Druggist suspected in illegal steroids [and HGH] found dead
7:45 AM EST, January 29, 2008
AP NEWS/ DAILYNEWS.COM
NEW YORK - A Brooklyn pharmacist who was under investigation for selling millions of dollars in steroids was found shot to death Monday evening in an office above his pharmacy, in what police said appears to be a suicide.
A suicide note and gun were found next to the body of John Rossi, 56, who was shot in the head, police said.
Rossi's store, Lowen's Pharmacy, in Bay Ridge, is an old-fashioned neighborhood drugstore that investigators said had expanded into selling steroids and growth hormone locally and abroad.
A multistate investigation conducted by Albany County district attorney, P. David Soares, resulted in a raid of Lowen's by the State Bureau of Narcotic Enforcement last year. More than $100,000 in steroids was seized in May, and a larger raid in mid-October seized $7.5 million worth of human growth hormone and anabolic steroids.
It is not illegal in New York for pharmacies to dispense steroids and human growth hormone for valid medical purposes, but their activities are tightly regulated and it is a crime for a doctor to prescribe drugs without examining the patient.
After seeing Rossi earlier on Monday, employees noticed that he was missing late in the day. They found his body in the second floor office around 7 p.m.
Public Health Service Food and Drug Administration
Los Angeles District Pacific Region 19701 Fairchild Irvine, CA 92612-2506
Telephone: 949-608-2900 FAX: 949-608-4415
WARNING LETTER
CERTIFIED MAIL RETURN RECEIPT REQUESTED
January 7, 2007
W/L 08-08
Mr. Jeffrey Barris, Owner Pacifica Pharmacy 23560 S. Madison Torrance, CA 90505
Dear Mr. Barris:
We recently reviewed your firm's website, www.pacificapharmacy.com. 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(0(1) of the FDCA [21 U.S.C. § 352(0(1)] in that their labeling fails to bear adequate directions for use.
A. Misbranded Drugs Under Section 502(a) of the FDCA
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 mate rial 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 FDCA for the following reasons :
1. Unsubstantiated Efficacy Claims
Your firm's website contains claims concerning your firm's compounded hormone therapy drugs, including:
• "Protection against heart disease" • "Reduced risk of breast cancer"
FDA regards these claims as false and misleading. FDA is not aware of substantial evidence (consisting of adequate and well controlled clinical investigations) that supports these claims.
2. Unsubstantiated Superiority Claims
Your firm's website contains a statement suggesting the superiority of your finn's compounded hormone therapy drugs:
• "Fewer side effects versus synthetic derivatives"
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 evidence (consisting of adequate and well controlled clinical investigations)---is false and misleading.
3. Unsubstantiated "Bio-identical" Claims
Your website claims that your firm's compounded hormone therapy drugs are "bio-identical." This claim implies that your compounded hormone therapy drugs are natural, or identical to the hormones made by the body. FDA is unaware of substantial evidence (consisting of adequate and well controlled clinical investigations) to support the claimed "bio-identical" nature of your hormone therapy drugs.
As explained above, the claims made for your hormone therapy drugs are false and misleading in that they are not supported by substantial evidence. These claims cause your hormone therapy drugs to be misbranded under section 502(a) of the FDCA.
B. Unapproved New Drug Under Section 505 of the FDCA: Estriol
Because your products are intended to treat, mitigate, and prevent disease (a conclusion supported by the claims described above), the estriol products compounded by your firm are drugs within the meaning of section 201(g) of the 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 (5th 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, FDA has 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. Western 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.
FDA's current enforcement policy with respect to the compounding of human drugs is articulated in Compliance Policy Guide section 460.200 ["Pharmacy Compounding"], issued by FDA on May 29, 2002 (see Notice of Availability, 67 Fed. Reg. 39,409 (June 7, 2002))2 The CPG identifies factors that the Agency considers in deciding whether to initiate enforcement action with respect to compounding.3 These factors include whether a firm is "[c]ompounding finished drugs from bulk active ingredients that are not components of FDA approved drugs without an FDA sanctioned investigational new drug application (IND) in accordance with 21 U.S.C. § 355(i) and 21 CFR 312."
