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10.34.19.00.htm 10.34.19.00. Title 10 DEPARTMENT OF HEALTH AND MENTAL HYGIENE Subtitle 34 BOARD OF PHARMACY Chapter 19 Sterile Pharmaceutical Compounding Authority: Health Occupations Article, §12-205, 12-403, 12-503, 12-505, 12-6C-01, and 12-6C-03, Annotated Code of Maryland
10.34.19.01.htm 10.34.19.01. 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; andB. Compounding of radiopharmaceuticals, except where U.S. Pharmacopeia (USP) General Chapter 797 Pharmaceutical Compounding―Sterile Preparations addresses radiopharmaceuticals, U.S. Pharmacopeia (USP) Chapter 821 Radioactivit
10.34.19.02.htm 10.34.19.02. 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(b) (as amended)B. U.S. Pharmacopeia (USP) General Chapter 795 Pharmaceutical Compounding―Non-Sterile Preparations (USP 795 Standards) which has been incorporated by reference in 21 U.S.C. §3
10.34.19.03.htm 10.34.19.03. 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 contamination above the threshold set forth in USP 797 Standards.2) "Antineoplastic" means an agent that prevents the development, growth, or proliferation of malignant cells.3) "Anteroom" means the a
10.34.19.04.htm 10.34.19.04. 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.
10.34.19.05.htm 10.34.19.05. 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 control and supervise the section of the pharmacy that prepares compounded sterile preparations and is responsible for, at a minimum, the following:
10.34.19.06.htm 10.34.19.06. 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 sterile preparations, during handling and administration to the patient including:1) A reasonable effort to provide tamper-evident packaging if appropriate to setting;.
10.34.19.07.htm 10.34.19.07. 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 complete record of the formulations of the solutions that were compounded.. 3) The pharmacy shall keep completed patient prescription records in a retrievable manner for at least 5 years, either:
10.34.19.08.htm 10.34.19.08. 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 compounded sterile preparations is acceptable if the:. 1) Pharmacist can document a history of valid prescriptions or physician orders that have been generated solely within an established professional pre
10.34.19.09.htm 10.34.19.09. 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 the preparation of compounded sterile preparations, or such other tasks that require a controlled environment.3) The permit holder shall ensure that the controlled environment is:. a) Structurally isolated
10.34.19.10.htm 10.34.19.10. 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 for:. a) Used needles and syringes; and. b) Cytotoxic waste including disposable apparel used in its preparation, if applicable;. 4) Laminar air flow workstation or compounding aseptic isolator that meets
10.34.19.11.htm 10.34.19.11. 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) Masks;. 3) Non-shedding gowns;. 4) Shoe covers;. 5) Hair covers;. 6) Beard covers; and. 7) Other personal protective equipment;. B. Disposable syringes and needles in necessary sizes;. C. Disinfectant cleaning
10.34.19.12.htm 10.34.19.12. 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 with regard to compounding sterile preparations.B. The permit holder shall insure that the policy and procedure manual that sets forth the standard operating procedures with regard to compounding st
10.34.19.13.htm 10.34.19.13. 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 times, which consists of:. a) A non-shedding coverall or gown;. b) Head and facial hair covers;. c) A face mask; and. d) Shoe covers;. 4) Clean room garb, with the exception of sterile gloves, shall be donned a
10.34.19.14.htm 10.34.19.14. 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 ensure that pharmacy personnel engaging in compounding sterile preparations are trained and demonstrate competence in the safe handling and compounding of compounded sterile preparations and parente
10.34.19.15.htm 10.34.19.15. 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 to assure that compounded sterile preparations shall be kept under appropriate controlled conditions before dispensing, during transport, and at the location of use by providing adequate labeling and verbal or
10.34.19.16.htm 10.34.19.16. 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 containing drug stability and compatibility data; and. C. Reference materials concerning drug interactions and incompatibility..
10.34.19.17.htm 10.34.19.17. 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 in Regulation .18 of this chapter;. 3) Microbial testing of a sampling of the sterile compounded preparations of the pharmacy if applicable according to USP 797 Standards; and
10.34.19.18.htm 10.34.19.18. 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; andB. Report to the Board within 5 calendar days:. 1) Adverse events that have been discovered including corrective actions taken or proposed;. 2) Deficiencies related to the sterile compounding process;. 3) Disciplinary actions in other states or by other state agencies;.
10.34.19.19.htm 10.34.19.19. 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 the safety of sterile compounded medications for office use; andB. If applicable, a wholesale distributor’s permit, issued by the Board under Health Occupations Article, Title 12, Subtitle
10.34.19.9999.htm 10.34.19.9999. Administrative History Effective date: February 19, 1990 (17:3 Md. R. 299). Regulation .04B amended effective July 20, 1992 (19:14 Md. R. 1284). Regulation .05 amended effective July 20, 1992 (19:14 Md. R. 1284) ―. Regulations .01―06 repealed and new Regulations .01―16 adopted effective September 10, 2007 (34:18 Md. R. 1580)Regulation .01 amended effective February 23, 2009 (36:4 Md. R. 354). Regulation .02 amended effective February 23, 2009 (36:4 Md. R. 354).
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