2005P-0116
CP 1
Volume 1

Citizen Petition

Tab 1 - Press Release, Missouri State Board of Pharmacy, Missouri Board Takes Action Against Kansas City Company (Mar. 10, 2003) available at http://pr.mo.gov/boards/pharmacy/press/2003-10-03.pdf

Tab 2 - Letter from Peter Cooney, FDA, to David Watton, Vice President, Pascal Co. Inc. (June 21, 2000) available at http://www.fda.gov/foi/warning.htm

Tab 3 - Letter to Missouri State Board of Pharmacy from L.D. King, Executive Director, IACP (Jan. 31, 2003)

Tab 4 - Letter to Revisions Committee fitom L.D. King, Executive Director, IACP (Dec. 2, 2002)

Tab 5 - Letter to Arizona Board of Pharmacy from L.D. King, Executive Director, IACP (Nov. 26, 2002)

Tab 6 - New Requirements for Sterile Compounding; Request for Comments (IACP 2002) (Sterility testing proposed by the USP is currently not performed in pharmacy practice

Tab 7 - Int'l Acad. of Compounding Pharms., Draft Comments to USP Proposed Chapter 797: Pharmaceutical Compounding- Sterile Preparations (July 23, 2002)

Tab 8 - Greg Jones, State of Florida Department of Health, Testimony before FDA Pharmacy Compounding Advisory Committee Meeting 33-35 (Jul. 14, 2000) (Jones Testimony)

Tab 9 - Subramaniam V, Sokol G, and Zenger V et al. Survey of drug products compounded by a group of community pharmacies: Findings from an Food and Drug Administration Study

Tab 10 - FDA Recall Notice No. D-207-2: Med-Mart Pulmonary Services (Mar. 27, 2002) available at http://www.fda.gov/bbs/topics/enforce/2002/ENF00736.html; Kris Hundley, Lincare Pharmacy Runs Afoul
of Missouri Regulators, St. Petersburg Times, Apr. 18, 2003, at 1E.

Tab 11 - S.A. Seifert, Pharmacy prescription errors reported to a regional poison control center, 40 J. of Toxicology 919, 922

Tab 12 - Eugene Sullivan, Ph.D., FDA, Testimony before FDA Drug safety and Risk Management Advisory Committee 20-21 (May 5, 2004) ("Chemical components in inhalation drug products may be associated with a variety of adverse effects, including irritant and immunologic effects, leading to acute bronchospasm and airway inflammation and hyperresponsiveness, other toxicologic injury, or even potentially carcinogenicity")

Tab 13 - Abstracts: T. Kawajiri et al. Pathology and mechanism of lung toxicity following inhalation of hair spray in rats, 16 Inhal. Toxicol. 147 (2004); Ronald D. Reynolds, MD & Richard M. Smith, MD, Nebulized bacteriostatic saline as a cause of bronchitis, 40 J. Fam. Pract. 35 (1995); J. Pauluhn, Comparative analysis of pulmonaly irritation by measurements of Pehn and protein in bronchoaveolar lavage fluid, in brown Norway rats and Wistar rats exposed to irritant aerosols, 16 Inhal. Toxicol. 159 (2004); Neil E. Alexis, PhD, et at, Effect of inhaled endotoxin on airway and circulating inflammatory cell phagocitosis and CD11b expression in atoptic
asthma subjects, 112 J. Allergy and Clin. Immunol. 353 (2003)

Tab 14 - The Letco Companies, Respiratory Pharmacy Products (2004) available at www.letcoinc.com (last visited Feb. 11, 2004). (listing USP grade chemicals as well as non-USP chemicals)

Tab 15 - Redbook Database Services, Redbook 243,357,400 (2004)

Tab 16 - Counterfeit Bulk Drugs: Hearing Before the Subcomm. on Oversight and Investigations of the House Comm. on Energy and Commerce, 106th Cong. (Jun. 8, 2000)

Tab 17 - Letter to California State Board of Pharmacy from L.D. King, Executive Director, International
Academy of Compounding Pharmacists 3 (Oct. 21, 2002)

Tab 18 - Vibhakar Shah PH.D., FDA, Presentation before the Drug Safety and Risk Management Advisory Committee, inhalation drug products in LPDE Containers: A Quality (CMC) Perspective, at slide no. 7, 8, 10-13, 19-23 (May 5, 2004)

Tab 19 - John H. Perrin, Comments on drugs difficult to compound and the quality of chemicals used in compounding., 25 Drug Dev. and Indus. Pharm. 553, (1999)

Tab 20 - Myrna A. Dolovich, P. Eng, et al., Consensus Statement: Aerosols and Delivery Devices, 45 Respir. Care 589, 589-90 (2000)

Tab 21 - R. Beasley, Adverse reactions to the non-drug constituents of nebulizer solutions, 25 Br. J. Clin. Pharmacol. 283 (1988)

Tab 22 - R.J. Kuhn, Formulation of Aerosolized Therapeutics, 120 Chest 97s (2001)

Tab 23 - Marcello Trevisani et al., Ethanol Causes Inflammation in the Airways by a Neurologenic and TRPVI-Dependent Mechanism, 309 J. of Pharmacology and Experimental Therapeutics 1167, 1169 (2004)

Tab 24 - Ronald D. Reynolds, MD & Richard M. Smith, MD, Nebulized Bacteriostatic Saline as a Cause of Bronchitis, 40 J. of Fam. Prac. 35, 38-9 (1995)