Your firm is compounding drugs containing estriol, which is not a component of an FDA-approved drug, without an FDA-sanctioned IND. These are unapproved new drugs and their compounding violates section 505(a) of the FDCA. Based on FDA's consideration of the circumstances he re, FDA is prepared to take enforcement action to halt your compounding of drugs containing estriol.
C. Misbranded Drugs Under Section 502(fl(1) of the FDCA: Estriol
The estriol drugs compounded by your firm are also misbranded under section 502(0(1) of the FDCA [21 U.S.C. § 352(0(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 FDCA and they lack approved applications filed pursuant to section 505 of the FDCA.
D. Conclusion
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility, and they may not be limited to the above-cited drug products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence and the occurrence of other violations. It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the cited violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
Your response should be sent to:
Pamela B. Schweikert, Director Compliance Branch, Los Angeles District U.S. Food & Drug Administration 19701 Fairchild Irvine, CA 92612
If you have any questions, please contact John Stamp, Compliance Officer, at (949) 608-4464.
Sincerely,
/S/
Alona E Cruse Director Los Angeles District U.S. Food and Drug Administration
1 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.
2 Although Section 503A of the FDCA [21 U.S.C. § 353a] addresses pharmacy compounding, this provision was invalidated by the Ninth Circuit's ruling in Western States Medical Center v. Shalala, 238 F.3d 1090 (9th Cir. 2001), that Section 503A included unconstitutional restrictions on commercial speech and those restrictions could not be severed from the rest of 503A. In Thompson v. Western States Medical Center, 535 U.S. 357 (2002), the Supreme Court affirmed the Ninth Circuit ruling that the restrictions in question violated the First Amendment, but it did not consider whether these restrictions could be severed from the rest of section 503A. FDA shares the Ninth Circuit's view that section 503A is now void.
3 As stated in the CPG, °[t]he . . . list of factors is not intended to be exhaustive." See CPG section 460.200 ["Pharmacy Compounding"].
Public Health Service Food and Drug Administration
Los Angeles District Pacific Region 19701 Fairchild Irvine, CA 92612-2506
Telephone: 949-608-2900 FAX: 949-608-4415
WARNING LETTER
CERTIFIED MAIL RETURN RECEIPT REQUESTED
January 7, 2008
W/L 05-08
Mr. Earl Broidy, Owner Panorama Compounding Pharmacy 6744 Balboa Boulevard Lake Balboa, CA 91406
Dear Mr. Broidy:
We recently reviewed your firm's website, www.uniquerx.com. 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.
A. Misbranded Drugs Under Section 502(a) of the FDCA
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 FDCA for the following reasons:
1. Unsubstantiated Efficacy Claims
Your firm's website contains claims concerning your firm's compounded hormone therapy drugs, including:
"Bio-identical estrogen replacement therapy can benefit a woman by . . . reducing the risk of heart disease, reducing the risk of Alzheimer's . . . ."
FDA regards these claims as false and misleading. FDA is not aware of substantial evidence (consisting of adequate and well controlled clinical investigations) that supports these claims.
2. Unsubstantiated Superiority Claims
Your firm's web site contains a statement suggesting the superiority of your firm's compounded hormone therapy drugs:
"Bio-identical hormones differ from synthetic hormones in that synthetics are not identical in either structure or function to the natural hormones they emulate. Because synthetics are not identical to the hormones in the body, they do not attach to receptor sites in the same way that bio-identicals do. Some of the possible unwanted side effects may include: breast tenderness, fluid retention, headaches, vaginal bleeding, high blood pressure, leg cramps, etc."
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 evidence (consisting of adequate and well controlled clinical investigations)-is false and misleading.
3. Unsubstantiated "Bio-identical" Claims
Your website claims that your firm's compounded hormone therapy drugs are "bio-identical." This claim implies that your compounded hormone therapy drugs are natural, or identical to the hormones made by the body. FDA is unaware of substantial evidence (consisting of adequate and well controlled clinical investigations) to support the claimed "bio-identical" nature of your hormone therapy drugs.
As explained above, the claims made for your hormone therapy drugs are false and misleading in that they are not supported by substantial evidence. These claims cause your hormone therapy drugs to be misbranded under section 502(a) of the FDCA.
