Source: https://quackwatch.org/cases/fdawarning/comp/pcs/
Timestamp: 2020-08-09 22:53:00
Document Index: 463542931

Matched Legal Cases: ['§ 352', '§ 355', '§ 352', '§ 321', '§ 321', '§ 321', '§ 355', '§ 355', '§ 321', '§ 352', '§ 201']

Warning Letter to Pharmacy Compounding Specialties | Quackwatch
Warning Letter to Pharmacy Compounding Specialties
Ref: 2008-DAL-WL-04
Mr. James Porter, Owner
8061 Walnut Hill Lane, Suite 924
We recently reviewed your firm’s website, www.pharmacyspecialties,corn. As explained below, your website contains false and misleading claims for your firm’s compounded hormone therapy drugs, causing those drugs to be misbranded in violation of Section 502(a) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 USC § 352(a)]. Additionally, your firm compounds a hormone therapy drug containing estriol, without an FDA-approved new drug application or an FDA-sanctioned investigational new drug application, in violation of Section 505 of the FDCA(21 USC § 355). Hormone therapy drugs containing estriol are also misbranded in violation of section 502(f)(1) of the FDCA [21 U.S.C. § 352(f)(1)] in that their labeling fails to bear adequate directions for use.
Under section 502(a) of the FDCA, a drug is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the FDCA [21 U.S.C. § 321(n)] provides that, in determining whether a drug’s labeling or advertising “is misleading, there shall be taken into account… not only representations made or suggested… but also the extent to which the labeling or advertising… fails to reveal facts material in light of such representations….”
Your website advises that you compound hormone therapy drugs that are available for purchase and distribution. These compounded hormone therapy drugs are misbranded within the meaning of section 502(a) of the FDCAfor the following reasons:
“Protection against fibrocystic breast disease”
“Protection against cardiovascular disease, the #1 killer of women”
“Acts as a natural antidepressant and enhances sleep”
“Maintains thyroid function and normalizes blood sugar levels”
“Progesterone-not to be confused with synthetic progestins cited in the published studies as putting women at risk of disease and the side effects of fluid retention, irritability and depression, natural progesterone has many positive benefits.”
This statement represents and suggests that your firm’s compounded hormone therapy drugs are superior to other hormone therapy products, including FDA-approved drugs. This claim-which is unsupported by substantial (consisting of adequate and well controlled clinical investigations) -is false and misleading.
Because your products are intended to treat, mitigate, and prevent disease (a conclusion supported by the claims described above), the estriol products compoundedby your firm are drugs within the meaning of section 201(g) ofthe FDCA [21 U.S.C. § 321(g)]. Further, as these products are not generally recognized by qualified experts as safe and effective for their labeled uses, they are new drugs, as defined by section 201(p) of the FDCA [21 U.S.C.§ 321(p)]. No FDA-approved applications pursuant to section 505 of the FDCA [21 U.S.C. § 355] are effective with respect to these drugs.
Accordingly, their introduction or delivery for introduction into interstate commerce violates section 505(a) of the Act [21 U.S.C. § 355(a)].
The FDCA establishes agency jurisdiction over “new drugs,” including compounded drugs. Compounded drugs are “new drugs” within the meaning of 21 U.S.C. § 321(p), because they are not “generally recognized, among experts… as safe and effective” for their labeled uses. See Weinberger v. Hynson, Westcott & Dunning, 412 U.S. 609, 619, 629-30 (1973) (explaining the definition of “new drug”). There is substantial judicial authority supporting FDA’s position that compounded drugs are not exempt from the new drug definition. See Prof’ls & Patients for Customized Care v. Shalala, 56 F.3d 592, 593 n.3 (5″ Cir. 1995) (“Although the [FDCA] does not expressly exempt ‘pharmacies’ or ‘compounded drugs’ from the new drug… provisions, the FDA as a matter of policy has not historically brought enforcement actions against pharmacies engaged in traditional compounding.”); In the Matter of Establishment Inspection of: Wedgewood Village Pharmacy, 270 F. Supp. 2d 525, 543-44 (D.N.J. 2003), aff’d, Wedgewood Village Pharmacy v. United States, 421 F.3d 263, 269 (3d Cir. 2005) (“The FDCA contains provisions with explicit exemptions from the new drug… provisions. Neither pharmacies nor compounded drugs are expressly exempted.”). Because they are “new drugs” under the FDCA, compounded drugs may not be introduced into interstate commerce without FDA approval.1
The drugs that pharmacists compound are not FDA-approved and thus lack an FDA finding of safety and efficacy. However, FDAhas long recognized the important public health function served by traditional pharmacy compounding. FDA regards traditional compounding as the extemporaneous combining, mixing, or altering of ingredients by a pharmacist in response to a physician’s prescription to create a medication tailored to the specialized needs of an individual patient. See Thompson v. Westem States Medical Center, 535 U.S. 357, 360-61 (2002). Traditional compounding typically is used to prepare medications that are not available commercially, such as a drug for a patient who is allergic to an ingredient in a mass-produced drug, or diluted dosages for children.
C. Misbranded Druas Under Section 502(f)(1) of the FDCA: Estriol
The estriol drugs compounded by your firm are also misbranded under section 502(f)(1) of the FDCA[21 U.S.C. § 352(f)(1)] in that their labeling fails to bear adequate directions for their use. Further, these drugs are not exempt from this requirement under 21 CFR § 201.115 because they are new drugs within the meaning of section 201(p) of the FDCAand they lack approved applications filed pursuant to section 505 of the FDCA.
Please direct your response to the U.S. Food and Drug Administration, Attn: Edwin Ramos, Compliance Officer, Dallas District Office, 4040 North Central Expressway, Suite 300, Dallas, TX 75204. You should contact Mr. Ramos at 214-253-5218 to discuss the contents of this letter.
Elaine R. Crosby
In August 2006, the U.S. District Court for the Western District of Texas issued a ruling in Medical Center Pharmacy v. Gonzales interpreting, among other things, the application of the “new drug” provisions of the FDCA to compounded drugs. See Medical Center Pharmacy v. Gonzales, MO-04-CV130, (W.D. Tex, Aug. 30, 2006). The government has appealed this decision to the U.S. Court of Appeals for the Fifth Circuit.