Maryland Administrative Code

.01-1 Definitions. A. In this chapter, the following term has the meaning indicated. B. Live Instruction. (1) “Live instruction” means a course offering the ability for the participant to have real-time interaction with the presenter. (2) “Live instruction” includes programs appr…

.02 Exceptions. A. This chapter does not apply to pharmacists applying for renewal for the first renewal period following the issuance of the original license, if the pharmacist obtains a license within 1 year of the completion of the pharmacist's pharmaceutical education. B. The…

.03 Requirements for Pharmacists Practicing in Maryland. A. A pharmacist license expires on the last day of the pharmacist's birth month every other year. B. Before the expiration date of the pharmacist's license, the pharmacist shall: (1) File a renewal application; (2) Pay any …

.04 Requirements for Pharmacists Not Practicing in Maryland. A licensed pharmacist not practicing in Maryland shall fulfill the continuing education requirements of Maryland.

.05 Requirements for Pharmacists who are Authorized Prescribers. A pharmacist who is also an authorized prescriber licensed by a board (in Maryland or another state) may use the continuing education (CE) credits applied toward that board toward the Board of Pharmacy's CE requirem…

.06 Accredited Continuing Education Programs. A. The Board and the following providers are approved for any programs they offer which otherwise qualify for continuing education (CE) credit: (1) American Council on Pharmaceutical Education (ACPE); (2) Schools of pharmacy accredite…

.07 Acceptance of Previously Unapproved Continuing Education Programs. A. A pharmacist who completes a program of continuing education that is not previously approved by the Board may request in writing that the Board approve the program for credit. B. The pharmacist making a req…

.08 Miscellaneous. A. Credits may not be carried over from one licensing renewal period to another. B. Falsifying continuing education CE records is grounds for disciplinary action. C. The pharmacist shall use a Board approved form to supply the pharmacist's CE information to the…

.01 Scope. This chapter applies to a licensed pharmacy in Maryland engaging in: A. Compounding or mixing sterile prescription solutions or suspensions to be administered parenterally or by irrigation, inhalation, or intraocular routes; and B. Compounding of radiopharmaceuticals, …

.02 Incorporation by Reference. In this chapter, the following documents are incorporated by reference: A. U.S. Pharmacopeia (USP) General Chapter 797 Pharmaceutical Compounding — Sterile Preparations (USP 797 Standards), which has been incorporated by reference in 21 U.S.C. §351…

.03 Definitions. A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Adverse event” means: (a) Any adverse patient outcome related to the sterile compounding process; or (b) Evidence of environmental contamination, including microbial conta…

.04 Pharmacy Environment. The compounding, preparation, and dispensing of compounded sterile preparations shall be accomplished in a pharmacy environment subject to State and federal laws, regulations, and standards.

.05 General Requirements. A licensed pharmacist who has appropriate practical and didactic training in compounding sterile preparations, clean room technology, laminar flow technology, quality assurance techniques, and clinical application of intravenous drug therapy shall contro…

.06 Special Handling, Packaging, Labeling, and Beyond Use Dating. A. The pharmacy shall make available special handling and packaging materials to maintain container integrity and drug stability of the prepared prescription orders, including antineoplastic or other hazardous ster…

.07 Record-Keeping Requirements. A. Patient Prescription Records. (1) The pharmacy shall maintain records of patient prescriptions. (2) Patient prescription records shall contain: (a) Available medical information consistent with prevailing pharmacy standards; and (b) The complet…

.08 Batch Preparation. A. A pharmacist may prepare batched sterile preparations for future use in limited quantities supported by prior valid prescriptions or physician orders before receiving a valid written prescription or medication order. B. Batch preparation of specific comp…

.09 Minimum Facility Requirements. A. Controlled Environment. (1) The pharmacy shall have a controlled environment that meets USP 797 Standards. (2) A pharmacist shall ensure that the controlled environment is: (a) Accessible only to designated personnel; and (b) Used only for th…

.10 Minimum Requirements for Equipment. A. The permit holder shall provide at least the following equipment that is maintained in working order: (1) Adequate refrigerator and freezer space (if applicable); (2) A sink and wash area in the anteroom; (3) Appropriate waste containers…

.11 Minimum Requirements for Supplies. A pharmacy engaging in compounding sterile preparations shall maintain adequate stock levels of the following supplies according to USP 797 Standards, including but not limited to: A. Personal protective equipment: (1) Sterile gloves; (2) Ma…

.12 Minimum Requirements for Policies and Procedures. A. The permit holder shall ensure that the pharmacist or the pharmacist's designee shall maintain a policy and procedure manual, reviewed annually, that sets forth in detail the permit holder's standard operating procedures wi…

.13 Attire. A. When compounding sterile preparations, individuals shall comply with the following standards: (1) Sequencing of garbing that complies with USP 797 Standards; (2) Thorough hand-washing before gowning; (3) Wearing clean room garb inside the designated area at all tim…

.14 Training of Staff, Patient, and Caregiver. A. The pharmacist shall make counseling available to the patient or primary caregiver, or both, concerning proper use of compounded sterile preparations and related supplies furnished by the pharmacy. B. The permit holder shall ensur…

