reglab/statecodes huggingface dataset:
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1161a - DISPENSARIES › Section 1161a.30 - Access to dispensary facilities

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A dispensary shall post a sign in a
				conspicuous location at each entrance of the facility that reads:
THESE PREMISES ARE UNDER CONSTANT VIDEO SURVEILLANCE. NO ONE
				  UNDER THE AGE OF 18 IS PERMITTED TO ENTER UNLESS THE INDIVIDUAL IS A PATIENT OR
				  IS ACCOMPANIED BY A PARENT, GUARDIAN OR CAREGIVER.
(b) Except as provided in subsections (a) and
				(c), or in §
									1161a.26(d)
				(relating to dispensary facilities), only patients, caregivers and authorized
				employees of a dispensary may enter a limited access area.
(c) When an individual who is not approved to
				enter the facility requires access to a limited access area in the dispensary
				facility to provide goods or services to the facility, to assist a patient with
				product selection as the certifying practitioner or for potential investment or
				employment when patients and caregivers are not at the dispensary, a dispensary
				shall require the individual to present government-issued identification, to
				sign a log for that specific facility, detailing the need for entry, and to
				wear a temporary identification badge that is visible to others at all times
				while in a limited access area. The identification of a certifying practitioner
				must match the name and medical credentials documented on the accompanied
				patient's certification.
(d) When
				admitting an individual under subsection (c) to a limited access area, a
				dispensary shall:
(1) Require the individual
				to sign a log and detail the need for entry upon entering and sign the log when
				leaving the limited access area.
(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 a limited access area.
(5) Ensure that the individual does not touch
				any medical marijuana products located in a limited access area.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1161a - DISPENSARIES › Section 1161a.31 - Security and surveillance

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A
				dispensary 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 all of 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 medical marijuana 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 security and surveillance systems 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 1161a - DISPENSARIES › Section 1161a.32 - Inventory data

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A dispensary
				shall maintain the following inventory data in its electronic tracking system:
(1) Medical marijuana products received from
				a grower/ processor.
(2) Medical
				marijuana products dispensed to a patient or caregiver.
(3) Damaged, defective, expired or
				contaminated medical marijuana products awaiting return to a grower/ processor
				or awaiting disposal.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1161a - DISPENSARIES › Section 1161a.33 - Storage requirements

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A
				dispensary shall have separate and locked limited access areas for storage of
				medical marijuana products that are expired, damaged, deteriorated, mislabeled,
				contaminated, recalled, or whose containers or packaging have been opened or
				breached until the medical marijuana products are returned to a
				grower/processor, destroyed or otherwise disposed of as required under §
									1151a.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.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1161a - DISPENSARIES › Section 1161a.34 - Sanitation and safety in a facility

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A
				dispensary shall maintain a facility in a sanitary condition to limit the
				potential for contamination or adulteration of the medical marijuana products
				stored in or dispensed at the facility. The following requirements apply:
(1) Trash shall be properly
				removed.
(2) Floors, walls and
				ceilings shall be kept in good repair.
(3) Adequate protection against pests shall
				be provided through the use of integrated pest management practices and
				techniques that identify and manage pest problems, and the regular disposal of
				trash to prevent infestation.
(4)
				Toxic cleaning compounds, sanitizing agents, solvents and pesticide chemicals
				must be labeled and stored in a manner that prevents contamination of medical
				marijuana products and in a manner that otherwise complies with other
				applicable laws and regulations.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1161a - DISPENSARIES › Section 1161a.35 - Transportation of medical marijuana products

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A dispensary may transport and deliver
				medical marijuana products to a medical marijuana organization in this
				Commonwealth in accordance with this section. The following apply:
(1) Unless otherwise approved by the
				Department, a dispensary may deliver medical marijuana products to a medical
				marijuana organization only between 7 a.m. and 9 p.m. for the purposes of
				transporting medical marijuana products among the permittee's dispensary
				locations and returning medical marijuana products 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 products 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 products to a medical marijuana
				organization.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1161a - DISPENSARIES › Section 1161a.36 - Transport manifest

