[51 Pa.B. 1141]
[Saturday, March 6, 2021]
[Continued from previous Web Page]
CHAPTER 1171a. LABORATORIES Sec.
1171a.22. Laboratories generally. 1171a.23. Approval of laboratories. 1171a.24. Suspension or revocation of an approval issued to a laboratory. 1171a.25. Renewal of an approval issued to a laboratory. 1171a.26. Stability testing and retention of samples. 1171a.27. Sampling procedures for testing. 1171a.28. Selection protocol for samples. 1171a.29. Testing requirements. 1171a.30. Standards for testing. 1171a.31. Test results and reporting. 1171a.32. Quality assurance program. 1171a.33. Transporting samples. 1171a.34. Department request for testing. 1171a.35. Laboratory reporting. 1171a.36. Advertising. 1171a.37. Ownership prohibitions. 1171a.38. Appeals. § 1171a.22. Laboratories generally.
(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 at least one 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, at least one 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.
(d) A principal or employee of a medical marijuana organization may not also own, be employed by or be affiliated with an approved laboratory that has a contract with that medical marijuana organization.
(e) An approval issued by the Department to a laboratory under this part is valid for 2 years from the date of issuance and is valid only for the laboratory named and the location specified in the approval.
(f) An approval issued by the Department to a laboratory under this part is not transferable to any other person or any other location unless the laboratory obtains the prior written consent of the Department.
§ 1171a.23. Approval of laboratories.
(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 on a form and in a manner prescribed by the Department.
(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.
(c) By submitting an application for approval to the Department, a laboratory applicant consents to an investigation of any person, information or physical location the Department or its authorized agents deem appropriate for the Department to make a determination of the laboratory applicant's ability to meet the requirements under the act and this part.
(d) An application for approval submitted under this chapter must include a statement that a false statement made in the application is punishable under the applicable provisions of 18 Pa.C.S. Chapter 49 (relating to falsification and intimidation).
(e) The Department may issue an approval under this chapter if the Department determines that the laboratory applicant is financially and professionally suitable to conduct the testing required under the act and this part.
§ 1171a.24. Suspension or revocation of an approval issued to a laboratory.
(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.
(b) An approval issued by the Department under this chapter may be revoked if the Department determines that the approved laboratory has engaged in any of the following conduct:
(1) Dishonest reporting.
(2) Repeated errors in conducting the required testing.
(3) Allowing unauthorized individuals to perform testing or to sign reports.
(4) Inclusion of false statements in the application for approval or renewal.
(5) Advertising of medical marijuana testing services to the general public.
(6) Knowingly accepting a sample from an individual other than a grower/processor or a test sample from an individual other than the Department or an authorized agent of the Department.
(7) Failure to maintain standard operating procedures approved by the accreditation body that issued the certificate of accreditation to the approved laboratory.
(8) Failure to properly enter test results into the electronic tracking system.
(9) Loss by the approved laboratory of its certificate of accreditation.
§ 1171a.25. Renewal of an approval issued to a laboratory.
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.
§ 1171a.26. Stability testing and retention of samples.
(a) A grower/processor shall request that a sample be identified and collected by an approved laboratory from each harvest batch sufficient to perform stability testing at 6-month intervals for a 1-year period.
(b) The stability test shall be performed to ensure product potency and purity and provide support for expiration dating.
(c) An approved laboratory shall retain a sample from each harvest batch sufficient to provide for stability testing and properly store the sample for 1 year.
§ 1171a.27. Sampling procedures for testing.
(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, at a minimum, meet the following requirements:
(1) Be appropriate to the matrix being sampled.
(2) Be in accordance with guidance provided by the Department.
(c) The sampling procedures must include the following procedures:
(1) Surveying the conditions in which the sample is being stored.
(2) Using appropriate sampling equipment and consistent procedures.
(3) Selecting and removing equal portions for each sample.
(4) Random or systematic taking of samples throughout the harvest batch or harvest lot.
(5) Obtaining a minimum number of samples based on harvest batch or harvest lot size.
(6) Checking all parts of the harvest batch when harvest lots are created from that harvest batch.
(7) Recording on a form prescribed by the Department all observations and procedures used when collecting the sample.
(8) Creating a unique sample identification number that will be linked to the harvest batch or harvest lot number assigned by the grower/processor in the electronic tracking system.
(9) Entering all required information into the electronic tracking system.
§ 1171a.28. Selection protocols for samples.
(a) An employee of an approved laboratory may only enter a grower/processor facility for the purpose of identifying and collecting samples and shall 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.
§ 1171a.29. Testing requirements.
(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) At a minimum, testing, as prescribed by the Department, 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.
(d) The samples identified in subsection (c) shall be tested, at a minimum, for the following:
(1) Pesticides.
(2) Solvents.
(3) Water activity and moisture content.
(4) THC and CBD concentration.
(5) Microbiological contaminants.
(6) Terpenes.
(e) Sampling and testing under this chapter shall be conducted with a statistically significant number and size of samples and with methodologies acceptable to the Department to ensure that all harvest batches, harvest lots and medical marijuana products are adequately tested for contaminants and that the cannabinoid profile is consistent throughout the harvest batch, harvest lot or medical marijuana products.
(f) An approved laboratory may not test any samples when there is evidence of improper collection, improper preservation, apparent spoilage, excessive time lapse between collection of the sample and testing, or any other factor sufficient to render the findings of questionable validity.
(g) An approved laboratory shall enter test results for samples collected under § 1171a.28(c) (relating to selection protocols for samples) into the electronic tracking system and, under § 1151a.40 (relating to management and disposal of medical marijuana waste), properly dispose of all tested and untested samples and test samples.
§ 1171a.30. Standards for testing.
An approved laboratory shall follow the methodologies, ranges and parameters acceptable to the Department that are contained in the scope of the certificate of accreditation issued to the laboratory.
§ 1171a.31. Test results and reporting.
(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 either an employee of a grower/processor or an employee of an approved laboratory.
(b) The test results for each sample collected under § 1171a.28(c) (relating to selection protocols for samples) shall be entered into the electronic tracking system and shall only be accessible to the grower/processor submitting the sample and to the Department.
(c) If a sample fails any test required under § 1171a.29, the following apply to the sample:
(1) The approved laboratory that performed the initial test may re-test the sample upon a request from the grower/processor in accordance with subsection (d).
(2) If the sample passes the re-test, another approved laboratory shall sample the same harvest batch, harvest lot or process lot to confirm the passing test result.
