Extemporaneous compounding: A return to regulatory limbo?

Journal of Pain and Palliative Care Pharmacotherapy

Volumn 16, Issue 4, 2002, Pages 71-78

  Winckler, Susan C ^a  

^a AMERICAN PHARMACISTS ASSOCIATION   (United States)

Author keywords

Compounding; Extemporaneous; FDA; FDAMA; FDCA; Law; Regulation; Supreme Court

Indexed keywords

COURT; DRUG FORMULATION; DRUG LEGISLATION; FOOD AND DRUG ADMINISTRATION; HEALTH CARE POLICY; HUMAN; MEDICAL PRACTICE; PHARMACY; PRACTICE GUIDELINE; REVIEW;

EID: 0036447325     PISSN: 15360288     EISSN: None     Source Type: Journal    
DOI: 10.1080/J354v16n04_08     Document Type: Review

References (11)

1. Wooten, A.C., Chronicles of Pharmacy, quoted in Dinah G. Jordan, Pharmacist Compounding v. Veterinarian Compounding: Similarities and Differences, 205 JAVMA 256 (1994).
2. Wooten, A.C., Chronicles of Pharmacy, quoted in Dinah G. Jordan, Pharmacist Compounding v. Veterinarian Compounding: Similarities and Differences, 205 JAVMA 256 (1994).
3. The pharmaceutical manufacturers recognize the need for compounding, because they include instructions for compounding specialized dosage forms, such as oral suspensions, in some of their package inserts, which are the instructions for use that accompany any drug product and must be approved prior to distribution by the FDA.
4. Hospice Care and the Pharmacist, 1 International Journal of Pharmaceutical Compounding 11 (January/February 1997).
5. See NABPLAW® Pharmacy law database, NABP's database of state pharmacy practice acts and regulations.
6. Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy, § 104 (1998).
7. Id., § 105(f).
8. Subsequent amendments to the act expanded the requirements of a "new drug" to include efficacy. 21 U.S.C. §§ 201(p)(1) and (2); 21 U.S.C. § 355(b), (d) and (e). The legislation exempts pharmacists from registration and inspection requirements, further indicating that compounding was not contemplated within the definition of "new drug." See 21 U.S.C. § 360(g)(1) and 21 U.S.C. § 374(a)(2)(A).
9. See Professionals & Patients for Customized Care v. Shalala, 847 F. Supp. 1359, 1363-64 (S.D. Tex. 1994), aff'd at 56 F.3d 592 (5th Cir. 1995).
10. S. Rep. No. 43, 105th Cong., 1st Sess., 67-68 (1997).
11. Western States v. Thompson, 535 US 122 S.Ct. 1497 (2002).