Current through Register Vol. 54, No. 28, July 13, 2024
(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.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1161a - DISPENSARIES › Section 1161a.37 - Evidence of adverse loss during transport

Current through Register Vol. 54, No. 28, July 13, 2024
(a) If a dispensary receiving a delivery of
				medical marijuana products from a medical marijuana organization discovers a
				discrepancy in the transport manifest that remains unresolved 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, and to the appropriate law enforcement authorities.
(b) If a dispensary discovers evidence of, or
				reasonably suspects, a theft or diversion of 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, and to law
				enforcement.
(c) If a dispensary
				discovers a discrepancy in the transport manifest, the dispensary shall do all
				of the following:
(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 requirements apply:
(i) The dispensary shall submit a written
				preliminary report of the investigation to the Department within 7 days of
				discovering the discrepancy.
(ii)
				The dispensary 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 1161a - DISPENSARIES › Section 1161a.38 - 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 received 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 dispensed by the dispensary.
(b) Upon notification by the grower/processor
				under §
									1151a.42 (relating to complaints
				about or recall of medical marijuana products), the dispensary shall cease
				dispensing the affected medical marijuana products immediately.
(c) A dispensary shall coordinate the return
				of the recalled medical marijuana products with the grower/
				processor.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1161a - DISPENSARIES › Section 1161a.39 - Electronic tracking system

Current through Register Vol. 54, No. 28, July 13, 2024
A dispensary 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 system shall allow for two-way communication, automation and secure
				  application-programming interface of a medical marijuana organization's
				  enterprise resource planning, inventory, accounting and point-of-sale software
				  and allow for accessing all data required to be transmitted to the Department
				  to ensure compliance with the operational reporting requirements of the act and
				  these regulations.
This section cited in 28 Pa. Code §
											1211a.33 (relating to dispensing
					 and tracking medical marijuana products).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1161a - DISPENSARIES › Section 1161a.40 - Additional dispensary locations

Current through Register Vol. 54, No. 28, July 13, 2024
(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
				nonrefund-able.
(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 permit is not granted.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1171a - LABORATORIES › Section 1171a.22 - Laboratories generally

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A laboratory
				may not identify, collect, handle or conduct tests on samples from a
				grower/processor or conduct tests on test samples for the Department unless the
				laboratory has been approved by the Department under §
									1171a.23 (relating to approval of
				laboratories) and has entered into a written contract with the grower/
				processor under §
									1171a.29 (relating to testing
				requirements).
(b) The Department
				will post on its web site a current list of approved laboratories.
(c) An approved laboratory shall employ a
				director to oversee and be responsible for the identification, collection,
				handling and testing operations of the approved laboratory. A director shall
				have earned, from a college or university accredited by a National or regional
				accrediting authority, one or more of the following:
(1) A doctorate of science or an equivalent
				degree in chemistry, biology, or a subdiscipline of chemistry or
				biology.
(2) A master's level
				degree in a chemical or biological science and a minimum of 2 years post-degree
				laboratory experience related to testing of medicinal or pharmaceutical
				products or other experience as approved by the Department.
(3) A bachelor's degree in a biological
				science and a minimum of 4 years post-degree laboratory experience related to
				testing of medicinal or pharmaceutical products or other experience as approved
				by the Department.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1171a - LABORATORIES › Section 1171a.23 - Approval of laboratories

