amer1ca 

Submitted via www.regulations.gov 

Federal Aviation Administration 

U.S. Department of Transportation 

Docket Operations 

February 28, 2013 

West Building Ground Floor, Room W12-140 

1200 New Jersey Avenue, SE 

Washington, DC 20590 

Re: Petition for Exemption; 14 C.F.R. § 121.803 

Ladies and Gentlemen: 

Pursuant to 14 C.F.R. §§ 11.63 and 11.81, Virgin America Inc. ("Virgin America"), a part 121 

passenger-carrying operator, respectfully petitions for an exemption from 14 C.F.R. 

121.803(c)(3) and part 121, Appendix A, to relieve Virgin America for a period of one year from 

the requirement to carry Dextrose in on board Emergency Medical Kits ("EMKs"), as more fully 

described herein. Virgin America asks that the FAA, in considering this request, take notice of a 

petition submitted by Airlines for America, the National Air Carrier Association and the 

Regional Airline Association to the FAA on February 26,2013, in Docket FAA-2013-0201, 

seeking similar relief ("Association Petition"). Virgin America further asks that the FAA 

expedite this Petition1 and, until such time as it acts on this Petition, exercise its discretion not to 

enforce the regulations that are the subject of the relief requested herein. 

By letter dated February 21, 2013, MedAire, Inc. ("MedAire"), Virgin America's supplier of 

EMKs, notified air carriers that it had depleted its supply of Dextrose 50%/50 cc injectable due 

to a national pharmaceutical production shortage, and, as a consequence, would only be able to 

refurbish used and expired EMKs which still contain Dextrose that has not yet expired. A copy 

of the letter is included with this Petition as Attachment A. 

The national Dextrose shortage has been widely documented. Dextrose 50%/50 mL injectable is 

listed on the Food and Drug Administration's ("FDA") Cun·ent Drug Shortages list? Similarly, 

2 

Accordingly, Virgin America respectfully requests a waiver from 14 C.F.R. § 11.63(d), 

requiring any petition for an exemption to be submitted 120 days before the requested 

effective date. 

See Www.fda.gov/Drugs/DrugSafety/DrugShortages. The FDA last revised or re-verified 

these entries in February of2013. 
Federal Aviation Administration 

February 28, 2013 

Page 2 

the American Society of Health-System Pharmacists ("ASHP") lists Dextrose 50%/50 mL 

injectable on its online Drug Shortages Resource Center.3 Both the FDA and ASHP lists state 

that the acute national shortage is the result of increased demand. This national shortage extends 

to Dextrose 25% as well.4 Virgin America understands that there are, at present, only two 

Dextrose pharmaceutical manufacturers authorized to supply the U.S. market-Hospira, Inc. and 

Amphastar Pharmaceuticals, Inc. 

As recounted in the MedAire letter, pharmaceutical manufactures of Dextrose have indicated that 

they plan to resume distribution of the drug shortly. However, these manufacturers do not 

anticipate that availability will be able to meet the national demand for Dextrose until sometime 

during the second calendar quarter of2013. Furthermore, as MedAire advises in the letter, "once 

distribution begins again, distribution is at the discretion ofthe 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, [MedAire] anticipate[s] that this shortage may extend to 

the end ofQ22013 or longer." Attachment A at 2 (emphasis added). Significantly, MedAire 

also observes in its letter that, based on a recent review of in-flight medical cases, fewer than 

0.02% of such cases were serious enough to warrant the use of Dextrose or Glucogan- a drug 

that is reported to achieve similar results in certain passengers experiencing severe 

hypoglycemia, but is not identical to Dextrose.5 · 

As a direct result of the acute national Dextrose shortage, Virgin America's on board EMKs for 

which Dextrose has been depleted or expired cannot presently be refurbished and returned to 

service. Under such circumstances, Virgin America will not have a means to comply with the 

requirements of 14 C.P.R. 121.803(c)(3) and part 121, Appendix A. Thus, Virgin America is 

compelled to seek an exemption from the applicable regulations, as set forth below. 

The Specific Regulation from Which an Exemption is Sought (14 C.F.R. § 11.81(b)) 

Virgin America petitions the FAA for an exemption from 14 C.P.R. 121.803(c)(3), requiring 

passenger-carrying airplanes to be equipped with an EMK containing Dextrose in the manner 

prescribed at part 121, Appendix A, EMK requirements, paragraph 2 when, due to the national 

shortage described herein, Virgin America is unable to procure such Dextrose for its on board 

EMKs. Virgin America also asks that the FAA allow the use of Dextrose 25% injectable in two 

doses or Glucagon 1mg kit (dry powder and water reconstitution kit) as acceptable substitutes 

during the requested exemption period, to the extent that Virgin America is able to procure such 

3 

4 

5 

See www.ashp.org/menu/DrugShortages. 

Ibid. Virgin America understands that Hospira, Inc., is the sole supplier of Dextrose 25% 

synnges. 

