Here is a list of the federal cases involving Wedgewood Village Pharmacy were a decision was rendered: Note read entire case for a complete understanding. These are merely short summaries/quotes taken from decisions.
Wedgewood Village Pharmacy v. D.E.A., 509 F.3d 541 (D.C. Cir., 2007) December 11, 2007
The FDAMA contained a definition of "compounding" that required a prescription therefor to be unsolicited by a retail pharmacy and prohibited the pharmacy from advertising the compounding of a particular drug. Pub.L. No. 105-115 § 127 (codified at 21 U.S.C. § 353a(a), (c)). Several pharmacies with large compounding practices, including Wedgewood, challenged these provisions as violative of the First Amendment.
In its closed distribution system, the CSA created three categories of registrants: "manufacturer," "distributor" and "practitioner"—each with distinct requirements for registration. See 21 U.S.C. § 823(a) (criteria for "manufacturer" registration), 823(b) (criteria for "distributor" registration), 823(f) (criteria for "practitioner" registration). A "manufacturer" is authorized to engage in "[t]he production, preparation, propagation, compounding, or processing of a drug." Id. § 802(15) (emphasis ...
Wedgewood Village Pharmacy, Inc. v. U.S., 421 F.3d 263 (Fed. 3rd Cir., 2005) September 1, 2005
Wedgewood is a pharmacy specializing in compounding drugs used for treating humans and animals. "Compounding" refers to the process of modifying prescription drugs to meet the specific needs of individual patients.
Wedgewood Village Pharmacy, Inc. v. Ashcroft, 293 F.Supp.2d 462 (D.N.J., 2003) December 15, 2003
In arguing that the public interest requires that this Court keep Wedgewood in operation, Wedgewood argues only that Wedgewood's customers will suffer because they will not be able to tap Wedgewood's expertise. While it might be true that the type of compounding that Wedgewood performs for its physicians and its patients is not something that can be done by any corner pharmacy, other compounding pharmacies exist that engage in the exact same activity as Wedgewood, namely, Wedgewood's competitors ...
In re of Estbl. Insp. of: Wedgewood Village Pharm., 270 F.Supp.2d 525 (D.N.J., 2003) July 7, 2003
Wedgewood is a New Jersey licensed pharmacy that has operated in good standing for twenty-two years. (See Wedgewood "Motion to Quash Warrant For Inspection Under the Federal Food, Drug, and Cosmetic Act" (hereinafter "Wedgewood Br.") at 7; Wedgewood Reply at 4). Located in Sewell, New Jersey, Wedgewood is owned and operated by George Malmberg, a pharmacist who holds a current and valid New Jersey license. (Id.). Wedgewood specializes in compounding, selling, and dispensing pharmaceuticals for human ...
W. States Medical Center v. Shalala, 238 F.3d 1090 (9th Cir., 2001) February 6, 2001
Evidence in the legislative record interpreting the final legislation demonstrates that Congress meant to exempt compounding pharmacists from FDCA requirements only in return for a prohibition on the promotion of specific compounded drugs. A House report explained that FDAMA was designed to "ensure continued availability of compounded drug products as a component of individualized drug therapy, while limiting the scope of compounding so as to prevent manufacturing under the guise of compounding." ...
Western States Medical Center v. Shalala, 69 F.Supp.2d 1288 (D. Nev., 1999) September 16, 1999 WESTERN STATES MEDICAL CENTER, a Nevada Corporation; Women's International Pharmacy, a Wisconsin corporation; Health Pharmacy, a Wisconsin corporation; Apothecure, a Texas corporation; College Pharmacy, a Colorado corporation; Lakeside Pharmacy, a Tennessee corporation; and Wedgewood Village Pharmacy, a New Jersey corporation, Plaintiffs, v. Donna SHALALA, in her official capacity as Secretary, United States Department of Health and Human Services, and Michael A. Friedman, in his official capacity ...
Wedgewood Village Pharmacy v. D.E.A., 509 F.3d 541 (D.C. Cir., 2007) December 11, 2007
The FDAMA contained a definition of "compounding" that required a prescription therefor to be unsolicited by a retail pharmacy and prohibited the pharmacy from advertising the compounding of a particular drug. Pub.L. No. 105-115 § 127 (codified at 21 U.S.C. § 353a(a), (c)). Several pharmacies with large compounding practices, including Wedgewood, challenged these provisions as violative of the First Amendment.
In its closed distribution system, the CSA created three categories of registrants: "manufacturer," "distributor" and "practitioner"—each with distinct requirements for registration. See 21 U.S.C. § 823(a) (criteria for "manufacturer" registration), 823(b) (criteria for "distributor" registration), 823(f) (criteria for "practitioner" registration). A "manufacturer" is authorized to engage in "[t]he production, preparation, propagation, compounding, or processing of a drug." Id. § 802(15) (emphasis ...
Wedgewood is a pharmacy specializing in compounding drugs used for treating humans and animals. "Compounding" refers to the process of modifying prescription drugs to meet the specific needs of individual patients.
Wedgewood Village Pharmacy, Inc. v. Ashcroft, 293 F.Supp.2d 462 (D.N.J., 2003) December 15, 2003
In arguing that the public interest requires that this Court keep Wedgewood in operation, Wedgewood argues only that Wedgewood's customers will suffer because they will not be able to tap Wedgewood's expertise. While it might be true that the type of compounding that Wedgewood performs for its physicians and its patients is not something that can be done by any corner pharmacy, other compounding pharmacies exist that engage in the exact same activity as Wedgewood, namely, Wedgewood's competitors ...
In re of Estbl. Insp. of: Wedgewood Village Pharm., 270 F.Supp.2d 525 (D.N.J., 2003) July 7, 2003
Wedgewood is a New Jersey licensed pharmacy that has operated in good standing for twenty-two years. (See Wedgewood "Motion to Quash Warrant For Inspection Under the Federal Food, Drug, and Cosmetic Act" (hereinafter "Wedgewood Br.") at 7; Wedgewood Reply at 4). Located in Sewell, New Jersey, Wedgewood is owned and operated by George Malmberg, a pharmacist who holds a current and valid New Jersey license. (Id.). Wedgewood specializes in compounding, selling, and dispensing pharmaceuticals for human ...
W. States Medical Center v. Shalala, 238 F.3d 1090 (9th Cir., 2001) February 6, 2001
Western States Medical Center v. Shalala, 69 F.Supp.2d 1288 (D. Nev., 1999) September 16, 1999 WESTERN STATES MEDICAL CENTER, a Nevada Corporation; Women's International Pharmacy, a Wisconsin corporation; Health Pharmacy, a Wisconsin corporation; Apothecure, a Texas corporation; College Pharmacy, a Colorado corporation; Lakeside Pharmacy, a Tennessee corporation; and Wedgewood Village Pharmacy, a New Jersey corporation, Plaintiffs, v. Donna SHALALA, in her official capacity as Secretary, United States Department of Health and Human Services, and Michael A. Friedman, in his official capacity ...
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