THE FOONT LAW FIRM, LLC

11909 REYNOLDS AVENUE

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E-MAIL: FOONT@FOONTLAW.COM / WEB: WWW.FOONTLAW.COM

Brian E. Foont, Esq.

Admitted in NY, VA, MD and DC

February 19, 2013

VIA ELECTRONIC SUBMISSION

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 Emergency Exemption from Inclusion of Atropine in Emergency

Medical Kits (14 C.F.R. § 121.803(c)(3) / 14 C.F.R. Part 121, App. A)

Dear Sir or Madam:

Pursuant to 14 C.F.R. §§ 11.63, 11.81, and 11.87, Frontier Airlines, Inc. (“Frontier”), 

petitions for expedited and emergency approval of a limited exemption from 14 C.F.R.

§ 121.803(c)(3). That regulation requires airlines operating pursuant to authority under 14 C.F.R. 

Part 119 and, therefore, under the operating requirements of 14 C.F.R. Part 121, to carry 

equipment specified in Appendix A to Part 121. Among the items required is an emergency 

medical kit (“EMK”) that includes “Atropine, 0.5 mg, 5 cc (single dose ampule or equivalent).” 

Frontier respectfully requests a temporary, one-year exemption from that latter requirement to 

carry Atropine in its EMKs.

Frontier makes this request because of a severe nationwide shortage of Atropine. This 

shortage has been documented by and is being monitored by the U.S. Food and Drug 

Administration (“FDA”).1 While some production is being accelerated, no estimate is provided 

as to when supplies will be restored and Atropine again readily available. Because of this, 

Frontier has been advised by its EMK provider, Banyan International, that it is unable to obtain

Atropine.2

We respectfully note that the same exemption sought here was recently granted pursuant 

to Exemption No. 10690 to those members of Airlines for America, the National Air Carrier 

Association, and the Regional Airline Association to which the same rule applies.

3

That 

exemption covers Frontier’s three sister carriers, Chautauqua Airlines, Republic Airlines and 

 

1

See http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm314739.htm#atropine (extract enclosed).

2

See enclosed copy of a letter from Banyan International dated February 15, 2013.

3

See enclosed copy of Exemption No. 10690. We respectfully note that a comparable exemption has been granted 

to Spirit Airlines, Inc. under Exemption No. 10694.
Petition for Emergency Exemption from Inclusion of Atropine in Emergency Medical Kits

February 19, 2013

Page 2 of 3

Shuttle America (all, like Frontier, are subsidiaries of the same parent company, Republic 

Airways Holdings, Inc.). It does not apply to Frontier because Frontier is not a member of any of 

those three organizations. As explained in the request for that exemption and recognized in the 

exemption that was granted, there exists a manufacturing supply shortage of Atropine leaving 

airlines without the means to comply with the requirement to carry that drug. The FAA also 

recognized the rarity with which Atropine is used in flight and that “it is not in the public interest 

for EMK suppliers to airlines to be competing with the greater need and demand of ground-based 

medical providers for these medications.” Frontier respectfully submits that it is similarly 

situated to those carriers to which Exemption No. 10690 was granted and seeks the same 

exemption to avoid grounding aircraft in the event that adequate Atropine cannot be obtained.

As provided in Exception No. 10690, Frontier also respectfully requests that it be allowed 

to exercise the exception requested above outside of the United States. In that regard, we note 

that while the International Civil Aviation Organization (“ICAO”) recommends that Atropine be 

included in EMKs, it is not a requirement. Thus, Frontier will not violate ICAO rules by not 

having Atropine in it EMKs in its international operations.

Given the urgency of this matter, pursuant to 14 C.F.R. § 11.87 and, in particular, 14 

C.F.R. § 11.87(b) in that the “the relief requested is identical to exemptions granted previously” 

and 14 C.F.R. § 11.87(c) in that delay would adversely impact Frontier, Frontier requests that the 

FAA waive publication and immediately act on this exemption request.

Pursuant to 14 C.F. R. § 11.81(f) we offer the following summary of this petition:

Petitioner: Frontier Airlines, Inc. (“Frontier”)

Rule 14 C.F.R. § 121.803(c)(3) and 14 C.F.R. Part 121, App. 