Tab 25 - Declaration of Robert J. Kuhn, Pharm. (Sept. 30, 2004)

Tab 26 - Abhishek Gupta, B.S. et al., Balancing Ethanol Cosolvent Concentration with Product Performance in 134a-Based Pressurized Metered Dose Inhalers, 16 J. of Aerosol Med. 167, 171-73 (2003)

Tab 27 - Declaration of Dr. Richard Moss, M.D., F.C.C.P. (Sept. 24, 2004)

Tab 28 - Dear Colleague Letter from Michael Schatz, MD, MS, FAAAAI, President, AAAA, and Michael Blaiss, MD, President, ACAAI, (Aug. 31, 2004)

Tab 29 - Patrick J. Coyne, APRN, BC et al, Compounded, 103 Am. J. Nurs. 76, 85 (2003)

Tab 30 - Lawrence Trissel, B.S., FASHP, Editorial: Compounding Our Problems - Again, 60 Am. J. Health-Syst. Pharm., 432 (2003) (emphasis added)

Tab 31 - American Society of Health-System Pharmacists, Helping Members Respond to Problems with the Supply of Quality Pharmaceuticals (2004)

Tab 32 - Compounding Sterile Preparations Raises Informed-Consent Issues AJHP News (Jun. 15, 2003) (statements of Robert E. Rapp, Chair of the University of Kentucky, Human Investigations Committee, Kevin Kinkade, Missouri Board of Pharmacy Executive Director, Jesse C. Vivian, Professor, Wayne State University College of Pharmacy, Jane J. McCaffrey, President, American Society of Healthcare Risk Assessment

Tab 33 - Thomas Kaye, R.Ph., MBA, The Quandary of Compounding for MCOs: Administrative Costs, Risks, and Waste, 2003 Managed Care 42, 46

Tab 34 - Testimony of Carlos Gomez, M.S., Ph.D., at 1017-1018, U.S. v. Arias., No. 00-683-CR-LENARD (S.D. Fla. 2002)

Tab 35 - E. Beaulieu, DuoNeb pricing spells trouble for HMEs, HME NEWS, Jul. 2001, available at http://www.hmenews.com/july2001/news/topstory4.htm

Tab 36 - Various prescription forms: Prescription Form from Concern Care Pharmacy (A); Prescription Form from NationsHealth (B); Order Form from Respiratory Services (C); Confldential Patient Information Form from Bright Medical Technologies [referring to professional sterile lab on premises] (D); Doctor Order Form Better Living Now, Inc. (E); Rx - Respiratory Medications and Supplies form from Jefferson Medical (F); Doctor order Form from Liberty Home Pharmacy Corporation (G); Handwritten Price List from Reliant Pharmacy (H); Prescription Fbrm from Zincare (I); Form from American Homepatient (J); Form from Home Medical Pharmacy (K).

Tab 37 - Letter to physician from Rotech ("Rotech is now able to offer Budesonide...Budesonide is the first FDA approved aerosolized steroid offered in a .4 mg dose...")

Tab 38 - Budesonide/Formoterol Nebulizer Medications from Rotech ("Several studies comparing the response of budesonide/formoterol with currently available steroid/long-acting beta agonist in asthma and COPD are very favorable")

Tab 39 - Fact Sheet from Med Link America, Inc. ("Budesonide...gives you a powerful, safe and effective tool")

Tab 40 - Order Form from Morgan Drugs ("Budesonide...Is a safe and effective steroid nasal spray")

Tab 41 - Promotional materials from Pulmodose including report of clinical study on Symbicort product approved in Europe

Tab 42 - Dear Doctor Letter from RRT Group, Inc.(Sept. 8, 2004)

Tab 43 - Product label from Gino’s Pharmacy ("Equivalent to ATROVEN")

Tab 44 - Order Form from Morgan Drugs ("It is comparable to other prescription steroid Nasal sprays. Such as RhinoCort...Flonase...NasaCbrt AQ...")

Tab 45 - Prescription Form from Prescriptions Plus Pharmacy ("Budesonide (Generic for Pulmicort)")

Tab 46 - New Compounded Product Announcement from BMS Company, Inc.

Tab 47 - Ward Drug Company, Website, available at www.warddrug.com (last accessed Feb. 11, 2005)

Tab 48 - Broncho Dose, Website, available at http://broncho-dose.com/patients.htm (last accessed Mar. 22, 2005) ("Spend less time on your nebulizer. Avoid mis-dosing. No Risk!")

Tab 49 - Med-Equip, Website, available at http://www.med-equip.com/Resp%20Meds.htm (last accessed Mar. 22, 2005)

Tab 50 - Phil Johnson, M.S., R.Ph.& Gregg Jones, R.Ph., Editorial: Pharmacist Compounding of Analgesic Medication: The Risk of a Little-Known Practice, 84 J. FLA. M.A. 13 (1997)

Tab 51 - Carrie Teegardin, Druggists Disciplined for Mixing Overdoses, The Atlanta J. Const., Feb. 21, 2002, at 1A

Tab 52 - Paticia Simms & Deborah Rades, Debate Rages over Designer Hormones, Wisconsin State J., Jun. 22, 2002, available at http://www.madison.com/wsj/index.php

Tab 53 - Carrie Teegardin, Probe Questions Safety of Pharmacy-Made Drugs, The Atlanta J. - Const., Mar. 30, 2001, at 3C

Tab 54 - Declaration of Dr. Christopher Landon, M.D., F.A.A.P., F.C.C.P. Para 12 (Sept. 30, 2004)