.15 Quality Assurance. The permit holder shall ensure that the compounded sterile preparation retains its potency and sterility throughout the assigned “beyond use” dating period through a written quality assurance program that includes: A. A reasonable effort by the pharmacist t…

.16 Reference Library. Minimum reference materials in a pharmacy shall include: A. U.S. Pharmaceutical, General Chapter 797, Pharmaceutical Compounding — Sterile Preparations and other applicable reference materials in order to perform sterile compounding; B. Reference materials …

.17 Minimum Requirements for Inspections. A. The Board shall inspect pharmacies located in Maryland at least annually. B. The pharmacy shall provide as part of the inspection process: (1) Quality assurance testing reports; (2) Documentation of reporting adverse events as required…

.18 Reporting Requirements Pharmacies. A pharmacy shall: A. Document and perform routine testing as required by USP 797 Standards for the appropriate risk levels of sterile compounded preparations; and B. Report to the Board within 5 calendar days: (1) Adverse events that have be…

.19 Office Use. Unless otherwise authorized, a person that prepares and distributes sterile compounded medications for office use into, out of, or within the State shall hold: A. A manufacturer’s permit or other permit designated by the U.S. Food and Drug Administration to ensure…

.01 Scope. This chapter applies to the conveyance or transmission of prescription orders from authorized prescribers to pharmacies in the State.

.02 Requirements for Prescription Validity. A. A valid prescription shall be: (1) Valid in the professional judgment of the pharmacist responsible for filling the prescription; and (2) Conveyed: (a) In a manner that contains the handwritten, pen-to-paper signature of the prescrib…

.03 Prescription Records. The pharmacy permit holder shall maintain prescription records in a form that: A. Is readily and accurately retrievable; B. Is maintained for at least 5 years from the date of dispensing; and C. Protects the confidentiality and security of the prescripti…

.04 Controlled Dangerous Substances. Transmission and dispensing of controlled dangerous substances shall be in accordance with applicable State and federal statutes and regulations.

.01 Scope. This chapter establishes standards of practice and the responsibilities of licensed pharmacists and pharmacy permit holders when using unlicensed personnel in the prescription area of a pharmacy.

.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) “Operational support” means tasks performed by: (a) An administrative clerk; (b) A billing clerk; (c) A cashier; (d) Delivery…

.03 Duties of the Permit Holder. The permit holder shall: A. Determine which operational support tasks the pharmacist may assign unlicensed personnel to perform in the prescription area; B. Ensure that unlicensed personnel: (1) Receive appropriate training for the tasks that the …

.04 Duties of the Pharmacist. A. The pharmacist shall provide supervision to unlicensed personnel. B. The pharmacist may not delegate any pharmacy acts to unlicensed personnel. Cross References 10.34.21.06A

.05 Duties of Unlicensed Personnel. A. Unlicensed personnel under the supervision of a pharmacist may perform operational support which the unlicensed personnel have been trained to adequately perform in the prescription area. B. Unlicensed personnel who perform duties in the pre…

.06 Grounds for Discipline. A. A pharmacist licensee may be subject to discipline if the pharmacist licensee violates any provision of Regulation .04 of this chapter. B. A permit holder may be subject to disciplinary action if: (1) The permit holder fails to take reasonable safeg…

.01 Scope. This chapter applies to any person engaged in the wholesale distribution of prescription drugs or devices in Maryland.

.02 Definitions. A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “ANDA” means an Abbreviated New Drug Application number and contains data that, when submitted to the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation a…

.03 Minimum Application Requirements for Applicants Holding Product. A. The Board shall require the following minimum information from a wholesale distributor as part of an application for a permit and as part of a renewal of a permit: (1) The type of business form under which th…

.03-1 Minimum Application Requirements for Virtual Manufacturers. The information and qualification requirements for obtaining a permit under Regulation .03 of this chapter, beyond that required by federal law, do not apply to a virtual manufacturer that meets the following requi…

.04 Personnel. A. The permit holder shall affirm in the initial application and subsequent renewal applications that personnel employed in wholesale distribution have appropriate education and experience to assume responsibilities related to compliance with State licensing requir…

.05 Violations and Penalties. A. After a hearing held under Health Occupations Article, §12-601, Annotated Code of Maryland, the Board may deny, suspend, revoke, or place on probation a permit holder, reprimand a permit holder, or impose a fine if the permit holder: (1) Is convic…

.06 Minimum Requirements for the Storage and Handling of Prescription Drugs or Devices. A. Facilities. Facilities at which prescription drugs or devices are stored, warehoused, handled, held, offered, marketed, or displayed shall: (1) Be of suitable size and construction to facil…

.07 Minimum Requirements for Maintenance of Prescription Drug or Device Distribution Records. A. Record Keeping. (1) A wholesale distributor shall establish and maintain inventories and records of transactions regarding the receipt and distribution or other disposition of prescri…

.08 Due Diligence. Wholesale distributors having transactions with persons not licensed by the Board or not certified by a third party recognized by the Board shall have in place policies and procedures to perform due diligence on transactions that take place that include: A. Ver…

.09 Reinstatement. A. The wholesale distributor permit shall expire on the last day of its term. B. The Board may not reinstate the wholesale distributor permit unless the applicant pays a reinstatement fee set by the Board.