A as applicable to the inclusion of Atropine, 0.5 mg, 5 cc 

(single dose ampule or equivalent) in emergency medical 

kits

Exemption 

Sought

Temporarily exempt Frontier from having to carry 

Atropine in emergency medical kits due to a chronic 

shortage of that drug

Respectfully submitted,

Brian E. Foont

Counsel for Frontier Airlines, Inc.

cc: Mr. John Allen

Director, Flight Standards Service, AFS-1

Federal Aviation Administration

800 Independence Avenue, SW

Washington, DC 20591
Petition for Emergency Exemption from Inclusion of Atropine in Emergency Medical Kits

February 19, 2013

Page 3 of 3

Mr. John Duncan

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

Federal Aviation Administration

800 Independence Avenue, 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

Mr. Douglas W. Diehl

Director of Safety

Frontier Airlines, Inc.

7001 Tower Road

Denver , CO 80249

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

(reformatted)

Atropine Sulfate Injection

Company Product Availability and 

Estimated 

Shortage Duration

Related Information Shortage 

Reason

(per New 

LegislationFDASIA)*

Date 

Updated

Amphastar 

Pharmaceuticals Inc.

Customer Service:

1-800-423-4136

0.1 mg/mL, 10 mL, LuerJet Prefilled Syringe

NDC 76329-3339-1

(old NDC 00548-3339-00)

Amphastar will 

regularly release 

products.

Amphastar is experiencing a 

product shortage due to an 

increase in product demand 

caused by market supply issues.

Demand 

increase for the 

drug

Reverified

2/11/2013

Hospira, Inc.

Customer Service:

1-877-946-7747

0.1 mg/mL; 10 mL Ansyr 

syringe

(NDC 0409-1630-10)

Next delivery and 

estimated recovery 

TBD

Please check with your 

wholesaler for available 

inventory. 

Shortage per Manufacturer:

Manufacturing delay; Material 

shortage

Other Revised

2/1/2013

0.05 mg/mL; 5 mL Ansyr 

syringe

(NDC 0409-9630-05)

Next delivery and 

estimated recovery 

TBD

0.1 mg/mL; 5 mL 

Lifeshield syringe

(NDC 0409-4910-34)

Next delivery 

March

Estimated recovery: 

2Q 2013

0.1 mg/mL; 10 mL 

Lifeshield syringe

(NDC 0409-4911-34)

Company estimates 

a release date by 

2Q 2013

Estimated recovery: 

3Q 2013

American Regent/Luitpold

1-800-645-1706

0.4 mg/mL, 0.5 mL 

ampule, package of 25

(NDC 00517-0805-25)

Unavailable Shortage per Manufacturer: 

American Regent/Luitpold has 

discontinued manufacturing the 

ampules

Discontinuation 

of the 

manufacture of 

the drug.

Reverified

1/23/2013

0.4 mg/mL, 1 mL singledose vial, package of 25

(NDC 00517-0401-25)

Available American Regent is currently 

releasing Atropine Sulfate

Injection 0.4 mg/mL, 1 mL 

single-dose vial

1 mg/mL, 1 mL singledose vial, package of 25

(NDC 00517-1010-25)

Available American Regent is currently 

releasing Atropine Sulfate 

Injection 1 mg/mL, 1 mL singledose vial

1 mg/mL, 1 mL ampule, 

package of 25 (NDC 

00517-0101-25)

Unavailable Shortage per Manufacturer: 

American Regent/Luitpold has 

discontinued manufacturing the 

ampules

West-Ward 

Pharmaceuticals

Customer Service:

1-800-631-2174

0.4 mg/mL, 20 mL vial

(NDC 0641-6006-10)

West-Ward 

currently 

experiencing a 

backorder sitation.

West-Ward has accelerated 

production to meet increased 

demand.

Several lots are scheduled for 

production and anticipated to be 

available by the end of February 

2013.

Product will be made available as 

it is released.

Demand 

increase for the 

drug.