(3) If the Department does not agree to accept the confirming results from the approved laboratory, the sample shall be disposed of by the approved laboratory under § 1151a.40 (relating to management and disposal of medical marijuana waste).
(4) If the re-tested sample fails, the lot shall be disposed of under § 1151a.40.
(d) A grower/processor shall notify the Department and the approved laboratory through the electronic tracking system of its intent to re-test the sample or test another sample from the same harvest batch, harvest lot or process lot that failed a test.
(e) An approved laboratory shall issue to a grower/processor a certificate of analysis, including the supporting data, for each harvest batch, harvest lot or process lot sample that was tested at the request of the grower/processor. The certificate of analysis must include the following information:
(1) Whether the chemical profile of the harvest batch, harvest lot or process lot conforms to the chemical profile of the strain as determined by the Department for the following compounds:
(i) THC.
(ii) THCA.
(iii) CBD.
(iv) CBDA.
(v) CBC.
(vi) CBN.
(vii) THCV.
(viii) CBDV.
(ix) CBG.
(x) D8.
(2) That the presence of the following contaminants within the harvest batch, harvest lot or process lot does not exceed the levels as determined by the Department for the following:
(i) Heavy metals, mercury, lead, cadmium or arsenic.
(ii) Foreign material such as hair, insects, or any similar or related adulterant.
(iii) Any microbiological impurity, including:
(A) Total aerobic microbial count.
(B) Total yeast mold count.
(C) P. aeruginosa.
(D) Aspergillus spp.
(E) S. aureus.
(F) Aflatoxin B1, B2, G1 and G2.
(G) Ochratoxin A.
(H) Pesticide residue.
(iv) Whether the harvest batch, harvest lot or process lot is within the specification for the strain for the characteristics of:
(A) Odor.
(B) Appearance.
(C) Fineness.
(D) Moisture content.
§ 1171a.32. Quality assurance program.
(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 routinely and properly calibrated.
(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.
§ 1171a.33. Transporting samples.
(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 process lot 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 other environmental factors that may work to jeopardize the integrity of the sample.
§ 1171a.34. Department request for testing.
(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.
§ 1171a.35. Laboratory reporting.
(a) An approved laboratory shall enter into the electronic tracking system the following information for each sample collected under § 1171a.28(c) (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).
(b) An approved laboratory shall keep for 4 years a paper or electronic copy of the certificate of analysis performed on samples submitted by a grower/processor or test samples submitted by the Department including test results not required to be entered into the electronic tracking system under § 1171a.29 (relating to testing requirements).
(1) Regarding tests results not entered into the electronic tracking system, the approved laboratory shall immediately provide to the Department an electronic copy of the certificate of analysis.
(2) Regarding test results entered into the electronic tracking system, the approved laboratory shall provide a copy of a certificate of analysis to the Department within 2 days of a request made by the Department.
(c) The Department may conduct an investigation based on the results shown on any certificate of analysis.
§ 1171a.36. Advertising.
(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.
§ 1171a.37. Ownership prohibition.
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, medical marijuana or medical marijuana products.
§ 1171a.38. Appeals.
Chapter 5, Subchapter A 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).
CHAPTER 1181a. PHYSICIANS AND PRACTITIONERS Sec.
1181a.22. Practitioners generally. 1181a.23. Medical professionals generally. 1181a.24. Physician registration. 1181a.25. Practitioner registry. 1181a.26. Denial, revocation or suspension of a practitioner registration. 1181a.27. Issuing patient certifications. 1181a.28. Modifying a patient certification. 1181a.29. Revocation of a patient certification. 1181a.30. Prescription drug monitoring program. 1181a.31. Practitioner prohibitions. 1181a.32. Training. 1181a.33. Appeals. § 1181a.22. Practitioners generally.
(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 physician 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.
§ 1181a.23. Medical professionals generally.
(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.
§ 1181a.24. Physician registration.
(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, at a minimum, 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:
(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).
(c) Based on the information provided by the physician under subsection (b), the Department will determine whether to approve the physician to issue patient certifications.
(d) The Department may list a physician on the practitioner registry only after the physician has successfully completed the training course required under § 1181a.32 (relating to training) and any other requirements for registration under the act and this part.
§ 1181a.25. Practitioner registry.
(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.
§ 1181a.26. Denial, revocation or suspension of a practitioner registration.
(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 physician 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 in accordance with applicable law.
(e) The Department may revoke or suspend the registration of a practitioner for any of the following:
(1) A violation of the act or this part.
(2) A violation of an order issued under the act or this part.
(3) A violation of a regulation promulgated under the act.
(4) For conduct or activity that would have disqualified the practitioner from receiving a registration.
(5) Pending the outcome of a hearing in a case which the practitioner's registration could be suspended or revoked.
§ 1181a.27. Issuing patient certifications.
(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 and any other factor deemed relevant by the practitioner, that the patient has a serious medical condition and has included that condition in the patient's health care record.
(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.
(b) Notwithstanding subsection (a), the following requirements apply:
(1) A practitioner who is not board-eligible or board-certified in pediatrics or a pediatric specialty, neurology with special qualifications in child neurology, child and adolescent psychiatry, or adolescent medicine (whether through pediatrics, internal medicine or family practice) may not issue a patient certification to a minor patient.
(2) Paragraph (1) will be effective upon the registration of a sufficient number of eligible practitioners to ensure adequate access for minor patients needing services under the act and this part based on location, serious medical condition and number of patients, specialty, and number and availability of practitioners. The Department will publish a notice in the Pennsylvania Bulletin 1 month before paragraph (1) becomes effective, stating that a sufficient number of eligible practitioners have registered to effectuate this subsection.
(c) A patient certification that is issued by a practitioner must include, at a minimum, all of the following:
(1) The patient's name, home address, telephone number, date of birth and e-mail address, if available.
(2) The practitioner's name, business address, telephone numbers, professional e-mail address, medical license number, area of specialty, if any, and signature.
(3) The date of the patient consultation for which the patient certification is being issued.
(4) The patient's specific serious medical condition.
(5) A statement by the practitioner that the patient has a serious medical condition, and the patient is under the practitioner's continuing care for the condition.
(6) A statement as to the length of time, not to exceed 1 year, for which the practitioner believes the use of medical marijuana by the patient would be therapeutic or palliative.
(7) A statement by the practitioner that includes one of the following:
(i) The recommendations, requirements or limitations as to the form or dosage of medical marijuana product.