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A
				laboratory wishing to identify, collect, handle and conduct tests on samples
				and test samples and other items used by a grower/processor in the growing and
				processing of medical marijuana and medical marijuana products as required
				under the act and this part shall submit an application for approval to the
				Department. The application is available on the Department's public web
				site.
(b) An application submitted
				under this section must include the following information:
(1) The name and address of the laboratory
				applicant or its authorized agent.
(2) The name and address of the owner of the
				laboratory applicant, and if applicable, the medical or pharmacy licensure
				information regarding the owner.
(3) The name of the laboratory applicant's
				proposed director and technical personnel who are or will be employed by the
				laboratory at the location to be approved.
(4) A copy of the laboratory applicant's most
				recent certificate of accreditation.
(5) Copies of the standard operating
				procedures and sampling procedures adopted by the laboratory applicant and
				approved by the accreditation body that issued the certificate of accreditation
				to the laboratory applicant.
(6) A
				list of the specialized laboratory equipment utilized or to be utilized by the
				laboratory applicant in its testing operations, including the manufacturer's
				name and the serial and model number of the equipment, and other specifications
				as may be required by the Department.
(7) A description of the tests which are
				capable of being conducted by the laboratory applicant at the location to be
				approved.
(8) A description of the
				laboratory applicant's quality assurance program, which must be in compliance
				with §
										1171a.32 (relating to quality
				assurance program).
(9) The
				procedures to be followed to establish chain of custody when collecting samples
				or test samples.
(10) A copy of the
				evaluation process that the laboratory applicant uses or will use to monitor,
				evaluate and document the competency of employees when testing samples and test
				samples and overseeing quality assurance controls.
(11) Other information required by the
				Department.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1171a - LABORATORIES › Section 1171a.24 - Suspension or revocation of an approval issued to a laboratory

Current through Register Vol. 54, No. 28, July 13, 2024
(a) An approval
				issued by the Department under this chapter may be suspended or revoked if the
				Department determines that the approved laboratory has engaged in unethical
				practices or has failed to do any of the following:
(1) Maintain proper standards of
				accuracy.
(2) Comply with the
				requirements of the act or this part applicable to the approved
				laboratory.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1171a - LABORATORIES › Section 1171a.25 - Renewal of an approval issued to a laboratory

Current through Register Vol. 54, No. 28, July 13, 2024
An approved laboratory wishing to renew its approval under
				  this chapter shall, not more than 6 months nor less than 4 months prior to the
				  expiration of the approval, submit an application under §
									1171a.23 (relating to approval of
				  laboratories) and update the information required to be submitted with the
				  application as necessary.
This section cited in 28 Pa. Code §
											1171a.22 (relating to laboratories
					 generally).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1171a - LABORATORIES › Section 1171a.26 - Stability testing and retention of samples

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A grower/processor shall retain a sample
				in an amount sufficient to perform stability testing from each process lot to
				ensure product potency and purity, and shall maintain documentation to support
				the expiration date.
(b) The
				stability test shall be performed at 6-month intervals for the duration of the
				expiration date period as listed on the medical marijuana product and once
				within 6 months of the expiration date if the medical marijuana product is
				still in inventory at a dispensary in this Commonwealth as determined by the
				seed-to-sale system.
(c) A
				grower/processor shall retain a sample from each process lot for subsequent
				stability testing, in an amount equivalent to the sample size initially
				identified and collected by an approved laboratory, for the duration of the
				expiration date period as listed on the medical marijuana product.
This section cited in 28 Pa. Code §
											1171a.22 (relating to laboratories
					 generally).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1171a - LABORATORIES › Section 1171a.27 - Sampling procedures for testing

Current through Register Vol. 54, No. 28, July 13, 2024
(a) An approved laboratory shall ensure that
				its employees prepare all samples in accordance with policies and procedures
				that include appropriate information necessary for identifying, collecting and
				transporting samples in a manner that does not endanger the integrity of the
				samples for any testing required by this part.
(b) The sampling policies must:
(1) Be appropriate to the matrix being
				sampled.
(2) Require samples to be
				representative of the harvest batch, harvest lot or process lot.
(3) Require the amount being removed to be
				based on applicable statistical criteria.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1171a - LABORATORIES › Section 1171a.28 - Selection protocols for samples

