Bill > SB778

This bill establishes a new permit for "clinical research pharmacies," which are pharmacies exclusively compounding, dispensing, or distributing drugs for scientific research conducted under approved protocols and not open to the general public. The State Board of Pharmacy, referred to as the "Board," will issue these permits and set operational standards. Importantly, the bill allows a "health care provider," defined as someone licensed under the relevant health occupations article, to have an ownership interest in a clinical research pharmacy under specific conditions, including that a licensed pharmacist is always on-site and responsible for all pharmacy operations, and that no referring health care provider receives payment for patient referrals. Furthermore, individuals are generally not required to hold a license or certification to own or have an ownership interest in a clinical research pharmacy, and such ownership alone will not be grounds for disciplinary action against them, though their employees can still be investigated for practicing without proper authorization or violating regulations. The bill also clarifies that a substantial ownership interest does not permit a health care provider to act as a clinical investigator for the research conducted at the pharmacy or to interfere with a pharmacist's professional judgment.