marijuana plants, medical
				marijuana or medical marijuana products, and pesticide chemicals must be
				labeled and stored in a manner that prevents contamination and that otherwise
				complies with other applicable laws and regulations.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1151a - GROWERS/PROCESSORS › Section 1151a.34 - Packaging and labeling of medical marijuana products

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A grower/processor shall package and
				label at its facility each form of medical marijuana products prepared for
				sale. The original seal of a package may not be broken, except for quality
				control testing at an approved laboratory, for adverse loss investigations
				conducted by the Department or by a dispensary that purchased the medical
				marijuana products.
(b) A
				grower/processor shall package the medical marijuana products in a package that
				minimizes exposure to oxygen and that:
(1) Is
				child-resistant.
(2) Is
				tamper-proof or tamper-evident.
(3)
				Is opaque. This requirement does not apply to packages containing dry
				leaf.
(4) Is resealable.
(5) Clearly distinguishes the contents of the
				package from the contents of any other package of similar appearance.
(6) Lists all product ingredients and
				includes a warning for known allergens, such as tree nuts.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1151a - GROWERS/PROCESSORS › Section 1151a.35 - Transportation of medical marijuana

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A
				grower/processor may transport and deliver seeds, immature medical marijuana
				plants, medical marijuana plants, postharvest plant material, and medical
				marijuana products to a medical marijuana organization or an approved
				laboratory in this Commonwealth in accordance with this section. All of the
				following requirements apply:
(1) Unless
				otherwise approved by the Department, a grower/processor may deliver seeds,
				immature medical marijuana plants, medical marijuana plants, postharvest plant
				material, and medical marijuana products to a grower/processor, dispensary, or
				an approved laboratory only between 7 a.m. and 9 p.m.
(2) A grower/processor may contract with a
				third-party contractor for delivery so long as the contractor complies with
				this section.
(3) A
				grower/processor may not transport seeds, immature medical marijuana plants,
				medical marijuana plants, medical marijuana, postharvest plant material or
				medical marijuana products to any location outside of this
				Commonwealth.
(4) A
				grower/processor shall use a global positioning system to ensure safe,
				efficient delivery of the seeds, immature medical marijuana plants, medical
				marijuana plants, postharvest plant material, and medical marijuana products to
				a medical marijuana organization or an approved laboratory.
(5) A grower/processor shall obtain and
				transport postharvest plant material only from another grower/ processor within
				this Commonwealth to process medical marijuana.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1151a - GROWERS/PROCESSORS › Section 1151a.36 - Transport manifest

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A
				grower/processor shall generate a printed or electronic transport manifest that
				accompanies every transport vehicle and contains all of the following
				information:
(1) The name, address and permit
				number of the grower/processor and the name of and contact information for a
				representative of the grower/processor who has direct knowledge of the
				transport.
(2) The name, address
				and permit number of the medical marijuana organization facility or approved
				laboratory receiving the delivery and the name of and contact information for a
				representative of the medical marijuana organization facility or approved
				laboratory.
(3) The quantity, by
				weight or unit, of each seed, immature medical marijuana plant, medical
				marijuana plant, medical marijuana harvest batch, harvest lot or process lot,
				postharvest plant material and medical marijuana product contained in the
				transport, along with the identification number for each batch or
				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.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1151a - GROWERS/PROCESSORS › Section 1151a.37 - Transportation of seeds, immature medical marijuana plants, medical marijuana plants and postharvest plant material

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A grower/processor may transport seeds,
				immature medical marijuana plants and medical marijuana plants within this
				Commonwealth for the growing and processing of medical marijuana.
(b) A grower/processor shall obtain and
				transport postharvest plant material only from another grower/ processor within
				this Commonwealth to process medical marijuana.
(c) A grower/processor may not transport
				seeds, immature medical marijuana plants, medical marijuana plants or
				postharvest plant material to a location outside of this
				Commonwealth.
(d) A
				grower/processor's authorization to transport seeds, immature medical marijuana
				plants, medical marijuana plants or postharvest plant material shall be subject
				to §§
									1151a.35,
				1151a.36 and
				1151a.38 (relating to
				transportation of medical marijuana; transport manifest; and evidence of
				adverse loss during transport).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1151a - GROWERS/PROCESSORS › Section 1151a.38 - Evidence of adverse loss during transport

