Maryland Health Occupations Section 12-602
§ 12-602.
(a) (1) In this section the following words have the meanings indicated.
(2) "Distribution permit" means a permit issued by the Board under this section to distribute prescription drugs or devices into, out of, or within the State as a distributor, jobber, manufacturer, or wholesaler, wherever located.
(3) "Prescription drugs or devices" means any drug or device that, because of its toxicity or other potential for harmful effect, the method of its use, or the collateral measures necessary for its use, is required by federal law to bear a cautionary label warning against dispensing without a prescription or is designated by the Department as not safe for use except under the supervision of a practitioner licensed to administer drugs or devices of this nature.
(b) This section 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; or
(8) Devices, drugs, or supplies of any kind for the treatment, care, or cure of farm animals.
(c) A person shall hold a distribution permit issued by the Board before the person may distribute prescription drugs or devices as a distributor, jobber, manufacturer, or wholesaler.
(d) To qualify for a distribution permit, an applicant shall:
(1) Satisfy the Board that the applicant will distribute prescription drugs or devices in compliance with the restrictions specified in subsection (e) of this section; and
(2) Comply with any pertinent regulations adopted under subsection (i) of this section.
(e) A distribution permit holder may distribute prescription drugs or devices only:
(1) To the following persons:
(i) An authorized prescriber;
(ii) A pharmacy permit holder;
(iii) A distribution permit holder; or
(iv) Any other person approved by the Board; and
(2) In compliance with any rules and regulations adopted under this section.
(f) To apply for a distribution permit, an applicant shall:
(1) Submit an application to the Board on the form that the Board provides; and
(2) Pay to the Board an application fee set by the Board.
(g) The Board shall issue a distribution permit to any applicant who meets the requirements of this section.
(h) A distribution permit issued under this section authorizes the distribution permit holder to distribute prescription drugs or devices as a distributor, jobber, manufacturer, or wholesaler while the distribution permit is effective.
(i) To protect the public health and safety, the Board may adopt rules and regulations regarding the distribution of prescription drugs or devices including regulations regarding:
(1) Qualifications and information required from an applicant seeking issuance or renewal of a distribution permit;
(2) Minimum requirements for the receipt, storage, and handling of prescription drugs or devices, security precautions, quality control, record keeping, and establishment of written procedures, policy, and responsibilities of personnel;
(3) The education and experience of personnel employed in positions responsible for duties referenced in paragraph (2) of this subsection and generally responsible for carrying out those duties that are subject to State licensure requirements under this subtitle; and
(4) Disciplinary action to be taken against a permit holder who is convicted of or pleads guilty or nolo contendere to a violation of State, federal, or local drug laws or who violates regulations promulgated by the Board under this section.
(j) (1) A distribution permit expires on the December 31 after its effective date, unless the distribution permit is renewed for a 1-year term as provided in this subsection.
(2) At least 1 month before a distribution permit expires, the Board shall send to the distribution permit holder, by first-class mail to the last known address of the distribution permit holder, a renewal notice that contains a statement of:
(i) The date on which the current distribution permit expires;
(ii) The date by which the renewal application must be received by the Board for the renewal to be issued and mailed before the distribution permit expires; and
(iii) The amount of the renewal fee.
(3) Before a distribution permit expires, a distribution permit holder periodically may renew it for an additional 1-year term, if the distribution permit holder:
(i) Otherwise is entitled to a distribution permit;
(ii) Pays to the Board a renewal fee set by the Board; and
(iii) Submits to the Board a renewal application on the form that the Board requires.
(4) The Board shall renew the distribution permit of each distribution permit holder who meets the requirements of this section and any regulation adopted under this section.
(k) Each distribution permit shall be displayed conspicuously in the place for which it is issued.
(l) A distribution permit is not transferable.
(m) Subject to any other restriction provided by law, a person may not purchase or obtain any prescription drugs or devices unless the drug or device is obtained from a distribution permit holder, a licensed pharmacist, or an authorized prescriber.
(n) A person may not violate any rule or regulation adopted under this section.
(o) A distribution permit is void on conviction of the distribution permit holder for any violation of:
(1) This section; or
(2) Any rule or regulation adopted by the Board under this section.
