AFS-16-14145-E 

 Exemption No. 10690H 

UNITED STATES OF AMERICA 

DEPARTMENT OF TRANSPORTATION 

FEDERAL AVIATION ADMINISTRATION 

WASHINGTON, DC 20591 

 

In the matter of the petition of 

 

AIRLINES FOR AMERICA, Regulatory Docket No. FAA-2013-0034 

NATIONAL AIR CARRIER ASSOCIATION, 

AND REGIONAL AIRLINE ASSOCIATION 

for an exemption from §121.803(c)(3) 

and part 121, Appendix A, paragraph (2) 

of Title 14, Code of Federal Regulations 

 

 

GRANT OF EXEMPTION 

By letter dated December 29, 2015, Airlines for America (A4A), the National Air Carrier 

Association (NACA), and the Regional Airline Association (RAA), on behalf of their 

passenger airline members and similarly situated air carriers, petitioned the Federal Aviation 

Administration (FAA) for a limited exemption from Title 14 of the Code of Federal 

Regulations (14 CFR) section 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, they requested 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, Epinephrine and/or Lidocaine, as 

required in Appendix A to part 121. The FAA is reissuing the January 29, 2016 grant of 

Exemption No. 10690. Corrections were made to update information concerning how 

certificate holders that are not members of the associations to which this exemption is granted 

may petition for similar relief. 

The pertinent requirements from 14 CFR from which A4A, NACA, and RAA seek relief are: 

 Section 121.803 Emergency medical equipment. 

Section 121.803(c) generally requires, for treatment of injuries, medical events, or minor 

accidents that might occur during flight time, each airplane must have equipment that meets 

the specifications and requirements of Appendix A of this part. Section 121.803(c)(3) 
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specifically requires, in airplanes for which a flight attendant is required, an approved 

emergency medical kit as modified effective April 12, 2004. 

Appendix A to Part 121—First Aid Kits and Emergency Medical Kits 

EMERGENCY MEDICAL KITS

Appendix A to part 121 specifically requires, as of April 12, 2004, at least one approved 

emergency medical kit that must contain certain appropriately maintained medical equipment 

and drugs in specified quantities, which includes: 

 Atropine, 0.5 mg, 5 cc (single dose ampule or equivalent) Quantity-2 

 Dextrose, 50%/50 cc injectable, (single dose ampule or equivalent) Quantity-1 

 Epinephrine 1:1000, 1 cc, injectable, (single dose ampule or equivalent) Quantity-2 

 Epinephrine 1:10,000, 2 cc, injectable, (single dose ampule or equivalent) Quantity-2 

 Lidocaine, 5 cc, 20 mg/ml, injectable (single dose ampule or equivalent) Quantity-2 

The petitioners require relief from the following requirements: 

 

Section 121.803(c)(3) prescribes, in pertinent part, that airplanes with seating capacity of 

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

in Appendix A to part 121, which includes Atropine, Dextrose, Epinephrine and Lidocaine. 

 

The petitioners support their request with the following information: 

The petitioners noted that, 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. The scope of that requirement was expanded in 1995 to cover 20-30 seat 

commuter aircraft (60 FR 65831). In 2001, the 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, Epinephrine and Lidocaine (66 FR 

19028). 

The petitioners additionally noted that the regulatory provisions enhancing the required 

contents of the EMK took effect April 12, 2004, and apply to all airplanes for which a flight 

attendant is required, which currently includes all passenger-carrying aircraft having a seating 

capacity of more than nine passengers. The petitioners added that the EMK is considered a 

“no-go” item that must be on board for the airplane to be operated, 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. They further noted that there 

is no MEL relief permitting a carrier to depart with an EMK missing any specified contents 

beyond the one flight relief previously described. 

The petitioners added that shortages occur due to multiple factors, including overall nonaviation demand and manufacturing shortfalls and relate not simply to shortages of substance 

but also to shortages of prescribed aviation packaging (e.g. ampules/pre-filled syringes or 
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proper dosages). The petitioners additionally noted that suppliers and refurbishers report that 

they are often unaware of an impending drug shortage until they experience a back-order 

notification. The petitioners commented that the Atropine and Dextrose shortages in 2012-

2014 were good examples of drug shortages that surfaced with little notice. They further 

commented that the U.S. Food and Drug Administration (FDA) does not require timely 

manufacturer drug shortage notices and therefore, FDA is not a source for advance 

information. 

