(a) In this subtitle the following words have the meanings indicated. (b) “Authenticate” means to affirmatively verify, before any wholesale distribution of a prescription drug occurs, that each transaction listed on the pedigree for the prescription drug has occurred. (c) “Authorized distributor of record” means a wholesale distributor with whom a manufacturer has established an ongoing relationship to […]
This subtitle does not affect any person while distributing: (1) Feed for livestock or poultry; (2) Fertilizers; (3) Fungicides; (4) Insecticide; (5) Land plaster; (6) Lime; (7) Seeds; (8) Devices, drugs, or supplies of any kind for the treatment, care, or cure of farm animals; or (9) Compounded nonsterile preparations or compounded sterile preparations provided in accordance with § 12–510 of this title to […]
(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 […]
(a) The Department may purchase and distribute prescription drugs and prescription devices for public health purposes. (b) The Department shall adopt regulations, in consultation with the Board, to implement this section.
(a) Notwithstanding any other provision of this subtitle, a wholesale distributor applicant or permit holder that prepares sterile drug products shall submit to the Board a report of an inspection conducted by the U.S. Food and Drug Administration or a Board designee: (1) At the time of application; and (2) On renewal. (b) The inspection report required under subsection […]
(a) (1) In this section the following words have the meanings indicated. (2) “Accreditation organization” means a private entity that: (i) Is recognized by the Board; and (ii) Conducts inspections and surveys of wholesale distributors based on nationally recognized and developed standards. (3) “Deemed status” means a status under which a wholesale distributor may be exempt from initial and routine inspection […]
(a) To apply for a wholesale distributor permit, an applicant shall: (1) Pay to the Board an application fee set by the Board; and (2) Submit an application to the Board on the form that the Board requires. (b) The application shall include the following: (1) The name, full business address, and telephone number of the applicant; (2) All trade or […]
(a) (1) In this subsection, “Central Repository” means the Criminal Justice Information System Central Repository of the Department of Public Safety and Correctional Services. (2) This subsection applies to applicants located in the State. (3) As part of an application to the Central Repository for a State and national criminal history records check, the designated representative and the immediate […]
(a) A wholesale distributor permit expires on May 31 after its effective date, unless the wholesale distributor permit is renewed for an additional 2–year term as provided in this section. (b) (1) Except as provided in paragraph (2) of this subsection, at least 1 month before a wholesale distributor permit expires, the Board shall send to the wholesale […]
The Board: (1) Shall adopt regulations that require routine inspections of wholesale distributor facilities; and (2) May adopt regulations establishing: (i) Minimum requirements for the receipt, storage, and handling of prescription drugs or prescription devices, security precautions, quality control, record keeping, and procedures, policy, and responsibilities of personnel; and (ii) Education and experience requirements for personnel employed in positions […]
Information provided by a wholesale distributor or an applicant for a wholesale distributor permit under this subtitle may not be disclosed to any person or entity except a State licensing or permitting authority, State board, or government agency that needs the information for licensing, permitting, monitoring, or law enforcement purposes.
(a) (1) A wholesale distributor shall receive prescription drug returns or exchanges from a pharmacy or pharmacy warehouse according to the terms and conditions of the agreement between the wholesale distributor and the pharmacy or pharmacy warehouse. (2) Returns of expired, damaged, recalled, or otherwise nonsaleable prescription drugs shall be distributed by the receiving wholesale distributor only to […]
(a) A person who is engaged in the wholesale distribution of a prescription drug that leaves, or has ever left, the normal distribution channel shall provide, before each wholesale distribution of the prescription drug, a pedigree to the person who receives the prescription drug. (b) A retail pharmacy or pharmacy warehouse shall comply with the requirements of […]
(a) (1) If a person knowingly violates any provision of this subtitle or any regulation adopted under this subtitle, the Board may impose a fine not to exceed $500,000. (2) Before the Board imposes a fine, the Board shall consider the appropriateness of the fine in relation to: (i) The size of the wholesale distributor; (ii) The gravity of the […]
On or before January 1, 2008, the Board shall adopt regulations to implement this subtitle.
On or before January 1, 2008, and on or before January 1 of each subsequent year, the Board shall report to the Governor and, in accordance with § 2–1257 of the State Government Article, to the General Assembly on the implementation of this subtitle.
