February 26, 2013

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

Reference: Emergency Medical Equipment; 14 CFR 121.803

Dear Sir or Madam:

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

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

of their passenger airline members (See enclosure 1) and similarly-situated air carriers, 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 suspend for one year a requirement for air carriers to 

include Dextrose in the emergency medical kits (EMKs) of their aircraft during flight operations because of 

a manufacturing supply shortage leaving airlines without the means to comply with the requirements of 

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.1FAA has required a single Dextrose 

dose ampule or equivalent since the 1986 EMK final rule. The requirement to carry an EMK was 

extended in 1996 to cover 20-30 seat commuter aircraft.2In 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.3The 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 would include all passenger-carrying aircraft having a seating 

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

the airplane to be operated,6and current Master Minimum Equipment List (MMEL) relief requires a carrier 

to refurbish or replace the EMK within one flight after it has been used or otherwise becomes incomplete; 

there is no MEL relief permitting a carrier to depart with an EMK missing Dextrose, 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.”
EMK Petition for Exemption – Dextrose

February 26, 2013

Current Dextrose Shortage

Dextrose, a required component of EMKs since 1986,

8

is a medicine used to treat acute or severe 

hypoglycemia which may appear in diabetic passengers. Part 121, Appendix A specifies that an EMK 

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

Historically, 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. MedAire and Banyan have notified operators and provided letters to A4A (see 

enclosures)9stating there is currently a critical shortage of Dextrose in the U.S. and that it will be 

impossible to supply EMKs with fresh Dextrose to our members after February 20, 2013. This shortage is 

due to multiple factors including overall demand and a manufacturing shortfall. The manufacturers have 

indicated that backlogged demand should be fulfilled by late second quarter 2013, with a ramp up of 

supply in the meantime. MedAire predicts the shortage will affect their specific supply until late second 

quarter 2013 or after. Finally, 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 alternatives10 but the future availability of 

these alternative drugs is uncertain.

Refurbishers report that they are often unaware of an impending drug shortage until they experience a 

back-order notification. The Atropine and Dextrose shortages 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. 

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

of accommodations. 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 shelflife of as little as one year. During the early portion of this shortage, EMK providers refurbished kits using 

Dextrose from EMKs that were returned before their normal shelf-life expiration date. However, when that 

supply was consumed, , kits could no longer be refurbished and returned to use, leaving the airline 

without the means to comply with the requirements of Appendix A.11 Both MedAire and Banyan report 

they have exhausted all supplies at this time. MedAire has already begun notification to airlines that they 

have no means to supply Dextrose, and absent an exemption, can no longer supply FAA-complaint 

EMKs.12

The Applicable Regulations and Relief Sought

We seek exemption from 14 CFR 121.803(c)(3), which requires passenger-carrying airplanes to be 

equipped with an EMK containing Dextrose as specified in part 121 Appendix A, EMK requirements, 

paragraph 2. We also request that FAA approve the Dextrose substitutes listed, below so that carriers 

could voluntarily use them as a substitute for Dextrose if the drugs become available during the requested 

exemption period.

 Dextrose 25% which may be given at twice the 50 cc dosage, or

 Glucagon 1mg kit (dry powder and water reconstitution kit)

 

8

51 Fed. Reg. 1223.

9 MedAire letter to Robert Ireland, A4A, dated February 21, 2013, enclosure 3; Banyan letter to Robert Ireland, A4A, dated February 

22, 2013, enclosure 2.

10 See also, Comparison of intravenous glucagon and dextrose in treatment of severe hypoglycemia in an accident and emergency 

department, Diabetes Care, Volume 10, No. 6, November-December 1987.

11 See MedAire letter page 1.

12 MedAire notification to Alaska Airlines, copied by email to Robert Ireland, A4A, February 22, 2013
EMK Petition for Exemption – Dextrose

February 26, 2013

* Note: According to MedAire Dextrose 25% currently is unavailable; the availability of Glucagon as an 

approved substitute is uncertain.

Reasons for seeking the relief include: 

1) Suppliers cannot provide EMKs stocked with Dextrose because recent pharmaceutical 

manufacturing conditions have reduced the availability of Dextrose and manufacturers have 

only speculated on further availability.

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

3) The only suggested substitutes are Glucagon and Dextrose 25%.

4) Primary kit provider/refurbishers Banyan and MedAire have exhausted their supply of 

Dextrose.

5) Dextrose is rarely used; having been recommended during approximately .02% in-flight 

consultations provided by MedAire in 201213. Banyan estimates that Dextrose has used in 

fewer than 0.4% of inflight emergencies reported to them in 15 years.

6) Airlines contacting A4A have indicated their supply of EMKs with unexpired Dextrose will be 

depleted soon, and FAA-complaint EMKs cannot be supplied.