The petitioners commented that suppliers and refurbishers, led by MedAire, Inc. (MedAire) 

and Banyan International Corporation (Banyan) also regularly compete with hospitals and 

other ground-based users to obtain these drugs. The petitioners further commented that 

hospitals and first responders actually use the substances rather than discarding them through 

expiration (as usually occurs in aviation). Petitioners noted, for example, that Banyan reported 

that during one shortage, drug manufacturers 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 for use in aviation. 

The petitioners additionally noted that thus far, airlines and their EMK suppliers have been 

able to address temporary shortages through a variety of accommodations and FAA 

exemptions. They commented that ordinarily, airlines maintain a certain number of extra 

EMKs to replace those that are opened during a medical event and the opened EMKs are then 

sent back to the EMK 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. Petitioners added, however, that during a shortage, EMKs in which Atropine, Dextrose, 

Epinephrine or Lidocaine 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 to part 121. 

The petitioners also noted that 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. Petitioners finally noted that Appendix A to part 

121 permits carriers and suppliers to provide equivalent substances. However, according to 

MedAire (and confirmed by certain 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 noted that they requested, and were granted, separate exemptions that 

addressed Atropine and Dextrose shortages with short notice to the FAA in early 2013. 

Petitioners also noted that, with subsequent extensions, these exemptions expire on January 

31, 2016, and March 31, 2016, respectively. The petitioners added that a petition was also 

submitted in 2010 regarding Epinephrine but was withdrawn as supply recovered. 
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Petitioners commented that the pattern established by the short-fused Atropine and Dextrose 

petitions, and the withdrawn Epinephrine petition, reflect the uncertainties of information 

flowing from the drug manufacturers. They further commented that, 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). They also 

commented that it is important to note that suppliers of EMKs and the air carriers 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. 

 

Petitioners added that the lack of timely predictability of shortages, taken with the highly 

responsible behavior of kit suppliers, refurbishers, and operators, together underscore the 

appropriateness of a long-term exemption that will be used only when supplies are impaired 

beyond the control of the operators. 

Current Shortages 

Petitioners noted that, currently, only the manufacturer Hospira, Inc. (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 Airlines for America 

by Banyan on or about December 9, 2015. 

Atropine 

Petitioners noted that 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.” They added that Appendix A to part 121 specifies that an EMK must include 

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

Petitioners additionally noted that major EMK airline suppliers and refurbishers MedAire and 

Banyan obtain Atropine from four producers in the United States: Amphastar Pharmaceuticals 

Inc. (Amphastar), Hospira, American Regent/Luitpold (AR/L), and West-Ward 

Pharmaceuticals (West-Ward). Petitioners also noted that, in its letter that accompanied the 

first petition addressing Atropine, Banyan pointed out that there are no FDA-approved foreign 

Atropine manufacturers authorized to import Atropine into the United States to relieve the 

shortage. 

Dextrose 

Petitioners also noted that Dextrose, a required component of EMKs since 1986, is a 

“medicine used to treat acute or severe hypoglycemia which may appear in diabetic 

passengers.” They added that Appendix A to part 121 specifies that an EMK must include 

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

Petitioners additionally noted that major EMK airline suppliers and refurbishers MedAire and 

Banyan obtain Dextrose from two producers in the United States: Amphastar and Hospira. 
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They added that Appendix A to part 121 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 

Petitioners also noted that Epinephrine, a required component of EMKs since 2004, is a 

“medication used mainly for cardiac resuscitation.” They added that Appendix A to part 121 

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. 

Petitioners additionally noted that major EMK airline suppliers and refurbishers MedAire and 

Banyan obtain Epinephrine from four producers in the United States: Amphastar, Hospira, 

AR/L, and Par Pharmaceuticals (Par). 

Lidocaine 

Lastly, petitioners noted that 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.” They added that 

Appendix A to part 121 specifies that an EMK must include two 5 cc, 20 mg/ml, injectable 

(single dose ampule or equivalent) of Lidocaine. 

Petitioners additionally noted that major EMK airline suppliers and refurbishers MedAire and 

Banyan obtain Lidocaine from four producers in the United States: Amphastar, Hospira, 

Aurobinda Pharma (Aurobinda), and Fresenius Kabi USA, LLC (Fresenius Kabi). 

