Maryland Administrative Code

.01 Scope. This chapter governs all licensees, permit holders, registrants, or applicants for licenses or permits issued by the Board.

.02 Fees. The following fees are established by the Board: A. Pharmacist Fees. (1) Pharmacist examination fee — $150; (2) Pharmacist reciprocity fee — $300; (3) Pharmacist renewal fee — $225; (4) Pharmacist reinstatement fee for up to 2 years after license expiration, payable in …

.03 Change of Fees. Fees are subject to change by action of the Board of Pharmacy. Licensees, registrants, and applicants shall be notified of the change.

.01 Patient Safety and Welfare. A. A pharmacist shall: (1) Abide by all federal and State laws relating to the practice of pharmacy and the dispensing, distribution, storage, and labeling of drugs and devices, including but not limited to: (a) United States Code, Title 21, (b) He…

.02 Compensation. A pharmacy technician, pharmacy intern, or a pharmacist may not fraudulently seek or accept compensation for a pharmacy product or service not provided.

.03 Patient Privacy. A. The pharmacy technician, pharmacy intern, pharmacist, and pharmacy permit holder shall ensure confidentiality in creating, storing, accessing, transferring, and disposing of a patient record. B. A pharmacy technician, pharmacy intern, or pharmacist may not…

.04 Competence. A pharmacy technician, pharmacy intern, or a pharmacist shall: A. Maintain knowledge of the current pharmacy and drug laws and health and sanitation laws relevant to the practice of pharmacy; and B. Provide a pharmaceutical service only within the scope of the pha…

.05 Duty to Report. A. Except when the conduct in question includes drug or alcohol abuse or dependency, a pharmacy technician, pharmacy intern, or pharmacist shall report to the Board: (1) Conduct which violates a statute or regulation pertaining to the practice of pharmacy; (2)…

.06 Discrimination, Harassment, and Sexual Misconduct. A. In the practice of pharmacy, a pharmacy technician, pharmacy intern, or pharmacist may not: (1) Discriminate based on age, gender, race, ethnicity, national origin, religion, sexual orientation, disability, socioeconomic s…

.07 Disposition and Return of a Prescription Drug or Device. A. A pharmacist may accept the return of a properly labeled and properly sealed manufacturer’s package or individual unit dose of a drug or device that the pharmacist determines to have been handled in a manner which pr…

.08 Refusing to Dispense a Controlled Substance. A. If, based on generally accepted professional standards for the practice of pharmacy, a pharmacist has reason to believe, or should have reason to believe, that a prescription for a controlled dangerous substance was not issued f…

.09 Sanctions. A. The Board may take action to reprimand a licensee, place the licensee on probation, or suspend or revoke the licensee's license if the licensee commits a violation of this chapter. B. The Board may take action to reprimand a registrant, place the registrant on p…

.10 Whole or Substantial Ownership of a Pharmacy by an Authorized Prescriber. A. In this regulation, “owned wholly or substantially” means ownership of 10 percent or more of a pharmacy. B. A pharmacist may not associate as a partner, coowner, or employee of a pharmacy that is own…

.01 Scope. This chapter establishes standards for the imposition of disciplinary sanctions, monetary penalties, and civil fines for violations of Health Occupations Article, Title 12, Annotated Code of Maryland.

.02 Definitions. A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Act” means Health Occupations Article, Title 12, Annotated Code of Maryland. (2) “Board” means the State Board of Pharmacy. (3) “Civil fine” means a fine assessed by the B…

.03 Imposition of Disciplinary Sanctions or Monetary Penalties Generally. A. After a hearing pursuant to Health Occupations Article, §12-315, 12-601, 12-6B-09, or 12-6D-11, Annotated Code of Maryland, the Board may impose a penalty against a pharmacy technician, pharmacy intern, …

.04 Guidelines for Imposition of Disciplinary Sanctions or Monetary Penalties on Pharmacists. A. Subject to the provisions of this chapter, the Board may impose the following sanctions and, if appropriate, penalties for violations of the Act and its regulations according to the m…

.04-1 Guidelines for Imposition of Disciplinary Sanctions or Monetary Penalties on Pharmacy Interns. A. Subject to the provisions of this chapter, the Board may impose the following sanctions and, if appropriate, penalties for violations of the Act and its regulations according t…

.05 Guidelines for Imposition of Disciplinary Sanctions or Monetary Penalties on Pharmacy Technicians. A. Subject to the provisions of this chapter, the Board may impose the following sanctions and, if appropriate, penalties for violations of the Act and its regulations according…

.06 Guidelines for Imposition of Disciplinary Sanctions or Monetary Penalties on Pharmacy Permit Holder. A. Subject to the provisions of this chapter, the Board may impose the following sanctions and, if appropriate, penalties for violations of the Act and its regulations accordi…

.07 Guidelines for Imposition of Disciplinary Sanctions or Monetary Penalties on Wholesale Distributor Permit Holder. A. Subject to the provisions of this chapter, the Board may impose the following sanctions and, if appropriate, penalties for violations of the Act and its regula…

.08 Mitigating and Aggravating Factors to Be Considered in the Assessment of the Sanction and Penalty. A. Depending upon the facts and circumstances of each case, and to the extent that they apply, the Board may consider the following mitigating and aggravating factors in determi…

.09 Civil Fines to Pharmacists, Pharmacy Technicians, and Pharmacy Permit Holders. A. Practicing on an Expired License. The Board may assess a civil fine against a pharmacist who practices on an expired license in the amount of $1,000 per month of practice past the expiration dat…

