(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.
Structure Maryland Statutes
Title 12 - Pharmacists and Pharmacies
Subtitle 6C - Wholesale Distributor Permitting and Prescription Drug Integrity Act
Section 12-6C-01 - Definitions
Section 12-6C-03 - Permit Required
Section 12-6C-03.1 - Purchase and Distribution of Prescription Drugs and Devices by Department
Section 12-6C-03.2 - Inspection of Sterile Drug Products; Report
Section 12-6C-04 - Accreditation and Reciprocity
Section 12-6C-05 - Application Requirements
Section 12-6C-06 - Expiration and Renewal
Section 12-6C-07 - Regulations -- Inspections; Requirements
Section 12-6C-08 - Disclosure of Information
Section 12-6C-09 - Distribution of Prescription Drugs; Returns or Exchanges
Section 12-6C-11 - Violations; Penalties