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10.32.23.00.htm 10.32.23.00. Title 10 MARYLAND DEPARTMENT OF HEALTH Subtitle 32 BOARD OF PHYSICIANS Chapter 23 Permits for the Dispensing of Prescription Drugs Authority: Health Occupations Article, §12-102, 14-205, 14-306, 14-404, and 14-408; State Government Article, §10-206 and 10-226; Annotated Code of Maryland
10.32.23.01.htm 10.32.23.01. 01 Scope.. This chapter defines the parameters under which a physician may obtain a permit to dispense prescription drugs to that physician’s patients, dispense prescription drugs to the patients of other prescribers under certain circumstances, and delegate parts of the dispensing process to others in accordance with Health Occupations Article, §12-102 and 14-306, Annotated Code of Maryland.
10.32.23.02.htm 10.32.23.02. 02 Definitions.. A. In this chapter, the following terms have the meanings indicated.. B. Terms Defined.. 1) “Board” means the State Board of Physicians.. 2) “Controlled dangerous substance (CDS) has the meaning stated in Criminal Law Article, §5-101(g) Annotated Code of Maryland.3) “Dispense” has the meaning stated in Health Occupations Article, §12-101, Annotated Code of Maryland.4) “Drug sample” has the meaning stated in 21 CFR §203.3 (i). 5) Final Check..
10.32.23.03.htm 10.32.23.03. 03 Permit Not Required.. A dispensing permit is not required to:. A. Dispense prescription drugs or devices at a health facility or center described in Health Occupations Article, §12-102(g)1)3) Annotated Code of Maryland; orB. Dispense to a patient, free of charge:. 1) A drug sample;. 2) A sample unit; or. 3) A starter dosage of a prescription drug, not to exceed a 72-hour supply..
10.32.23.04.htm 10.32.23.04. 04 Qualifications for Dispensing Permits.. A. An applicant for a dispensing permit shall:. 1) Possess a license to practice medicine in this State;. 2) Be in good standing as that term is defined in this chapter;. 3) Be of good moral character;. 4) Demonstrate a basic knowledge of the statutes and regulations governing the practice of dispensing prescription drugs;5) Complete the application on a form supplied by the Board; and.
10.32.23.05.htm 10.32.23.05. 05 Consideration of Applications.. The Board shall grant the application for a dispensing permit if:. A. The applicant meets the requirements of Regulation .04 of this chapter;. B. The applicant has not been sanctioned by the Board for dispensing drugs without a permit within the last 5 years; andC. Granting the application is in the public interest..
10.32.23.06.htm 10.32.23.06. 06 Requirements for Permit Holders.. A. A permit holder shall comply with all federal and State statutes and regulations regarding prescription drugs, including all requirements for:1) Dispensing, including labeling;. 2) Storing and securing inventory;. 3) Allowing access only to authorized individuals;. 4) Managing inventory controls;. 5) Recordkeeping; and. 6) Submitting prescription monitoring data to the Maryland Prescription Drug Monitoring Program in accordance with Health-Gen
10.32.23.07.htm 10.32.23.07. 07 Delegation of Dispensing Functions.. A. A permit holder may delegate to an unlicensed person only mechanical acts involved in dispensing a drug.B. Delegation to a Physician Assistant.. 1) Except as required in §B(2) of this regulation, a permit holder may delegate to a physician assistant with whom the permit holder has a delegation agreement under Health Occupations Article, §15-302, Annotated Code of Maryland, the dispensing of a drug prescribed by:
10.32.23.08.htm 10.32.23.08. 08 Dispensing Prescription Drugs Prescribed by Physician Assistants.. A. Except as required in §B and C of this regulation, a permit holder may dispense a drug prescribed by a physician assistant with whom the permit holder has a delegation agreement under Health Occupations Article, §15-302, Annotated Code of Maryland, which authorizes the physician assistant to prescribe the drug.B. The permit holder shall perform the final check.. C. The permit holder may
10.32.23.09.htm 10.32.23.09. 09 Dispensing Prescription Drugs Prescribed by Certified Registered Nurse Practitioners.. A. Except as required in §B and C of this regulation, a permit holder may dispense a drug prescribed by a certified registered nurse practitioner who is:1) Authorized under Health Occupations Article, Title 8, Annotated Code of Maryland, to prescribe the drug; and2) Working with the permit holder in the same office setting.. B. The permit holder shall perform the final check..