(ii) The recommendation that only a medical professional employed by the dispensary and working at the dispensary facility consult with the patient or the caregiver regarding the appropriate form and dosage of the medical marijuana product to be dispensed.
(8) A statement by the practitioner that the patient is terminally ill, if applicable.
(9) Any other information that the practitioner believes may be relevant to the patient's use of medical marijuana products.
(10) A statement that the patient is homebound or an inpatient during the time for which the patient certification is issued due to the patient's medical and physical condition and is unable to visit a dispensary to obtain medical marijuana products.
(11) A statement that the practitioner has explained the potential risks and benefits of the use of medical marijuana products to the patient and has documented in the patient's health care record that the explanation has been provided to the patient and informed consent has been obtained.
(12) A statement that a false statement made by the practitioner in the patient certification is punishable under the applicable provisions of 18 Pa.C.S. Chapter 49 (relating to falsification and intimidation).
(d) Upon completion of a patient certification, a practitioner shall:
(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.
§ 1181a.28. Modifying a patient certification.
(a) A practitioner may not modify the form of medical marijuana products on a patient certification for 30 days from the date the receipt is entered into the electronic tracking system by the dispensary unless the practitioner notifies the Department of the intent to modify the patient certification.
(b) After modifying a patient certification, a practitioner shall do 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.
§ 1181a.29. Revocation of a patient certification.
(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.
(b) The Department will revoke a patient certification upon receiving notification of the occurrence of an event listed in subsection (a).
(c) Notwithstanding subsection (a), a practitioner may withdraw the issuance of a patient certification at any time by notifying, in writing, both the patient and the Department.
(d) The Department will immediately notify a medical marijuana cardholder upon the revocation of a patient certification and the information shall be entered into the electronic tracking system.
§ 1181a.30. Prescription Drug Monitoring Program.
(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.
§ 1181a.31. Practitioner prohibitions.
(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.
§ 1181a.32. Training.
(a) Within the time specified, the following individuals shall complete a 4-hour training course approved by the Department:
(1) A physician prior to being included in the practitioner registry under § 1181a.24 (relating to physician registration).
(2) A medical professional prior to assuming any duties at a dispensary under § 1161a.25 (relating to licensed medical professionals at facility).
(b) The requirements of the training course required under subsection (a) must include, at a minimum, all of the following:
(1) The provisions of the act and this part relevant to the responsibilities of a practitioner or medical professional.
(2) General information about medical marijuana under Federal and State law.
(3) The latest scientific research on the endocannabinoid system and medical marijuana, including the risks and benefits of medical marijuana.
(4) Recommendations for medical marijuana as it relates to the continuing care of a patient in the following areas:
(i) Pain management, including opioid use in conjunction with medical marijuana.
(ii) Risk management, including drug interactions, side effects and potential addiction from medical marijuana use.
(iii) Palliative care.
(iv) The misuse of opioids and medical marijuana.
(v) Recommendations for use of medical marijuana and obtaining informed consent from a patient.
(vi) Any other area determined by the Department.
(5) Use of the Prescription Drug Monitoring Program.
(6) Best practices for recommending the form and dosage of medical marijuana products based on the patient's serious medical condition and the practitioner's or medical professional's medical specialty and training.
(c) Successful completion of the course required under subsection (a) 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.
(d) The individuals listed in subsection (a) shall submit documentation of the completion of the 4-hour training course to the Department.
(e) The Department will maintain on its publicly-accessible web site a list of approved training providers that offer the 4-hour training course.
§ 1181a.33. Appeals.
Chapter 5, Subchapter A 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).
CHAPTER 1191a. PATIENTS AND CAREGIVERS Sec.
1191a.22. Patient and caregiver registry. 1191a.23. Patients and caregivers generally. 1191a.24. Medical marijuana cardholder responsibilities. 1191a.25. Application for, and issuance or denial, of identification cards. 1191a.26. Application fees. 1191a.27. Criminal background checks. 1191a.28. Identification cards. 1191a.29. Renewing an identification card. 1191a.30. Revocation or suspension of identification card. 1191a.31. Obtaining medical marijuana products from a dispensary. 1191a.32. Medical marijuana patient authorization letters. 1191a.33. Appeals. § 1191a.22. Patient and caregiver registry.
(a) The Department will maintain a patient and caregiver registry.
(b) Patient and caregiver information maintained by the Department is confidential and not subject to public disclosure, including disclosure under the Right-to-Know Law (65 P.S. §§ 67.101—67.3104). Patient and caregiver information must include the following:
(1) Information provided in an identification card application.
(2) Information in a patient certification issued by a practitioner.
(3) Criminal history record check information provided as part of an identification card application submitted by a caregiver under § 1191a.27 (relating to criminal background checks).
(4) Information encoded in the 2D barcode of an identification card.
(5) Information relating to a patient's serious medical condition.
(c) A caregiver who is listed in the patient and caregiver registry may waive in writing the caregiver's right to confidentiality and consent to the caregiver's name and contact information being provided to a patient who has obtained a patient certification from a practitioner.
§ 1191a.23. Patients and caregivers generally.
(a) The qualifications that a patient or caregiver shall meet to be included in the patient and caregiver registry and to obtain an identification card or a medical marijuana patient authorization letter are continuing qualifications.
(b) Except with respect to a minor patient as provided in § 1191a.32 (relating to medical marijuana patient authorization letters), the Department may issue an identification card to an applicant who meets the qualifications in the act and this part.
(c) The Department may issue an identification card to an individual who is under 21 years of age to serve as a caregiver when a sufficient showing is made to the Department that the individual should be permitted to serve as a caregiver, as determined by the Department.
(d) A minor patient shall have a caregiver who is one of the following:
(1) A parent or legal guardian.
(2) An individual designated by a parent or legal guardian.
(3) An appropriate individual approved by the Department upon a sufficient showing that a parent or legal guardian is not appropriate or available.
§ 1191a.24. Medical marijuana cardholder responsibilities.
(a) A medical marijuana cardholder shall immediately contact the Department upon the occurrence of any of the following:
(1) A change of the medical marijuana cardholder's name or address.
(2) The withdrawal of a patient certification by a practitioner under § 1181a.29 (relating to revocation of a patient certification).
(3) A decision by a patient or the patient's legal guardian to discontinue the services of a caregiver.
(4) A decision by a caregiver to no longer serve as a caregiver for a patient.
(5) A decision by a patient, the patient's legal guardian or a parent on behalf of a patient to discontinue obtaining medical treatment from the practitioner who issued the patient certification.