B. Unapproved New Drug Under Section 505 of the FDCA: Estriol
Because your products are intended to treat, mitigate, and prevent disease (a conclusion supported by the claims described above), the estriol products compounded by your firm are drugs within the meaning of section 201(g) of the 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 (5th 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, FDA has 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. Western 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.
FDA's current enforcement policy with respect to the compounding of human drugs is articulated in Compliance Policy Guide section 460.200 ["Pharmacy Compounding"], issued by FDA on May 29, 2002 (see Notice of Availability, 67 Fed. Reg. 39,409 (June 7, 2002))2 The CPG identifies factors that the Agency considers in deciding whether to initiate enforcement action with respect to compounding.3 These factors include whether a firm is "[c]ompounding finished drugs from bulk active ingredients that are not components of FDA approved drugs without an FDA sanctioned investigational new drug application (IND) in accordance with 21 U.S.C. § 355(i) and 21 CFR 312."
Your firm is compounding drugs containing estriol, which is not a component of an FDA-approved drug, without an FDA-sanctioned IND. These are unapproved new drugs and their compounding violates section 505(a) of the FDCA. Based on FDA's consideration of the circumstances here, FDA is prepared to take enforcement action to halt your compounding of drugs containing estriol.
C. Misbranded Drugs Under Section 502(0(1) of the FDCA: Estriol
The estriol drugs compounded by your firm are also misbranded under section 502(0(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 FDCA and they lack approved applications filed pursuant to section 505 of the FDCA.
D. Conclusion
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility, and they may not be limited to the above-cited drug products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence and the occurrence of other violations. It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the cited violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
Your response should be sent to:
Pamela B. Schweikert, Director Compliance Branch, Los Angeles District U.S. Food & Drug Administration 19701 Fairchild Irvine, CA 92612
If you have any questions, please contact John Stamp, Compliance Officer, at (949) 608-4464.
Sincerely,
/S/
Alonza E Cruse Director Los Angeles District U.S. Food and Drug Administration
cc: Jeff Farrar, DVM, PhD, MPH Branch Chief Food and Drug Branch California Department of Public Health 1500 Capitol Avenue - MS 76702 P.O. Box 997413 Sacramento, CA 95899-7413
1 In August 2008, 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.
2 Although Section 503A of the FDCA [21 U.S.C. § 353a] addresses pharmacy compounding, this provision was invalidated by the Ninth Circuit's ruling in Western States Medical Center v. Shalala, 238 F.3d 9090 (9th Cir. 2001), that Section 503A included unconstitutional restrictions on commercial speech and those restrictions could not be severed from the rest of 503A. In Thompson v. Western States Medical Center, 535 U.S. 357 (2002), the Supreme Court affirmed the Ninth Circuit ruling that the restrictions in question violated the First Amendment, but it did not consider whether these restrictions could be severed from the rest of section 503A. FDA shares the Ninth Circuit's view that section 503A is now void.
3 As stated in the CPG, "[t]he . . . list of factors is not intended to be exhaustive." See CPG section 460.200 "Pharmacy Compounding"].
Public Health Service Food and Drug Administration
Los Angeles District 19701 Fairchild Irvine, California 92612-2506 Telephone(949) 608-2900
WARNING LETTER
CERTIFIED MAIL- RETURN RECEIPT REOUESTED
January 7, 2008
W/L O6-08
Mr. Thomas Reed and Ms. Dana Reed-Kane, Owners Reed's Compounding Pharmacy 2729 E. Speedway Tucson, AZ 85716
Dear Mr. Reed and Ms. Reed-Kane:
We recently reviewed your firm's website, www.reedsrx.com. 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 S02(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 S02(f)(1) of the FDCA [21 U.S.C. § 352(f)(1)] in that their labeling fails to bear adequate directions for use.
A. Misbranded Drugs Under Section 502(a) of the FDCA
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 FDCA for the following reasons:
1. Unsubstantiated Efficacy Claims
Your firm's website contains claims concerning your firm's compounded hormone therapy drugs, including:
"Better maintenance of muscle mass and strength."