10.32.23.10.htm 10.32.23.10. 10 Records.. A. A permit holder shall keep readily retrievable at each dispensing location:. 1) A copy of the dispensing permit issued by the Board;. 2) A record of each final check;. 3) A copy of the form, signed and dated by the patient, maintained in accordance with COMAR 10.13.01.04, indicating the patient’s determination that a pharmacy is not conveniently available and demonstrating that the determination was made solely by the patient;4) The delegation agreeme
10.32.23.11.htm 10.32.23.11. 11 Revision of Dispensing Permit.. A permit holder may revise a permit twice during its term, without charge, to change the location at which prescriptions will be dispensed.
10.32.23.12.htm 10.32.23.12. 12 Lapse of Dispensing Permit.. A. A permit automatically lapses if the permit holder:. 1) Dies;. 2) Fails to retain a valid and active Maryland medical license;. 3) Fails without good cause to file the annual report required by Health Occupations Article, §12-102(c)2)ii)4L, Annotated Code of Maryland, within 15 days of the anniversary date of the date the permit was issued; or4) Fails without good cause to notify the Board of a change of address as required by Health Occupat
10.32.23.13.htm 10.32.23.13. 13 Written Notice on Reactivation of Dispensing.. A permit holder who has reported pursuant to Health Occupations Article, §12-102(c)2)ii)4L, Annotated Code of Maryland, that the permit holder has not personally dispensed prescription drugs during the previous year:A. Will not be subject to inspections by OCSA pursuant to Health Occupations Article, §12-102.1(b) Annotated Code of Maryland, unless the permit holder begins dispensing again; andB. May not begin to dispe
10.32.23.14.htm 10.32.23.14. 14 Grounds for Revocation of Dispensing Permit.. A. Subject to the Administrative Procedure Act, and in addition to any sanction for violation of Health Occupations Article, §14-404(a)28) Annotated Code of Maryland, the Board may revoke a dispensing permit on any of the following grounds:1) Violating the attestations made pursuant to COMAR 10.13.01.05C(4). 2) Violating State or federal statutes or regulations regarding prescribing or dispensing prescription drugs;
10.32.23.15.htm 10.32.23.15. 15 Summary Suspension of Dispensing Permit.. A. The Board may summarily suspend a dispensing permit if it finds that the public safety, health, or welfare imperatively requires emergency action.B. Procedures for summary suspension shall be governed by COMAR 10.32.02.08..
10.32.23.16.htm 10.32.23.16. 16 Fraud or Deception in Obtaining a Permit.. Subject to the Administrative Procedure Act, a licensee who fraudulently or deceptively obtains or attempts to obtain a permit is guilty of violating Health Occupations Article, §14-404(a)1) Annotated Code of Maryland.
10.32.23.17.htm 10.32.23.17. 17 Permit Holders Sanctioned for Violating the Medical Practice Act.. A. If the Board sanctions a permit holder for violating Health Occupations Article, §14-404(a)7) (8) (9) (10) or (28) or §14-404(b) Annotated Code of Maryland, the Board shall, in addition to any sanctions imposed on the permit holder under COMAR 10.32.02.07 or 10.32.02.10, revoke the permit.B. Subject to the requirement of §C of this regulation, reinstatement of a revoked permit is at the discretion of the Board.
10.32.23.18.htm 10.32.23.18. 18 Dispensing Without a Permit.. Unless otherwise authorized by Health Occupations Article, §12-102, Annotated Code of Maryland, the dispensing of prescription drugs by a physician without a permit is a violation of Health Occupations Article, §14-404(a)28) Annotated Code of Maryland, and also may be considered unprofessional conduct in the practice of medicine in violation of Health Occupations Article, §14-404(a)3)ii) Annotated Code of Maryland.
10.32.23.19.htm 10.32.23.19. 19 Interpretation.. Nothing in this chapter relieves any permit holder from meeting the requirements of State or federal law or COMAR 10.13.01.
10.32.23.9999.htm 10.32.23.9999. Administrative History Effective date: March 26, 2018 (45:6 Md. R. 320).
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