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Assembly Bill A9425

2021-2022 Legislative Session

Relates to the supervision of the manufacturing and refilling of medical oxygen

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Archive: Last Bill Status - In Assembly Committee

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2021-A9425 (ACTIVE) - Details

Current Committee:
Assembly Higher Education
Law Section:
Education Law
Laws Affected:
Amd §6808, Ed L
Versions Introduced in 2023-2024 Legislative Session:
A5121

2021-A9425 (ACTIVE) - Summary

Relates to supervising the processing and refilling of medical oxygen; requires supervisors to undergo training for each particular operation that the supervisor performs or oversees and to maintaining good manufacturing practices.

2021-A9425 (ACTIVE) - Bill Text download pdf 

                             
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   9425
 
                           I N  A S S E M B L Y
 
                               March 7, 2022
                                ___________
 
 Introduced by M. of A. STIRPE -- read once and referred to the Committee
   on Higher Education
 
 AN  ACT  to  amend  the  education  law,  in relation to supervising the
   refilling of medical oxygen
 
   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. A. A PHARMACY, WHOLESALER, MANUFACTURER OR OUTSOURCING
 FACILITY REGISTERED UNDER THIS SECTION WHO REFILLS MEDICAL OXYGEN  SHALL
 ENSURE  ANY  PERSON RESPONSIBLE FOR SUPERVISING THE REFILLING OF MEDICAL
 OXYGEN HAS THE NECESSARY EDUCATION, TRAINING,  AND  EXPERIENCE,  OR  ANY
 COMBINATION THEREOF TO PERFORM ASSIGNED FUNCTIONS IN SUCH A MANNER AS TO
 PROVIDE  ASSURANCE  THAT  THE  MEDICAL  OXYGEN HAS THE SAFETY, IDENTITY,
 STRENGTH, QUALITY, AND PURITY THAT IT  PURPORTS  OR  IS  REPRESENTED  TO
 POSSESS.
   B.  A  SUPERVISOR SHALL UNDERGO TRAINING FOR EACH PARTICULAR OPERATION
 THAT THE SUPERVISOR SUPERVISES AND  SHALL  MAINTAIN  GOOD  MANUFACTURING
 PRACTICES  INCLUDING  CURRENT  GOOD  MANUFACTURING  PRACTICE REGULATIONS
 FOUND IN TITLE 21 OF THE CODE OF FEDERAL REGULATIONS AND WRITTEN  PROCE-
 DURES  REQUIRED BY SUCH FEDERAL REGULATIONS AS THEY RELATE TO A SUPERVI-
 SOR OF THE PROCESSING AND REPACKING  OF  MEDICAL  OXYGEN  FUNCTIONS.  AS
 DETERMINED  BY  THE BOARD OF PHARMACY, TRAINING ON CURRENT GOOD MANUFAC-
 TURING PRACTICE SHALL BE CONDUCTED BY QUALIFIED INDIVIDUALS ON A CONTIN-
 UING BASIS AND WITH SUFFICIENT  FREQUENCY  TO  ASSURE  THAT  SUPERVISORS
 REMAIN  FAMILIAR  WITH  CURRENT GOOD MANUFACTURING PRACTICE REQUIREMENTS
 APPLICABLE TO THEM.
   § 2. This act shall take effect on the thirtieth day  after  it  shall
 have become a law. Effective immediately, the addition, amendment and/or
 repeal  of  any  rule  or regulation necessary for the implementation of
 this act on its effective date are authorized to be made  and  completed
 on or before such effective date.
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD14783-02-2

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