S T A T E O F N E W Y O R K
________________________________________________________________________
3717
2021-2022 Regular Sessions
I N A S S E M B L Y
January 28, 2021
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Introduced by M. of A. STIRPE, BARCLAY, HUNTER, BLANKENBUSH, LUPARDO --
read once and referred to the Committee on Higher Education
AN ACT to amend the education law, in relation to the supervision of the
manufacturing and repacking of certain medical gases or wholesaling of
respiratory therapy agents
THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
BLY, DO ENACT AS FOLLOWS:
Section 1. Section 6808 of the education law is amended by adding a
new subdivision 9 to read as follows:
9. SUPERVISION. WHOLESALERS WHO DO NOT REPACK MAY DESIGNATE AS THE
SUPERVISOR A PERSON WHO PRESENTS EVIDENCE OF THE COMPLETION OF A MINIMUM
OF TWO YEARS OF EDUCATION BEYOND HIGH SCHOOL AND WHO HAS AT LEAST TWO
YEARS OF EXPERIENCE IN THE MANUFACTURING, REPACKING AND/OR WHOLESALING
OF DRUGS SATISFACTORY TO THE STATE BOARD OF PHARMACY. ESTABLISHMENTS
WHICH LIMIT THEIR OPERATION TO MANUFACTURING AND REPACKING OF COMPRESSED
MEDICAL GASES AND/OR WHOLESALING OF RELATED RESPIRATORY THERAPY AGENTS
SHALL HAVE EACH PERSON RESPONSIBLE FOR SUPERVISING THE MANUFACTURING,
PROCESSING, PACKING, OR HOLDING OF A DRUG PRODUCT HAVE THE EDUCATION,
TRAINING, AND EXPERIENCE, OR ANY COMBINATION THEREOF TO PERFORM ASSIGNED
FUNCTIONS IN SUCH A MANNER AS TO PROVIDE ASSURANCE THAT THE DRUG PRODUCT
HAS THE SAFETY, IDENTITY, STRENGTH, AND PURITY THAT IT PURPORTS TO
POSSESS.
§ 2. This act shall take effect immediately.
EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
[ ] is old law to be omitted.
LBD04721-01-1