Current through Register Vol. 54, No. 28, July 13, 2024
(a) If a grower/processor receiving a
				delivery of seeds, immature medical marijuana plants, medical marijuana plants,
				postharvest plant material or medical marijuana products from a medical
				marijuana organization discovers a discrepancy in the transport manifest that
				remains unresolved upon delivery, the grower/processor 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, and to the appropriate law enforcement
				authorities.
(b) If a
				grower/processor discovers evidence of, or reasonably suspects, a theft or
				diversion of seeds, immature medical marijuana plants, medical marijuana
				plants, postharvest plant material or medical marijuana products during
				transport, the grower/processor 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, and to
				law enforcement.
(c) If a
				grower/processor discovers a discrepancy in the transport manifest, the
				grower/processor shall:
(1) Conduct an
				investigation.
(2) Amend the
				grower/processor'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. All of the following requirements apply:
(i) The grower/processor shall submit a
				written preliminary report of the investigation to the Department within 7 days
				of discovering the discrepancy.
(ii) The grower/processor shall submit a
				final written report of the investigation to the Department within 30 days of
				discovering the discrepancy.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1151a - GROWERS/PROCESSORS › Section 1151a.39 - Electronic tracking system

Current through Register Vol. 54, No. 28, July 13, 2024
A grower/processor shall use the electronic tracking system
				  prescribed by the Department containing the requirements in section 701 of the
				  act (35 P.S. §
										10231.701).
				  The electronic tracking system prescribed by the Department shall allow for
				  two-way communication, automation and secure application-programming interface
				  with a medical marijuana organization's enterprise resource planning,
				  inventory, accounting and point-of-sale software. The electronic tracking
				  system prescribed by the Department shall include a secure application program
				  interface capable of accessing all data required to be transmitted to the
				  Department to ensure compliance with the operational reporting requirements of
				  the act and these regulations.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1151a - GROWERS/PROCESSORS › Section 1151a.40 - Management and disposal of medical marijuana waste

Current through Register Vol. 54, No. 28, July 13, 2024
(a) Medical marijuana waste generated by a
				grower/ processor or an approved laboratory shall be stored, collected and
				transported in accordance with 25 Pa. Code Chapter 285 (relating to storage,
				collection and transportation of municipal waste), provided the medical
				marijuana waste is not hazardous.
(b) The following types of medical marijuana
				waste shall be rendered unusable and unrecognizable prior to being transported
				from a grower/processor or an approved laboratory:
(1) Unused, surplus, returned, recalled,
				contaminated or expired medical marijuana.
(2) Medical marijuana plant material that is
				not used in the growing, harvesting or processing of medical marijuana,
				including flowers, stems, trim, leaves, seeds, dead medical marijuana plants,
				dead immature medical marijuana plants, unused medical marijuana plant parts,
				unused immature medical marijuana plant parts or roots.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1151a - GROWERS/PROCESSORS › Section 1151a.42 - Complaints about or recall of medical marijuana products

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A dispensary shall notify the Department
				and the grower/processor from which it obtained the medical marijuana product
				in question immediately upon becoming aware of any complaint made to the
				dispensary by a patient, caregiver or practitioner who reports an adverse event
				from using medical marijuana products purchased by the dispensary from the
				grower/processor. A grower/ processor shall investigate the report. The
				following requirements apply:
(1) A
				grower/processor shall immediately investigate a complaint to determine if a
				voluntary or mandatory recall of seeds, immature medical marijuana plants,
				medical marijuana plants, postharvest plant material, medical marijuana or
				medical marijuana products is necessary or if any further action is
				required.
(2) If a grower/processor
				determines that further action is not required, the grower/processor shall
				notify the Department of its decision and, within 24 hours, submit a written
				report to the Department stating its rationale for not taking further
				action.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1151a - GROWERS/PROCESSORS › Section 1151a.43 - Pesticides