The Applicable Regulations and Relief Sought 

The petitioners indicated that they seek a long-term exemption from § 121.803(c)(3), which 

requires passenger-carrying airplanes to be equipped with an EMK containing Atropine, 

Dextrose, Epinephrine and Lidocaine as specified in Appendix A to part 121, First Aid Kits 

and Emergency Medical Kits, during periods of supply disruptions beyond the control of the 

EMK suppliers and the air carriers, which may be on a EMK-by-EMK basis, with appropriate 

labeling of the EMK indicating the missing contents. 

Reasons for seeking the relief include: 

The petitioners noted that: 

1) Suppliers cannot provide EMKs stocked with the drugs when pharmaceutical 

manufacturers do not deliver product and have not supplied revised fulfillment dates. 

2) Replacement supplies of these substances cannot be imported from foreign manufacturers. 

3) There is no accepted substitute for Atropine, and where substitutes for other drugs may 

exist, their supplies are no more dependable. 
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4) These drugs are rarely used. 

 Banyan estimates that Atropine is used less than one time per one thousand units 

serviced 

 Dextrose is rarely used, having been recommended during approximately .02% inflight consultations provided by MedAire in 2012. Banyan estimates that Dextrose has 

been used in fewer than 0.4% of inflight emergencies reported to Banyan in 15 years. 

 Epinephrine is also rarely used, having been administered in 0.3% of inflight medical 

emergencies, per a 2013 study by the New England Journal of Medicine (NEJM). 

(“Outcomes of Medical Emergencies on Commercial Airline Flights”, Peterson, Drew 

C. M.D., et. al., The New England Journal of Medicine, May 30, 2013) 

 Lidocaine is even more rarely used, aggregated within “other” by the same NEJM 

study. 

5) When member air carriers contact the petitioners indicating their supply of EMKs with 

unexpired Atropine, Dextrose, Epinephrine or Lidocaine will be depleted soon, the problem is 

often merely weeks away with potential service disruption looming. 

The petitioners stated that, without the requested relief, air carriers will periodically and, with 

little notice, face the decision to ground aircraft. The petitioners requested long-term relief 

from the requirement to carry Atropine, Dextrose, Epinephrine or Lidocaine in an EMK due 

to shortages of those drugs resulting from uncontrollable supply deficit. 

Granting the Exemption Would be in the Public Interest 

The petitioners noted that, absent this relief, there are no means for airlines to comply with 

§ 121.803, Appendix A to part 121, and MEL requirements when shortages exist and the 

drugs need to be restocked in the EMK. They further noted that this creates the possibility that 

aircraft would have to be taken out of service until additional supplies can be obtained, and 

that, while this would be a last resort, it is not implausible. The petitioners added that 

grounding otherwise airworthy aircraft for this reason alone would disrupt air service and 

would not be in the interest of the traveling public. They added that granting this exemption 

would help to ensure that air service continues uninterrupted and, in this respect, would serve 

the public interest. 

Granting the Exemption Would Not Adversely Affect Safety 

The petitioners commented that shortages of these drugs to date have additionally brought to 

light their limited usage. They added that, for example, MedAire has reported that roughly 1% 

of EMKs returned for refurbishment are missing Atropine due to use, loss, or damage. The 

petitioners further added that a returned EMK, unless opened for use, represents 

approximately one year of service and is generally returned for replacement of expiring 

contents. The petitioners added that MedAire and Banyan have both reported to the 

petitioners qualitatively that the majority of drug usage for airline purposes has been due to 

expiration, not administration to passengers. Petitioners also noted that, for example, Banyan 
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reports that Atropine is used less than one time per one thousand units serviced, and as 

previously referenced, usage of the other injectables is also rare. 

The petitioners reiterated that suppliers and refurbishers of EMKs and the air carriers have 

unwaveringly demonstrated their responsibility to the public by placing the required drugs in 

EMKs, even during periods of exemption, whenever the products have been available. 

The petitioners generally noted that EMKs are not intended to be comprehensive, or to 

include treatment for every possible medical condition but instead provide options for 

addressing the most frequent types of in-flight medical emergencies. They added that the 

case-by-case removal of the EMK requirement for these drugs during acute shortages would 

not adversely affect the safety of the traveling public because they are used so infrequently. 

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

States 

The petitioners also noted that, due to the unpredictable nature of situations in which this 

exemption might be used, 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. They added that the International Civil Aviation Organization (ICAO) standard 

requires 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.” The petitioners further 

added that additional guidance provided by ICAO recommends, but does not require, 

Atropine, Dextrose, and Epinephrine. The petitioners noted, therefore, that the absence of 

Atropine, Dextrose, and Epinephrine in an EMK on an aircraft operating outside the United 

States would not violate ICAO requirements. 