Current through Register Vol. 54, No. 28, July 13, 2024
(a) An employee of an approved laboratory may
				enter a grower/processor facility for the purpose of identifying and collecting
				samples and shall only have access to limited access areas in the facility for
				these purposes.
(b) An employee
				identifying and collecting samples under subsection (a) shall follow the chain
				of custody procedures included in the approved laboratory's application and
				approved by the Department.
(c)
				While at a grower/processor facility, an employee of an approved laboratory
				shall identify and collect the following for testing:
(1) Samples at the time of harvest.
(2) Samples of medical marijuana product
				before being sold or provided to a dispensary.
(3) Test samples at other times when
				requested by the Department.
(4)
				Samples for stability testing.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1171a - LABORATORIES › Section 1171a.29 - Testing requirements

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
				Prior to conducting any testing of a sample at the request of a
				grower/processor, an approved laboratory shall enter into a written contract
				with the grower/ processor for testing services. The approved laboratory shall
				provide a copy of the contract to the Department within 2 days following the
				Department's request.
(b) A
				grower/processor shall submit through the electronic tracking system a request
				to the approved laboratory with which it has a written contract under
				subsection (a) for each test to be conducted.
(c) Testing shall be performed as follows:
(1) An approved laboratory shall test samples
				from a harvest batch or harvest lot prior to using the harvest batch or harvest
				lot to produce a medical marijuana product.
(2) An approved laboratory other than the one
				that tested the harvest batch or harvest lot shall test samples from each
				process lot before the medical marijuana is sold or offered for sale to another
				medical marijuana organization.
(3)
				An approved laboratory may test other samples and test samples at the request
				of a grower/processor or the Department.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1171a - LABORATORIES › Section 1171a.30 - Standards for testing

Current through Register Vol. 54, No. 28, July 13, 2024
(a) An approved
				laboratory shall follow the methodologies, ranges and parameters that are
				consistent with the scope of the certificate of accreditation issued to the
				laboratory and in accordance with this chapter.
(b) Testing methods used by an approved
				laboratory shall meet or exceed the minimum standards under the American Herbal
				Pharmacopeia's "Cannabis Inflorescence Standards of Identity, Analysis and
				Quality Control,'' 2014 Revision Edition.
This section cited in 28 Pa. Code §
											1151a.27 (relating to requirements
					 for growing and processing medical
					 marijuana).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1171a - LABORATORIES › Section 1171a.31 - Test results and reporting

Current through Register Vol. 54, No. 28, July 13, 2024
(a) Only the
				results of the following tests are in compliance with the testing requirements
				of this chapter:
(1) Tests conducted on
				harvest batch samples or harvest lot samples requested by a grower/processor
				under §
										1171a.29 (relating to testing
				requirements) and identified and collected by an employee of an approved
				laboratory.
(2) Tests conducted on
				process lot samples requested by a grower/processor under §
										1171a.29 and identified and
				collected by an employee of an approved laboratory.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1171a - LABORATORIES › Section 1171a.32 - Quality assurance program

Current through Register Vol. 54, No. 28, July 13, 2024
(a) An
				approved laboratory shall establish and implement a quality assurance program
				to ensure that measurements are accurate, errors are controlled, and devices
				used for testing are properly calibrated annually or more frequently if
				recommended by the manufacturer.
(b) The quality assurance program required
				under subsection (a) must include the following components:
(1) An organizational chart that includes the
				testing responsibilities of each employee of the approved laboratory named in
				the chart.
(2) A description of
				sampling procedures to be utilized.
(3) Appropriate chain of custody
				protocols.
(4) Analytical
				procedures.
(5) Data reduction and
				validation procedures.
(6) A plan
				for implementing corrective action, when necessary.
(7) A requirement for the provision of
				quality assurance reports to management.
(8) A description of the internal and
				external quality control systems.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1171a - LABORATORIES › Section 1171a.33 - Transporting samples

