Maryland Administrative Code

.06 Incomplete Applications. A. The Board may hold an incomplete initial or reinstatement application for a license, registration, or permit for up to one year from the date of receipt. B. After 1 year from the date of receipt, the Board shall close a pending application that is …

.01 Settings. A. If a setting otherwise complies with State and federal laws, a pharmacist may request Board approval to dispense or distribute at a setting that does not possess a pharmacy permit if: (1) The dispensing or distribution occurs while the pharmacist is providing dru…

.02 Pharmacist Approval. A. Before a pharmacist may dispense or distribute at a setting that does not hold a pharmacy permit under Regulation .01A(1) of this chapter, the pharmacist shall submit to the Board a request for approval signed by the pharmacist, which includes: (1) The…

.03 Grounds for Denial. The Board may deny a pharmacist's request for approval under Regulation .02 of this chapter if the: A. Pharmacist has: (1) A pending or final disciplinary action before the Board; or (2) A criminal history; or B. Criteria set forth in Regulations .01B or .…

.04 Change in Information. If any of the information set forth in Regulation .02 of this chapter changes during the effective period of the Board's approval: A. The pharmacist shall immediately advise the Board in writing of the change; and B. The change in information may cause …

.05 Approval During Catastrophic Health Emergency. In the event of a catastrophic health emergency proclaimed by the Governor under Article 41, §2-202, Annotated Code of Maryland, or by the Secretary under Health-General Article, §18-902, Annotated Code of Maryland, assignment of…

.06 Governing Laws. A. Except as provided in §B of this regulation, a pharmacist approved by the Board to dispense or distribute at a nonpharmacy setting shall comply with the Health Occupations Article, Title 12, Annotated Code of Maryland. B. A pharmacist approved by the Board …

.07 Term and Renewal. A. Unless otherwise determined by the Board, the Board's approval of a pharmacist's request to dispense or distribute at a setting that does not possess a pharmacy permit is in effect until the expiration of the pharmacist's license. B. The pharmacist shall …

.08 Pharmacy Rendered Inoperable. A. If a pharmacy for which a permit is issued is destroyed or otherwise rendered inoperable, a pharmacist may dispense or distribute from a temporary site if the permit holder: (1) Obtains approval from the Board before continuing pharmacy operat…

.01 Scope. This chapter does not limit or affect the right of an individual to practice a health occupation that the individual is authorized to practice. 53:13 25-248-E-1 (Regulations .02 — .08) EMERGENCY ACTION IN EFFECT 11/20/2025 — 11/28/2026

.02 Definitions. A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Board” means the State Board of Pharmacy. (2) “Pharmacist” means an individual who practices pharmacy regardless of the location where the activities of practice are perfo…

.03 Requirements to Administer Vaccinations. A. Registration. (1) A licensed pharmacist shall submit a registration to the Board on the form that the Board requires. (2) The registration form shall include verification from the licensed pharmacist of the following: (a) That the p…

.04 Record Keeping. A. The pharmacy permit holder shall maintain documentation in the pharmacy from which the vaccine was administered for a minimum of 5 years that includes: (1) The name, address, and date of birth of the individual receiving the vaccination; (2) The date of adm…

.05 Patient Information and Consent. A. Every patient receiving a vaccination shall be provided with a current vaccine information statement. B. Every patient receiving a vaccination shall: (1) Sign a consent form consenting to the administration of the vaccine; and (2) Be given …

.06 Approved Protocols. A. A pharmacist shall have and maintain a written protocol for any vaccine to be administered, including influenza vaccination. B. The pharmacist shall administer vaccinations in accordance with the written protocol. C. The written protocol for each vaccin…

.07 Fees. Fees charged for the administration of vaccinations may not exceed $50 in addition to the cost of each vaccination.

.01 Definitions. A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Board” means the State Board of Pharmacy. (1-1) “Donation program” means pharmacies that voluntarily participate as a drop-off site or repository, or both, to accept donat…

.01-1 Incorporation by Reference. In this chapter, the Secure and Responsible Drug Disposal Act of 2010, 21 U.S.C. 822 (as amended), has been incorporated by reference.

.02 Donation Program — Eligible Drugs. A. Prescription drugs or medical supplies may be donated at a drop-off site. B. Prescription drugs or medical supplies may be accepted for dispensing if the prescription drugs and medical supplies are: (1) In their original unopened and seal…

.03 Donation Program — Ineligible Drugs. A. Prescription drugs or medical supplies may not be accepted for dispensing if the prescription drugs or medical supplies: (1) Bear an expiration date that is less than 90 days from the date the drug is donated to ensure the potency and q…

.04 Donation Program — Donor Form. A. A donor of a prescription drug or medical supply shall sign a form containing the following statements: (1) That the donor is the owner or the owner's representative of the prescription drug or medical supply; and (2) That the donor intends t…

.05 Donation Program — Drop-Off Sites Requirements. A. In order to become a drop-off site, a pharmacy or other health care facility: (1) Shall submit an application to the Board to be designated as a voluntary drop-off site; (2) Shall be in good standing with the Board or the Off…

.06 Repositories — General Requirements. In order to become a repository, a pharmacy: A. Shall submit an application to the Board to be designated as a repository; B. Shall indicate on the application to the Board if the applicant intends to: (1) Participate in the Donation Progr…

.06-1 Repositories Participating in the Donation Program. A. Designated Pharmacist. A repository in the donation program shall designate a pharmacist who shall: (1) Accept donated prescription drugs or medical supplies forwarded by: (a) A drop-off site; or (b) A manufacturer regu…

.07 Disposal Program — Requirements. A. Pharmacies that collect returned prescription drugs or medical supplies for proper disposal shall be approved by the Board as repositories. B. Repositories that collect only non-controlled dangerous substances for proper disposal shall: (1)…

.01 Scope. This chapter applies to applicants for registration as pharmacy technicians and to registered pharmacy technicians.

