Fla. Admin. Code Ann. R. 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 requires 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 section 499.03, F.S.; and,

(c) Business establishments, 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 establishments must employ an individual that has training on the use and administration of emergency use oxygen.

(3) "Transfilling" means transferring the gas, either in a liquid or gaseous state, from a larger container into smaller containers (i.e., high-pressure cylinders or cryogenic vessels).

(4) A Florida-permitted prescription drug manufacturer, prescription drug repackager 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 on the cylinder or vessel label: "For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, prescription statement." The Prescription statement is "Rx Only" or the prescription symbol followed by the word "Only"; 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 section 499.89, F.S. If the distribution is to a person that does not have a license or permit, the establishment is not required to include the purchaser's license or permit number and its expiration date in the records. The record, including the invoice or delivery ticket, shall indicate that the distribution was for "emergency use" in the permit number field of the audit trail outbound document.

(7) Establishments distributing "emergency use" oxygen pursuant to this rule shall comply with the container labeling requirements and good manufacturing practices of the United State Food, Drug and Cosmetic Act, 21 U.S.C., Chapter 9, and rule 61N-1.007, F.A.C.

Notes

Fla. Admin. Code Ann. R. 61N-1.027

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

Adopted by Florida Register Volume 42, Number 002, January 5, 2016 effective 1/19/2016.

New 1-19-16.