The FAA has determined that good cause exists to waive publication of a summary of this 

petition for exemption in the Federal Register for public comment. Delaying action on this 

petition would adversely affect air carriers due to the imminent effect on operations that 

would be caused by the possible shortages of Atropine, Dextrose, Epinephrine or Lidocaine. 

The FAA’s analysis is as follows: 

The FAA has considered fully the petitioners’ request and supporting information and finds 

that a grant of exemption would be in the public interest. 

First, the FAA notes that there are two current exemptions related to this petition for 

exemption. Exemption No. 10690 (FAA-2013-0034) granted passenger member airlines of 

the Regional Airline Association, Airlines for America, and National Air Carrier Association, 

and all similarly situated air carriers, an exemption from § 121.803(c)(3) and Appendix A to 

part 121, to the extent necessary to relieve them from the requirement to carry two single dose 

ampules of Atropine 5cc injectable, in required on-board EMKs when, due to the nationwide 
8 

shortage, they are unable to procure these items for the kits. The current extension of 

Exemption No. 10690 (10690D) terminates on January 31, 2016. 

Exemption No. 10721 (FAA-2013-0201) granted passenger member airlines of Regional 

Airline Association, Airlines for America, and National Air Carrier Association, and all 

similarly situated air carriers, an exemption from § 121.803(c)(3) and Appendix A to part 121 

to the extent necessary to relieve them from the requirement to carry one single dose ampule 

of Dextrose 50cc injectable, in required on-board EMKs when, due to the nationwide 

shortage, they are unable to procure these items for the kits. The current extension of 

Exemption No. 10721 (10721A) terminates on March 16, 2016. 

Second, the FAA notes that the conditions and reasons relative to public interest and safety 

that were the basis for granting Exemption No. 10690, regarding the shortage of Atropine, and 

Exemption No. 10721, regarding the shortage of Dextrose, are also valid with respect to 

possible future shortages of Epinephrine and Lidocaine for suppliers and refurbishers of 

EMKs used in air carrier operations under part 121. 

All airplanes for which a flight attendant is required must carry an EMK with items listed in 

Appendix A to part 121. The EMK is considered a “no-go” item and is included on the 

MMEL. Current MMEL Policy Letter 73, titled “MMEL Relief for Emergency Medical 

Equipment,” requires an air carrier to repair or replace an EMK within one flight when it is 

incomplete, missing, or inoperative. There is no MMEL relief permitting an air carrier to 

depart with an EMK that is missing required EMK contents beyond the one flight relief 

described in MMEL Policy Letter 73. 

The inability of EMK suppliers and refurbishers to obtain and supply Atropine, Dextrose, 

Epinephrine and/or Lidocaine during shortages of one or more of these drugs creates the 

possibility that a significant number of aircraft would not be able to meet the requirements of 

Appendix A to part 121 and would have to be taken out of service. As discussed in the 

petition for exemption, safety would not be adversely affected because data from EMK 

suppliers and refurbishers demonstrate that Atropine, Dextrose, Epinephrine and/or Lidocaine 

are rarely used and predominantly replaced in EMKs due to expiration. Therefore, the caseby-case removal of the EMK requirement for these drugs during acute shortages would not 

adversely affect the safety of the traveling public because they are used so infrequently. 

Additionally, the FAA has determined that the impact on large numbers of passengers that 

would be caused by grounding these aircraft for lack of Atropine, Dextrose, Epinephrine 

and/or Lidocaine outweighs the benefit of having them, since they are used infrequently in 

response to in-flight medical events. 

As the petitioners indicate, shortages occur due to multiple factors, including overall nonaviation demand and manufacturing shortfalls, and relates not simply to shortages of 

substance but also to shortages of prescribed aviation packaging (ampules/pre-filled syringes 

or proper dosages). The FAA also agrees with the petitioners that the Atropine and Dextrose 
9 

shortages that occurred during 2012-2014 were appropriate examples of drug shortages that 

surfaced with little notice. 

Further, the FAA agrees with the petitioners that it is important to note that suppliers of 

EMKs and air carriers have consistently demonstrated their responsibility to the public by 

placing the drugs in EMKs whenever the products have been available, even during periods of 

exemption. 

