The purpose and effect of the proposed rule is to set forth the parameters under which an entity permitted under Chapter 499, F.S., Part III, may distribute emergency use medical oxygen.

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Drugs, Devices and Cosmetics

RULE NO.:RULE TITLE:

61N-1.027Distribution of Emergency Use Medical Oxygen

PURPOSE AND EFFECT: The purpose and effect of the proposed rule is to set forth the parameters under which an entity permitted under Chapter 499, F.S., Part III, may distribute emergency use medical oxygen.

SUMMARY: The proposed rule sets forth the conditions that a medical oxygen retail establishment must meet in order to distribute medical oxygen for emergency use by persons authorized to receive emergency use oxygen.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION: The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: the economic review conducted by the agency.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 499.85, FS.

LAW IMPLEMENTED: 499.83, 499.85, 499.86, 499.89, 499.90, FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Dinah Greene, Operations Review Specialist, Division of Drugs, Devices and Cosmetics, Department of Business and Professional Regulation, 1940 North Monroe Street Suite 26A, Tallahassee, Florida 32399-1047, [phone], [e-mail]

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

61N-1.027 Distribution of Medical Oxygen for Emergency Use.

(1) “Emergency use” means the administration of oxygen USP to an individual that is experiencing an unexpected, life-threatening, medical situation which required immediate action.

(2) “Persons authorized to receive emergency use oxygen” means:

(a) A person experiencing an unexpected, life-threatening, medical situation due to oxygen deficiency and requiring resuscitation;

(b) A person exempted pursuant to s. 499.03, F.S.; and

(c) Business entities, universities, schools, and other such entities or organization conducting lawful activities which include frequent contact or interaction with members of the public, e.g. banks, hotels, restaurants, recreation camps, theme parks and resorts, and sports arenas.  These entities must employ an individual that has training on the use and administration of emergency use oxygen.

(3) “Transfilling” means the process of taking a gas source, either compressed or in liquid form (usually in bulk containers), and transferring it into a different container (usually a smaller compressed cylinder).

(4) A Florida-permitted prescription drug or medical gas manufacturer may transfill and distribute a medical oxygen cylinder to persons authorized to receive emergency use oxygen for emergency use.

(5) A Florida-permitted medical gas wholesale distributor or medical oxygen retail establishment may distribute a medical oxygen cylinder to persons authorized to receive emergency use oxygen for emergency use.

(6) Entities distributing emergency use oxygen pursuant to this rule must:

(a) Have a current permit, or have a permit that is undergoing renewal and allowed to continue to operate during the division’s review and processing of the renewal;

(b) Have a policy and procedure in place governing its distribution of emergency use medical oxygen that complies with the requirements for wholesale distributions set forth in section 499.90, F.S.;

(c) Include the statement: “For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation” on the label; and

(d) Create contemporaneously with and no later than 24 hours after the distribution of emergency use medical oxygen to persons authorized to receive emergency use oxygen, records pertaining to the distribution that comply with the recordkeeping requirements set forth in s. 499.89, F.S.  If the distribution is to person that does not have a license or permit, the entity is not required to include the license or permit number and its expiration date in the records.

Rulemaking Authority 499.85 FS. Law Implemented 499.83, 499.85, 499.86, 499.89, 499.90 F.S. History-New___________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Reginald D. Dixon, Director

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Ken Lawson, Secretary

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: August 27, 2015

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: June 29, 2015