January 14, 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 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, 

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 the 

Federal Aviation Administration (FAA) 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 temporarily 

suspend for one year a requirement for air carriers to include Atropine in the 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.1That requirement was extended in 

1996 to cover 20-30 seat commuter aircraft.2In 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.

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 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 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 Atropine, 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

January 14, 2013

2

Current Shortage of 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.”

8 Part 121, Appendix A 

specifies that an EMK must include two Atropine 0.5 mg, 5 cc injectable single doses or an Atropine 

equivalent. 

Historically, major EMK airline suppliers and refurbishers MedAire, Inc. and Banyan International 

Corporation obtained Atropine from some of the four producers in the United States, Amphastar 

Pharmaceuticals Inc., Hospira, Inc., American Regent/Luitpold, and West-Ward Pharmaceuticals.

9

 Both 

MedAire and Banyan provided letters (see enclosures 2 and 3) stating there is currently a critical shortage 

of Atropine in the U.S. and that it will be impossible to supply EMKs with Atropine to our members after 

January 25, 2013. This shortage is due to multiple factors, including American Regent’s decision to stop 

producing Atropine and Hospira’ s decision to indefinitely postpone Atropine production.10 This 

production shortage has resulted in the two remaining suppliers, West-Ward and Amphastar rationing

remaining supplies to first-line responders such as hospitals and paramedic units.11 In addition, 

according to Banyan, there are no FDA-approved foreign Atropine manufacturers authorized to import 

Atropine into the U.S. to relieve the shortage. Also, while FDA has the authority to extend the expiration 

date on drugs such as Atropine, the drug manufacturer must petition the FDA with drug stability data

asking for an extension, which no manufacturer has done.12 Finally, Appendix A permits carriers and 

suppliers to provide an Atropine equivalent, however, according to MedAire (and confirmed by in house 

air carrier medical staff) there is no equivalent substitute for Atropine.13

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 shortage, EMKs in which Atropine has been used or has expired 

cannot be refurbished and returned to use, leaving the airline potentially without the means to comply with 

the requirements of Appendix A.14

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 two single Atropine doses as specified in part 121 Appendix A, EMK 

requirements, paragraph 2.

Reasons for seeking the relief include: 

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

manufacturing changes have reduced the availability of Atropine (also referred to as Atropine 

Sulfate) and manufacturers have not supplied revised fulfillment dates

2) Replacement supplies of Atropine cannot be imported from foreign manufacturers

3) There is no accepted substitute for Atropine

4) Primary kit provider/refurbisher MedAire will deplete its supply by January 25, 2013 and 

Banyan reports it has already depleted its Atropine supply

 

8

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

9

See FDA website concerning “Atropine Sulfate Injection” manufacturers at 

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

10 See enclosed Banyan letter page 1 and FDA website

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

11 See Banyan letter page 1.

12 See Id.

13 See MedAire letter page 1.

14 See Id.
EMK Petition for Exemption

January 14, 2013

3

5) Atropine is rarely used; Banyan estimates that Atropine is used less than one time per one

thousand units serviced

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

depleted soon, some within two weeks

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

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

from the date of granting this petition. 

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 

Atropine 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 Atropine 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 Atropine has additionally brought to light its limited usage. MedAire has reported that 

roughly 1% of EMKs returned for refurbishment are missing Atropine due to use, loss, or damage. A 

returned EMK, unless opened for use, represents approximately one year of service and is generally 

returned for replacement of expiring contents. MedAire and Banyan have both reported to A4A 

qualitatively that the predominance of Atropine usage for airline purposes has been due to expiration, not 

administration to passengers. Banyan reports that Atropine is used less than one time per one thousand 

units serviced.15

MedAire and Banyan also regularly compete with hospitals and other ground-based users to obtain 

Atropine who use the substance more often than discard it through expiration. Banyan reports that during 

this shortage, producers have adopted an Atropine distribution system that places acute care providers 

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

supply, making it even less likely that EMK providers will receive Atropine in the near future.16

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.17 The 

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

because it is used infrequently.

18

 

 

15 Banyan letter page 2.

16 Id.

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

18 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. 
EMK Petition for Exemption

January 14, 2013

4

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 Atropine 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 “Atropine –

injectable”.19 Absence of Atropine in an EMK on an aircraft operating outside the U.S. therefore would 

not violate ICAO requirements.

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

Atropine in the EMK for one year or until Atropine is once again commercially available.

Respectfully submitted January 14, 2013 by:

Douglas Mullen

Assistant General Counsel

Airlines for America

1301 Pennsylvania Ave. NW 

Suite 1100

Washington, DC 20004

Stacey Bechdolt, Esq.

