On March 5, 2021, the Pennsylvania Department of Health (the “Department”) proposed permanent regulations relating to medical marijuana, replacing the current temporary regulations at 28 Pa. Code Part IX. The proposed regulations can be accessed here, and the notice regarding the same can be accessed here.
The Proposed Regulations are in substantially the same form as the temporary regulations that have been in effect since April of 2017. [See our prior post on the Temporary Regulations and how they are applicable to physicians here]. However, there are a couple of notable proposed revisions for practitioners to be aware of:
- The Department intends to add ”anxiety disorders” and ”Tourette’s Syndrome” to the definition of ”serious medical condition”, as well as “any other condition recommended by the Medical Marijuana Advisory Board and approved by the Secretary.” These additions would widen the scope of conditions that can be treated with medical marijuana and pave the way for future conditions to be added through a Board recommendation process.
- “Continuing care” would be updated for consistency with the statutory definition by adding ”including an in-person consultation with the patient.” This change would eliminate any question of whether a practitioner can certify the use of medical marijuana for a patient without consulting with them in−person.
- Practitioners would now be prohibited from charging patients “excessive fees.” The Department is proposing the change “due to patient complaints of practitioners taking advantage of the certification process by charging excessive lab testing, follow-up, or other fees not initially disclosed.” Practitioners should reconsider their fees in light of this proposed regulation.
As a reminder, failure to comply with any provision of the Act applicable to practitioners can result in sanctions by the Pennsylvania State Board of Medicine or Osteopathic Medicine and removal from the practitioner registry.
The Proposed Regulations also address, among various topics, the following:
- Requirements for permits and applications for the same (and fees associated therewith).
- Requirements for the operation of a medical marijuana
- Visitor access to a medical marijuana facility and protocol pertaining to the same.
- Requirements for growing and processing medical marijuana.
- Acceptable forms of medical marijuana that a grower/processor may process.
- Limits on medical marijuana processing (e.g., THC and CBD).
- Inventory data, storage requirements, and equipment, operation and maintenance (including sanitation and safety).
- Packaging and labeling of medical marijuana products.
- Transportation of medical marijuana.
- Dispensaries and the general dispensing of medical marijuana products.
- Licensed medical professionals at a facility –
- Of particular interest, the Proposed Regulations provide that a physician or pharmacist must be present at the facility during operating hours and, if a permittee operates more than one facility under the same permit, a physician assistant or certified nurse practitioner may cover the other sites.
- Medical marijuana laboratories, including suspension, approval and/or revocation.
- Medical marijuana cardholder responsibilities and revocation or suspension of an identification card.