Ch. 499                          MARVIN MANDEL, Governor                              1115

(II)  PATIENT RECEIPTS

(III)  REPORT RECORDS

(IV) SPECIFIC PRODUCT AND QUANTITY LIMITATIONS

(V)  ADEQUATE ESTABLISHMENT FACILITIES

(VI)  REPORTS TO THE PHARMACY BOARD

(B) ANY JOBBER, DISTRIBUTOR, WHOLESALER, MANUFACTURER,
OR OTHER SUPPLIER OF HEMODIALYSIS DRUGS AND DEVICES IN
THE STATE WHO DISTRIBUTE SUCH DRUGS AND DEVICES
DIRECTLY TO HOME HEMODIALYSIS PATIENTS PURSUANT TO
SUBSECTION (A) OF THIS SECTION MUST APPLY TO THE BOARD OF
PHARMACY FOR A LICENSE AND MUST PAY A FEE TO THE BOARD
NOT TO EXCEED $100 PER YEAR.

(C)(1)         ANY         JOBBER,         DISTRIBUTOR,         WHOLESALER,

MANUFACTURER, OR OTHER SUPPLIER OF HEMODIALYSIS DRUGS
AND DEVICES LICENSED PURSUANT TO THIS SECTION WHO
VIOLATES ANY REGULATION OF THE BOARD OF PHARMACY
SHALL, UPON ORDER OF THE BOARD, SURRENDER THE LICENSE
AND CEASE AND DESIST DISTRIBUTING SUCH DRUGS AND
DEVICES TO HOME HEMODIALYSIS PATIENTS.

(2) ANY REGISTERED PHARMACIST WHO VIOLATES ANY
REGULATION OF THE BOARD IS SUBJECT TO SUSPENSION OR
REVOCATION OF HIS LICENSE PURSUANT TO PROCEDURES SET
FORTH IN SECTION 266A OF THIS ARTICLE.

(D)    [[IF THE BOARD FINDS ANY HEMODIALYSIS DRUG OR
DEVICE DISTRIBUTED UNDER THIS SECTION TO BE INEFFECTIVE
OR UNSAFE FOR THE INTENDED USE, THE BOARD MAY INSTITUTE
IMMEDIATE RECALL OF ANY AND ALL SUCH DEVICES
DISTRIBUTED TO INDIVIDUAL PATIENTS.]] THE BOARD WILL
CONSULT WITH THE COMMISSION ON KIDNEY DISEASE OF THE
STATE OF MARYLAND REGARDING THE EFFECTIVENESS AND
SAFETY OF ANY HEMODIALYSIS EQUIPMENT OR, DEVICES
DISTRIBUTED UNDER THIS SECTION FOR ITS INTENDED USE.

(E)  HOME HEMODIALYSIS PATIENTS WHO RECEIVE ANY DRUGS
OR DEVICES IN ACCORDANCE WITH THIS SECTION MUST, PRIOR
TO RECEIPT OF THESE DRUGS OR DEVICES, COMPLETE A FULL
COURSE OF HOME TRAINING GIVEN BY A [[RENAL DIALYSIS
CENTER, RESPECTIVELY ACCREDITED, APPROVED, AND CERTIFIED
BY THE KIDNEY DISEASE COMMISSION, THE COMPREHENSIVE
HEALTH PLANNING AGENCY, AND THE STATE DEPARTMENT OF
HEALTH AND MENTAL HYGIENE]] [[A]] HOME DIALYSIS
TRAINING FACILITY.

(F)   AS USED IN THIS SECTION,

(1) "HEMODIALYSIS" MEANS REGULAR TREATMENT BY A
KIDNEY MACHINE FOR PERSONS WHO HAVE PERMANENTLY LOST
THE FUNCTION OF THEIR KIDNEYS.

[[(2) "HOME HEMODIALYSIS PATIENT" MEANS A PERSON WHO
HAS BEEN TAUGHT WITH ANOTHER INDIVIDUAL PERSONALLY