Compounding Versus Manufacturing in Pharmacy Practice: A Regulatory Challenge

Anon : APhA works to protect pharmacy's 'heart and soul.' Pharm Today 31:1-2, 1992

Allen Lv : Compounding: A professional prerogative. Am Pharm NS 34:4, 1994

Dickinson Jg : Baxter Healthcare Corporation: When is a pharmacy more than just a pharmacy? Am J Hosp Pharm 45:1224, 1234, 1238, 1988

McLaughlin Ss : Federal appeals court says no to Baxter's regional compounding centers. Am J Hosp Pharm 47:2614, 2617, 2620, 1990

Fassett We , Fink III Jl : Extemporaneous compounding : Promotional and legal aspects. Am Pharm NS 24:550-555, 1984

Anon : FDA must reaffirm pharmacy's right to compound. Am Pharm NS 30:321, 1990

Cardinale V. : FDA lowers the boom on big-time compounding . Drug Topics 136:104, 107, 1992

Anon : Kessler affirms FDA's support for compounding by pharmacists. NACDS Executive Newsletter 7:1-2, 1992

Crawford Sy , Dombrowski Sr : Extemporaneous compounding activities and the associated informational needs of pharmacists. Am J Hosp Pharm 48:1205-1210, 1991

Anon : FDA takes aim at practitioners who 'manufacture' drugs. Drug Topics 122:8, 28, 1978

Anon : FDA recognizes anticipatory compounding. ASHP Newsletter 25:1, 1992

Anon : FDA moving to cut off last compounding duty. Drug Topics 124; 24, 1980

Model State Pharmacy Act and Model Rules of the National Association of Pharmacy, 1992

Good Compounding Practices Applicable to State Licensed Pharmacies . Park Ridge, IL, National Association of Boards of Pharmacy, approved May 26, 1993

21 U.S.C. §321(p)

21 C.F.R. §310.3(g) and (h)

21 U.S.C. §351(g)

21 U.S.C. §374(a) (2)

Food and Drug Administration Compliance Policy Guide 7132.16, Subject: Manufacture, distribution and promotion of adulterated, misbranded, or unapproved new drugs for human use by state-licensed pharmacies. FDA Office of Enforcement, Division of Compliance Policy, March 16, 1992

21 U.S.C. §353(b)

Food and Drug Administration Compliance Policy Guide 7132c.06, Subject: Regulatory action regarding approved new drugs and antibiotic drug products subjected to additional processing or other manipulations. FDA Office of Enforcement, Division of Compliance Policy, January 18, 1991

Food and Drug Administration Compliance Policy Guide 7132.06, Subject: Hospital pharmacies—status as drug manufacturers. FDA Division of Field Regulatory Guidance, October 1, 1980

Cedars North Towers Pharmacy, Inc. v U.S., (1978-79 Transfer Binder) Food Drug Cosm. L. Rep. (CCH) para. 38,200 (S.D. Fla., August 28, 1978)

U.S. v Sene X Eleemonsynary Corp., Inc., 479 F. Supp. 970 (S.D. Fla. 1979), affd (1982-83 Transfer Binder) Food Drug Cosm. L. Rep. (CCH) para. 38,207 (11th Cir. 1983)

Professionals and Patients for Customized Care v. Shalala, 847 F. Supp. 1359 (S.D. Texas, 1994)

Martin S. : APhA secures pharmacist's right to compound. Am Pharm NS: 882-883, 905, 1992