Febhruary 25, 2017

U.S. Department of Transportation 

Docket Operations 

West Building Ground Floor, Room W12-140 

1200 New Jersey Avenue, SE 

Washington, DC 20590

Subject: Petition for Exemption 10690E

Reference: Emergency Medical Equipment; 14 CFR121.803. 

Dear Sir or Madam: 

In accordance with the provisions of Title 14, Code of Federal Regulations (14 CFR) §11.63 and §11.81, Eastern 

Air lines petition for a limited exemption from 14 CFR §121.803(c)(3) which requires airplanes with seating 

capacity of more than nine passengers to carry an Emergency Medical Kit (EMK) with contents as specified in 

Appendix A to Part 121. Specifically, we request that FAA issue a long-term exemption for use during periods of 

temporary supply shortages, beyond operator control, affecting availability of injectable drugs Atropine, Dextrose, 

Lidocaine, or Epinephrine, named in Part 121, Appendix A. 

Background 

Since 1986, large passenger-carrying aircraft have been required to carry an EMK to assist crewmembers or 

other volunteers in responding to an in-flight medical emergency.1 That requirement was extended in 1996 to 

cover 20-30 seat commuter aircraft.2 In 2001, the Federal Aviation Administration (FAA) issued new regulations 

implementing the Aviation Medical Assistance Act of 1998, which among other provisions called for airlines to 

augment their EMKs and include Atropine, Dextrose, Lidocaine, and Epinephrine.3 The regulatory provision 

expanding the required contents of the EMK took effect April 12, 2004, and applies to all airplanes for which a 

flight attendant is required,4 which currently includes all passenger-carrying aircraft having a seating capacity of 

more than nine passengers.5 The EMK is considered a “no-go” item that must be on board for the airplane to be 

operated,6 and current Master Minimum Equipment List (MMEL) relief requires a carrier to repair or replace an 

EMK within one flight of an incomplete, missing or inoperative EMK; there is no MEL relief permitting a carrier to 

depart with an EMK missing any specified contents beyond the one flight relief described above.7 

1 Emergency Medical Equipment Requirements Rule, 51 Fed. Reg. 1218 (Jan. 9, 1986). 

2 60 Fed. Reg. 65831 (Dec. 20, 1995). 

3 66 Fed. Reg. 19028 (April 12, 2001). 

4 14 C.F.R. §121.801(c)(3). 

5 14 C.F.R. §121.391(a)(1). 

6 See 66 Fed. Reg 19033. 

7 See FAA MMEL Policy Letter 73, “MMEL Relief for Emergency Medical Equipment.” 

Shortages occur due to multiple factors including overall non-aviation demand and manufacturing shortfalls, and 

relates not simply to shortages of substance, but also shortages of prescribed aviation packaging (ampules/prefilled syringes or proper dosages). Refurbishers report that they are often unaware of an impending drug shortage 

until they experience a back-order notification. The Atropine and Dextrose shortages in 2012-2014 are good 

examples of drug shortages that surfaced with little notice. The FDA does 
not require timely manufacturer drug shortage notices and therefore, FDA is not a source for advance 

information. 

Suppliers/refurbishers, led by MedAire and Banyan also regularly compete with hospitals and other ground-based 

users to obtain these drugs. Hospitals and first responders use the substances more often than they discard it 

through expiration (as usually occurs in aviation). For example, Banyan reported that during one shortage, 

producers adopted an Atropine distribution system that placed acute care providers (such as hospitals) ahead of 

airlines; and even with this system acute care providers were not receiving enough supply, making it even less 

likely that EMK providers would receive Atropine. 

Thus far, airlines and their kit suppliers have been able to address temporary shortages through a variety of 

accommodations and FAA exemptions. Ordinarily, airlines maintain a certain number of extra EMKs to replace 

those that are opened during a medical event; the opened EMKs are then sent back to the kit supplier for 

refurbishment. In addition, all EMKs are restocked periodically since some of the medications they contain have a 

shelf-life of as little as one year. However, during a shortage, EMKs in which Atropine, Dextrose, Lidocaine, or 

Epinephrine have been used or have expired cannot be refurbished and returned to use, leaving the airline 

potentially without the means to comply with the requirements of Appendix A. 

Also, while FDA has the authority to extend the expiration date on the drugs, the drug manufacturer must petition 

the FDA with drug stability data asking for an extension, which no manufacturer has done. Finally, Appendix A 

permits carriers and suppliers to provide equivalent substances, however, according to MedAire (and confirmed 

by in house air carrier medical staff) there is no equivalent substitute for Atropine, for example. 

Previous Petitions for Exemption and Subsequent Operator Action 

The petitioners requested and were granted separate exemptions for Atropine and Dextrose on very short notice 

in early 20138. With subsequent extensions, these Exemptions currently expire on January 31, 2016 and March 

31, 2016 respectively. A petition was submitted in 2010 regarding Epinephrine was withdrawn as supply 

recovered. 

8 Exemption 10690, issued January 25, 2013 and Exemption 10721, issued March 14, 2013. 

The pattern established by the short-fused Atropine and Dextrose petitions, and the aborted Epinephrine petition, 

reflect the uncertainties of information flowing from the manufacturers. For apparently commercial reasons, 

shortage durations vary widely and are not communicated in a timely manner to suppliers and refurbishers of 

EMKs (principally MedAire and Banyan). 

It is important to note that suppliers of EMKs and the operators have unwaveringly demonstrated their 

responsibility to the public by placing the drugs in EMKs whenever the products have been available, even during 

periods of exemption. 

