THE FOONT LAW FIRM, LLC

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Brian E. Foont, Esq.

Admitted in NY, VA, MD and DC

February 22, 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, Mesa Airlines, Inc., operating as go!, Mesa 

Airlines, Inc., United Express and US Airways Express (“Mesa”), 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”). Mesa respectfully requests a temporary, one-year exemption from that latter 

requirement to carry Dextrose in its EMKs and to substitute Glucagon 1mg.

Mesa 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, Mesa has been advised by its EMK provider, MedAire, that it will no longer stock 

Dextrose in EMKs, and will “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.”

2 MedAire further notes 

(emphasis added):

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.

Thus, Mesa cannot reliably determine when Dextrose will again be dependably available for the 

restocking of its EMKs.

 

1

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

2

See enclosed copy of memorandum from MedAire dated February 21, 2013.
Petition for Emergency Exemption from Inclusion of Dextrose in Emergency Medical Kit

February 22, 2013

Page 2 of 3

As an alternative to Dextrose, MedAire notes in the attached letter that there are “two acceptable 

equivalent medications for the Dextrose 50%/50 cc (single dose ampule or equivalent).” They are: (1) 

Glucagon 1mg, and (2) Dextrose 25% (2 doses). Because there is also a shortage of the latter, Mesa 

proposes to substitute Glucagon 1mg for Dextrose.

MedAire notes that use of both Dextrose and Glucagon 1mg (which they note some carriers 

stock) is quite rare. Specifically, they note that in 2012 use of both was made in less than 0.02% of the 

approximately 25,000 cases in which MedAire was contacted for in-flight emergency medical 

consultations, i.e., less than 5 times.

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).

3 That request was, 

however, withdrawn on November 10, 2010 because supplies had been restored.

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 Mesa, Mesa 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,4

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: Mesa Airlines, Inc., operating as go!, Mesa Airlines, Inc., 

United Express and US Airways Express (“Mesa”)

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 Mesa 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

and allow the substitution of Glucagon 1mg.

Respectfully submitted,

Brian E. Foont

Counsel for Mesa Airlines, Inc.

 

3 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

4

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

February 22, 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. Deke Abbott

Supervisory Aviation Safety Inspector Air Carrier Operations

Federal Aviation Administration

800 Independence Ave., SW

Room 829 / Desk C-52

Washington, DC 20591

Chris Pappaioanou, Esq.

Vice President, General Counsel & Secretary

Mesa Air Group, Inc.

410 North 44th Street, Suite 700

Phoenix, AZ 85008

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 

February 

Estimated 

recovery 2Q 

2013

Shortage per 

Manufacturer: 

Manufacturing delay

Other Revised

2/1/2013

50%; 50mL 

Abboject 

Syringe (NDC 

00409-4902-34)

Next 

delivery 

February 

Estimated 

recovery 2Q 

2013

50%; 50mL 

Ansyr Syringe 

(NDC 00409-

7517-16)

Next 

delivery 

January 

Estimated 

recovery 2Q 

2013
February 21, 2013 

Dear Sir or Madame, 

MedAire produces FAR-compliant medical kits for your airline 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 your carrier 

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. 

Beginning today, we are coordinating with your carrier 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
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