Jan 20 2009 9:28 Ql/ 26/2889 89:24 858-415-8743 DOH/GENERAL COUNSEL PAGE 63/89 STATE OF FLORIDA DERANTIE DEPARTMENT OF HEALTH DUTY GretetLTH OLEAK: Racha DEPARTMENT OF HEALTH, bare ee PETITIONER, / ¥ CASE NO. 2008-24597 ALTAIRE PHARMACEUTICALS, INC., RESPONDENT. / ADMINISTRATIVE COMPLAINT COMES NOW, Petitioner, Department of Health (“Department”), by and through its undersigned, and files this Administrative Complaint against Respondent, Altaire Pharmaceuticals, Inc., and in support thereof alleges: 1. Petitioner is the state agency charged with regulating Drugs, Devices, and od Chapter 499, Florida Statutes. Cosmetics pursuant to Section 20.43, Florida 2. At all times material to this Complai... Respondent was not permitted within the state of Florida. 3. The Respondent’s mailing address of record is 31] West Lane, Aquebogue, NY 11934. 4, On or about March 28, 2007, Respondent sold, a prescription drug, Albafort Injectible, to Barolli, LLC. The prescription drugs were shipped into the state of Florida. 5, On or about April 8, 2008, sold, a prescription drug, Bezotic Otic Drops with Antipyrine, to Barolli, LLC. The prescription drugs were shipped into the state of Florida. 6. On or about April 16, 2008, Respondent sold, a prescription drug, Antitussive Expectorant, to Barolli, LLC. The prescription drugs were shipped into the state of Florida. Jan 20 2009 9:28 @l/2e/2889 8g: 24 858-413-8743 DOH/GENERAL COUNSEL PAGE @4/ag 7. On or about June 16, 2008, Respondent sold a prescription drug, Albafort “P” Injectible, to Barolli, LLC. The preseription drugs were shipped into the state of Florida. &. At all times material hereto, Altaire Pharmaceuticals, Inc. did not hold a permit to distribute prescription drugs into the State of Florida. 9. Section 499.01(2)(c), Florida Statutes, requires a nonresident prescription drug manufacturer permit for any person that distributes prescription drug it manufactures into the State of Florida. 10. Section 499.01(2)(d), Florida Statutes, requires a nonresident prescription drug wholesaler distributor permit to distribute prescription drugs into the State of Florida. COUNT ONE 11. Petitioner realleges and incorporates paragraphs one (1} through ten (10) as fully set forth herein. 12. Section 499.005(22), Florida Statutes, prohibits the failure to obtain a permit or registration, or operating without a valid permit when a permit of registration is required by ss. , “, 499.001-499.081 for that activity. 13. Based on the foregoing, the Respondent has violated Section 499.005(22), Florida Statutes, by failing to obtain a permit or registration, or operating without a valid permit when ‘a permit or registration is required by ss. 499.001-499.081 for that activity. COUNT TWO 14. Petitioner realleges and incorporates paragraphs one (1) through ten (10) as fully set forth herein. 15. Section 499.006(10), Florida Statutes, states a drug is adulterated if it has been purchased, held, sold or distributed at any time by a person not authorized under federal or state law to do $0. Jan 20 2009 9:28 @l/2e/2889 8g: 24 858-413-8743 DOH/GENERAL COUNSEL 16. Based on the foregoing, the Respondent violated Section 499.005(1), Florida Statutes, by manufacturing, repackaging, sale, delivery, or holding or offering for sale of any drug, device, or cosmetic that is adulterated or misbranded or has otherwise been rendered unfit for human or animal use. COUNT THREE 17, Petitioner realleges and incorporates paragraphs one (1) through ten (10) as fully set forth herein. . 18. Section 499.004(2), F.S. prohibits the adulteration or misbranding of any drug. 19, Based upon the foregoing, the Respondent violated Section 499.005(2), Florida Statutes by adulterating and misbranding a drug by purchasing from a person not authorized to distribute. REQUEST FOR RELIEF 20. The violations of Chapter 499, F.S. by Altaire Pharmaceuticals, Inc. as set forth in this Administrative «Complaint constitute sufficient grounds for the Department to impose an administrative fine of $80,000.00 or impose any other penalty authorized by Chapter 499, FS. and Chapter 64F-12, F.A.C., against Altaire Pharmaceuticals, Inc. 21. Rule 64F-12.024(4), F.A.C. sets the range of the penalty for violations of the Florida Drug and Cosmetic Act, Chapter 499, F.S. Pursuant to that rule, and the facts alleged in this administrative compliant, the Department is justified in, and intends to impose the following fines totaling $80,000.00 against Altaire Pharmaceuticals, Inc.: a. The rule authorizes a fine for failing to obtain a permit or registration, or operating without a valid permit when a permit or registration is required by ss. 499.001-499.081 for that activity (violation of 499.005(22) F.8.) ranging from $500.00 - $5,000.00 per violation per day and also authorizes the suspension or revocation of a permit with a fine. A fine is requested. PAGE @5/ag Jan 20 2009 9:29 @l/2e/2889 8g: 24 858-413-8743 DOH/GENERAL COUNSEL PAGE 86/a9 b. The rule authorizes a fine for manufacturing, repackaging, sale, delivery, or holding or offering for sale of any drug, device, or cosmetic that is adulterated or misbranded or has otherwise been rendered unfit for human or animal use (violation of 499.005(1) F.S.) ranging from $250.00 - $5,000.00 per violation per day and also authorizes the suspension or revocation ofa permit with a fine. A fine is requested. c. The mile authorizes a fine causing a drug to be adulterated or misbranded (violation of 499.005(2) F.S.) ranging ftom $250.00 - $5,000.00 per violation per day and also authorizes the suspension or revocation of a permit with a fine. A fine is requested. WHEREFORE, the Petitioner respectfully requests an order imposing the following penalty: assessment of an administrative fine in the amount of $80,000.00, or any other relief deemed appropriate. a Teg SIGNED this} dayof__ f¢ Ce ot dey , 2008. Ana M.. Viamonte Ros, M.D., M.P.H. State Surgeon General Jenniferd Céindd Assistant General Counce! 4052 Bald Cypress Way, Bin A-02- Tallahassee, FL 32399-3265 Florida Bar # 0011116 (850) 245-4025 (850) 413-8743 FAX

Docket for Case No: 09-000326