Ch. 508 1997 LAWS OF MARYLAND

(1) Submit an application to the Board on the form that the Board requires;

and

(2) Pay to the Board a fee set by the Board.

(e) The Board shall issue a home [hemodialysis] DIALYSIS distribution permit to
any applicant who meets the requirements of this section.

(f) A home [hemodialysis] DIALYSIS distribution permit issued under this
section authorizes the home [hemodialysis] DIALYSIS distribution permit holder to
distribute [hemodialysis] DIALYSIS drugs and devices to the home of a [hemodialysis]
DIALYSIS patient while the home [hemodialysis] DIALYSIS distribution permit is
effective.

(g) (1) The Board may approve local anesthetics AND OTHER DRUGS AND
DEVICES for distribution as [hemodialysis] DIALYSIS drugs AND DEVICES under this
section.

(2) The Board may adopt rules and regulations to assure safe, proper, and
uninterrupted distribution of [hemodialysis] DIALYSIS drugs and devices, including rules
and regulations as to:

(i) Maintaining facilities that are adequate to assure proper security
and control of [hemodialysis] DIALYSIS drugs and devices;

(ii) Keeping records;

(iii) Labeling [hemodialysis] DIALYSIS drugs and devices;

(iv) Receipts AND RETURNS from patients for [hemodialysis]
DIALYSIS drugs and devices;

(v) Reports to the Board; and

(vi) Restrictions on specific [hemodialysis] DIALYSIS drugs or
devices, including limitations on the amounts that may be distributed.

(h) A person authorized to distribute [hemodialysis] DIALYSIS drugs and devices
under this section may distribute only [hemodialysis] DIALYSIS drugs and devices:

(1) That the Board, after consultation with the State Commission on Kidney
Disease, has approved as effective and safe for their intended use;

(2) Under supervision of a person who the Board considers qualified to
safeguard and protect the public health;

(3) To an individual:

(i) Who has [permanently] IRREVERSIBLY lost [the] function of
the individual's kidneys and requires regular treatment with a kidney machine OR OTHER
TREATMENT MODALITY TO SUSTAIN LIFE; and

(ii) Who has completed a full course of training in providing the
individual's own [hemodialysis] DIALYSIS treatment f GIVEN BY:

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