"Improved sleep and better mood, concentration, and memory."
"May prevent senility and Alzheimer's disease."
FDA regards these claims as false and misleading. FDA is not aware of substantial evidence (consisting of adequate and well controlled clinical investigations) that supports these claims.
2. Unsubstantiated Superiority Claims
Your firm's website contains a statement suggesting the superiority of your firm's compounded hormone therapy drugs:
"Many fewer unwanted side effects than with synthetic hormones."
"Because progesterone is a naturally occurring hormone, there are very few side effects of natural hormone replacement therapy of progesterone."
These statements represent and suggest that your firm's compounded hormone therapy drugs are superior to other hormone therapy products, including FDA-approved drugs. These claims which are unsupported by substantial evidence (consisting of adequate and well controlled clinical investigations)-are false and misleading.
3. Unsubstantiated "Bio-identical" Claims
Your website claims that your firm's compounded hormone therapy drugs are "bio-identical." This claim implies that your compounded hormone therapy drugs are natural, or identical to the hormones made by the body. FDA is unaware of substantial evidence (consisting of adequate and well controlled clinical investigations) to support the claimed "bio-identical" nature of your hormone therapy drugs.
As explained above, the claims made for your hormone therapy drugs are false and misleading in that they are not supported by substantial evidence. These claims cause your hormone therapy drugs to be misbranded under section 502(a) of the FDCA.
B. Unapproved New Drug Under Section 505 of the FDCA: Estriol
Because your products are intended to treat, mitigate, and prevent disease (a conclusion supported by the claims described above), the estriol products compounded by your firm are drugs within the meaning of section 201(g) of the 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 (5th 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), affd, 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, FDA has 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. Western 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.
FDA's current enforcement policy with respect to the compounding of human drugs is articulated in Compliance Policy Guide section 460.200 ["Pharmacy Compounding"], issued by FDA on May 29, 2002 (see Notice of Availability, 67 Fed. Reg. 39,409 (June 7, 2002)).2 The CPG identifies factors that the Agency considers in deciding whether to initiate enforcement action with respect to compounding.3 These factors include whether a firm is "[c]ompounding finished drugs from bulk active ingredients that are not components of FDA approved drugs without an FDA sanctioned investigational new drug application (IND) in accordance with 21 U.S.C. § 355(i) and 21 CFR 312."
Your firm is compounding drugs containing estriol, which is not a component of an FDA-approved drug, without an FDA-sanctioned IND. These are unapproved new drugs and their compounding violates section 505(a) of the FDCA. Based on FDA's consideration of the circumstances here, FDA is prepared to take enforcement action to halt your compounding of drugs containing estriol.
C. Misbranded Drugs 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 FDCA and they lack approved applications filed pursuant to section 505 of the FDCA.
D. Conclusion
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility, and they may not be limited to the above-cited drug products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence and the occurrence of other violations. It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the cited violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
If you have any questions or need clarifications regarding this letter prior to your written response, you may contact John Stamp, Compliance Officer at telephone number (949) 608-4464.
Your written response should be directed to:
Pamela B. Schweikert Director, Compliance Branch U.S. Food and Drug Administration 19701 Fairchild Irvine, CA 92612
Sincerely,
/S/
Alonza E Cruse Director Los Angeles District U.S. Food and Drug Administration
1 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.
2 Although Section 503A of the FDCA [21 U.S.C. §353a] addresses pharmacy compounding, this provision was invalidated by the Ninth Circuit's ruling in Western States Medical Center v. Shalala, 238 F.3d 1090 (9th Cir. 2001), that Section 503A included unconstitutional restrictions on commercial speech and those restrictions could not be severed from the rest of 503A. In Thompson v. Western States Medical Center, 535 U.S. 357(2002), the Supreme Court affirmed the Ninth Circuit ruling that the restrictions in question violated the First Amendment, but it did not consider whether these restrictions could be severed from the rest of section 503A. FDA shares the Ninth Circuit's view that section 503A is now void.
3 As stated in the CPG, "[t]he . . . list of factors is not intended to be exhaustive." See CPG section 460.200 ["Pharmacy Compounding"].
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