SB 180

The Board of Pharmacy (“Board”) has worked for several years to amend Chapter 25, Title 24 of the Delaware Code to update the statute governing pharmacy licensure and practice in this State. The result of these efforts is this Act, which modernizes Chapter 25 to include a licensure system similar to those already in place in many other states, reflects current practices and standards, and clarifies the law. The Board’s priority in amending Chapter 25 was to ensure competence and accountability of individuals, pharmacies, and other establishments regulated by the Board. This Act expands and updates the definitions section to include terms related to current practice, such as “compounding” and “outsourcing facilities.” Board membership terms are increased: Board members will be eligible to serve for a maximum of three consecutive, three-year terms. The Board officers are identified as president and vice president. Several sections are added to the Board’s powers and duties, including the authority to promulgate a Code of Ethics. This Act amends the qualifications for licensure as a pharmacist to set forth clearly objective criteria. With respect to licensure as a pharmacist by reciprocity, the “good standing” requirement is clarified, and a criminal background check requirement is added. The requirements for license renewal, reinstatement, and reactivation are amended to provide that, after a certain time period has expired, a licensee will be required to undergo a criminal background check and the licensee’s disciplinary history will be reviewed. This Act revises the potential Grounds for Discipline of pharmacists to include violation of the Code of Ethics. Available sanctions are broadened to include permanent revocation and potential administrative penalties not to exceed $10,000 for the first violation with further penalties optional for subsequent violations. These changes will serve as a deterrent for licensee conduct posing a risk to the public health, safety, and welfare. This Act strikes the provision for “Counseling of Pharmacists” to align statutory language with actual practice. Disciplinary matters are public and are addressed by the entire Board. The requirements for prescription labeling, pharmacy closing, and prescription departments will be addressed in rules and regulations to allow for necessary revisions as practice standards evolve. This Act also revises the requirements for pharmacies and non-resident pharmacies in the interest of objectivity and consistency. Grounds for discipline and available sanctions are expanded. In particular, the Board will have the discretion to impose an administrative penalty not to exceed $250,000 for each violation with further penalties available for ongoing violations. Further, with respect to non-resident pharmacies, the Board will also have the authority to impose administrative penalties, up to $10,000 per day, for the infraction of delivering drugs into Delaware without a license issued by the Board. This Act adds a new section for licensure requirements for manufacturers, wholesale distributors, outsourcing facilities, medical gas distributors, and retail non-pharmacies. Key personnel will be required to undergo criminal background checks. Possible administrative penalties are revised significantly, from $50 per day, to a maximum of $250,000 for each violation with further penalties available for ongoing violations. The option of this sanction will serve as a deterrent for wrongful conduct by establishments that are often delivering drugs from out-of-state into Delaware. This Act also makes revisions to ensure that statutory provisions are consistent with other Title 24 professional licensing board practice acts. Technical corrections serve to conform existing law to the standards of the Delaware Legislative Drafting Manual. This Act takes effect 1 year after enactment.