Deficiencies of product labeling directions for the preparation of radiopharmaceuticals

Journal of the American Pharmacists Association

Volumn 44, Issue 1, 2004, Pages 30-35

  Hung, Joseph C ^a,b   Ponto, James A ^c   Gadient, Katie R ^d   Frie, Julia A ^d   Aksamit, Carolyn M ^d   Enquist, Cassandra L ^d   Carrels, Katie E ^d  

^a MAYO CLINIC   (United States)

^b Mayo Clinic College of Medicine   (United States)

^c UNIVERSITY OF IOWA HOSPITALS AND CLINICS   (United States)

^d Division of Nuclear Medicine   (United States)

Author keywords

Food and drug administration; Nuclear pharmacy; Preparation; Product labeling; Quality control; Radiopharmaceutical; Reconstitution

Indexed keywords

RADIOPHARMACEUTICAL AGENT;

ARTICLE; CHEMISTRY; COMPARATIVE STUDY; DRUG FORMULATION; DRUG INDUSTRY; DRUG LABELING; FOOD AND DRUG ADMINISTRATION; LEGAL ASPECT; QUALITY CONTROL; STANDARD; UNITED STATES;

DRUG COMPOUNDING; DRUG INDUSTRY; DRUG LABELING; QUALITY CONTROL; RADIOPHARMACEUTICALS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 1442357284     PISSN: 15443191     EISSN: 15443450     Source Type: Journal    
DOI: 10.1331/154434504322713200     Document Type: Article

References (19)

1. TechneScan HDP [package insert]. St. Louis, Mo.: Mallinckrodt Inc; 2000.
2. CIS-Sulfur Colloid [package insert]. Bedford, Mass.: CIS-US, Inc; 2002.
3. ProstaScint [package insert]. Princeton, N.J.: Cytogen Corporation; 1997.
4. Ceretec [package insert]. Arlington Heights, Ill.: Medi-Physics, Inc, Amersham Healthcare; 2000.
5. TechneScan MAG3 [package insert]. St. Louis, Mo.: Mallinckrodt Inc; 2000.
6. Mackenzie A. Reduction of extremity dose in the radiopharmacy. Nucl Med Commun. 1997;18:578-81.
7. Bogsrud TV, Chen MN, Herold TJ, et al. Effects of alternative reconstitution procedures on the labeling efficiency and in vitro stability of 99Tcm-labelled radiopharmaceuticals. Nucl Med Commun. 1999;20:61-5.
8. Choletec [package insert]. Princeton, N.J.: Bracco Diagnostics Inc; 2000.
9. Ultra-TechneKow DTE [package insert]. St. Louis, Mo.: Mallinckrodt Inc; 2001.
10. Macrotec [package insert]. Princeton, N.J.: Bracco Diagnostics Inc; 2000.
11. Parker JA, Coleman RE, Siegel BA, et al. Society of Nuclear Medicine procedure guidelines for lung scintigraphy 2.0. In: Procedure guidelines manual 2001-2002. Reston, Va: Society of Nuclear Medicine; 2001:161-6.
12. Cardiolite [package insert]. North Billerica, Mass.: Bristol-Myers Squibb Medical Imaging, Inc; 2001.
13. Cardiolite [license]. North Billerica, Mass.: Bristol-Myers Squibb Medical Imaging, Inc; 2001.
14. AcuTect [package insert]. Wayne, N.J.: Berlex Laboratories; 2001.
15. Federal False Claims Act 31 USC §3.37.3.729-33.
16. Ingredients and processes (general notices). In: USP 27-NF 22: United States pharmacopeia and national formulary. Rockville, Md.: United States Pharmacopeial Convention, Inc; 2004:5.
17. Authorization to prepare radiopharmaceutical reagent kits and elute radiopharmaceutical generators; use of radiopharmaceuticals for therapy, 55 Federal Register 34513-8.
18. Preparation, transfer for commercial distribution, and use of byproduct material for medical use, 60 Federal Register 322-5.
19. Nuclear pharmacy guideline criteria for determining when to register as a drug establishment. Washington, D.C: U.S. Food and Drug Administration; 1984.