(b) A medical marijuana cardholder shall apply to the Department for a replacement identification card within 10 business days of discovering the loss or defacement of the identification card.
§ 1191a.25. Application for, and issuance or denial of, identification cards.
(a) An applicant shall submit an identification card application on a form prescribed by the Department. The application will be made available on the Department's publicly-accessible web site and in hard copy upon request.
(b) An identification card application submitted by or on behalf of a patient must include, at a minimum, the following information:
(1) The name, address, telephone number, e-mail address, if available, and date of birth of the patient.
(2) The patient's Pennsylvania driver's license number, a Department of Transportation State-issued identification card, if applicable, or other documentation acceptable to the Department evidencing the patient's identification and residency in this Commonwealth.
(3) The name, address and telephone number of the practitioner who issued the patient certification.
(4) The name, birth date, address, telephone number and e-mail address, if applicable, of up to two individuals designated by the applicant to serve as caregivers, if applicable.
(5) The patient certification issued by the patient's practitioner, which shall be provided by the practitioner to the Department under § 1181a.27(d)(2) (relating to issuing patient certifications).
(6) The appropriate fee or proof of financial hardship as provided for in § 1191a.26 (relating to application fees).
(7) The signature of the applicant and the date signed.
(8) A statement that a false statement made in the application is punishable under the applicable provisions of 18 Pa.C.S. Chapter 49 (relating to falsification and intimidation).
(9) Any other information deemed necessary by the Department.
(c) For an application submitted under this section that designates an individual as a caregiver who is not authorized under the act or this part to serve as a caregiver, the following apply:
(1) The Department may deny that portion of the application and approve the balance of the application. In that case, an identification card may be issued to the patient but the designated caregiver will not be authorized to serve in that capacity.
(2) If the application is submitted on behalf of a minor patient but does not include the designation of another individual as a caregiver who is authorized under the act or this part to serve as a caregiver, the Department will deny the entire application unless and until the applicant designates an individual who is authorized to serve.
(3) An individual designated as a caregiver may not serve as a caregiver unless and until the individual submits an application under subsection (d) and the individual is issued an identification card by the Department.
(d) An identification card application submitted by a caregiver must include, at a minimum, the following information:
(1) The name, address, telephone number, e-mail address, if available, and date of birth of the caregiver.
(2) The caregiver's Pennsylvania driver's license number, a Department of Transportation State-issued identification card, if applicable, or other documentation acceptable to the Department evidencing the caregiver's identification.
(3) The name, address and telephone number of the practitioner who issued the patient certification.
(4) The patient certification issued by the patient's practitioner, which will be provided by the practitioner to the Department under § 1181a.27(d)(2).
(5) A copy of the criminal history record information required under § 1191a.27 (relating to criminal background checks).
(6) The name, address, telephone number and e-mail address, if available, of up to five patients for which the caregiver wishes to be approved by the Department as a caregiver.
(7) The appropriate fee or proof of financial hardship as provided for in § 1191a.26 (relating to application fees).
(8) The signature of the applicant and the date signed.
(9) A statement that a false statement made in the application is punishable under the applicable provisions of 18 Pa.C.S. Chapter 49.
(10) Any other information deemed necessary by the Department.
(e) The Department will review the criminal history record information obtained by a caregiver under § 1191a.27 and the Prescription Drug Monitoring Program database before approving the issuance of an identification card to the caregiver. The Department will deny the issuance of an identification card to a caregiver if the caregiver has been convicted of a criminal offense relating to the sale or possession of drugs, narcotics or controlled substances that occurred within the 5 years immediately preceding the submission of the application. The Department may deny the issuance of an identification card to a caregiver if the caregiver has a history of drug abuse or of diverting controlled substances or illegal drugs.
(f) The Department will promptly notify an applicant in writing if an identification card application is incomplete or factually inaccurate and provide the applicant with an explanation as to what documents or information are necessary for the Department to consider the identification card application to be complete and accurate.
(g) An applicant shall have 60 days from receipt of a notification under subsection (f) to submit to the Department the documents or information requested. If an applicant fails to submit the requested documents or information within 60 days, the Department may deny the identification card application.
(h) The Department will notify an applicant in writing of the reasons for the denial of an identification card application.
(i) An applicant whose identification card application is denied may submit a new identification card application. The Department may decline to consider a new application that does not correct the deficiencies in the initial application leading to a prior denial.
§ 1191a.26. Application fees.
(a) An applicant shall pay no more than one fee of $50 in a 12-month period for an identification card with an identification card application.
(b) Notwithstanding subsection (a):
(1) An applicant shall submit a fee of $25 if the Department issues a replacement identification card as a result of a lost, stolen, destroyed, defaced or illegible identification card.
(2) An applicant shall pay a second fee of $50 in the same 12-month period with an identification card renewal application.
(c) The Department may establish higher fees for issuance of a second and subsequent replacement identification cards by publishing notice of those fees in the Pennsylvania Bulletin.
(d) Subject to § 1191a.32 (relating to medical marijuana patient authorization letters), the Department may waive or reduce the fee for an identification card application or identification card renewal application for an applicant who demonstrates financial hardship. The Department will post on its publicly-accessible web site the qualifications for financial hardship that an applicant requesting a waiver or reduction of the application fee shall submit with an identification card application or identification card renewal application. The Department will publish notice of the qualifications for financial hardship in the Pennsylvania Bulletin.
§ 1191a.27. Criminal background checks.
(a) An individual applying for an identification card to serve as a caregiver shall submit fingerprints to the Pennsylvania State Police, or an authorized agent, for the purpose of obtaining a criminal history record check. The Pennsylvania State Police, or an authorized agent, will submit the fingerprints to the Federal Bureau of Investigation for the purpose of verifying the identity of the caregiver and obtaining a current record of any criminal arrests and convictions.
(b) The Department may only review the criminal history record information received under subsection (a) to determine the caregiver's character, fitness and suitability to serve as a caregiver under the act and this part.
§ 1191a.28. Identification cards.
(a) The Department will issue an identification card to a patient or caregiver as soon as reasonably practicable after approving an identification card application.
(b) An identification card will contain all of the following information:
(1) The full name of the medical marijuana cardholder.
(2) The address of the medical marijuana cardholder.
(3) A designation of the medical marijuana cardholder as a patient or a caregiver.
(4) The date of issuance and the date of expiration of the identification card.
(5) A unique identification number for the medical marijuana cardholder.
(6) A photograph of the medical marijuana cardholder unless the patient or caregiver provides the Department with a statement in accordance with subsection (c).