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The use of a
				pesticide by a grower/processor in the growing or processing of seeds, immature
				medical marijuana plants, postharvest plant material, medical marijuana plants
				or medical marijuana shall be in accordance with the Pennsylvania Pesticide
				Control Act of 1973 (3 P.S. §§
										111.21-112) and this part.
(b) The Department and the Department of
				Agriculture will cooperate to inspect for and enforce the requirements of this
				section.
(c) The following apply
				regarding recordkeeping requirements for pesticide applications:
(1) The grower/processor shall maintain a
				record of each application of a pesticide. The record must include the
				following information:
(i) The date of
				application. For a pesticide requiring a re-entry time, the date of application
				must include the hour completed.
(ii) The place of application, including the
				specific block, section, or immature medical marijuana plants or medical
				marijuana plants treated.
(iii) The
				size of the area treated.
(iv) The
				product name of every pesticide used.
(v) The United States Environmental
				Protection Agency product registration number. This requirement is unnecessary
				for products exempted under section 25 of the Federal Insecticide, Fungicide,
				and Rodenticide Act (7 U.S.C.
				§
												136w).
(vi) The total amount of every pesticide used
				in pounds, ounces, gallons or liters applied to a treated area.
(vii) The dosage or rate of application of
				every pesticide used.
(viii) If
				applicable, the employee identification numbers of the individuals involved in
				making the pesticide and the permit or certification numbers of the individuals
				making or supervising the application.
(ix) Copies of pesticide labels and Safety
				Data Sheets for the pesticides used at the facility.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1151a - GROWERS/PROCESSORS › Section 1151a.44 - Treatment and quarantine orders

Current through Register Vol. 54, No. 28, July 13, 2024
(a) If a
				grower/processor fails or refuses to eradicate a plant pest that is found at
				its facility, the Department, in cooperation with the Department of
				Agriculture, may issue and enforce a treatment order against the grower/
				processor, including an order to eradicate, for any immature medical marijuana
				plants or medical marijuana plants that may carry or harbor the plant pest. The
				order will be issued in writing and set forth the necessary treatment, control
				or eradication measures required. If the grower/processor fails or refuses to
				comply with the order, the Department, acting in cooperation with the
				Department of Agriculture, may carry out the control measures established in
				the treatment order with all expenses associated with the measures accruing to
				the grower/processor.
(b) The
				Department of Agriculture, acting with the cooperation of the Department, may
				establish a quarantine to prevent the dissemination of plant pests within this
				Commonwealth or to prevent or delay the introduction of a plant pest into this
				Commonwealth from any country, state or territory. The following requirements
				apply:
(1) Upon finding a plant pest in a
				facility that has the potential to cause serious damage to other growers/
				processors or to agriculture in general, the geographic area in which the plant
				pest was found and any adjacent areas as the Department of Agriculture deems
				necessary may be quarantined.
(2)
				The quarantine order will establish conditions and restrictions determined by
				the Department of Agriculture to be necessary to prevent or reduce the movement
				of the plant pest from the quarantined area. Vehicles or any means of
				conveyance suspected of carrying the plant pest may also be subject to
				quarantine and a treatment order under subsection (a) may be issued as
				necessary to eradicate the plant pest.
(3) The quarantine order may regulate the
				planting, growing or harvesting of any immature medical marijuana plants or
				medical marijuana plants that serve as a host or reservoir for the plant pest
				within the quarantined area and may include prohibiting the processing of a
				specific harvest batch or harvest lot of medical marijuana within a specific
				geographic area or during a specified time period. An immature medical
				marijuana plant or medical marijuana plant suspected of harboring the plant
				pest may be ordered to be treated or destroyed.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1161a - DISPENSARIES › Section 1161a.22 - Dispensaries generally