Without the requested relief carriers will face the decision to ground aircraft. 

Therefore, we request relief from the requirement to carry Dextrose in an EMK for a period of one year 

from the date of granting this petition, or until supplies have stabilized with availability to airline sources. 

Further, we also respectfully request that the Exemption, if granted, not require a PIC pre-flight briefing on 

Dextrose but instead require that the “certificate holder” inform the crew. Flight attendants will know if the 

EMK includes Dextrose because of mandatory pre-flight safety inspections and EMK labeling from the 

refurbishers. Alternatively, FAA could require that carriers provide a bulletin to flight attendants.

Request for Interim Relief

The exemption process is likely to take more than two weeks to complete and therefore we also request 

that FAA expedite this petition and in the interim use its discretion to not enforce the requirement to carry 

Dextrose in Emergency Medical Kits or use any other means to provide interim relief, until the agency is 

able to answer this petition. 

Granting the Exemption Would be in the Public Interest

Absent this relief, there is no means for airlines to comply with section 121.803, part 121 Appendix A, and 

MEL requirements when Dextrose needs to be restocked in the EMK. This creates the possibility that 

aircraft would have to be taken out of service until additional supplies can be obtained. While this would 

be a last resort, it is not implausible. Grounding otherwise airworthy aircraft for this reason alone would 

disrupt air service and is not in the interest of the traveling public. 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 shortage of Dextrose has additionally brought to light its limited usage. While Dextrose is important 

for certain types of emergency medical treatment, it is infrequently used. MedAire, which provides 

emergency medical consultation to airlines as well as supplying EMKs, estimates that in 2012, Dextrose 

was recommended during approximately 0.02% in inflight consultations, or five out of 25,000 , while 

Banyan similarly states a usage rate of 0.4% of all inflight emergencies known to them over a 15 year 

period. According to Banyan, EMK refurbishers also regularly compete with hospitals and other groundbased users of Dextrose who use the substance more often than discard it through expiration. Banyan 

reports that during this shortage, producers have adopted a distribution system that places acute care 

providers (such as hospitals) ahead of airlines; even with this system acute care providers are not 

 

13 MedAire letter, page 2
EMK Petition for Exemption – Dextrose

February 26, 2013

receiving enough supply, making it even less likely that EMK providers will receive Atropine in the near 

future.14

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 medical emergencies.15 The 

removal of the EMK requirement for Dextrose would not adversely affect the safety of the traveling public 

because it is used infrequently.16 Safety will also not be adversely impacted if the FAA approves 

equivalent drug substitutions.

A Summary of this Petition that FAA Could Publish in the Federal Register

Petitioners: Airlines for America, the National Air Carrier Association, and 

the Regional Airline Association

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 Dextrose 50%/50cc injectable ampules in EMKs due to a 

chronic shortage of the drug.

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, 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 “Dextrose –

injectable”.17 Absence of Dextrose in an EMK on an aircraft operating outside the U.S. therefore would 

not violate ICAO requirements.

 

14 Banyan letter page 2.

15 FAA Advisory Circular AC-121-33B, 1/12/2006

16 A4A further notes that a recent FAA decision to reduce MEL relief allowing only one flight before restocking an opened EMK 

instead of three flights results in many carriers purchasing and maintaining a second EMK for each airplane, which requires 

acquiring additional atropine. 

17 ICAO, International Standards and Recommended Practices, Annex 6 to the Convention on International Civil Aviation (Ninth 

Edition, July 2010), Part I, para. 6.2.2
EMK Petition for Exemption – Dextrose

February 26, 2013

Conclusion

For the foregoing reasons, we respectfully request an expedited exemption from the requirements of 14 

C.F.R. § 121.803(c)(3) and Appendix A to Part 121 pertaining to the provision of Dextrose in the EMK for 

one year or until Dextrose is once again commercially available.

Respectfully submitted February 26, 2013 by: 

 

Douglas Mullen Stacey Bechdolt, Esq.

Assistant General Counsel Director, Safety & Technical Affairs

Airlines for America Regional Airline Association

2025 M Street, NW

Suite 800

Washington, DC 20036

George Paul

Director of Technical Services

National Air Carrier Association

1000 Wilson Boulevard

Suite 1700

Arlington, Virginia 22209-3928

 

Enclosures/

cc:

Mr. John Allen Mr. Steve Douglas

Federal Aviation Administration Federal Aviation Administration

Director, Flight Standards Service, AFS-1 Flight Standards Service 

800 Independence Ave., SW Aircraft Maintenance Division, AFS-300

Washington, DC 20591 470 L’Enfant Plaza, SW 

Washington, DC 20024

Mr. John Duncan

Federal Aviation Administration

Deputy Director for Policy, Flight Standards, AFS-2P

800 Independence Ave., SW 

Washington, DC 20591 

Mr. Les Smith

Federal Aviation Administration

Flight Standards Service 

Air Transport Division, AFS-200

800 Independence Avenue, S.W.,

Washington, DC 20591
Enclosure 1

Passenger Airline Association Members

Airlines for America National Air Carrier 

Association

Regional Airline Association

Alaska Airlines Air Transport International Aerolitora

American Airlines Allegiant Air Air Wisconsin Airlines Corp.

