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Terms Used In Maryland Code, HEALTH OCCUPATIONS 12-6C-03

  • Person: includes an individual, receiver, trustee, guardian, personal representative, fiduciary, representative of any kind, corporation, partnership, business trust, statutory trust, limited liability company, firm, association, or other nongovernmental entity. See
  • state: means :

    (1) a state, possession, territory, or commonwealth of the United States; or

    (2) the District of Columbia. See
(a) A wholesale distributor shall hold a permit issued by the Board before the wholesale distributor engages in wholesale distribution in the State.

(b) (1) A manufacturer engaged in wholesale distribution shall hold a wholesale distributor permit issued under this subtitle.

(2) Notwithstanding paragraph (1) of this subsection, the information and qualification requirements for obtaining a permit under this subtitle, beyond that required by federal law, do not apply to:

(i) A manufacturer that distributes its own prescription drugs that are approved by the U.S. Food and Drug Administration; or

(ii) A manufacturer that distributes its own prescription devices that are approved or authorized by the U.S. Food and Drug Administration.

(c) A manufacturer’s exclusive distributor and a third-party logistics provider shall hold a wholesale distributor permit issued under this subtitle.

(d) A wholesale distributor permit shall be displayed conspicuously in the place of business for which the permit is issued.

(e) A wholesale distributor permit is not transferable.

(f) Subject to any other restriction provided by law, a person may not purchase or obtain a prescription drug or prescription device unless the prescription drug or prescription device is purchased or obtained from a person who holds a wholesale distributor permit, a licensed pharmacist, or an authorized prescriber.