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The
				qualifications that a dispensary shall meet to receive a permit are continuing
				qualifications to maintain the permit.
(b) In addition to any other requirements in
				the act or this part, a dispensary shall comply with the following:
(1) A dispensary may not engage in the
				business of possessing, dispensing, selling or offering to dispense or sell
				medical marijuana products to a patient or caregiver in this Commonwealth
				without first being issued a permit by the Department and without first being
				determined operational by the Department as required under §
										1141a.42 (relating to failure to
				be operational).
(2) A dispensary
				may not employ an individual at a facility who is under 18 years of
				age.
(3) A dispensary may not
				permit a patient to selfadminister medical marijuana products at the facility
				unless the patient is also an employee of the dispensary, and the dispensary
				permits self-administration of medical marijuana products at the facility by
				the employees.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1161a - DISPENSARIES › Section 1161a.23 - Dispensing medical marijuana products

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A dispensary may only dispense medical
				marijuana products to a patient or caregiver who presents a valid
				identification card to an employee who is authorized to dispense medical
				marijuana products at the facility. The valid identification card must be
				presented in-person at the facility or from within a vehicle on the
				dispensary's site.
(b) Prior to
				dispensing medical marijuana products to a patient or caregiver, the
				dispensary's medical professional shall:
(1)
				Verify the validity of the patient or caregiver identification card using the
				electronic tracking system.
(2)
				Review the information on the patient's most recent certification by using the
				electronic tracking system to access the Department's database. The following
				requirements apply:
(i) If a practitioner
				sets forth recommendations, requirements or limitations as to the form or
				dosage of a medical marijuana product on the patient certification, the medical
				marijuana product dispensed to a patient or a caregiver by a dispensary must
				conform to those recommendations, requirements or limitations.
(ii) If a practitioner does not set forth
				recommendations, requirements or limitations as to the form or dosage of a
				medical marijuana product on the patient certification, the physician,
				pharmacist, physician assistant or certified registered nurse practitioner
				employed by the dispensary and working at the facility shall consult with the
				patient or the caregiver regarding the appropriate form and dosage of the
				medical marijuana product to be dispensed.
(iii) The dispensary shall update the patient
				certification in the electronic tracking system by entering any recommendation
				as to the form or dosage of medical marijuana product that is dispensed to the
				patient.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1161a - DISPENSARIES › Section 1161a.24 - Limitations on dispensing

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A
				dispensary may not dispense to a patient or caregiver:
(1) A quantity of medical marijuana product
				that is greater than the amount indicated on the patient's
				certification.
(2) A form or dosage
				of medical marijuana product that is listed as a restriction or limitation on
				the patient certification.
(3) A
				form of medical marijuana products not permitted by the act or this part,
				unless otherwise adopted under section 1202 of the act (35 P.S. §
											10231.1202).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1161a - DISPENSARIES › Section 1161a.25 - Licensed medical professionals at facility

Current through Register Vol. 54, No. 28, July 13, 2024
(a) Except as provided in subsection (b), a
				dispensary shall ensure that a physician or a pharmacist is available, either
				in person or by synchronous interaction, to verify patient certifications and
				to consult with patients and caregivers at all times during the hours the
				facility is open to dispense or to offer to dispense medical marijuana products
				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
				available, either in person or by synchronous interaction, to verify patient
				certifications and to consult with patients and caregivers at each of the other
				locations instead of a physician or pharmacist. The physician, pharmacist,
				physician assistant or certified registered nurse practitioner may rotate
				coverage of the facilities, provided that a physician or pharmacist is always
				available, either in person or by synchronous interaction, at one of the
				facilities. Furthermore, no less than one dedicated medical professional must
				be present either, physically or by synchronous interaction, for each distinct
				dispensary facility location and shall not cover more than one dispensary
				facility location regardless of whether in-person coverage or synchronous
				interaction is used.
(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.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1161a - DISPENSARIES › Section 1161a.26 - Dispensary facilities