(7) Any requirement or limitation on the patient certification concerning the recommended form of medical marijuana products or limitation on the duration of use, if applicable.
(8) Any other information deemed necessary by the Department.
(c) Notwithstanding subsection (b)(6), the Department may not require a photograph on an identification card if a statement is provided to the Department in an identification card application that a photograph cannot be provided due to religious beliefs.
(d) An identification card issued to a patient will expire on the earlier to occur of the following:
(1) The date occurring 1 year from the date of issuance.
(2) The date, if any, contained in the patient certification issued to the patient beyond which the practitioner does not believe the use of medical marijuana by the patient would be therapeutic or palliative.
(3) The date the patient dies.
(e) An identification card issued to a caregiver will expire on the earlier to occur of the following:
(1) The date that occurs 1 year from the date of issuance.
(2) Any of the events listed under subsection (d)(2) or (3).
(3) The date the caregiver dies.
§ 1191a.29. Renewing an identification card.
(a) A medical marijuana cardholder shall submit an identification card renewal application to the Department no later than 30 days prior to the expiration date on the card. The form of the renewal application will be prescribed by the Department and will be made available on the Department's publicly-accessible web site and in hard copy upon request. If a medical marijuana cardholder's patient certification is expired, the cardholder shall obtain a new or updated patient certification issued by the patient's practitioner, which will be provided by the practitioner to the Department under § 1181a.27(d)(2) (relating to issuing patient certifications).
(b) If the Department denies an identification card renewal application or if the Department does not receive a complete identification card renewal application by the expiration date on the identification card, the identification card will no longer be valid beyond the expiration date and the Department may remove a medical marijuana cardholder from the patient and caregiver registry.
§ 1191a.30. Revocation or suspension of identification card.
(a) The Department may revoke or suspend a medical marijuana cardholder's identification card upon the occurrence of any of the following:
(1) The Department receives written notice from a practitioner under § 1181a.29(a) (relating to revocation of a patient certification).
(2) A caregiver notifies the Department in writing that the caregiver is no longer acting as a caregiver.
(3) The patient or caregiver has intentionally, knowingly or recklessly violated the act or regulations as determined by the Department. The suspension or revocation will be in addition to any criminal or other penalty that may apply.
(4) Except for good cause shown, a medical marijuana cardholder does not visit a dispensary within 60 days from the issuance date on an identification card.
(5) A patient notifies the Department in writing that the patient has removed or changed a current caregiver. If the caregiver is not serving as a caregiver for any other patient, the Department will issue a notification to the caregiver that the caregiver's identification card is invalid and shall be promptly returned to the Department.
(b) The Department will promptly notify a medical marijuana cardholder in writing of any action taken by the Department regarding the medical marijuana cardholder as a result of information received under subsection (a).
(c) If a patient's practitioner's registration has been revoked or suspended under § 1181a.26 (relating to denial, revocation or suspension of a practitioner registration) or if a patient's practitioner withdraws the patient's patient certification under § 1181a.29(c), a medical marijuana cardholder shall obtain a new patient certification within 90 days of receiving written notice from the Department or prior to the expiration date on the identification card, whichever is sooner.
§ 1191a.31. Obtaining medical marijuana products from a dispensary.
(a) A medical marijuana cardholder may only obtain medical marijuana products from a dispensary in accordance with § 1161a.24 (relating to limitations on dispensing).
(b) A medical marijuana cardholder may only obtain medical marijuana products from a dispensary based upon the recommendation in a patient certification that has not been revoked under § 1181a.29 (relating to revocation of a patient certification) and that may be accessed by a dispensary through the electronic tracking system.
§ 1191a.32. Medical marijuana patient authorization letters.
(a) The Department will issue a medical marijuana patient authorization letter to a minor patient instead of issuing an identification card to the minor patient. Upon reaching 18 years of age, a minor patient who has been issued a medical marijuana patient authorization letter will be entitled to receive an identification card upon application under § 1191a.25 (relating to application for, and issuance or denial of, identification cards).
(b) The Department may issue a medical marijuana patient authorization letter to an adult patient only when the patient's illness or infirmity permanently prevents the patient from visiting a dispensary.
(c) A patient who has been issued a medical marijuana patient authorization letter by the Department under this section shall have all of the rights and obligations of a medical marijuana cardholder under this chapter, except that an identification card shall be required for entry into a dispensary.
(d) A medical marijuana patient authorization letter is subject to the same terms and conditions, including expiration, revocation and suspension requirements, as an identification card under this chapter.
(e) A patient who has been issued a medical marijuana patient authorization letter by the Department under this section will not be required to pay an identification card application fee or an identification card renewal application fee.
§ 1191a.33. Appeals.
Chapter 5, Subchapter A 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).
CHAPTER 1211a. CLINICAL REGISTRANTS AND ACADEMIC RESEARCH CENTERS Sec.
1211a.22. Clinical registrants generally. 1211a.23. Limitations on permits. 1211a.24. Capital requirements. 1211a.25. Certifying ACRCs. 1211a.26. Revocation of a certification of an ACRC. 1211a.27. Application for approval of a clinical registrant. 1211a.27a. Research contracts. 1211a.28. Request for conversion of an existing permit. 1211a.29. Practices and procedures of research programs, projects or studies. 1211a.30. Approval or denial of an application for approval of a clinical registrant. 1211a.31. Renewal of approval of a clinical registrant. 1211a.32. Revocation of approval of a clinical registrant. 1211a.33. Dispensing and tracking medical marijuana products. 1211a.34. Prohibition. 1211a.35. Reporting requirements. 1211a.36. Sale or exchange. 1211a.37. Appeals. § 1211a.22. Clinical registrants generally.
(a) The qualifications that a clinical registrant shall meet to be approved by the Department are continuing qualifications.
(b) An applicant that has already been issued a grower/processor permit or a dispensary permit by the Department under sections 601—616 of the act (35 P.S. §§ 10231.601—10231.616) who wishes to become an approved clinical registrant shall:
(1) Submit a request to the Department under § 1211a.28 (relating to request for conversion of an existing permit) with the application for approval of a clinical registrant.
(2) Not be required to apply for, or be eligible to receive, an additional grower/processor permit or dispensary permit under the act, this chapter, Chapter 1141a, Chapter 1151a or Chapter 1161a (relating to general provisions; growers/processors; and dispensaries), as applicable.
(c) The Department will not approve more than eight clinical registrants.
