THE FOONT LAW FIRM, LLC

11909 REYNOLDS AVENUE

POTOMAC, MD 20854-3334

TEL. 202-236-4851 / FAX. 202-318-9195

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

Brian E. Foont, Esq.

Admitted in NY, VA, MD and DC

March 12, 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 Dextrose in Emergency

Medical Kit (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 “Dextrose, 50%/50 cc 

injectable, (single dose ampule or equivalent)” (“Dextrose”). Frontier respectfully requests a temporary, 

one-year exemption from that latter requirement to carry Dextrose in its EMKs.

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

has been documented by and is being monitored by the U.S. Food and Drug Administration (“FDA”).1

Because of this, Frontier has been advised by its EMK provider, Banyan International Corporation

(“Banyan”), that it is no longer able to acquire and, therefore, provide Dextrose in EMKs.

2 Thus, Frontier

cannot reliably determine when Dextrose will again be dependably available for the restocking of its 

EMKs. Banyan does note in its letter that the use of Dextrose inflight is quite rare with use in less than 

0.4% of all inflight emergencies over the past fifteen years.

We are aware that other airlines have applied for similar exemptions and have proposed to be 

allowed to substitute Glucagon 1mg for Dextrose as a condition of the exemption, on a permissive basis, 

or as an alternative to an outright exemption.

3 Banyan, however, has informed Frontier that it cannot 

provide Glucagon. Frontier, therefore, asks for an exemption without a requirement to substitute a 

different drug or, in the alternative, to be permitted to substitute Glucagon for Dextrose should it become 

available from our supplier.

 

1

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

2

See enclosed copy of memorandum from Banyan International Corporation dated March 12, 2013.

3

See, e.g., Application of Mesa Airlines, Docket FAA-2013-0200 (seeking permission to substitute Glucagon for 

Dextrose); Application of Airlines for America/The Regional Airline Association/National Air Carrier Association, 

Docket FAA-2013-0201 and Application of Virgin America, Docket FAA-2013-0224 (seeking permissive, but not

required, substitution of Glucagon); and Application of Spirit Airlines, Docket FAA-2013-0199 (seeking permission 

to substitute Glucagon as alternative to exemption).
Petition for Emergency Exemption from Inclusion of Dextrose in Emergency Medical Kit

March 12, 2013

Page 2 of 3

We respectfully note that a similar exemption was sought for the then members of Airlines for 

America (then the Air Transport Association of America), the National Air Carrier Association, and the 

Regional Airline Association in August 10, 2010 (Docket No. FAA-2010-0832).

4 That request was, 

however, withdrawn on November 10, 2010 because supplies had been restored.

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 “Dextrose 50% (or equivalent) – injectable: 50 ml” be included 

in EMKs, it is not a requirement.5 Thus, Frontier will not violate ICAO rules by not having Dextrose 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(c) in that delay would adversely impact Frontier, Frontier requests that the FAA waive publication 

and immediately act on this exemption request. We respectfully further note that, because the request 

discussed above under Docket No. FAA-2010-0832 was published in the Federal Register for comment,6

the public has, in fact, had an opportunity to comment on this issue.

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 Dextrose, 50%/50 cc injectable, 

(single dose ampule or equivalent) in emergency medical kits

Exemption 

Sought

Temporarily exempt Frontier from having to carry Dextrose, 

50%/50 cc injectable, (single dose ampule or equivalent) in 

emergency medical kits due to a chronic shortage of that drug.

Respectfully submitted,

Brian E. Foont

Counsel for Frontier Airlines, Inc.

 

4 That request also sought an exemption with respect to Epinephrine 1:10,000, 2 cc, injectable, (single dose ampule 

or equivalent), which is not at issue in the present case

5

ICAO, International Standards and Recommended Practices, Annex 6 to the Convention on International Civil 

Aviation (Ninth Ed., July 2010), Attachment B supplementary to Chapter 6.

6

75 Fed. Reg. 51,525 (Aug. 20, 2010).
Petition for Emergency Exemption from Inclusion of Dextrose in Emergency Medical Kit

March 12, 2013

Page 3 of 3

cc: Mr. John Allen

Director, Flight Standards Service, AFS-1

Federal Aviation Administration

800 Independence Avenue, SW

Washington, DC 20591

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#dextrose

(reformatted)

Dextrose Injection (Initial posting – 5/23/2012)

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

50%, 50mL 

Luer-Jet 

Prefilled 

Syringe

NDC 76329-

3301-1

(old NDC 0548-

3301-00)

Amphastar 

will 

regularly 

release 

products

Amphastar is 

experiencing a 

product shortage due 

to an increase in 

product demand 

caused by market 

supply issues.

Shortage per 

Manufacturer:

Increased Demand

Demand 

increase for 

the drug.

Reverified

2/11/2013

Hospira, Inc.

Customer 

Service 

1-877-946-7747

50%; 50mL vial 

(NDC 00409-

6648-02)

Next 

delivery 

mid April

Estimated 

recovery 2Q 

2013

Shortage per 

Manufacturer: 

Manufacturing delay

Other: 

Demand 

increse for 

the drug

Revised

3/8/2013

50%; 50mL 

Abboject 

Syringe (NDC 

00409-4902-34)

Next 

delivery 

March 

Estimated 

recovery 2Q 

2013

50%; 50mL 

Ansyr Syringe 

(NDC 00409-

7517-16)

Next 

delivery 

March 

Estimated 

recovery 2Q 

2013
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

March 12, 2013

Kathy Miller

Manager of Emergency Response

Frontier Airlines

Re: Dextrose shortage

Dear Ms. Miller,

As you know, 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. 
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