February 22, 2013 

U.S. Department of Transportation 

Docket Operations 

West Building Ground Floor, Room W12-140

1200 New Jersey Avenue, SE 

Washington, DC 20590 

RE: Petition for Emergency Exemption regarding Emergency Medical Equipment; 14 CFR § 

121.803 

Dear Sir or Madam: 

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

11.87, Spirit Airlines, Inc. petitions for emergency expedited approval of 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, Spirit requests a temporary exemption from the requirements of 14 

CFR § 121.803(c)(d) Part 121, Appendix A to the extent necessary to relieve it from the 

requirement to carry one single dose ampule of Dextrose, 50%/50 cc injectable in required onboard EMKs. Due to a manufacturing shortfall, Spirit’s EMK provider is currently unable to 

restock this medication, creating the potential that Spirit will be unable to comply with the 

requirements of Appendix A. Due to the expected temporary nature of the shortage, Spirit 

requests an exemption from this requirement through July 31, 2013 or until the shortage is 

resolved. 

Current Shortage of Dextrose: 

On February 21, 2013, Spirit was advised by its medical kit provider MedAire that as of 

February 20, 2013 it has depleted its stock of dextrose, and due to manufacturing shortages, does 

not expect to be able to provide dextrose for inclusion in EMKs until at least the end of June 

2013. (See February 20, 2013 MedAire notice attached). 

Dextrose 50% (also known as d-50) is an injectable solution of sugar in water at a 50% 

concentration, which is used to restore blood glucose levels in acute severe hypoglycemia or insulin 

shock. It has been a required component of EMKs since 1986. Appendix A calls for it to be stocked 

in injectable single dose ampules. There are currently two companies producing this product in the 

United States, Amphastar (IMS) and Hospira, Inc. Both report shortages of the product due to 

manufacturing delays and increased demand and currently have the product on back order.1 Hospira 

expects to have the product available this month, and Amphastar is intermittently releasing the 

 

1

 FDA, Current Drug Shortages, http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm314739.htm#dextrose

(enclosed) 
Petition for Exemption 

February 22, 2013 

2 

product as it becomes available. However, as explained by MedAire, priority for filling back orders 

will be given to first line medical facilities and emergency response units. MedAire does not expect 

the drug to be available for inclusion in EMKs until at least the end of June 2013. 

Ordinarily, Spirit maintains a certain number of extra EMKs to replace those that are opened during a 

medical emergency. The used EMKs are then sent back to MedAire for refurbishment. In addition, 

all EMKs are restocked periodically to replace expired products. Beginning today, MedAire plans to 

return kits without restocking dextrose 50% if this drug has not expired or been used. However, if 

the dextrose in the EMK has expired or been used, MedAire will not replace this product and the kit 

cannot be returned to use under the requirements of Appendix A. 

Applicable Regulation and Relief Sought: 

14 C.F.R. § 121.803(c)(3) requires aircraft with more than nine passenger seats to be equipped with 

EMKs, and Part 121, Appendix A specifies that the EMK contains, among other items, dextrose 

50%. Although Appendix A states that the EMK include these formulations “or equivalent,” in the 

case of dextrose 50% there is no true equivalent. 

Spirit requests a temporary, one-year exemption from the requirements of 14 CFR § 

121.803(c)(d) Part 121, Appendix A to the extent necessary to relieve it from the requirement to 

carry one single dose ampule of dextrose, 50%/50 cc injectable in required on-board EMKs 

through July 31, 2013 or until this shortage has been alleviated. EMKs lacking dextrose would be 

clearly labeled and flight attendants informed of this change in the EMK contents as part of preflight briefing.

Alternatively, the FAA could grant Spirit approval to use glucagon 1 mg as a substitute for dextrose, 

subject to availability, through July 31, 2013 or until this shortage has been alleviated. Although not 

an identical product, glucagon 1 mg will achieve similar results to dextrose in the majority of the 

population by raising the blood glucose levels in passengers with severe hypoglycemia. Again, the 

EMKs containing this substitution would be clearly labeled and flight attendants informed of this 

change in the EMK contents as part of pre-flight briefing. 

Due to the current unavailability of dextrose and the unpredictability of when Spirit’s current supply 

of the product will be exhausted, pursuant to 14 CFR § 11.87, Spirit requests that the FAA waive 

publication and expeditiously provide the relief requested.

Granting this Exemption would be in the Public Interest: 

Absent this relief, Spirit would be unable to fully comply with FAR 121.803 should dextrose need to 

be restocked in an EMK, creating the possibility that aircraft would have to be taken out of service. 