Atlas Air, Inc. Atlas Air, Inc. AirNet Systems Inc. 

Delta Air Lines, Inc. Everts Air Cargo American Eagle Airlines 

Hawaiian Airlines, Inc. Kalitta Air Cape Air 

JetBlue Airways Corp. Lynden Air Cargo Chautauqua Airlines 

Southwest Airlines Co. Miami Air International CommutAir

United Air Lines, Inc. National Airlines Compass Airlines 

US Airways, Inc. National Air Cargo Empire Airlines 

Air Canada (Associate Member) Northern Air Cargo Era Aviation 

Omni Air International ExpressJet 

Ryan International Airlines GoJet

Southern Air Grand Canyon Airlines/Scenic 

Sun Country Airlines Great Lakes Aviation 

USA Jet Airlines Horizon Air

World Airways Island Air

Jazz Air

Mesaba Aviation 

New England Airlines 

Piedmont Airlines 

Pinnacle Airlines, Inc. 

PSA Airlines 

Republic Airlines 

Seaborne Airlines

Shuttle America 

Silver Airways

SkyWest Airlines, Inc. 

Trans States Airlines
2118 E. Interstate 20 • P.O. Box 1779 • Abilene, Texas USA 79604-1779

Within USA: 800.351.4530 • International (001): 325.677.1874 • Facsimile: 325.677.1372

www.StatKit.com • drdon@statkit.com 

February 22, 2013 

Robert L. Ireland 

Director, Technical Operations 

Airlines for America 

1301 Pennsylvania Avenue NW Suite 1100 

Washington, D.C. 20004-1707 

Re: Dextrose shortage 

Dear Mr. Ireland, 

My name is Dr. Don Cohen and I am the Chief Compliance Officer for Banyan International Corporation in 

Abilene, Texas. Banyan is a leading provider of emergency medical kits (EMKs) to office-based physicians, 

commercial airlines and government customers with over 40 years of experience. As a core part of our 

business, Banyan provides FAA-mandated EMKs to major commercial air carriers in the United States. 

Banyan is the only EMK provider that is also an FAA approved Repair Station for the emergency medical 

kits and AEDs that are required by the FAA for all airlines. 

I am writing to inform you of an indefinite shortage of Dextrose (which is one of the FAA-mandated 

components of EMKs) in the market. Supply of this product has sporadic at best for several months and has 

now come to a complete stop. Hospira has notified us that they have no stock on hand to deliver. It is also 

our understanding that the limited amount of product that is being produced by IMS-Amphastar is 

insufficient to cover the Hospira shortfall and is being rationed out to first-line responders (such as hospitals 

and paramedic units), who are receiving small quantities that are not sufficient to meet their needs. We 

believe the limited supply that is making its way to acute care providers is insufficient because Banyan 

receives numerous calls each day from all over the country from ambulance services, fire departments, 

physicians and even hospitals looking for Dextrose and other drugs in short supply. 

 

According to the Food and Drug Administration’s drug shortage index (http://www.fda.gov/drugs/ 

drugsafety/drugshortages/ucm050792.htm), the release date for Hospira’s Dextrose product shows February 

but this date has already been pushed back more than once and we have every reason to expect it will be 

again. It is our experience that even when they do release product, it is only a partial shipment and is to 

first-line responders and even then only in limited supply. The result is that Banyan (along with all other 

similarly situated companies) is unable to acquire Dextrose through any legitimate channel. 

 

Long-term shortages of Dextrose and close to 200 other prescription medications have been caused by a 

combination of manufacturing problems, shortages of active pharmaceutical ingredients (API) and generic 

drug manufacturers withdrawing from the production of what they consider to be low profit margin 

products. Emergency medications (namely generic prefilled syringes and ampules), anesthesia and cancer 

treatments have been particularly impacted. 

Enclosure 2
2118 E. Interstate 20 • P.O. Box 1779 • Abilene, Texas USA 79604-1779

Within USA: 800.351.4530 • International (001): 325.677.1874 • Facsimile: 325.677.1372

www.StatKit.com • drdon@statkit.com 

Page 2 of 2 

 

The situation has reached crisis levels, as some hospitals are being forced to schedule surgeries around the 

availability of anesthetics, relapses have increased for children with Hodgkin's lymphoma due to the 

unavailability of preferred oncology medications and paramedics in some metropolitan areas have been 

forced to use recently expired emergency medications to treat patients. As noted above, manufacturers have 

been rationing the drugs in short supply, making hospitals and emergency responders the first recipients of 

any product that comes available. The shortages pose such a significant public health risk that both houses 

of Congress unanimously passed a bill in July 2012 called the Food and Drug Administration Safety and 

Innovation Act to address the issue. 