.02 Definitions. A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Board” means the State Board of Pharmacy. (2) Compounding. (a) “Compounding” means the preparation, mixing, assembling, packaging, or labeling of a drug or device: (i) As …

.03 Delegated Pharmacy Acts. A. A pharmacy technician may not: (1) Represent themselves as a pharmacist; (2) Dispense prescription medications when the pharmacist is not in the pharmacy; (3) Be present in the pharmacy when the pharmacist is not physically available onsite; (4) Pr…

.04 Validated Pharmacy Technician. A. Validated Pharmacy Technician — Minimum Requirements. (1) Experience. Prior to working as a validated pharmacy technician, an individual shall have a minimum of 1 year of experience as a registered pharmacy technician in the State. (2) Traini…

.05 Registration Requirements. A. An applicant currently certified by a national pharmacy technician certification program shall: (1) Submit to the Board a signed completed application on a form provided by the Board; (2) Submit to the Board evidence of current certification by a…

.06 Pharmacy Students —Exemptions. A. Pharmacy students who are practicing in a pharmacy as part of a school of pharmacy sanctioned experiential learning rotation are not subject to the registration requirements of Regulation .04 of this chapter. B. Pharmacy students who are curr…

.07 Standards for Pharmacy Technician Training Programs. A. Minimum Standards. (1) Pharmacy technician training programs shall, at a minimum, cover the following areas of pharmacy practice: (a) Roles and responsibilities of the pharmacy technician; (b) Knowledge of prescription m…

.08 Standards for Examination Approval. The Board shall approve examinations which have: A. Content criteria set forth in Regulation .06 of this chapter; B. A minimum of 100 multiple choice questions; C. Sufficient additional questions so that the examination questions may be rot…

.09 Renewal Requirements. A. The pharmacy technician's registration shall expire on the last day of the birth month following 1 year after initial registration. B. Following initial registration, a pharmacy technician's registration: (1) Expires on the date set by the Board unles…

.10 Continuing Education. A. Requirements. (1) A pharmacy technician registered to practice in Maryland shall: (a) Earn 20 hours of approved continuing pharmaceutical education within the 2-year period immediately preceding the registrant’s renewal application; and (b) If the reg…

.11 Reinstatement. A. A pharmacy technician whose Maryland registration expired less than 2 years before applying for reinstatement shall: (1) Complete 20 hours of continuing education; and (2) Pay to the Board the reinstatement fee established by the Board in COMAR 10.34.09. B. …

.12 Reciprocity. A. An individual applying to register as a pharmacy technician by reciprocity shall: (1) Submit to the Board an application on a form approved by the Board; (2) Pay to the Board the fee set forth in COMAR 10.34.09; and (3) Submit a request for a State Criminal Hi…

.01 Definitions. A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Alternate site care environment” means the location where the patient is receiving infusion therapy other than an inpatient hospital setting. (2) “Compounding worksheet” m…

.02 Permit Holder Responsibilities. The permit holder shall: A. Develop and maintain a policy and procedure manual which establishes the pharmacy’s policies and standard operating procedures related to the provision of infusion therapy services; B. Ensure that an annual review of…

.03 Supervising Pharmacist Responsibilities. The supervising pharmacist or the supervising pharmacist's designee shall ensure compliance with: A. State and federal regulations; B. Infusion pharmacy practice standards: (1) As set forth in this chapter; and (2) As established by na…

.04 Pharmacist Responsibilities. A. A pharmacist in an infusion pharmacy shall adhere to the policies and procedures set forth in Regulation .06 of this chapter. B. A pharmacist shall: (1) Provide infusion therapy services in accordance with: (a) Orders issued by a licensed autho…

.05 Support Personnel. A. Pharmacy Technicians. (1) A pharmacist working in an infusion pharmacy may delegate pharmacy acts to a pharmacy technician in accordance with COMAR 10.34.34. (2) A pharmacy technician working in an infusion pharmacy may not perform delegated pharmacy act…

.06 Minimum Requirements for Policies and Procedures. The policies and procedures shall: A. Be congruent with State regulations and standards of care from accrediting bodies and professional organizations; and B. Address: (1) Personnel: (a) Training and Orientation; (b) Duties; a…

.07 Training Requirements. A. Personnel shall be trained in the following areas where appropriate: (1) Patient rights and responsibilities; (2) Patient safety; (3) Performance improvement program; (4) Universal precautions which are incorporated by reference in COMAR 10.06.01.01-…

.08 Performance Improvement Program. A. The performance improvement program shall consist of: (1) A committee which: (a) Consists of representation of personnel and varied areas of job responsibility; and (b) Is responsible for analysis of data, reporting trends and corrective ac…

.09 Discontinuation of Infusion Therapy. A. If not addressed in the initial order, the infusion pharmacy shall verify an end of therapy order. B. The infusion pharmacist shall: (1) Communicate with the licensed authorized prescriber of record or agent of the prescriber of record …

.10 Reference Materials. A. An infusion pharmacy shall maintain an adequate reference library to enable it to prepare and dispense infusion therapy properly. B. In addition to the requirements of COMAR 10.34.07.03, an infusion pharmacy’s reference library shall include: (1) Mater…