BEFORE THE IOWA BOARD OF PHARMACY
Re:
Iowa Nonresident Pharmacy License of
WEDGEWOOD PHARMACY,
License No. 3577,
Respondent.
Case No. 2012-200
STATEMENT OF CHARGES
& NOTICE OF HEARING
COMES NOW the Iowa Board of Pharmacy (Board) and files this Notice of
Hearing and Statement of Charges against Wedgewood Pharmacy of 405 Heron Drive,
Suite 200, Swedesboro, New Jersey 08085, pursuant to Iowa Code sections 17A.12(2)
and i7A.i8(3). Respondent's Iowa nonresident pharmacy license number 3763 was
renewed on December 6, 2011.
A. TIME, PLACE, AND NATURE OF HEARING
Hearing. A Disciplinary contested case hearing shall be held on March 12, 2013,
before the Iowa Board of Pharmacy. The hearing shall be held during the morning
hearing session, beginning at 9:00 a.m. and shall be located in the Board conference
room located at 400 S.W. 8th Street, Des Moines, Iowa.
Presiding Officer. The Board shall serve as presiding officer, but the Board may
request an Administrative Law Judge from the Department of Inspections and Appeals
make initial rulings on prehearing matters, and be present to assist and advise the board
at hearing.
Hearing Procedures. The procedural rules governing the conduct of the hearing
are found at 657 Iowa Administrative Code rule 35.19. At hearing you will be allowed
the opportunity to respond to the charges against you, to produce evidence on your
behalf, cross-examine witnesses, and examine any documents introduced at hearing.
You may appear personally or be represented by counsel at your own expense. The
hearing may be open to the public or closed to the public at your discretion.
Prosecution. The office of the Attorney General is responsible for representing
the public interest (the State) in this proceeding. Pleadings shall be filed with the Board
and copies should be provided to counsel for the State at the following address:
Theresa O'Connell Weeg
Assistant Attorney General
Iowa Attorney General's Office
2nd Floor Hoover State Office Building
Des Moines, Iowa 50319
Ms. Weeg may also be reached by phone at (515) 281-5328 or bye-mail at
Theresa.Weeg@iowa.gov.
Communications. You may contact the Board office (515) 281-5944with
questions regarding this notice and other matters relating to these disciplinary
proceedings. However, you may NOT contact individual members of the Board to
discuss these proceedings by phone, letter, facsimile, email, or in person. Board
members can only receive information about the case when all parties have notice and
an opportunity to participate, such as at the hearing or in pleadings you file with the
Board office and serve upon all parties in the case. You may also direct questions
relating to settlement of these proceedings to Assistance Attorney General Theresa
O'Connell Weegat (515) 281-5328 or at Theresa.Weeg@iowa.gov.
B. LEGAL AUTHORITY AND JURISDICTION
Jurisdiction. The Board has jurisdiction in this matter pursuant to Iowa Code
chapters 17A, 147,155A, and 272C(2011).
Legal Authority. If any of the allegations against you are founded, the Board has
authority to take disciplinary action against you under Iowa Code chapters17A, 147,
148C, and 272C (2011) and 657 Iowa Administrative Code chapter 36.
Default. If you fail to appear at the hearing, the Board may enter a default
decision or proceed with the hearing and render a decision in your absence, in
accordance with Iowa Code section 17A.12(3) and 657 Iowa Administrative Code rule
35-21.
C. CHARGES
Count I
FAILURE TO COMPLY WITH PHARMACY COMPOUNDING
REQUIREMENTS
Respondent is charged with failing to comply with pharmacy compounding
requirements, pursuant to Iowa Code sections 155A.13A(3) and155A.15 and in violation
of 657 Iowa Administrative Code 20.1 and 20.3.
Count II
ENGAGING IN THE UNLAWFUL MANUFACTURE
OF UNAPPROVED DRUG PRODUCTS
Respondent is charged with the unlawful manufacture and distribution of prescription
drug products which are unapproved by the FDA, misbranded and adulterated in
violation of Iowa Code sections 126.3, 155A.15(2X1), i55A.23(i)(f) and i55A.23(i)(g);
657 Iowa Administrative Code 20.2 and 20.3(4); 21 U.S.C.§ 355; 21 U.S.C. §352(f)(i); 21
U.S.C. § 351(a)(5); 21 U.S.C. § 352(0); and Title 21 Code of Federal Regulations Parts
210 and 211.
D. FACTUAL CIRCUMSTANCES
1. Respondent is an Iowa nonresident pharmacy. It has been licensed as
such since prior to December 4, 2006. Its current license was renewed
on December 6, 2011.