Current through Register Vol. 54, No. 28, July 13, 2024
(a) An employee
				of an approved laboratory, grower/ processor or third-party contractor shall
				follow the transportation requirements under §§
									1151a.35 and
				1151a.36 (relating to
				transportation of medical marijuana; and transport manifest) when transporting
				a sample or test sample under this part.
(b) An employee of an approved laboratory,
				grower/ processor or third-party contractor who transports samples from a
				grower/processor to an approved laboratory shall:
(1) Protect the physical integrity of the
				sample.
(2) Keep the composition of
				the sample intact.
(3) Protect the
				sample against factors that interfere with the validity of testing results,
				including the factors of time, temperature and any other circumstance that
				appears to have compromised the sample.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1171a - LABORATORIES › Section 1171a.34 - Department request for testing

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
				The Department, in its sole discretion, may identify and collect a test sample
				from a grower/processor at any time and request an approved laboratory to
				conduct proficiency testing, conduct quality assurance measures and perform
				tests under this chapter.
(b) The
				approved laboratory shall provide the Department with a written report of the
				test results from a test sample tested under subsection (a) within 7 days of
				the collection of the test sample, or sooner if requested by the
				Department.
This section cited in 28 Pa. Code §
											1171a.35 (relating to laboratory
					 reporting).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1171a - LABORATORIES › Section 1171a.35 - Laboratory reporting

Current through Register Vol. 54, No. 28, July 13, 2024
(a) An
				approved laboratory shall enter into the electronic tracking system the
				following information for each sample collected under §
									1171a.28(c)(1) and (2)
				 (relating to selection protocols for
				samples) and each test conducted:
(1) The
				unique sample identification number the approved laboratory assigns to the
				sample.
(2) The name of the
				grower/processor that supplied the sample.
(3) The employee identification number of the
				employee of the approved laboratory who identified and collected the sample at
				the request of the grower/processor.
(4) The date and time the sample was
				collected from the grower/processor.
(5) The date and time the sample was received
				by the approved laboratory.
(6) The
				date the test was completed.
(7)
				The condition of the sample when it was received by the approved
				laboratory.
(8) A description of
				each test performed.
(9) The
				results from the certificate of analysis issued under §
										1171a.31 (relating to test results
				and reporting).
(10) The date the
				testing results were provided to the grower/processor under §
										1171a.31 or the Department under
				§
										1171a.34 (relating to Department
				request for testing).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1171a - LABORATORIES › Section 1171a.36 - Advertising

Current through Register Vol. 54, No. 28, July 13, 2024
(a) An approved
				laboratory may not advertise, market or otherwise promote its medical marijuana
				testing services to the general public.
(b) An approved laboratory may only promote
				its medical marijuana testing services to a grower/processor. An approved
				laboratory may use advertising, marketing and promotional materials directed at
				a grower/processor to promote its medical marijuana testing services. The
				advertising, marketing and promotional materials proposed to be used by an
				approved laboratory under this section shall be reviewed and approved by the
				Department prior to circulation or other use.
(c) Personal solicitation by an employee,
				representative or agent of an approved laboratory to a grower/processor is
				considered advertising, marketing or otherwise promoting its medical marijuana
				testing services for the purposes of this section.
(d) An approved laboratory may only
				advertise, market or otherwise promote its medical marijuana testing services
				that are performed onsite at the location designated in the laboratory's
				application.
(e) A sign installed
				at the location of an approved laboratory that is designed to identify the
				laboratory or access to the laboratory is permissible as long as the sign meets
				local zoning requirements and does not violate the provisions of this
				section.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1171a - LABORATORIES › Section 1171a.37 - Ownership prohibition

