References
- Wooten A. C. Chronicles of Pharmacy. Pharmacist Compounding v. Veterinarian Compounding: Similarities and Differences, Dinah G. Jordan, 1994, 205 JAVMA 256 quoted in
- 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
- Hospice Care and the Pharmacist. 1 International Journal of Pharmaceutical Compounding January/February, 1997; 11
- , See NABPLAW(r) Pharmacy law database, NABP's database of state pharmacy practice acts and regulations
- Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy. 1998; 104, §
- Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy, Id., § 105(f)
- 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)
- 1359; 1363–64, See Professionals & Patients for Customized Care v. Shalala, 847 F. Supp (S.D. Tex. 1994), aff'd at 56 F.3d 592 (5th Cir. 1995)
- 1997, S. Rep. No. 43, 105th Cong., 1st Sess., 67–68
- Western States v. Thompson. 2002, 535 US 122 S.Ct. 1497