Director, Safety & Technical Affairs

Regional Airline Association

2025 M Street, NW

Suite 800

Washington, DC 20036

 

19 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

January 14, 2013

5

George Paul

Director of Technical Services

National Air Carrier Association

1000 Wilson Boulevard

Suite 1700

Arlington, Virginia 22209-3928

 

cc:

Mr. John Allen

Federal Aviation Administration

Director, Flight Standards Service, AFS-1 

800 Independence Ave., SW 

Washington, DC 20591 

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, SW

Washington, DC 20591

Mr. Steve Douglas

Federal Aviation Administration

Flight Standards Service 

Aircraft Maintenance Division, AFS-300

470 L’Enfant Plaza, SW 

Washington, DC 20024

Enclosures/
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 Airlines, 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 Airlines

SkyWest Airlines, Inc. 

Trans States Airlines
January 8, 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 Atropine. Atropine (also 

referred to as Atropine Sulfate) is a required drug according to 14 CFR Part 121.803, Appendix A. 

Based on the current availability of Atropine and MedAire’s historical production data for producing new 

and refurbished medical kits, MedAire anticipates its current supplies of Atropine will be depleted on or 

about January 25, 2013. 

If Atropine manufacturers cannot supply the additional quantities of the drug once the MedAire supplies 

are depleted, MedAire will be unable to provide FAR-compliant kits to commercial carriers. 

 

Based on a formal review by MedAire’s Medical Equipment Review Board, an acceptable alternative 

medication for Atropine currently does not exist. 

MedAire has been in communication with suppliers about the availability of Atropine on a daily basis. The 

suppliers have indicated that additional access to stocks will be made available depending on demand 

levels, but have not provided any additional fulfillment forecasts. 

Manufacturers continue to place Atropine orders on hold, which is the manufacturers’ primary method of 

apprising clients of Atropine’s availability. 

For additional information about the Atropine shortage, visit: 

http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm

Thank you for your assistance. 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 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

January 10, 2013 

Robert L. Ireland 

Director, Technical Operations 

Airlines for America 

1301 Pennsylvania Avenue NW Suite 1100 

Washington, D.C. 20004-1707 

Re: Atropine 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 Atropine (which is one of the FAA-mandated 

components of EMKs) in the market. In early November, we received an industry-wide announcement that 

Hospira would not be producing or taking orders for Atropine for an indeterminate period of time. It is our 

understanding that due to manufacturing difficulties, Hospira decided to indefinitely postpone a production 

run of Atropine; this delay resulted in acute shortages of this product at IMS-Amphastar and West-Ward 

Pharmaceuticals (the only other manufacturers). It is also our understanding that the limited amount of 

product that is being produced by 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 Atropine and other drugs in short supply. 

Banyan has repeatedly contacted IMS-Amphastar and West-Ward Pharmaceuticals for release dates for 

their Atropine products, but they are refusing new orders from any organization other than first-line 

responders. The result is that Banyan (along with all other similarly situated companies) is unable to 

acquire Atropine through any legitimate channel. 

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

drugsafety/drugshortages/ucm050792.htm), no release date has been set for Hospira’s Atropine product. 

Long-term shortages of Atropine 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 3
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 Ms. Susie Dill with the FDA’s CDER Drug Shortage Program. 

There was a discussion regarding drug importation from sources outside the U.S. Ms. Dill stated said that it 

is possible for manufacturers to import medications when there are shortages, but she indicated there are no 

FDA-approved foreign manufacturers authorized to import Atropine into the U.S. at this time. She also 

stated that 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. There was also discussion about extending the expiration dating on existing product and Ms. 

Dill stated that the drug manufacturer must request an expiration dating extension and provide the FDA 

with drug stability data for each product. The FDA considers manufacturer requests for extending 

expiration dating on a case-by-case basis. We later contacted our representative at Hospira to discuss an 

expiration dating extension and they are not pursuing an extension for Atropine at this time. At our request 

and on our behalf, Ms. Dill emailed her drug shortage contacts at Hospira and IMS, and told them of our 

dilemma. Both companies were willing to move us up the list for shipments to meet our short term needs for 

several of the other prefills that are in short supply (e.g. Epinephrine and Lidocaine) but each could only 

commit to providing minimal allocations of Atropine as it is being rationed. We received a small shipment 

of Atropine from Hospira’s remaining marketing stock in early December and have yet to receive any from 

IMS, as promised. 

At this time, Banyan has exhausted all of its stock of Atropine and has no viable source, primary or 

secondary, to obtain more. Should Banyan receive any Atropine in the near future from IMS, we are 

assured that it will only be in minimal increments of 10 to 20 units, which is 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 Atropine in FAAmandated EMKs until such time as the manufacturers can substantially meet the markets’ needs (our 

sources suggest that may be as late as 2014). Please note that in Banyan’s experience refurbishing EMKs 

for its airline customers for over 15 years, we estimate that Atropine is used less than one time per one 

thousand units serviced. 

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 3