Current through Register Vol. 54, No. 28, July 13, 2024
The following individuals may not have a management, a direct
				  or indirect financial, or other ownership interest in an approved
				  laboratory:
(1) A principal, owner,
				financial backer or employee of a medical marijuana organization.
(2) A practitioner.
(3) A physician, pharmacist, physician
				assistant or certified registered nurse practitioner who is currently employed
				by a medical marijuana organization.
(4) Any other person, other than a patient,
				who may receive a direct or indirect financial benefit from the growing,
				processing, transporting, dispensing or selling of seeds, immature medical
				marijuana plants, medical marijuana plants, postharvest plant material, medical
				marijuana or medical marijuana products.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1171a - LABORATORIES › Section 1171a.38 - Appeals

Current through Register Vol. 54, No. 28, July 13, 2024
Sections 501-508 of 2 Pa.C.S. (relating to practice and
				  procedure of Commonwealth agencies) and the accompanying regulations, as
				  modified by Chapter 1230a (relating to practice and procedure), apply to all
				  actions of the Department under this chapter constituting an adjudication as
				  defined in
				  2
				  Pa.C.S. §
										101 (relating to
				  definitions).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1171a - LABORATORIES › Section 1171a.39 - Clarification of the requirements of Sections 1171a.29(c) and 1171a.31(c)-statement of policy

Current through Register Vol. 54, No. 28, July 13, 2024
(a) This section
				clarifies §§
									1171a.29(c)
				(relating to testing requirements) and 1171a.31(c) (relating to test results
				and reporting). The Department interprets "an approved laboratory other than
				the one that tested the harvest batch or lot'' in §
									1171a.29(c)(2) to
				be a separate and distinct approved laboratory that meets all financial and
				professional suitability requirements under this chapter independently from the
				approved laboratory that conducted the harvest batch or harvest lot test. The
				Department will consider the following factors to determine whether an approved
				laboratory is a separate and distinct laboratory:
(1) Separate, independent location from the
				other approved laboratory, such as no interest in the land or the building in
				which the other approved laboratory is located or part interest in any
				mortgage, deed, trust, note or the long-term liability secured in whole or in
				part by the land or building in which the other approved laboratory conducts
				testing. For clarification, this statement of policy does not impact the
				Department's ability to approve laboratories with multiple locations, including
				those with shared finances, staffing or operations.
(2) Separate legal entity from the other
				approved laboratory.
(3) No shared
				financial ownership with the other approved laboratory, such as filing joint
				tax returns, shared Federal or Tax Identification Numbers, having direct or
				indirect ownership interest in another laboratory, commingling of funds or
				shared bank accounts.
(4) Separate
				ownership and management in terms of members of a board of directors,
				shareholders or partners that represent a controlling interest, or management,
				compliance staff or employees in common with the other approved laboratory.
(5) Separate accreditation from
				the other approved laboratory.
(6)
				Separate operations from the other approved laboratory, such as no shared
				policies or standard operating procedures, reliance on input or oversight of
				the other approved laboratory or reliance on the other approved laboratory to
				financially support the approved laboratory's operations.
(7) No shared equipment or interest in any
				mortgage, deed, trust, note or other long-term liability secured in whole or in
				part by equipment used by the other approved laboratory.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1181a - PHYSICIANS AND PRACTITIONERS › Section 1181a.22 - Practitioners generally

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The
				qualifications that a physician shall meet to be registered with the Department
				and approved as a practitioner are continuing qualifications.
(b) A physician may not issue a patient
				certification without being registered by the Department as a practitioner in
				accordance with §
									1181a.24 (relating to practitioner
				registration).
(c) A practitioner
				shall notify a dispensary by telephone of a patient's adverse reaction to
				medical marijuana products dispensed by that dispensary immediately upon
				becoming aware of the reaction.
(d)
				A practitioner may petition the Medical Marijuana Advisory Board (Board) for
				the Board to review on a continuing basis, and recommend to the secretary for
				approval, that serious medical conditions be changed, reduced or added to those
				conditions for which medical marijuana is likely to provide therapeutic or
				palliative benefit to a patient.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1181a - PHYSICIANS AND PRACTITIONERS › Section 1181a.23 - Medical professionals generally