(d) An approved clinical registrant may not dispense or offer to dispense, as a clinical registrant, any medical marijuana products at the clinical registrant dispensary location until:
(1) The Department has determined that an approved clinical registrant is ready, willing and able to operate as a grower/processor and a dispensary.
(2) The approved clinical registrant demonstrates to the satisfaction of the Department that it will be able to begin an approved research program or research study within 6 months following the date the Department determines the approved clinical registrant's dispensary to be operational.
(e) An approved clinical registrant may 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 a dispensary location operated by an approved clinical registrant under this chapter regardless of whether the patient is a participant in a research study.
§ 1211a.23. Limitation on permits.
(a) An approved clinical registrant may not hold more than one grower/processor permit and one dispensary permit.
(b) A dispensary permit held by an approved clinical registrant for use under this chapter may be used to dispense medical marijuana products at no more than six separate locations as approved by the Department, each of which shall be dispensing medical marijuana for the purpose of conducting research.
(c) An approved clinical registrant may not locate more than three of its approved dispensaries in the same medical marijuana region or in the same county.
§ 1211a.24. Capital requirements.
An applicant shall provide all of the following information with its application under § 1211a.27 (relating to application for approval of a clinical registrant):
(1) An affidavit, on a form prescribed by the Department, stating that the applicant has at least $15 million in capital, which must include evidence that the applicant meets the capital requirements of a medical marijuana organization under § 1141a.30 (relating to capital requirements).
(2) A release sufficient to obtain information from a state governmental agency, financial institutions, an employer or any other person to verify the requirements of paragraph (1). Failure to provide a release will result in the rejection of the application for approval of a clinical registrant.
§ 1211a.25. Certifying ACRCs.
(a) The qualifications that an ACRC shall meet to be approved by the Department are continuing qualifications.
(b) An accredited medical school may file an application with the Department to be certified as an ACRC using a form prescribed by the Department. The Department will publish a notice in the Pennsylvania Bulletin announcing the availability of the application and the time period during which the Department will accept applications.
(c) An application submitted under subsection (b) must include all of the following information:
(1) The legal name, address and telephone number of the accredited medical school and the name, telephone number and professional e-mail address of an individual at the accredited medical school who will be the primary contact for the Department during the Department's review of the application.
(2) The legal name, address and telephone number of the acute care hospital that is operated by or partnered with the accredited medical school and the name, telephone number and professional e-mail address of an individual at the accredited medical school who will be the primary contact for the Department during the Department's review of the application.
(3) An affidavit, on a form prescribed by the Department, disclosing any payments to the accredited medical school or any of its affiliates made by a person with whom the accredited medical school intends to enter into a research contract for purposes of operating as an approved clinical registrant or by any principal or financial backer of the person, up to and including the date of the submission of the application. The affidavit must include the amount and purpose of each payment made.
(4) A statement that the accredited medical school is currently accredited by the Liaison Committee of Medical Education or the Commission on Osteopathic College Accreditation.
(5) A statement that the acute care hospital designated by the accredited medical school under paragraph (2) holds a valid license from the Department.
(6) The State and Federal tax identification numbers of the accredited medical school.
(7) A statement that a false statement made by the accredited medical school submitting the application is punishable under the applicable provisions of 18 Pa.C.S. Chapter 49 (relating to falsification and intimidation).
(8) Any other information deemed necessary by the Department.
(d) The Department will publish a list containing the name and address of each ACRC on its publicly-accessible web site and in the Pennsylvania Bulletin.
§ 1211a.26. Revocation of a certification of an ACRC.
(a) The certification of an ACRC will be revoked by the Department upon the occurrence of any of the following:
(1) The ACRC is no longer accredited by the Liaison Committee of Medical Education or the Commission on Osteopathic College Accreditation, as applicable.
(2) The ACRC no longer operates or is partnered with the acute care hospital listed in its application for certification.
(3) The ACRC is no longer located in this Commonwealth.
(b) If the Department intends to revoke the certification of an ACRC under this section, the Department will provide written notice of its intention to the ACRC. Upon receipt of a notice under this subsection, the ACRC shall have 90 days from the date of the notice to provide the Department with evidence satisfactory to the Department that it has received reaccreditation by the Liaison Committee of Medical Education or the Commission on Osteopathic College Accreditation, as applicable, that it operates or is partnered with another acute care hospital or that it has relocated within this Commonwealth. If the ACRC does not comply with this subsection within 90 days from the date of the notice, the Department may revoke the certification of the ACRC.
§ 1211a.27. Application for approval of a clinical registrant.
(a) An applicant shall file an application for approval of a clinical registrant with the Department on a form prescribed by the Department. The Department will publish a notice in the Pennsylvania Bulletin announcing the availability of applications and the time period during which the Department will accept applications.
(b) An application for approval of a clinical registrant submitted under this section must include all of the following information:
(1) The legal name, address and telephone number of the applicant and the name, telephone number and professional e-mail address of an individual who will be the primary contact for the Department during the Department's review of the application.
(2) The name of the ACRC under § 1211a.25 (relating to certifying ACRCs).
(3) The applicant's State and Federal tax identification numbers.
(4) An affidavit, on a form prescribed by the Department, disclosing any payments made by the applicant, a principal or financial backer of the applicant to an ACRC or any affiliates of an ACRC, up to and including the date of the submission of the application. The affidavit must include the amount and purpose of each payment made.
(5) The name of an institution of higher education, if any, that will be participating in an approved research program or research study.
(6) An affidavit and release under § 1211a.24 (relating to capital requirements).
(7) Evidence that the applicant is responsible and capable of successfully operating as an approved clinical registrant, including all of the following:
(i) A copy of the research contract between the applicant and the ACRC.
(ii) A description of the research program or research study the applicant and the ACRC intend to conduct.
(iii) A statement that the applicant may not engage in the business of selling, dispensing or offering to dispense medical marijuana products at an applicant's dispensary as a clinical registrant until the clinical registrant dispensary is ready, willing and able to dispense medical marijuana products.
(8) Except as provided in § 1211a.28 (relating to request for conversion of an existing permit), an application for a grower/processor permit under Chapters 1141a and 1151a (relating to general provisions; and growers/processors).
(9) Except as provided in § 1211a.28, an application for a dispensary permit under Chapter 1141a and Chapter 1161a (relating to dispensaries).
(10) A statement that a false statement made by the applicant is punishable under the applicable provisions of 18 Pa.C.S. Chapter 49 (relating to falsification and intimidation).