This rate is similar to that provided by another EMK supplier, Banyan International Corp. 

See Association Petition, Enclosure 2 (estimating that Dextrose is used in less than 0.4% of 

inflight emergencies). 
Federal Aviation Administration 

February 28, 2013 

Page 3 

substitutes for its on board EMKs.6 Finally, Virgin America requests that the FAA, in permitting 

the exercise of the privileges conferred by the exemption, not require a pilot-in-command preflight briefing regarding Dextrose and instead require Virgin America and other part 119 

certificate holders conducting part 121 passenger-carrying operations to inform the flight crew. 

In this regard, the FAA could require such operators to provide a bulletin to flight attendants, as 

proposed in the Association Petition. Id at 3. Regardless, Virgin America submits that its flight 

attendants, due to mandatory pre-flight inspections and EMK labeling provided by suppliers, will 

know whether the EMK contains Dextrose. 

The Extent of and Reasons for the Requested Relief (14 C.F.R. § 11.81(c)) 

Virgin America requests an exemption from 14 C.F.R. 121.803(c)(3) and part 121, Appendix A, 

only to the extent necessary to relieve Virgin America from the requirement to carry one single 

dose ampule of Dextrose, 50%/50 cc injectable in required on board EMKs, when, due to the 

nationwide shortage described herein, Virgin America is unable to procure such Dextrose for its 

on board EMKs. 

Virgin America submits that good cause exists for the FAA to expedite, and waive publication of 

a summary of, this Petition before acting on the request. Moreover, until such time as the FAA 

acts on this Petition, Virgin America asks that the FAA exercise its discretion not to enforce the 

regulations that are the subject of the relief requested herein. 

In support ofthis requested relief, Virgin America submits that the national Dextrose shortage 

has significantly increased the likelihood that many passenger-carrying aircraft will be unable to 

meet the requirements of part 121, Appendix A. As set forth above, this shortage has been 

documented by both the FDA and the ASHP. As set forth in the attached letter, Virgin 

America's EMK supplier is unable to replenish Dextrose when providing new or refurbished on 

board EMKs to Virgin America due to this acute shortage. Moreover, it is reasonably expected 

that Dextrose availability will not be able to meet demand until the second calendar quarter of 

2013. Finally, even upon a resumption of distribution by pharmaceutical manufacturers, 

distribution may be rationed to assign priority to first line medical facilities and emergency 

response units, as is often the case during recovery periods following national drug shortages, 

raising the likelihood that EMK suppliers will not be in a position to supply Dextrose to air 

carriers until after the second calendar quarter of 2013. 

Granting of the Exemption Would Be in the Public Interest and Benefit the Public as a 

Whole (14 C.F.R. § 11.81(d)) 

Without the relief requested herein, it is not possible for Virgin America to comply with the 

6 According to MedAire and as set forth above, the national shortage currently extends to 

Dextrose 25%. See Attachment A at 2. The availability of Glucagon 1mg kit as a substitute 

is unknown at this time. 
Federal Aviation Administration 

February 28, 2013 

Page4 

requirement under 14 C.F.R. 121.803(c)(3) and part 121, Appendix A, with respect to Dextrose 

in on board EMKs. 7 As a consequence, unless the relief is granted, Virgin America would have 

no choice but to remove aircraft from passenger-carrying operations pending procurement of 

additional Dextrose supplies. Grant of the relief requested herein would allow the continuation 

of uninterrupted, critical air service, and, therefore, would be in the public interest. 

Furthermore, given that a rationing system may be implemented for Dextrose, whereby 

preference is assigned to front-line responders such as hospitals and paramedic units, continuing 

to require Virgin America and similarly-situated air carriers to comply with the requirement to 

include Dextrose in EMKs during this critical period of national shortage would be contrary to 

the national interest, as doing so would place air carriers in competition with the more immediate 

and compelling needs of ground-based medical providers. 

Finally, grant of this Petition would be consistent with recently-issued FAA limited exemptions 

from the requirements of 14 C.F.R. 121.803(c)(3) and part 121, Appendix A, in response to a 

nationwide shortage of Atropine, another drug required to be included in the on board EMKs of 

part 119 certificate holders conducting part 121 passenger-carrying operations. See FAA 

Exemption Nos. 10690 (issued Jan. 25, 2013) and 10702 (issued Feb. 15, 2013). There, under 

remarkably similar circumstances, the FAA quite properly found: 

The documented Atropine shortage 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 ... EMK suppliers report that 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 benefit of having the medication, which reportedly is 

infrequently used in response to on board medical events. 

Further ... the nationwide Atropine shortage is affecting not only EMK suppliers to 

airlines, but also ground-based medical service providers. The FAA also finds 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 for these medications. 

Exemption No. 10690 at 3. 