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The qualifications that a medical
				professional shall meet to be employed by a dispensary are continuing
				qualifications.
(b) A medical
				professional may not assume any duties at a dispensary until the training
				required under §
									1181a.32 (relating to training)
				and any other requirements for medical professionals under the act and this
				part are completed.
(c) A medical
				professional shall notify by telephone the practitioner listed on a patient
				certification of a patient's adverse reaction to medical marijuana products
				dispensed by that dispensary immediately upon becoming aware of the
				reaction.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1181a - PHYSICIANS AND PRACTITIONERS › Section 1181a.24 - Practitioner registration

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A
				physician who has an active and unrestricted medical license in this
				Commonwealth in accordance with the Medical Practice Act of 1985 (63 P.S.
				§§
										422.1- 422.51a) or the
				Osteopathic Medical Practice Act (63 P.S. §§
										271.1-271.18) may file an application for
				registration with the Department as a practitioner on a form prescribed by the
				Department.
(b) An application for
				registration must include the following requirements:
(1) The physician's full name, business
				address, professional e-mail address, telephone numbers and, if the physician
				owns or is affiliated with a medical practice, the name of the medical
				practice.
(2) The physician's
				credentials, education, specialty, training and experience, and supporting
				documentation when available.
(3)
				The physician's medical license number.
(4) A certification by the physician that
				states all of the following:
(i) That the
				physician's Pennsylvania license to practice medicine is active and in good
				standing.
(ii) Whether the
				physician has been subject to any type of professional disciplinary action that
				would prevent the physician from carrying out the responsibilities under the
				act and this part, together with, if applicable, an explanation of the
				professional disciplinary action.
(iii) That the physician does not hold a
				direct or economic interest in a medical marijuana organization.
(5) A statement that a false
				statement made by a physician in an application for registration is punishable
				under the applicable provisions of 18 Pa.C.S. Chapter 49 (relating to
				falsification and intimidation).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1181a - PHYSICIANS AND PRACTITIONERS › Section 1181a.25 - Practitioner registry

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The
				Department will maintain a practitioner registry for use by a patient or
				caregiver registered by the Department. The practitioner registry will include
				only the practitioner's name, business address and medical
				credentials.
(b) The inclusion of a
				physician in the practitioner registry will be subject to annual review by the
				Department to determine if the physician's license is inactive, expired,
				suspended, revoked, limited or otherwise restricted by the applicable medical
				board, or if the physician has been subject to professional disciplinary
				action.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1181a - PHYSICIANS AND PRACTITIONERS › Section 1181a.26 - Denial, revocation or suspension of a practitioner registration

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A practitioner
				registration will be denied, revoked or suspended if the practitioner's medical
				license is inactive, expired, suspended, revoked, limited or otherwise
				restricted by the applicable medical board.
(b) A practitioner registration may be
				denied, revoked or suspended if the practitioner is or has been the subject of
				professional disciplinary action, including an immediate temporary
				action.
(c) A physician who has
				been denied registration or whose practitioner registration has been revoked or
				suspended may reapply to the Department for inclusion in the practitioner
				registry in accordance with §
									1181a.24 (relating to practitioner
				registration) if the event that led to the physician's denial, revocation or
				suspension has been resolved and the physician's medical license is designated
				as active without limitation by the applicable medical board. The physician's
				application for registration under this subsection must include evidence of the
				resolution.
(d) A physician who has
				been denied registration or whose practitioner registration has been revoked or
				suspended may not do any of the following:
(1)
				Have electronic access to a patient certification.
(2) Issue or modify a patient
				certification.
(3) Provide a copy
				of an existing patient certification to any person, including a patient or a
				caregiver, except where a patient is entitled by law to obtain copies of their
				own medical records, such as in
				42 Pa.C.S. §
											6155(b)(1) (relating to
				rights of patients).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1181a - PHYSICIANS AND PRACTITIONERS › Section 1181a.27 - Issuing patient certifications