.10 Civil Fines to Wholesale Distributor Permit Holders. A. Operating on an Expired Wholesale Distributor Permit. The Board may assess a civil fine against a permit holder that operates on an expired wholesale distributor permit in the following amount: (1) A maximum of $10,000 p…

.11 Payment of a Penalty. A. A licensee, registrant, or permit holder shall pay to the Board a penalty imposed under this chapter within 30 days of the date the Board's order is issued, unless the Board's order specifies otherwise. B. Filing an appeal under State Government Artic…

.01 Manufacturer's Expiration Date. A. A wholesale distributor, pharmacist, or pharmacy shall distribute or hold for sale medications bearing a manufacturer's expiration date pursuant to 21 C.F.R. §211.137. B. A wholesale distributor, pharmacist, or pharmacy shall have adequate a…

.01 Definitions. A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Board” means the State Board of Pharmacy. (2) “MPJE” means the Multistate Pharmacy Jurisprudence Examination. (3) “NAPLEX” means the North American Pharmacist Licensure Ex…

.02 Reinstatement Fee. The reinstatement fee authorized by Health Occupations Article, §12-310(a)(2), Annotated Code of Maryland, shall be as determined in COMAR 10.34.09.

.03 Reinstatement Requirements. A. General Requirements. A pharmacist who wishes to reinstate an expired license to practice pharmacy shall: (1) Provide evidence of the completed amount of approved continuing education required by the Board in COMAR 10.34.18 in conjunction with t…

.04 Waiver. The Board may waive any of the requirements set forth in Regulation .03 of this chapter in reinstating a pharmacist's expired license.

.01 Definitions. A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Closing of a pharmacy” means a licensed pharmacy will cease operations for more than 7 consecutive days, except when: (a) A licensed pharmacy is destroyed or otherwise ren…

.02 Opening a Pharmacy. A. To apply for a pharmacy permit, an applicant shall: (1) Submit an application to the Board on the form that the Board requires; (2) Pay to the Board an application fee set by the Board in COMAR 10.34.09; and (3) Submit to an opening inspection, at which…

.03 Notification of Closing of a Pharmacy. A. At least 14 days before a licensed pharmacy’s anticipated date of closing, the pharmacy permit holder shall: (1) Notify the: (a) Board in writing by certified mail, return receipt requested, or hand delivery to the Board’s office, of …

.03-1 Notification by Pharmacy Permit Holder of Anticipated Sale of Pharmacy Operations. A. At least 30 days before a licensed pharmacy’s sale or transfer of its pharmacy operations at the permitted establishment, the pharmacy permit holder shall: (1) Notify the: (a) Board in wri…

.04 Required Information and Procedure. A. At the closing inspection of a licensed pharmacy, the pharmacy permit holder shall provide to the Board, or the Board’s agent, information and documentation required by Regulation .05 of this chapter. B. The pharmacy permit holder shall …

.05 Information and Documentation Due at the Closing Inspection. Information and documentation due at the closing inspection shall include: A. The exact date on which the pharmacy ceased to operate as a pharmacy; B. A copy of the inventory required by the Drug Enforcement Adminis…

.06 Disposition of Prescription Drugs Other than Controlled Dangerous Substances. With the exception of controlled dangerous substances, prescription drugs in stock shall be disposed of by one or more of the following means: A. Returning them to a distributor or manufacturer; or …

.07 Disposition of Controlled Dangerous Substances. The pharmacy permit holder shall comply with the procedures set forth in this chapter in addition to those set forth in COMAR 10.19.03.10C — E governing the disposal of controlled dangerous substances. Cross References 10.34.14.…

.01 Requirements. A. An individual applying for licensure as a pharmacist by reciprocity shall: (1) Submit to the Board an application on a form provided by the Board; (2) Pay to the Board the fee as specified in COMAR 10.34.09; (3) Submit to the Board evidence of completion of a…

.01 Definitions. A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Committee” means, in this chapter, a joint committee of representatives from the Board of Pharmacy and the Board of Nursing. (2) “Portable drug kit” means a container comp…

.02 Requirements for Prescription Protocol. Before distributing a portable drug kit, the pharmacist shall ensure that the prescription protocol includes: A. The name, strength, and quantity of a drug to be included in the portable drug kit; B. The name of the receiving agency or …

.03 Records. A pharmacist shall: A. File the prescription protocol in a readily retrievable manner; B. Document the: (1) Date of distribution of the portable drug kit, (2) Name of the person or agency to whom the kit is delivered, and (3) Date of delivery for each kit distributed…

.04 Requirements of the Portable Drug Kit. A. The pharmacist shall ensure that the portable drug kit: (1) Is sealed with a tamper evident tag or other means for detecting entry to the kit; (2) Displays on the outside of the kit: (a) A serial number unique to the kit; (b) An expir…

.05 Contents of Portable Drug Kit. The committee shall review annually the approved prescription drugs and nonprescription items to ensure that the contents of a portable drug kit are appropriate.

.06 Distribution of Portable Drug Kits. Portable drug kits may only be distributed to licensed health care providers who are authorized by law to administer the contents of a portable drug kit.

.01 Definitions. A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Board” means the State Board of Pharmacy. (2) “Comprehensive care facility” means a facility which admits patients suffering from disease, disabilities, or advanced age, r…

.02 Pharmaceutical Specialty. A. The Board may recognize as a pharmaceutical specialty not listed under Regulation .01B(4) of this chapter, upon written application and supporting documentation to the Board by an applicant for a waiver permit. B. When evaluating an application fo…