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10.34.22.00.htm 10.34.22.00. Title 10 MARYLAND DEPARTMENT OF HEALTH Subtitle 34 BOARD OF PHARMACY Chapter 22 Licensing of Wholesale Prescription Drug or Device Distributors Authority: Health Occupations Article, §12-205, 12-601, and 12-6C-01―12-6C-13, Annotated Code of Maryland
10.34.22.01.htm 10.34.22.01. 01 Scope.. This chapter applies to any person engaged in the wholesale distribution of prescription drugs or devices in Maryland.
10.34.22.02.htm 10.34.22.02. 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 and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product.1-1) "Authenticate" means to affirmatively verify, before any wholesale dis
10.34.22.03.htm 10.34.22.03. 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 the applicant operates, such as partnership, corporation, or sole proprietorship;2) The full name or names of the owner and the operator of the wholesale distributor applying for or renewing a permit, including:
10.34.22.03-1.htm 10.34.22.03-1. 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 requirements:A. Provides a list of drug or device products it distributes;. B. Provides a list of the NDA or ANDA numbers associated with each drug it distributes;.
10.34.22.04.htm 10.34.22.04. 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 requirements.B. Registered Agent.. 1) Each licensed wholesale distributor located outside of this State that wholesale distributes prescription drugs or devices in this State shall designate a registered agent
10.34.22.05.htm 10.34.22.05. 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 convicted of, or pleads guilty or nolo contendere to, violations of federal, State, or local drug or device laws or regulations;2) Is convicted of, or pleads guilty or nolo contendere to, a felony or to
10.34.22.06.htm 10.34.22.06. 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 facilitate:. a) Cleaning;. b) Maintenance; and. c) Proper operations;. 2) Have storage areas designed to provide adequate:. a) Equipment;. b) Humidity control;. c) Lighting;. e) Security conditions;. f) Space;.
10.34.22.07.htm 10.34.22.07. 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 prescription drugs or devices.2) The records required under §A(1) of this regulation shall include the following information:. a) The source of the prescription drugs or devices, including the:.
10.34.22.08.htm 10.34.22.08. 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. Verification of alternate licensure;. B. Verification of identity; and. C. Verification of recent inspections by a state or third party entity recognized by the Board..
10.34.22.09.htm 10.34.22.09. 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.
10.34.22.10.htm 10.34.22.10. 10 Required Information and Procedures for Ceasing to Operate.. A. If a wholesale distributor is located in another state, a wholesale distributor anticipating ceasing to operate in Maryland shall return the permit to the Board within 10 days of ceasing to operate in Maryland.B. Procedures for Wholesale Distributors Located in this State for Ceasing to Operate.. 1) Notification.. a) At least 30 days before a wholesale distributor’s anticipated date of ceasing to operate, the who
10.34.22.11.htm 10.34.22.11. 11 Relocation.. A. At least 30 days before relocation, a permit holder shall submit an application to the Board.. B. If relocation is due to a catastrophic event or State of Emergency, the relocation applicant shall:1) Notify the Board within 48 hours; and. 2) Submit an application to the Board within 30 days.. C. A relocation applicant:. 1) If the applicant holds products, shall comply with Regulation .07 of this chapter;. 2) Shall submit a surety bond or other equivalent
10.34.22.9999.htm 10.34.22.9999. Administrative History Effective date: August 31, 1992 (19:17 Md. R. 1607). Regulation .03B amended effective November 7, 1994 (21:22 Md. R. 1877). Regulation .04 amended effective November 7, 1994 (21:22 Md. R. 1877) ―. Regulations .01―10 repealed and new Regulations .01―09 adopted effective March 28, 2005 (32:6 Md. R. 636) ―Regulations .01―09 repealed and new Regulations .01―08 adopted effective April 7, 2008 (35:7 Md. R. 748)Regulation .02B amended as an emergency provision
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