Revised

2/11/2013
2118 E. Interstate 20 • P.O. Box 1779 • Abilene, Texas USA 79604-1779

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

www.StatKit.com 

02/15/2013

To whom it may concern,

Banyan International Corporation is currently unable to obtain the Atropine that is a required component of 

your FAA mandated medical kit. If you would like to take advantage of the exemption granted by the FAA 

that allows you to leave this item out of your kits, please contact us for suggestions on how to implement 

this for your fleet.

Best regards,

Doug Phariss 

Accountable Manager
Exemption No. I 0690 

UNITED STATES OF AMERICA 

DEPARTMENT Of TRANSPORT AriON 

FEDERAL AVIATION ADMINISTRATION 

WASHINGTON, DC 20591 

In the matter of the petition of 

AIRLINES FOR AMEI{ICA 

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 

Regulatory Docket No. 

FAA-2013-0034 

PARTIAL GRANT OF EXEMPTION 

By letter received on January 14,2013. Airlines for America, the National Air Carrier 

Association, and the Regional Airline Association 1301 Pennsylvania Avenue NW., 

Washington, DC 20004, petitioned the Federal Aviation Administration (FAA) on behalf of 

the airlines named in their petition for an exemption from § 121 .803( c )(3) and Appendix A of 

part 121, Title 14, Code ofF ederal Regulations. The proposed exemption, if granted, would 

provide relief from the requirement to include Atropine in an Emergency Medical Kit (EMK). 

The petitioners indicate they arc making this request due to a nationwide manufacturing 

supply shortage that leaves affected certificate holders without an alternate means to comply 

with the requirements of Appendix A. 

The petitioners require relief from the following regulations: 

Section 121.803(c)(3) prescribes, in pertinent part, that passenger-carrying airplanes 

operating under part 121 mles for which a flight attendant is required must have 

approved emergency medical kits that meet the specifications and requirements of Part 

121, Appendix A. 

Part 121, Appendix A, '·Emergency Medical Kits" specifies, in pertinent part, that an 

EMK must include two single dose ampules of Atropine 0.5, Sec injectable or 

equivalent. 

AFS-13-159-E 
2 

The petitioner supports its request with the following information: 

The petitioners state that Atropine, a medication required to be carried in EMKs, is not 

available due to a manufacturing shortfall and an increase in demand. One major EMK 

supplier has informed the petitioners that it will deplete its Atropine supply as of 

January 25, 2013; another indicates that its Atropine supply is already depleted. As such, the 

petitioners indicate that their member air carriers are not able to meet the atropine 

requirement. 

The petitioners enclosed two letters from major EMK airline suppliers and refurbishers, 

Banyan International Corporation and MedAire. as evidence ofthe Atropine shortage. The 

petitioners state that Banyan and MedAire are major EMK airline suppliers. The petitioners 

indicate that of the four pharmaceutical companies that manufacture Atropine one 

manufacturer has decided to stop producing Atropine and another has decided to indefinitely 

postpone Atropine production. The petitioners state that this lack of production has resulted 

in two remaining manufacturers rationing remaining supplies to first-line responders such as 

hospitals and paramedic units. In addition. the letter trom Banyan states that it has verified 

with the Food and Drug Administration (FDA) that there are no FDA-approved foreign 

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

shortage. The petitioners assert that, while the FDA has the authority to extend the expiration 

date on drugs such as Atropine, the manufacturer must petition the FDA for an extension of 

the expiration date by providing drug stability data, which no manufacturer has done. 

The petitioners state that MedAire has reported that roughly 1% of the EMKs returned for 

refurbishment (to restock an EMKs contents) are missing Atropine due to use, loss, or 

damage. The petitioners also state that Banyan reports that Atropine is used less than one 

time per 1,000 units serviced. 

