Drug Labeling: FDA Requires New Label for Antibiotics to Prevent Overuse

Press Release, Food & Drug Administration, FDA Publishes Final Rule To Require Labeling About Antibiotic Resistance (February 5, 2003), available at <http://www.fda.gov/bbs/topics/NEWS/2003/NEW00869.html>.

21 C.F.R. § 201.5 (2003).

Labeling Requirements for Systemic Antibacterial Drug Products Intended for Human Use, 68 Fed. Reg. 6062, 6073 (February 6, 2003).

Id. at 6077.

Id. at 6075.

Id. at 6062.

Id. at 6063.

Interagency Task Force on Antimicrobial Resistance, A Public Health Actions Plan To Combat Antimicrobial Resistance, Part 1: Domestic Issues 2001, available at http://www.cdc.gov/drugresistance/actionplan/2001report/index.htm.

Id. at 2.

See generally id.

Centers for Disease Control and Prevention & American Academy of Pediatrics, “Principles of Judicious Use of Antimicrobial Agents for Pediatric Upper Respiratory Tract Infections,” Supplement to Pediatrics, 101 (1998): 163–164.

Levy S. , “The Challenge of Antibiotic Resistance,” Scientific American, 278(3) (1998): 46–53, at 49.

Neu H.C. , “The Crisis in Antibiotic Resistance,” Science, 257 (1992): 1064–1073, at 1064.

Id at 1065.

Levy , supra note 15, at 49, 46.

Markow S.B. , Note, “Penetrating the Walls of Drug-Resistant Bacteria: A Statutory Prescription To Combat Antibiotic Misuse,” Georgetown Law Journal, 87 (1998): 531–562, at 535.

Id. at 535.

Id. at 536.

Id. at 534.

See id. at 543.

Telephone conversation between the author and Stuart Levy, March 6, 2003.

Telephone conversation between the author and Stephen Calderwood, February 26, 2003.

Labeling Requirements for Systemic Antibacterial Drug Products Intended for Human Use, 68 Fed. Reg. at 6065.