Maryland Statutes
Subtitle 6C - Wholesale Distributor Permitting and Prescription Drug Integrity Act
Section 12-6C-04 - Accreditation and Reciprocity

(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 requirements under this subtitle.
    (b)    The Board may only grant deemed status to a wholesale distributor that is:
        (1)    Currently accredited by an accreditation organization, wherever the wholesale distributor is located; or
        (2)    Located in a state that has requirements that:
            (i)    Are substantially equivalent to the requirements of this State; and
            (ii)    Include pedigrees, routine inspections of wholesale distributors, operation of wholesale distributors in a commercial nonresidential facility, and security measures.
    (c)    (1)    The Board may issue a wholesale distributor permit by reciprocity to a wholesale distributor who holds a license or permit under the laws of another state if the Board determines that the requirements of that state are substantially equivalent to the requirements of this State.
        (2)    A wholesale distributor that receives a permit by reciprocity shall comply with the requirements of § 12–6C–05(e) and (f) of this subtitle.
        (3)    In addition to meeting the requirements under this subtitle, a wholesale distributor located out–of–state that is not eligible for reciprocity shall be accredited by an accreditation organization.
        (4)    The Board shall grant deemed status to a wholesale distributor that:
            (i)    Is currently accredited by an accreditation organization; or
            (ii)    Has been granted reciprocity by the Board.
    (d)    The Board or its designee may inspect a wholesale distributor who is accredited or has been issued a permit by reciprocity to:
        (1)    Determine compliance with any permit requirement under this subtitle; or
        (2)    Investigate a complaint.