(11) Any other information deemed necessary by the Department.
(c) An applicant may only include one ACRC in its application for approval of a clinical registrant.
(d) The following documents provided to the Department under this chapter are confidential and not subject to disclosure under the Right-to-Know Law (65 P.S. §§ 67.101—67.3104):
(1) A research contract.
(2) A description of a research program or research study.
(3) An ACRC's intellectual property.
(4) An approved clinical registrant's intellectual property.
§ 1211a.27a. Research contracts.
(a) An applicant for approval as a clinical registrant shall provide, with its application, either an executed agreement or a letter of intent to enter into an agreement, with an ACRC, the effective date of which shall be on or after the effective date of the ACRC certification.
(b) A clinical registrant applicant may submit more than one application, with separate applications identifying distinct ACRCs.
(c) An ACRC may enter into a letter of intent with more than one clinical registrant applicant but may only execute a research contract with one approved clinical registrant.
(d) If more than one applicant for approval as a clinical registrant submits an application that includes a letter of intent with the same ACRC, the Department shall follow the following process in approving the applications:
(1) Determine initially that the CR application meets the following qualifications:
(i) Is complete;
(ii) Complies with the act and this part, and
(iii) Meets the following minimum scoring requirements in each of the following application sections:
Grower Processor Application Max Points/Section Minimum Acceptable Score 8—Operational Timetable 75 31 9—Employee Qualifications, Description of Duties and Training 25 11 10—Security and Surveillance 50 21 11—Transportation of Medical Marijuana 25 11 12—Storage of Medical Marijuana 25 11 13—Packaging and Labeling of Medical Marijuana 25 11 14—Inventory Management 25 11 15—Management and Disposal of Medical Marijuana Waste 25 11 16—Diversion Prevention 50 21 17—Growing Practice 100 41 18—Nutrient and Additive Practices 100 41 19—Processing and Extraction 100 41 20—Sanitation and Safety 25 11 22—Recordkeeping 25 11 24—Business History and Capacity to Operate 75 31 Attachment D: Site and Facility Plan 50 21
Dispensary Application Max Points/Section Minimum Acceptable Score 8—Operational Timetable 100 41 9—Employee Qualifications, Description of Duties and Training 50 21 10—Security and Surveillance 100 41 11—Transportation of Medical Marijuana 50 21 12—Storage of Medical Marijuana 75 31 14—Inventory Management 75 31 15—Diversion Prevention 100 41 16—Sanitation and Safety 50 21 17—Recordkeeping 75 31 19—Business History and Capacity to Operate 75 31 Attachment D: Site and Facility Plan 50 21
(2) The Department shall approve clinical registrant applicants that meet the standards of paragraph (1) in the following order:
(i) A clinical registrant applicant that holds a grower/processor permit and a dispensary permit, both of which are in good standing, and both medical marijuana organizations have been deemed operational by the Department. In applying this preference, the Department will look at the clinical registrant's primary dispensary location only.
(ii) A clinical registrant applicant that holds a grower/processor permit only that is in good standing and the applicant's medical marijuana organization has been deemed operational by the Department.
(iii) A clinical registrant applicant that holds a dispensary permit only that is in good standing and the applicant's primary dispensary location has been deemed operational by the Department.
(iv) A clinical registrant applicant that holds a grower/processor permit only that is in good standing, but has not been deemed operational by the Department.
(v) A clinical registrant applicant that holds a dispensary permit only that is in good standing, but has not had its primary location deemed operational by the Department.
(vi) A clinical registrant applicant that is applying for both a grower/processor permit and dispensary permit under this chapter. Awarding of approval to these clinical registrant applications shall be prioritized by ranking the sum of the grower/processor permit and dispensary permit application scores highest to lowest.
§ 1211a.28. Request for conversion of an existing permit.
(a) An applicant holding a grower/processor permit or a dispensary permit, or both, under sections 601—616 of the act (35 P.S. §§ 10231.601—10231.616), shall submit a request for conversion of an existing permit under this section on a form prescribed by the Department when submitting an application for approval of a clinical registrant under § 1211a.27 (relating to application for approval of a clinical registrant).
(b) Upon approval of a clinical registrant under subsection (a), the clinical registrant shall surrender its grower/processor permit or dispensary permit, or both, previously issued under sections 601—616 of the act.
(c) A grower/processor permit or dispensary permit, or both, surrendered under subsection (b) will increase the number of grower/processor permits or dispensary permits, as applicable, available to other persons applying for permits under sections 601—616 of the act, Chapter 1141a (relating to general provisions) and Chapter 1151a or Chapter 1161a (relating to growers/processors; and dispensaries), as applicable.
(d) An applicant may include additional dispensary locations in its request for conversion of an existing permit or may request additional dispensary locations at a later date under § 1161a.40 (relating to application for additional dispensary locations).
§ 1211a.29. Practices and procedures of research programs, projects or studies.
(a) Medical marijuana dispensed as part of a research program shall be dispensed only in a form permitted by the act or this part and only from a dispensary to a patient or to a caregiver.
(b) Marijuana dispensed under a research project or study may be dispensed, in any form deemed medically safe by an IRB, from a clinical registrant dispensary directly to an ACRC.
(c) A RAC or IRB shall adopt research procedures and shall review and approve each research program in accordance with the RAC or IRB established practices and procedures.
(d) An IRB shall review each proposed research project or study in accordance with the IRB's practices, procedures and protocols.
(e) A RAC or IRB shall, at a minimum, ensure that each research program, project or study addresses all of the following:
(1) Protecting the rights and welfare of patients involved in research programs conducted under this chapter.
(2) Minimizing the risk to patients by using procedures that are consistent with sound research design and that do not unnecessarily expose patients to risk being performed on subjects for diagnosis or treatment purposes.
(3) Determining that the risks to patients involved in research programs are reasonable in relation to the anticipated benefits (if any) to the patients, and the importance of the knowledge that may be expected to result from the research program.
(4) Guaranteeing that informed consent will be sought from each prospective patient or the patient's legally authorized representative and is properly documented.
(5) Protecting the privacy of every patient.
§ 1211a.30. Approval or denial of an application for approval of a clinical registrant.
(a) An applicant shall be an approved clinical registrant upon the Department's approval of an application under § 1211a.27 (relating to application for approval of a clinical registrant).
(b) The Department may deny the application for approval of a clinical registrant if the payments disclosed in the affidavit submitted under § 1211a.27(b)(4) violate the prohibition in § 1211a.34 (relating to prohibition).