Knowing the importance of sustaining the airline fleets and meeting the FAA requirements, Banyan’s 

Regulatory Affairs department contacted the FDA’s CDER Drug Shortage Program. There was a discussion 

regarding drug importation from sources outside the U.S. and it was stated that it is possible for 

manufacturers to import medications when there are shortages, but there are no FDA-approved foreign 

manufacturers authorized to import Dextrose into the U.S. at this time and even if there was an approved 

foreign manufacturer available, U.S. drug manufacturers often do not choose to import to resolve drug 

shortages due to the FDA’s stringent lab testing and stability data requirements. 

At this time, Banyan has exhausted its stock of Dextrose and has no viable source, primary or secondary, to 

obtain more. Should Banyan receive any Dextrose in the near future from IMS or Hospira, we are assured 

that it will only be in minimal increments insufficient to supply the thousands of units necessary to service 

the airline industry. Banyan respectfully requests Airlines for America, on behalf of its airline constituents, 

to submit a petition for an exemption of Dextrose in FAA-mandated EMKs until such time as the 

manufacturers can substantially meet the markets’ needs (our sources suggest that may be later in the year). 

Please note that in Banyan’s experience refurbishing EMKs for its airline customers for over 15 years, we 

estimate that Dextrose is used in less than .4% of inflight emergencies. 

Please feel free to contact me with any questions or concerns that you may have. 

Sincerely, 

Don Cohen, DMD 

Chief Compliance Officer 

Banyan International Corporation 

Enclosure 2
February 21, 2013 

Robert L. Ireland 

Director, Technical Operations 

Airlines for America®

1301 Pennsylvania Avenue NW, Suite 1100 

Washington, D.C. 20004-1707 

Dear Mr. Ireland, 

MedAire produces FAR-compliant medical kits for airlines subject to Part 121 

requirements. 

Recent pharmaceutical manufacturing changes have reduced the availability of 

Dextrose. Dextrose 50%, inj. 50 mL is an FAA-required component for onboard medical 

kits according to 14 CFR Part 121.803, Appendix A. 

As of February 20, MedAire has depleted its supply of Dextrose. Should carriers 

request new medical kits, or request refurbishment of existing medical kits with expired 

or missing Dextrose, MedAire will be unable to provide FAR-compliant kits to 

commercial carriers. 

Beginning today, we are coordinating with carriers to re-furbish only those used and 

expired medical kits which still contain Dextrose that has not yet expired. In these 

cases, the kits will be usable for only the period of time in which the existing Dextrose is 

usable—dating that varies from 1 to 11 months. For kits containing expired Dextrose, 

we are not able to refurbish them at this time. 

 

The manufacturers have indicated that they will begin distributing the drug again 

sometime in February and anticipate that availability will meet demand sometime in Q2 

2013. This timeline is dynamic, however, and once distribution begins again, distribution 

is at the discretion of the manufacturer. The typical distribution will be to first line 

medical facilities and emergency response units and finally to suppliers such as 

MedAire. To that end, we anticipate that this shortage may extend to the end of Q2 

2013 or longer. 

For additional information about the Dextrose production shortage, please refer to the 

following links: 

http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm314739.htm#dextrose

http://www.ashp.org/DrugShortages/Current/bulletin.aspx?id=988

Enclosure 3
Based on a formal review by MedAire’s Medical Equipment Review Board, there are 

two acceptable equivalent medications for the Dextrose 50%/50 cc (single dose ampule 

or equivalent) requirement: 

• Glucagon 1mg-- Although not an identical product, glucagon 1 mg will achieve 

similar results in the majority of the population by raising the blood glucose levels 

in passengers with severe hypoglycemia. 

• Dextrose 25% [2 doses]. Note: There is also currently a shortage of Dextrose 

25%. 

MedAire supports airlines with in-flight medical advisory services, assisting with 

approximately 25,000 events each year. A recent review of data from 2012 suggests 

that .02% of in-flight cases were serious enough to call for use of Glucagon [which 

some airlines stock] or Dextrose-- the necessary intervention to manage the medical 

emergency. It should be noted that these drugs are indicated in cases of severe 

hypoglycemia which although uncommon could be life-threatening. 

Please let us know if we can provide any additional information. 

Sincerely, 

Heidi MacFarlane 

Vice President, Strategic Development 

MedAire, an International SOS company 

Paulo Alves, MD, MSc, FAsMA 

Vice President, Aviation and Maritime 

Health 

MedAire, an International SOS company 

Enclosure 3