Generic-substitution laws

U.S. Pharmacist

Volumn 33, Issue 6, 2008, Pages 30-34

  Vivian, Jesse C ^a  

^a WAYNE STATE UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AMINOPHYLLINE; ANTIARRHYTHMIC AGENT; ANTIASTHMATIC AGENT; ANTICOAGULANT AGENT; ANTICONVULSIVE AGENT; CARBAMAZEPINE; CARDIAC GLYCOSIDE; CLINDAMYCIN; CLONIDINE; CONJUGATED ESTROGEN; CYCLOSPORIN; DIGITALIS; DIGOXIN; ESTROGEN DERIVATIVE; ETHOSUXIMIDE; GENERIC DRUG; GLYCOSIDE; INSULIN; LEVOTHYROXINE SODIUM; LITHIUM SALT; MINOXIDIL; PHENOBARBITAL; PHENYTOIN; PRAZOSIN; PRIMIDONE; PROCAINAMIDE; THEOPHYLLINE; UNINDEXED DRUG; VALPROATE SEMISODIUM; WARFARIN;

ARTICLE; BIOEQUIVALENCE; DRUG APPROVAL; DRUG EFFICACY; DRUG SAFETY; EPILEPSY; FOOD AND DRUG ADMINISTRATION; GOOD MANUFACTURING PRACTICE; GOVERNMENT REGULATION; HEALTH CARE POLICY; HUMAN; PHARMACY; SEIZURE; UNITED STATES;

EID: 48649105309     PISSN: 01484818     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Article

References (28)

1. FDA. Approved Drug Products with Therapeutic Equivalence Evaluations. 28th ed. 2008. www.fda.gov/cder/orange/obannual.pdf. Accessed April 17, 2008.
2. Kazmi S. Pharmacy practice: controversies in drug substitution. Medscape Pharmacists. November 7, 2007. www.medscape.com/viewarticle/ 563959_print. Accessed April 15, 2008.
3. Id.
4. See note 1, supra.
5. FDA. Electronic orange book. Approved drug products with therapeutic equivalence evaluations. www.fda.gov/cder/ob/. Accessed April 11, 2008.
6. §505 [21 USC 355] of the Federal Food, Drug, and Cosmetic Act of 1938 (as amended). www.fda.gov/opacom/laws/fdcact/fdcact5a.htm#sec505. Accessed April 11, 2008.
7. 52 Stat. 1040 (1938), 21 USC §301 et seq.
8. FDA. Guidance for FDA Staff and Industry Marketed Unapproved Drugs - Compliance Policy Guide, Sec. 440. 100, Marketed New Drugs Without Approved NDAs or ANDAs. Appendix A. Brief history of FDA marketing approval requirements and categories of drugs that lack required FDA approval. Revised June 2006. www.fda.gov/cder/Guidance/ 6911fnl.htm#_Toc128533964. Accessed April 11, 2008.
9. FDA. Preface. Approved Drug Products with Therapeutic Equivalence Evaluations. 28th ed. 2008. www.fda.gov/cder/ob/docs/preface/ ecpreface.htm. Accessed April 11, 2008.
10. 76 Stat. 780 (1962).
11. Introduction. §1.5, General Policies and Legal Status: x. Electronic Orange Book. See note 5, supra.
12. "Therapeutic equivalence evaluations in this publication are not official FDA actions affecting the legal status of products under the Act." See note 5, supra.
13. See note 7, supra.
14. Id.
15. National Association of Boards of Pharmacy. Survey of Pharmacy Laws. XIX: Drug product selection laws. 2006.
16. State regulations on generic substitution (as modified July 3, 2007). Pharmacist's Letter. 2006;22:220901. www.pharmacistsletter.com/(S (grtd3055rt3i2cb0c14kjh23))/pl/ArticleDD.aspx?nidchk=1&cs= FACULTY&s=PL&pt=2&dd=220901#STATE. Accessed April 15, 2008.
17. Christiansen TP, Kirking DM, Ascione FJ, et al. Drug product selection: legal issues. J Am Pharm Assoc. 2001;41:868-873.
18. OS 1961.
19. Department of Commerce & Consumer Affairs. Hawaii revised statutes. www.hawaii.gov/dcca/areas/pvl/main/hrs. Accessed April 15, 2008.
20. Online Sunshine. The 2007 Florida statutes. www.leg.state.fl.us/Statutes/ index.cfm?App_mode=Display_Statute&URL=Ch0465/ch0465.htm. Accessed April 15, 2008.
21. 2007 Iowa Code Chapter 155A. Iowa Pharmacy Practice Act. www.state.ia.us/ ibpe/pdf/IC155A.pdf. Accessed April 15, 2008.
22. 201 KAR 2:116. Drug products with therapeutic problems. www.lrc.state.ky.us/kar/201/002/116.htm. Accessed April 15, 2008.
23. North Carolina Board of Pharmacy. Pharmacy rules, statutes, and board policies. www.ncbop.org/LawsRules/StatutesMay2007.pdf. Accessed April 15, 2008.
24. Commonwealth of Pennsylvania generic drug equivalency/substitution laws & regulations. http://ecapps.health.state.pa.us/pdf/ddc/ generic33.ps.pdf. Accessed April 15, 2008.
25. South Carolina Code of Laws (unannotated). www.scstatehouse.net/code/ t39c024.htm. Accessed April 15, 2008.
26. See note 16, supra; Public Acts, 2006. Chapter No. 866. Senate Bill No. 3738. www.state.tn.us/sos/acts/104/pub/pc0866.pdf. Accessed April 15, 2008.
27. Therapeutic equivalence of generic drugs: response to National Association of Boards of Pharmacy. April 16, 1997. www.fda.gov/cder/news/ ntiletter.htm. Accessed April 15, 2008.
28. Scale-up and post-approval changes for intermediate release products (SUPAC-IR) guidance document. Appendix A: Narrow therapeutic range drugs. www.fda.gov/cder/guidance/cmc5.pdf. Accessed April 15, 2008.