The lack of timely predictability of shortages, taken with the highly responsible behavior of kit suppliers and 

operators, together underscore the appropriateness of a long-term Exemption that will be used only when 

supplies are impaired beyond their control. 
Current Shortages 

Currently only Hospira is reporting a potential disruption of the four injectables in the first quarter of 2016. 

Specifically, there is a possible recall of pre-filled syringes impending. This was disclosed to A4A by Banyan on or 

about December 9, 2015. 

Atropine 

Atropine, a required component of EMKs since 2004, is a “medicine used mainly to increase heart rate that may 

be needed to assist a passenger with an unstable cardiac rhythm.”9 Part 121, Appendix A specifies that an EMK 

must include two Atropine 0.5 mg, 5 cc injectable single doses or an Atropine equivalent. 

9 See 65 FR 33726; FAA Advisory Circular AC-121-33B, “Emergency Medical Equipment,” January 12, 2006. 

10 See FDA website concerning “Atropine Sulfate Injection” manufacturers at http://www.accessdata.fda.gov/scripts/drugshortages/default.cfm 

See also http://www.medaire.com/solutions/airlines/solutions/medical-kits-equipment/medical-equipment-details; and 

http://www.statkit.com/aviation-medicine/aviation-medicine-and-banyan-9-9.html 

11 65 FR 33726; FAA Advisory Circular AC-121-33B 

12 FDA website 

13 65 FR 33726; FAA Advisory Circular AC-121-33B 

14 FDA website 

Major EMK airline suppliers and refurbishers MedAire, Inc. and Banyan International Corporation, obtain Atropine 

from four producers in the United States, Amphastar Pharmaceuticals Inc., Hospira, Inc., American 

Regent/Luitpold, and West-Ward Pharmaceuticals.10 In Banyan’s letter that accompanied the first petition 

addressing Atropine, they pointed out that there are no FDA-approved foreign Atropine manufacturers authorized 

to import Atropine into the U.S. to relieve the shortage. 

Dextrose 

Dextrose, a required component of EMKs since 1986, is a “medicine used to treat acute or severe hypoglycemia 

which may appear in diabetic passengers.”11 Part 121, Appendix A specifies that an EMK must include one 

Dextrose 50%/50 cc injectable single dose or a Dextrose equivalent. 

Major EMK airline suppliers and refurbishers MedAire, Inc. and Banyan International Corporation, obtained 

Dextrose from two producers in the United States, Amphastar Pharmaceuticals Inc. and Hospira, Inc.12 

Appendix A permits carriers and suppliers to provide a Dextrose equivalent and MedAire states two Dextrose 

25% doses (equivalent to one 50% dose) or one 1mg Glucagon dose (providing similar therapeutic effects) would 

be equally effective alternatives but the future availability of these alternative drugs is also unpredictable. 

Epinephrine 

Epinephrine, a required component of EMKs since 2004, is a “medication used mainly for cardiac resuscitation.”13 

Part 121, Appendix A specifies that an EMK must include two 1:1000, 1cc single dose ampules and two 1:10,000, 

2cc single dose ampules of Epinephrine or respective equivalents. 

Major EMK airline suppliers and refurbishers MedAire, Inc. and Banyan International Corporation, obtain 

Epinephrine from four producers in the United States, Amphastar Pharmaceuticals Inc., Hospira, Inc., American 

Regent/Luitpold, and Par Pharmaceuticals.14 

Lidocaine 

Lidocaine, a required component of EMKs since 2004, is a “medication used mainly in cases of 

unresponsiveness to defibrillation and possibly for maintenance of normal heart rhythm after successful 
defibrillation”.15 Part 121, Appendix A specifies that an EMK must include two 5 cc, 20 mg/ml, injectable (single 

dose ampule or equivalent) of Lidocaine. 

15 65 FR 33726; FAA Advisory Circular AC-121-33B 

16 FDA website 

Affected Regulations: 14 CFR 121.803(c)(3) and 14 CFR part 121, Appendix A - First Aid Kits and Emergency 

Medical Kits. 

Summary of Relief Sought: The relief would temporarily exempt passenger-carrying airlines from having to carry 

certain injectable drugs in EMKs only during acute shortages beyond operator control. 

Granting this exemption is in the public interest as it avoids potential, unpredictable disruptions in scheduled and 

unscheduled air transport service. 

Reasons for Exercising the Privileges of the Requested Exemption Outside the United States 

Due to the unpredictable nature of situations in which this exemption might be triggered, and in order to avoid 

disruptions in international operations, U.S. carriers would need to be able to exercise the privileges of this 

exemption outside the United States. The International Civil Aviation Organization (ICAO) standard calls for 

aircraft to be equipped with “accessible and adequate medical supplies,” and recommends that these supplies 

include, for aircraft authorized to carry more than 100 passengers on a flight of more than two hours, “a medical 

kit, for the use of medical doctors or other qualified persons in treating in-flight medical emergencies.” Additional 

guidance provided by ICAO recommends but does not require Atropine, Dextrose, and Epinephrine.20 Absence of 

Atropine, Lidocaine, Dextrose, or Epinephrine in an EMK on an aircraft operating outside the U.S. therefore would 

not violate ICAO requirements. 

John Furneaux

VP Flight Operations Eastern Air Linnes

4200 NW 36th Street Bldg 5A

Miami, Florida 33166
Summary

For the foregoing reasons, we respectfully request a long term exemption from the requirements of 14CFR § 

121.803(c)(3) and Appendix A to Part 121 pertaining to the provision of 

Atropine, Dextrose, Lidocaine, and Epinephrine in the EMK during periods of commercially unavailability.