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A
				practitioner may issue a patient certification to a patient if the following
				conditions are met:
(1) The practitioner has
				determined, based upon a patient consultation that the patient has a serious
				medical condition and has included that condition in the patient's health care
				record.
(1.1) The patient is under
				the practitioner's continuing care for the serious medical condition.
(2) The practitioner has determined the
				patient is likely to receive therapeutic or palliative medical benefit from the
				use of medical marijuana based upon the practitioner's professional opinion and
				review of the following:
(i) The patient's
				prior medical history as documented in the patient's health care records if the
				records are available for review.
(ii) The patient's controlled substance
				history if the records are available in the Prescription Drug Monitoring
				Program.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1181a - PHYSICIANS AND PRACTITIONERS › Section 1181a.28 - Modifying a patient certification

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A practitioner may modify a patient
				certification at any time after issuance and before expiration.
(b) After modifying a patient certification,
				a practitioner shall do all of the following:
(1) Provide a copy of the patient
				certification to the patient or the patient's caregiver, if the patient is a
				minor, and to an adult patient's caregiver if authorized by the
				patient.
(2) Provide the patient
				certification with the original signature to the Department, which may be
				submitted electronically.
(3) File
				a copy of the patient certification in the patient's health care
				record.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1181a - PHYSICIANS AND PRACTITIONERS › Section 1181a.29 - Revocation of a patient certification

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A practitioner shall immediately notify
				the Department in writing if the practitioner knows or has reason to know that
				any of the following events are true with respect to a patient for whom the
				practitioner issued a patient certification:
(1) The patient no longer has the serious
				medical condition for which the patient certification was issued.
(2) The use of medical marijuana products by
				the patient would no longer be therapeutic or palliative.
(3) The patient has died.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1181a - PHYSICIANS AND PRACTITIONERS › Section 1181a.30 - Prescription Drug Monitoring Program

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A practitioner shall review the
				Prescription Drug Monitoring Program prior to issuing or modifying a patient
				certification to determine the controlled substance history of the patient to
				determine whether the controlled substance history of the patient would impact
				the patient's use of medical marijuana products.
(b) A practitioner may access the
				Prescription Drug Monitoring Program to do any of the following:
(1) Determine whether a patient may be under
				treatment with a controlled substance by another physician or other
				person.
(2) Allow the practitioner
				to review the patient's controlled substance history as deemed necessary by the
				practitioner.
(3) Provide to the
				patient, or caregiver if authorized by the patient, a copy of the patient's
				controlled substance history.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1181a - PHYSICIANS AND PRACTITIONERS › Section 1181a.31 - Practitioner prohibitions

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A
				practitioner may not accept, solicit or offer any form of remuneration from or
				to any individual, prospective patient, patient, prospective caregiver,
				caregiver or medical marijuana organization, including an employee, financial
				backer or principal, to certify a patient, other than accepting a fee for
				service with respect to a patient consultation of the prospective patient to
				determine if the prospective patient should be issued a patient certification
				to use medical marijuana products.
(b) A practitioner may not hold a direct or
				economic interest in a medical marijuana organization.
(c) A practitioner may not advertise the
				practitioner's services as a practitioner who can certify a patient to receive
				medical marijuana products.
(d) A
				practitioner may not issue a patient certification for the practitioner's own
				use or for the use of a family or household member.
(e) A practitioner may not be a designated
				caregiver for a patient that has been issued a patient certification by that
				practitioner.
(f) A practitioner
				may not receive or provide medical marijuana product samples.
(g) A practitioner may not excessively charge
				a patient for any expense related to the certification and follow-up
				process.