In considering this petition for exemption, the FAA recognizes that air carriers must cope with 

periodic nationwide manufacturing shortages for certain drugs that leave affected certificate 

holders without an alternate means to comply. Further, the nationwide shortages affect not 

only EMK suppliers for aviation use, but also ground-based medical service providers such as 

hospitals and first responders that provide acute medical care on a frequent basis. 

The FAA notes that the great majority of passenger-carrying air carriers operating under 

part 121 use EMKs that are supplied and/or refurbished by only three companies: MedAire, 

Inc., Banyan International Corporation and Aerospace Accessory Service, Inc. Additionally, 

all EMK suppliers and/or refurbishers must obtain these drugs from four or fewer drug 

manufacturers. Therefore, regardless of air carrier size, fleet type(s), operating environment 

or business model, all air carriers operating under part 121 are similarly situated regarding the 

ability to obtain Atropine, Dextrose, Lidocaine and/or Epinephrine for EMKs used on their 

aircraft. 

Previously, when A4A, RAA and NACA petitioned the FAA for relief from certain 

requirements regarding EMK contents, the FAA granted relief to member airlines of these 

petitioners, as well as to all other “similarly situated air carriers”, which included any air 

carrier operating under the provisions of part 121 (Exemption Nos. 10690D and 10721A). 

However, in an effort to manage the exemptions granted by the FAA and to facilitate operator 

compliance with the conditions and limitations of a grant of exemption, the FAA is no longer 

including “similarly situated air carriers” in the grants of exemption. 

In order for any air carrier that is not a member or associate member of A4A, RAA or NACA 

to exercise the relief provided by this grant of exemption, they must submit a petition for 

similar relief to the docket. After analysis of the petition, if appropriate, the FAA will amend 

Exemption No. 10690 to include the additional air carrier. An air carrier may only exercise 

the relief provided by this grant of exemption when it is listed in Attachment 1 to Exemption 

No. 10690, as amended. 

The FAA’s Decision: 

In consideration of the foregoing, I find that a grant of exemption is in the public interest. 

Therefore, pursuant to the authority contained in 49 U.S.C. §§ 106(f), 40113, and 44701, 

delegated to me by the Administrator, I grant the current members and associate members of 

Airlines for America, the National Air Carrier Association, and the Regional Airline 

Association, an exemption from 14 CFR § 121.803(c)(3) to the extent necessary to allow 
10 

aircraft to be operated without meeting the requirements of Appendix A to part 121 regarding 

emergency medical kit (EMK) required contents Atropine, Dextrose, Epinephrine and/or 

Lidocaine, when EMK suppliers and/or refurbishers are unable to obtain and supply Atropine, 

Dextrose, Epinephrine and/or Lidocaine. 

As previously noted, this grant is limited to the members and associate members, as of the 

date of this Grant of Exemption, of Airlines for America, the National Air Carrier 

Association, and the Regional Airline Association, as listed in Attachment 1 of this Grant of 

Exemption. Any new or additional members of these associations or other air carriers 

operating under the provisions of part 121 must petition the FAA separately to be able to 

exercise similar relief as that provided by this grant of exemption. Air carriers may only 

exercise the relief provided by this grant of exemption when they are listed in Attachment 1 to 

Exemption No. 10690, as amended. This exemption is subject to the following conditions and 

limitations. 

Conditions and Limitations 

1. A copy of this exemption must be carried on board each aircraft operating with an 

emergency medical kit (EMK) that does not include Atropine, Dextrose, Epinephrine 

and/or Lidocaine as required by Appendix A to part 121. 

2. As part of the requirement under §119.43(c) to keep each of its employees and other 

persons used in its operation informed of the provisions of its operations specifications 

that apply to that employee’s or person’s duties and responsibilities, the certificate 

holders must inform crewmembers that an emergency medical kit on board that 

aircraft may not contain Atropine, Dextrose, Epinephrine and/or Lidocaine. 

3. Should the supply of Atropine, Dextrose, Epinephrine and/or Lidocaine become 

available to EMK suppliers and/or refurbishers, exemption holders must refurbish the 

EMK with the missing drug(s) at the next scheduled refurbishment date. 

4. This exemption may be used for flights conducted outside of the United States. 

This exemption terminates on January 31, 2020, unless sooner superseded or rescinded. 

Issued in Washington, DC, on December 12, 2016. 

/s/ 

John Barbagallo 

Deputy Director, Flight Standards Service