In this subtitle the following words have the meanings indicated. “Permit” means a permit issued by the Secretary: To operate a tissue bank in this State; or To represent or service in this State a tissue bank that is outside this State. “Tissue bank” means an establishment that obtains, stores, processes, distributes, or sells human blood or other human tissue for use in the human body. “Tissue bank” includes a blood bank.

The Secretary shall adopt rules and regulations that set standards for tissue banks. The rules and regulations shall contain the standards that the Secretary considers necessary to assure the citizens of this State that tissue banks provide safe and reliable services. To assure compliance with the standards adopted under this subtitle, the Secretary shall: Have an inspection made of each tissue bank for which a permit to operate is sought; and Have an inspection made periodically or make an agreement with an organization to do, at no cost to this State, a periodic inspection of each tissue bank for which a permit has been issued.

The Secretary shall adopt rules and regulations that set qualifications for directors of tissue banks. The rules and regulations shall require that a tissue bank in this State employ or retain under contract: A technical director, qualified by training and experience for the scope of activities being pursued, who will oversee and be responsible for all technical aspects of the tissue bank’s operations; and A medical director who will be a physician licensed to practice medicine in this State and who will be responsible for all medical aspects of the tissue bank’s operations, unless the technical director qualifies as a medical director under this section.

Except as provided in §§ 10–14A–03 and 10–14B–03 of the State Government Article, a person shall hold a permit issued by the Secretary before the person may: Operate a tissue bank in this State; or Represent or service in this State any tissue bank that is outside this State.

To qualify for a permit, an applicant shall satisfy the Secretary that the tissue bank to be operated, represented, or serviced and its director meet the requirements that the Secretary adopts under this subtitle.

An applicant for a permit shall submit an application to the Secretary on the form that the Secretary requires. An application for a permit to operate a tissue bank shall include: The name of the owner; The classes of services that the tissue bank would provide; and Any other information that the Secretary requires. An application for a permit to represent or service a tissue bank shall include satisfactory evidence that the tissue bank to be represented or serviced and its director meet the requirements that the Secretary adopts under this subtitle.

The Secretary shall issue a permit to any applicant who meets the requirements of this subtitle. The Secretary shall include on each permit that the Secretary issues: The name of the tissue bank; The name of its director; The name of its owner; and The classes of services that the tissue bank may offer.

While it is effective, a permit authorizes the permit holder: To operate or to represent or service the tissue bank named in the permit; and To offer and perform the classes of services set forth in the permit.

The Secretary may deny a permit to any applicant or suspend or revoke a permit or the authority to offer or perform any class of service that the permit sets forth, if the tissue bank or its director fails to meet the requirements that the Secretary adopts under this subtitle. Except as otherwise provided in the Administrative Procedure Act, before the Secretary takes any action under this section, the Secretary shall give the applicant or permit holder notice and an opportunity for a hearing.

A person may not operate a tissue bank in this State unless the person holds a permit issued by the Secretary. A permit holder may not offer or perform any class of service of a tissue bank that is not authorized by the permit.

A person may not represent or service any tissue bank, regardless of location, unless the tissue bank and its director meet the standards and qualifications that the Secretary adopts under this subtitle. A person may not represent or service in this State any tissue bank that is not in this State unless the person holds a permit to represent or service the tissue bank.

A person who violates any provision of this subtitle is guilty of a misdemeanor and on conviction is subject to a fine not exceeding $100 for the first offense and not exceeding $500 for each subsequent conviction for a violation of the same provision. Each day a violation is continued after the first conviction is a subsequent offense.