§12–6C–03.2.

    (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) of this section shall:

        (1)    Be conducted within 1 year before the date of application or renewal; and

        (2)    Demonstrate compliance with applicable federal good manufacturing practice standards.

    (c)    An applicant or permit holder is responsible for obtaining an inspection to meet the requirements of this section.