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 serve the public interest by 

helping to ensure that Spirit’s operations continue uninterrupted. 

Further, as this shortage is affecting all types of medical service providers, it would be in the public 

interest to prioritize the needs of first line medical facilities and emergency response providers by 

preventing airlines from needing to compete with these entities for the limited stock of dextrose. 
Petition for Exemption 

February 22, 2013 

3 

Granting this Exemption would not adversely affect safety: 

While dextrose may be important in cases of severe hypoglycemia, such cases are exceedingly 

rare. A recent review of 2012 data by MedAire, a major provider of EMKs and in-flight medical 

advisory services, suggests that only .02% of in-flight cases were serious enough to call for the 

use of dextrose or glucagon in order to manage the medical emergency. Accordingly, the risk of 

the lack of dextrose resulting in a life-threatening situation during the limited period when this 

exemption would apply is very low. Further, should the FAA allow the substitution of glucagon 

that risk decreases even more. 

 

Exercise of this Exemption outside the United States: 

Spirit also requests that it be allowed to exercise this privilege outside of the United States. The 

International Civil Aviation Organization recommends that dextrose be included in EMKs but 

does not specifically require it.2 Accordingly, Spirit would not violate ICAO requirements if 

dextrose was not present in an EMK. 

Summary of Petition: 

Petitioner: Spirit Airline, Inc. 

 

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 Spirit Airlines, Inc. 

from having to carry dextrose in EMKs due to a 

manufacturing shortage of the drug 

Granting this exemption is in the public interest as it avoids potential, unpredictable 

disruptions in scheduled air transport service. 

For the foregoing reasons, Spirit 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 through July 2013 or until this shortage is resolved. 

 

2

 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 
Petition for Exemption 

February 22, 2013 

4 

Respectfully submitted February 22, 2013 by: 

Joanne W. Young 

David M. Kirstein 

Kirstein & Young PLLC 

1750 K Street N.W. 

Suite 200 

Washington, D.C. 20006 

(202) 331-3348 (telephone) 

(202) 331-3933 (facsimile) 

 

Counsel for SPIRIT AIRLINES, INC.

CC (by email): 

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 

Enclosure/ 
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 
2/22/13 Drug Shortages > Current Drug Shortages A - D

www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm314739.htm#dextrose 12/15

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

Diazepam Injection

Company Product Availability and

Estimated Shortage

Duration

Related Information Shortage

Reason

(per New

LegislationFDASIA)*

Date

Updated

Hospira, Inc.

Customer Service:

1-877-946-7747

5 mg/mL; 2 mL Carpuject

(0409-1273-32)

Available Shortage per Manufacturer: manufacturing delayOther Reverified

2/1/2013

5 mg/mL; 10 mL vial

(0409-3213-12)

Next delivery February

Estimated recovery: 1Q

2013

Dipyridamole Injection (Initial posting-7/24/12)

Company Product Availability and

Estimated Shortage

Duration

Related Information Shortage

Reason

(per New

LegislationFDASIA)*

Date

Updated

West-Ward Pharmaceuticals

Customer Service:

1-800-631-2174

Dipyridamole Injection, USP

(Formerly a Baxter Product)

5 mg/mL; 10 mL vial

(NDC 0641-2569-44)

West-Ward is currently

experiencing a

backorder situation.

West-Ward has

increased production

and is anticipating

having product available

by the end of January

2013.

Additional lots are

projected to be

available in February

2013.

Product will be made

available as it is

released.

Shortage per Manufacturer:

Increase in product demand due to market supply issues.

West-Ward has accelerated

production on this product.

Demand

increase for

the drug.

Revised

1/7/2013

Doxorubicin (adriamycin) lyophilized powder (updated 12/2/2011)

Company Product Availability and

Estimated Shortage

Duration

Related Information Shortage

Reason

(per New

LegislationFDASIA)*

Date

Updated

Bedford Laboratories Customer Service

1-800-562-4797

10 mg vials (NDC 55390-

0231-01)

Bedford Laboratories

has 10 mg available in

limited quantities.

Once this supply is

depleted, the next

estimated release

dates are unknown.

Other presentations

are pending release

with release date yet

to be determined.

Availability of products is

updated on the Bedford

Laboratories website.

Shortage per Manufacturer:

Manufacturing delays

Discontinuation

of the manufacture of

the drug.

Revised

4/10/2012

20 mg vials (NDC 55390-

0232-10)

50 mg vials (NDC 55390-

0233-01)