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A
				dispensary may only dispense medical marijuana products to a patient or
				caregiver in an indoor, enclosed, secure facility that has been inspected and
				deemed operational by the Department, or to a patient or caregiver who is in a
				vehicle on the dispensary's operational site.
(b) A dispensary may not be located:
(1) Within 1,000 feet of a public, private or
				parochial school, or a daycare center providing services to children under 18
				years of age, measured from the property line of the public, private or
				parochial school, or daycare center nearest to the dispensary to the nearest
				physical wall of the dispensary.
(2) At the same site used for growing and
				processing medical marijuana.
(3)
				In the same office space as a practitioner or other physician.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1161a - DISPENSARIES › Section 1161a.27 - Items and services provided at a dispensary

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A dispensary shall dispense the form of
				medical marijuana products under §
									1161a.23(b)(2)
				(relating to dispensing medical marijuana products).
(b) A dispensary shall purchase medical
				marijuana products only from a grower/processor.
(c) A dispensary may sell, offer for sale or
				provide at a facility, with the prior written approval of the Department,
				instruments, devices and services related to the use of medical marijuana
				products.
(d) A dispensary may
				dispense a medical marijuana product with a THC concentration of 0.3% or less
				so long as the dispensary purchases it from a grower/processor.
(e) A dispensary may not:
(1) Provide medical marijuana products at no
				cost or free, unless the patient is approved for financial assistance by the
				Department.
(2) Make the dispensing
				of medical marijuana products to a patient or caregiver conditional upon:
(i) The purchase of a medical device,
				instrument or service provided at a dispensary facility.
(ii) The purchase of a medical device,
				instrument or service provided at a location other than a dispensary
				facility.
(3) Deliver,
				or contract to a third party the delivery of, medical marijuana products to a
				patient or caregiver at the patient's or caregiver's home or any other
				location.
(4) Sell, offer for sale
				or provide at a facility, items and services unrelated to the use of medical
				marijuana products.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1161a - DISPENSARIES › Section 1161a.28 - Labels and safety inserts

Current through Register Vol. 54, No. 28, July 13, 2024
(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 products to a patient or caregiver in a sealed and
				properly labeled package.
(c) The
				dispensary shall inspect the label to ensure that the label meets all of the
				following requirements:
(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 number of individual doses
				contained within the package and the species and percentage of THC and CBD and
				other cannabinoids enumerated in §
										1151a.29 (relating to limit on
				medical marijuana processing), and the individual terpenes and corresponding
				percentages.
(7) Contains a warning
				that the medical marijuana product 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) Includes the
				identification number of the sales clerk dispensing the medical marijuana
				products to the patient or caregiver and the patient identification
				number.
(11) Lists a use by or
				expiration date.
(12) Lists the
				packaging date.
(13) Includes
				instructions for proper storage of the medical marijuana product in the
				package.
(14) Contains a process
				lot identification number.
(15) Is
				firmly affixed to the container directly holding medical marijuana or is firmly
				affixed to outer packaging if used.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1161a - DISPENSARIES › Section 1161a.29 - Plans of operation

Current through Register Vol. 54, No. 28, July 13, 2024
(a) At the time
				the Department determines a dispensary to be operational, the dispensary shall
				provide the Department with a full and complete plan of operation for review
				that includes all of the following:
(1)
				Employment policies and procedures.
(2) Security policies and protocols,
				including all of the following:
(i) Staff
				identification measures.
(ii)
				Monitoring of attendance of staff and individuals requiring access to the
				facility.
(iii) Alarm
				systems.
(iv) Video
				surveillance.
(v) Monitoring and
				tracking inventory.
(vi) Personnel
				security.
(3) A process
				for receiving, packaging, labeling, handling, tracking, transporting, storing,
				disposing, returning and recalling medical marijuana products 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.
(8)
				The use of the electronic tracking system prescribed by the
				Department.