2. In its most recent renewal application, Respondent describes itself as "a
compounding pharmacy...that provides customized compounded
prescription medications upon receipt of prescriptions or orders from
licensed practitioners."
3. At all times material to this Statement of Charges, Respondent held a
current and active Iowa nonresident pharmacy license.
4. Respondent received a Warning Letter from the U.S. Food and Drug
Administration (FDA) dated October 31, 2006. The letter indicated that
(1) Respondent produces finished drug products that are essentially
copies of commercially available products and (2) Respondent does not
document a medical need for particular patients for these versions of
otherwise commercially available products. The letter also indicated
that (1) Respondent's facility and equipment are of a scale capable of
producing large quantities of products and are thus indicative of
practice beyond traditional pharmacy compounding and (2)
Respondent has manufacturing equipment which can produce large
quantities of drugs that are inconsistent with traditional pharmacy
compounding. The letter also states "[Respondent] is engaged in the
large-scale manufacturing of unapproved drugs, including copies of
commercially available FDA-approved drugs, which raises safety
concerns and poses a significant threat to the new drug approval
process of the Federal Food, Drug and Cosmetic Act." A copy of the
FDA Warning Letter is attached to this Statement of Charges and Notice
of Hearing and is hereby incorporated by reference.
5. Respondent received a follow-up letter from the FDA dated June 29,
2012, regarding Respondent's compounding of 17-hydroxyprogesterbne
caproate (Makena®). The letter stated "FDA does not consider
compounding large volumes of copies, or what are essentially copies, of
any approved commercially available drug to fall within the scope of
traditional pharmacy practice."The letter also stated, "As we explained
in our October 31, 2006, Warning Letter to you, 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 product, or diluted dosages for
children." A copy of the letter is attached to this Statement of Charges
and Notice of Hearing and is hereby incorporated by reference.
6. Respondent was inspected by an authorized agent of the Iowa Board of
Pharmacy, on December 12, 2012. That inspection report indicates the
following:
a. The pharmacist in charge', Anthony Grzib, was unable to
generate a report to show which products were shipped into
Iowa. As a result, the inspection was extremely limited and the
Board's inspector was unable to conduct a complete review of
Respondent's facility and records.
b. The Board's inspector was allowed to view several
compounding rooms. Those rooms contained large, professional
grade equipment.
c. The pharmacist in charge, Anthony Grzib, stated that
Respondent is shipping non-patient specific products into Iowa
for "office use". This includes products for humans and animals.
It also includes sterile and non-sterile products.
d. The pharmacist in charge, Anthony Grzib, stated that
Respondent does not have approved New Drug Applications
(NDAs) with the FDA for the products that it prepares.
7. On December 24, 2012, the Board received additional information from
Respondent, including the following:
a. Between June 12, 2012 and December 11, 2012,
Wedgewood dispensed 6.5 patient-specific orders
per day into Iowa (1.2 to human patients; 5.3 to
animal patients; 3.0 were sterile preparations; 3,3
were non-sterile preparations; and 0.2 were sterile
preservative-free preparations).
b. Between June 12, 2012 and December 11, 2012,
Wedgewood distributed 11.4 non-patient-specific "office
use" orders per day into Iowa (0.4 to prescribers treating
• human patients; 11.0to prescribers treating animal
patients; 4.8 were sterile preparations; 7.4 were non-sterile
preparations; and 0.7 were sterile preservative-free
preparations). "Office use" orders, while to one prescriber,
may contain more than one compounded preparation.
8. Between June 12, 2012 and December 11, 2012,
Respondent dispensed and/or distributed various
sterile preparations into Iowa including the
following: Amikacin Sulfate, Apomorphine,
Cimetidine, Corticotrophin, Cyclosporine, Demecarium
Bromide, Desmopressin Acetate, Diphenhydramine,
Dipyrone, Edetafe Disodium, Epinephrine, Guaifenesin,
Idoxuridine, Lidocaine, Medetomidine, Meloxicam,
Methocarbamol, Metoclopramide, Papaverine,
Pentosan, Potassium Chloride, Tacrolimus, Trifluridine,
Trip'elennamine, Vitamin B-12, Vitamin BComplex,
Xylazine, and Sodium Chloride 0.9%.
9. Respondent has dispensed compounded preparations of 17-
hydroxyprogesterone caproate to Iowa patients as recently as
December 7, 2012.
10. Respondent has distributed large quantities of various
compounded preparations for non-patient-specific "office use" into
Iowa for use as stock supply.
11. In Iowa, "manufacturing", includes the promotion, marketing, or
preparationfrombulkdrugsubstances ofcommercially available products
for resale by pharmacists,.practitioners, or other persons.
