2023 Maryland Statutes › Health Occupations › Title 12 - Pharmacists and Pharmacies › Subtitle 6 - Board Regulation of Drugs, Medicines, and Other Products › Section 12-603 - Home Dialysis Distribution Program

(a)    (1)    In this section the following words have the meanings indicated.
(2)    “Dialysis drugs and devices” means:
(i)    Dialysate and dialysis solutions;
(ii)    Dialyzers, delivery systems, and their accessory equipment necessary to administer these products;
(iii)    Heparin;
(iv)    Local anesthetics and any other drugs and devices approved by the Board under subsection (g) of this section;
(v)    Needles;
(vi)    Syringes; and
(vii)    Sterile sodium chloride and sterile potassium chloride.
(3)    “Home dialysis distribution permit” means a permit issued by the Board to distribute dialysis drugs and devices to the homes of dialysis patients.
(b)    (1)    Except as provided under this subsection, a person shall hold a home dialysis distribution permit issued by the Board before the person may distribute dialysis drugs and devices to the home of a dialysis patient.
(2)    A licensed pharmacist may distribute dialysis drugs and devices under this section without the home dialysis distribution permit otherwise required by this section.
(c)    To qualify for a home dialysis distribution permit, an applicant shall satisfy the Board that the applicant will distribute dialysis drugs and devices in compliance with subsection (h) of this section.
(d)    To apply for a home dialysis distribution permit, an applicant shall:
(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 dialysis distribution permit to any applicant who meets the requirements of this section.
(f)    A home dialysis distribution permit issued under this section authorizes the home dialysis distribution permit holder to distribute dialysis drugs and devices to the home of a dialysis patient while the home dialysis distribution permit is effective.
(g)    (1)    The Board may approve local anesthetics and other drugs and devices for distribution as dialysis drugs and devices under this section.
(2)    The Board may adopt rules and regulations to assure safe, proper, and uninterrupted distribution of dialysis drugs and devices, including rules and regulations as to:
(i)    Maintaining facilities that are adequate to assure proper security and control of dialysis drugs and devices;
(ii)    Keeping records;
(iii)    Labeling dialysis drugs and devices;
(iv)    Receipts and returns from patients for dialysis drugs and devices;
(v)    Reports to the Board; and
(vi)    Restrictions on specific dialysis drugs or devices, including limitations on the amounts that may be distributed.
(h)    A person authorized to distribute dialysis drugs and devices under this section may distribute only 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 irreversibly lost function of the individual’s kidneys and requires regular treatment; and
(ii)    Who has completed a full course of training in providing the individual’s own dialysis treatment given by:
1.    A home dialysis training facility; or
2.    An end stage renal disease clinic certified under Medicare; and
(4)    In compliance with the rules and regulations adopted by the Board under this section.
(i)    Subject to the Administrative Procedure Act, the Board may suspend or revoke the home dialysis distribution permit of any home dialysis distribution permit holder who fails to comply with subsection (h) of this section.