Finally, the petitioners request that they be able to exercise the privileges of the exemption 

outside the United States. They state that the International Civil Aviation Organization 

(ICAO) standards require aircraft authorized to carry more than 100 passengers to be equipped 

with "accessible and adequate medical supplies: · but recommends that injectable Atropine be 

available as part of a medical kit tor use by medical doctors or other qualified persons on 

certain aircraft. Accordingly. the petitioners state that the absence of Atropine 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 because delaying action would adversely affect the petitioners due to 

the imminent effect on operations caused by the Atropine sh011age. 
3 

The FAA's analysis is as follows: 

The FAA has considered fully the petitioners' request and supp011ing information and finds 

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

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

part 121 , Appendix A. The EMK is considered a ··no-go'· item and is included on the Master 

Minimum Equipment List (MMEL). Current MMEL Policy Letter relief requires an air 

carrier to repair or replace an EMK within one tlight when it is incomplete, missing, or 

inoperative. There is no minimum equipment list relief permitting an air carrier to depart with 

an EMK missing Atropine, beyond the one llight relief described in MMEL policy Letter 73, 

titled "MMEL Rclieffor Emergency Medical Equipment." 

The documented Atropine shottage creates the possibility that a significant number of aircraft 

would not be able to meet the requirements of Appendix A of part 121 and would have to be 

taken out of service. As discussed in the petition. EMK suppliers report that Atropine is used 

for medical purposes less than one time per thousand EMK units serviced, and Atropine is 

predominantly replaced in EMKs due to expiration. Accordingly, the FAA has determined 

that the impact on large numbers of passengers that would be caused by grounding these 

aircraft for lack of Atropine outweighs the bene tit of having the medication, which reportedly 

is infrequently used in response to on board medical events. 

Further, as discussed in the petition, the nationwide Atropine shortage is affecting not only 

EMK suppliers to airlines, but also ground-based medical service providers. The FAA also 

fmds that, because this medication is reported to rarely be used in flight, it is not in the public 

interest for EMK suppliers to airlines to be competing with the greater need and demand of 

ground-based medical providers tor these medications. 

The FAA's Decision 

In consideration of the foregoing, I tind that a partial grant of exemption is in the public 

interest. Thcref()re. pursuant to the authority contained in 49 U.S.C. §§ 40113 and 44701 , 

delegated to me by the Administrator, the certificate holders listed in Condition and 

Limitation No. I to this Partial Grant. are granted an exemption from 14 CFR § 121.803(c)(3) 

and Part 12L Appendix A only to the extent necessary to relieve them from the requirement to 

carry two single dose ampules of Atropine Sec injectable, in required on-board EMKs when, 

due to the nationwide shortage discussed herein. they are unable to procure these items for the 

kits. The FAA is granting this exemption only to the part 119 cettificate holders named in the 

petition that conduct part 121 passenger canying operations. 
4 

Conditions and Limitations 

1. This exemption applies to the part 119 certiiicate holders authorized to conduct 

part 121 passenger carrying operations listed below. 

Air Transport International ExpressJct Republic Airlines 

Air Wisconsin Airlines GoJet Ryan International Airlines 

Corp. 

Alaska Airlines Great Lakes Aviation Seaborne Airlines 

Allegiant Air Hawaiian Airlines. Inc. Shuttle America -··· -·· 

American Airlines Horizon Air Silver Airlines 

American Ea le Island Air SkyWest Airlines, Inc. 

Atlas Air, Inc. JetBlue Airways Corp. Southwest Airlines, Inc. 

Cape Air Miami Air International Sun Country Airlines 

Chatauqua Airlines National Airlines Trans States Airlines 

ConunutAir National Air Cargo United Airlines, Inc. 

Compass Airlines Omni Air International US Airways, Inc. 

Delta Air Lines, Inc. Piedmont Airlines - USA Jet Airlines 

Era Aviation Pinnacle Airlines, Inc. World Airways 

Everts Air Cargo PSA Airlines 

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

emergency medical kits that do not include Atropine as required by Appendix A of 

part 121. 

3. The pilot in command must inform crewmembers that any emergency medical kits 

on board the aircraft may not contain Atropine as part of the pre-flight briefing. 

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

This exemption terminates on January 31. 2014. unless sooner superseded or rescinded. 

Issued in Washington, DC, on JAN 2 5 2013 

)7-J .. Mhn M. Allen 

D1rector, Flight Standards Service