(c) Before the Department denies an application for approval of a clinical registrant under subsection (b), the Department will provide the applicant with written notice specifying the violation. The applicant may submit to the Department, within 10 days following receipt of the Department's written notice, a supplemental affidavit indicating that the ACRC or its affiliate has refunded to the applicant or a principal or financial backer of the applicant that portion of payments in violation of § 1211a.34. Upon receipt of the supplemental affidavit, the Department may approve the application for approval of a clinical registrant. If the applicant fails to provide a supplemental affidavit within 10 days of the Department's written notice, the Department will deny the application for approval of a clinical registrant.
(d) An approved clinical registrant shall have the same rights and obligations as a medical marijuana organization that holds a grower/processor permit or a dispensary permit under sections 601—616 of the act (35 P.S. §§ 10231.601—10231.616) and Chapters 1141a, 1151a and 1161a (relating to general provisions; growers/processors; and dispensaries), as applicable, subject to any modifications or limitations in sections 2001—2003 of the act (35 P.S. §§ 10231.2001—10231.2003) and this chapter.
(e) A grower/processor permit and a dispensary permit issued to an approved clinical registrant will expire upon the nonrenewal, revocation or suspension by the Department of the approved clinical registrant's approval.
§ 1211a.31. Renewal of approval of a clinical registrant.
(a) The term of an approval of a clinical registrant will coincide with the term of the clinical registrant's grower/processor permit and dispensary permit.
(b) An approved clinical registrant shall renew its approval as part of the renewal for a grower/processor permit and a dispensary permit under § 1141a.36 (relating to permit renewal applications). The renewal application must be on a form prescribed by the Department and include all of the following:
(1) A copy of the research contract.
(2) A list of the approved research programs or research studies that are continuing or, if any of them are concluded, the dates they were concluded.
(3) A report of the current status of active research programs or research studies being conducted under the research contract, including preliminary findings, if applicable, and any expectations and projections the approved clinical registrant and the ACRC have for future research programs or research studies over the course of the 2 years following the date of submission of the report.
(4) A description of proposed research programs or research studies covered by the research contract that the approved clinical registrant intends to conduct within the next year following submission of the renewal application including evidence of IRB approval for each research program or research study.
(5) A statement that a false statement made by the approved clinical registrant or the ACRC is punishable under the applicable provisions of 18 Pa.C.S. Chapter 49 (relating to falsification and intimidation).
(6) Any other information deemed necessary by the Department.
(c) The Department will not renew an approval for a clinical registrant under this section if the Department determines that none of the dispensary locations under the dispensary permit held by the approved clinical registrant are participating in an approved research program or research study and the approved clinical registrant does not intend to begin any additional approved research programs or research studies within the first six months following the approval of its application for renewal.
§ 1211a.32. Revocation of approval of a clinical registrant.
(a) The approval of a clinical registrant will be revoked immediately by the Department upon the occurrence of any of the following:
(1) The Department revokes, suspends or does not renew the grower/processor permit or dispensary permit held by the approved clinical registrant.
(2) Subject to subsection (b), the Department revokes the certification of the ACRC listed in the clinical registrant's application under § 1211a.27 (relating to application for approval of a clinical registrant).
(3) The research contract between the approved clinical registrant and the ACRC expires without being renewed or is terminated by either party.
(b) If the Department intends to revoke the certification of the ACRC under subsection (a)(2), the Department will provide written notice of its intention to the approved clinical registrant. Upon receipt of a notice under this subsection, the approved clinical registrant shall have 90 days from the date of the notice to contract with another ACRC that is not already a party to a research contract with another approved clinical registrant and to provide the Department with all relevant information relating to the ACRC. If the approved clinical registrant does not comply with this subsection within 90 days from the date of the notice, the Department may revoke the clinical registrant's approval.
§ 1211a.33. Dispensing and tracking medical marijuana products.
In addition to the information to be entered in the electronic tracking system under § 1161a.39 (relating to electronic tracking system) with respect to medical marijuana products dispensed to all patients and caregivers, the dispensary of an approved clinical registrant shall enter information into the electronic tracking system as required by the Department that identifies patients that are enrolled in an approved research program or research study.
§ 1211a.34. Prohibition.
Except for reasonable remuneration specifically in a research contract for the services to be performed or costs to be incurred by an ACRC, an ACRC may not solicit or accept anything of value from an approved clinical registrant or a principal or financial backer of an approved clinical registrant. Reasonable remuneration may include up-front deposits or other payments to an ACRC under a research contract to defray start-up and ongoing costs of the ACRC in connection with the establishment of the contractual relationship in the research contract. This section does not apply to charitable contributions that are part of a history of giving to an ACRC established 1 year or more prior to the effective date of the act.
§ 1211a.35. Reporting requirements.
(a) Except as provided in subsection (b), an approved clinical registrant shall provide a written report of the findings of its research program or research study to the Department within 365 days of the completion of an approved research program or research study.
(b) In the event the approved clinical registrant or its ACRC intends to submit a manuscript of the results of an approved research program or research study to a peer-reviewed medical journal for publication, the written report required under subsection (a) shall be provided to the Department within 30 days following publication.
(c) The Department may post the findings received under this section on its publicly-accessible web site and share them with other approved clinical registrants, ACRCs or any other person it determines would benefit from the findings.
§ 1211a.36. Sale or exchange.
(a) The grower/processor of an approved clinical registrant may sell or exchange the following items to another grower/processor:
(1) Seeds.
(2) Immature medical marijuana plants.
(3) Medical marijuana plants.
(4) Medical marijuana products.
(b) The grower/processor of an approved clinical registrant may only sell its medical marijuana products to either its own approved dispensaries or any other approved dispensaries of an approved clinical registrant.
(c) Notwithstanding subsection (b), an approved clinical registrant may petition the Department, on a form prescribed by the Department, to sell its medical marijuana products to a dispensary holding a permit under sections 601—616 of the act (35 P.S. §§ 10231.601—10231.616).
(d) A petition filed under subsection (c) must include either the report or manuscript required under § 1211a.35 (relating to reporting requirements). If a clinical registrant fails to provide the report or manuscript required under § 1211a.35, the petition will be denied.
§ 1211a.37. Appeals.
Chapter 5 of 2 Pa.C.S. (relating to practice and procedure) and its accompanying regulations, as modified by Chapter 1230a (relating to practice and procedure), apply to actions of the Department under this chapter constituting an adjudication as defined in 2 Pa.C.S. § 101 (relating to definitions).
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