7 Under FAA policy standardizing Master Minimum Equipment List ("MMEL") requirements 

for the deferral of approved emergency medical equipment, including EMKs, the continued 

operation of an aircraft with an incomplete EMK is only authorized for a maximum of one 

flight to a location where repairs or replacements can be made. See FAA MMEL Policy 

Letter (PL) 73, Revision 5 (Jun. 15, 2011). 
Federal Aviation Administration 

February 28, 2013 

Page 5 

Granting of the Exemption Would Not Adversely Affect Safety (14 C.F.R. § 11.81(e)) 

As set forth in the attached MedAire letter, the usage of Dextrose during on board medical events 

is extraordinarily uncommon. Moreover, in Virgin America's experience, and as confirmed in 

our discussions with MedAire, when Dextrose is replaced in EMKs, the predominant reason is 

expiration -not the depletion of Dextrose in connection with on board medical events. Thus, 

exempting Virgin America would not adversely impact the safety of the traveling public. 

Suitable Summary for Publication in the Federal Register (14 C.F.R. § 11.81(e))8 

Petitioner 

Regulation from which exemption sought: 

Nature of requested exemption: 

Virgin America Inc. 

14 C.F.R. 121.803(c)(3) and part 121, 

Appendix A - First Aid Kits and Emergency 

Medical Kits 

The requested relief would temporarily 

exempt, for one year, the petitioner from the 

requirement to include Dextrose in its on board 

emergency medical kits when, due to a 

nationwide shortage of the drug, it is unable to 

procure this item for such kits. 

Reasons Why the Privileges Need to be Exercised Outside the U.S. (14 C.F.R. § 11.81(g)) 

Virgin America will be required to exercise the privileges of the requested exemption outside the 

United States, given that its aircraft with on board EMKs are routinely rotated between domestic 

and international passenger-carrying operations. Guidance provided by the International Civil 

Aviation Organization (ICAO) recommends but does not require "Dextrose 50% (or equivalent) 

-injectable: 50 ml" in EMKs. As a consequence, grant of the relief requested herein would not 

be contrary to ICAO requirements. 

Conclusion 

Based on the foregoing, Virgin America respectfully requests an exemption from 14 C.F.R. 

121.803(c)(3) and part 121, Appendix A, to the extent necessary to relieve Virgin America, for a 

period of one year, from the requirement to carry one single dose ampule of Dextrose 50%/50 cc 

injectable in on board EMKs, when, due to the nationwide shortage described herein, Virgin 

America is unable to procure such Dextrose for its on board EMKs. Virgin America further 

8 As previously noted, Virgin America is seeking a waiver of the advance publication 

requirement due to the urgent nature of the relief requested. 
Federal Aviation Administration 

February 28, 2013 

Page6 

requests that the FAA grant such additional or other relief as the FAA may deem necessary or 

appropriate. Finally, Virgin America asks that the FAA expedite this Petition and, until such 

time as it acts on the Petition, exercise its discretion not to enforce the regulations that are the 

subject of the relief requested herein. 

Respectfully submitted, 

General 

~;~Counsel ~::J Virgin America Inc. 

555 Airport Boulevard, Suite 500 

Burlingame, CA 94010 

(650) 762-7108 

john. varley@virginamerica.com 
Federal Aviation Administration 

February 28, 2013 

Page 7 

cc: Mr. John Allen 

Federal Aviation Administration 

Director, Flight Standards Service, AFS-1 

800 Independence Avenue, SW 

Washington, DC 20591 

john.allen@faa. gov 

Mr. John Duncan 

Federal Aviation Administration 

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

800 Independence Avenue, SW 

Washington, DC 20591 

john.s.duncan@faa.gov 

Mr. Les Smith 

Federal Aviation Administration 

Flight Standards Service 

Air Transport Division, AFS-200 

800 Independence Avenue, SW 

Washington, DC 20591 

leslie.smith@faa.gov 

Mr. Steve Douglas 

Federal Aviation Administration 

Flight Standards Service 

Aircraft Maintenance Division, AFS-300 

470 L'Enfant Plaza, SW 

Washington, DC 20024 

steven. w.douglas@faa.gov 
[ Attachment A ) 

~ 

MedAiree 

An International SOS Company 

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 02 

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 02 

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 

1250 West Washington Street, Suite 442 I Tempe, Arizona, USA 85281 Tel:+ 1 480 333 3700 I Fax: + 1 480 333 3592 

--- -- -~~----~~~~-~--~-~~~~--~----~~ --

www.medaire.com Americas • Asia Pacific, Middle East, Africa • Europe .,_ EXPERT CARE, EVERYWHERE.'M 
0 

MedAire~ An International SOS Company 

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 1 mg-- 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 

C)J ___ _ 

Paulo Alves, MD, MSc, FAsMA 

Vice President, Aviation and Maritime 

Health 

MedAire, an International SOS company 

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www.medaire.com Americas · Asia Pacific, Middle East, Africa · Europe • EXPERT CARE, EVERYWHERE."'