Section 216-RICR-40-15-1.16 - Violations, Complaints, and Sanctions1.16.1Grounds for Denial or Discontinuation of LicenseA. The Board, with the approval of the Director, may deny, suspend, revoke or otherwise discipline the licensee upon proof of the conduct described in R.I. Gen. Laws § 5-19.1-21: 1. Good and sufficient cause shall exist for the refusal to renew and/or for the revocation of any pharmacy license if, after hearing, the Board determines that:a. Practitioners with authority to prescribe medications maintain a financial interest which, in the aggregate, exceeds ten percent (10%) of the total ownership of the subject pharmacy, drug store or licensee; orb. More than forty percent (40%) of the prescription filled by the subject pharmacy or drug store within any three (3) month period were issued by practitioners with any ownership interest in the subject pharmacy, drug store, or licensee.(1) The pharmacist-in-charge of said pharmacy shall furnish and deliver to the Department, upon request, all dispensing reports, and any other required documents necessary to determine the percentage of prescriptions filled.B. Penalties for unlawful practices are pursuant to R.I. Gen. Laws § 5-19.1-23.1.16.2Violations and SanctionsA. Every person, co-partnership or corporation who shall violate any of the provisions of this Act and the Rules and Regulations thereof shall, unless otherwise provided, be subject to such penalties as specified in R.I. Gen. Laws § 5-19.1-27.B. Any licensed pharmacist who shall have been convicted of a violation of the provisions of Chapter 28 of the Title 21 of the United States Code approved October 27, 1970, as amended entitled "Comprehensive Drug Abuse Prevention and Control Act of 1970" (21 U.S.C. § 84 (1236)), and all Regulations pertaining thereto shall be deemed to have forfeited his/her right to licensure, and the Board of Pharmacy shall thereupon discontinue his/her license.C. A licensed pharmacist may decline to dispense a drug or device, pursuant to an order or prescription, on ethical, moral, or religious grounds only if the licensed pharmacist has previously notified the pharmacy owner, in writing, of the device(s), drug or class of drugs to which he/she objects, and the pharmacy owner can, without creating undue hardship, provide a reasonable accommodation of the licensed pharmacist's objection. The licensed pharmacy owner shall establish protocols to ensure that the patient has timely access to the prescribed drug or device despite the licensed pharmacist's refusal to dispense the prescription or order. For the purpose of this section, "reasonable accommodation" shall mean the pharmacy owner has demonstrated that they explored any available reasonable alternative means of accommodating the licensed pharmacist's ethical, moral, or religious objections, including the possibilities of excusing the licensed pharmacist from those duties or permitting those duties to be performed by another person, but is unable to reasonably accommodate the ethical, moral, or religious objections without undue hardship on the conduct of the pharmacy owner's business.1.16.3ComplaintsA. Any person, pharmacist, business entity or public officer, including a licensee, may submit a complaint to the Board against any licensee or person believed to be engaged in activity which violates the Act or this Part.B. All complaints must be submitted to the Department by the complainant or an authorized representative of the complainant. A complaint must state the grounds for the complaint, including a statement of facts or circumstances upon which the complaining party relies for the charge. A complaint shall state the name, address, and telephone number or email address of the complainant or representative to be contacted by the Board or its investigative designees for purposes of investigation or issuance of notice.C. Within twenty-one (21) calendar days of receipt of notice that a complaint has been filed, the licensee or person against whom the complaint has been filed must respond in writing to the Board and the Department.1.16.4Variance ProcedureA. The Department may grant a variance from the provisions of a Rule or Regulation in a specific case if it finds that a literal enforcement of such provision will result in unnecessary hardship to the applicant and that such a variance will not be contrary to the public interest and/or health and safety of the public. 1. Variances may be granted only for the provisions of §§ 1.6 through 1.11 of this Part and shall be for a limited period of time, generally not to exceed one (1) year.B. A request for a variance shall be filed by an applicant in writing, setting forth in detail the basis upon which the request is made.1. Upon the filing of each request for variance with the Department, and within a reasonable time thereafter, the Department shall notify the applicant by certified mail of its approval or in the case of a denial, a hearing date, time and place may be scheduled if the person appeals the denial.C. At a hearing held in furtherance of an appeal from a denial for a variance in accordance with §1.6.3(B)(1) of this Part, the applicant shall bear the burden of proof that a literal enforcement of the Rules will result in unnecessary hardship, and that a variance will not be contrary to the public interest and/or health and safety of the public.1.16.5Rules Governing Practices and ProceduresUpon due notice in accordance with R.I. Gen. Laws Chapter 42-35 (the Administrative Procedures Act), all hearings and reviews required under the provisions of the Act shall be held in accordance with the Rules and Regulations pertaining to Practices and Procedures Before the Rhode Island Department of Health (Part 10-05-4 of this Title).
216 R.I. Code R. § 216-RICR-40-15-1.16
Adopted effective 5/17/2021
Amended effective 12/8/2022