12. Respondent is manufacturing and distributing unapproved new drugs
in violation of federal law. Respondent is manufacturing products
which are drugs within the meaning of 21 U.S.C. § 321(g)(1) because
they are intended for use in the diagnosis, cure, mitigation, treatment,
or prevention of disease, or because they are intended to affect the
structure or function of the body. These products are "new drugs"
within the meaning of 21 U.S.C. § 32i(p) because they are not generally
recognized as safe and effective for their labeled uses. Under 21 U.S.C.
§§ 331(d) and 355(a), a new drug may not be introduced into or
delivered for introduction into interstate commerce unless an
application approved by FDA under either 21 U.S.C. §355(b) or (j) is in
effect for the product. There are no FDA-approved applications on file
for the products manufactured by Respondent. The marketing of these
products without an approved application constitutes a violation of
federal law.
13. Respondent has engaged in drug manufacturing without complying
with CGMP requirements for finished pharmaceuticals as required by
21 U.S.C.§ 351(a)(2)(B) and Title 21Code of Federal Regulations Parts
210 and 211.
E. SETTLEMENT
This matter maybe resolved by settlement agreement. The procedural rules
governing the Board's settlement process are found at 657 Iowa Administrative Code
rule 36.3. If you are interested in pursuing settlement of this matter, please contact
Assistant Attorney General Theresa Weeg.
***********************************************
4i
F. PROBABLE CAUSE FINDING
On this IW day of January, 2013, the Iowa Board of Pharmacy found
probable cause to file this Notice of Hearing and Statement of Charges.
cc: Theresa Weeg
Assistant Attorney General
Hoover State Office Building
Des Moines, Iowa 50319
U^C^O^t
SUSAN M. FREY, Chairperson
Iowa Board of Pharmacy
400 SW Eighth Street, Suite E
Des Moines, Iowa 50309-4688
PROOF OF SERVICE
The undersigned certifies that the foregoing instrument was served upon Respondent to the above cause by:
( ) personal service ( ) first class mail
N) certified mail, return receipt requested •'••( ) facsimile
Article Number 9171999991703105609825 ( ) other
on the 111\ day of January, 2013.
I declare that the statements above are true to the best of my information, knowledge and belief.
Lu^^A-g^ b
Debbie S. Jorgenson
Wedgewood Village Pharmacy 31-Oct-06
/—i
Department of Health and Human Services
Telephone (973) 526-6010.
Public Health Service
Food and Drug Administration
Waterview Corporate Center
10 Waterview Blvd., 3rd Floor
Parsippany, NJ 07054
WARNING LETTER
October 31, 2006
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Mr. George Malmberg, R.Ph.
Owner
Wedgewood Village Pharmacy
405 Heron Drive
Swedesboro, New Jersey 08085
06-NWJ-03
Dear Mr. Malmberg:
On October 4-28, 2005, investigators from the U.S. Food and Drug Administration
(FDA) inspected, your firm, Wedgewood Village Pharmacy, located at 405 Heron Drive,
Swedesboro, NewJersey. This inspection revealed that your firm produces human and
animal prescription drugs in various dosage forms and strengths. The inspection also
revealed serious violations of the Federal Food, Drug, and Cosmetic Act (FDCA),
including violations of its new drug, new animal drug, and misbranding provisions. In
particular, and as explained below, the products compounded by your firm are drugs
within the meaning of section 201(g) of the FDCA [21 U.S.C. § 321(g)]. These products
are new drugs under section 201 (p) of the FDCA [21 U.S.C. § 321 (p)], and new animal
drugs under section 201 (v) of the FDCA [21 U.S.C. § 321 (v)], because they are not
generally recognized by qualified experts as safe and effective for their labeled uses.
These new drugs and new animal drugs, and your production and distribution of them,
violate the FDCA.
A. Compounded Drugs Under the FDCA and FDA's Regulatory Approach to
Compounding
FDA's position is that the Federal Food, Drug, and Cosmetic Act (FDCA) establishes
agency jurisdiction over "new drugs," including compounded drugs. FDA's view is that
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 ProfIs &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 FDAas 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 Wedgewood Village Pharmacy 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."). FDA
maintains that, because they are "new drugs" under the FDCA, compounded drugs may
not be introduced into interstate commerce without FDA approval.
The drugs that pharmacists compound are rarely 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 product, or diluted dosages for
children.
Through the exercise of enforcement discretion, FDA historically has not taken
enforcement actions against pharmacies engaged in traditional pharmacy
compounding. Rather, FDA has directed its enforcement resources against
establishments whose activities raise the kinds of concerns normally associated with a
drug manufacturer and whose compounding practices result in significant violations of
the new drug, adulteration, or misbranding provisions of the FDCA.
FDA's current enforcement policies with respect to the compounding of human drugs
and compounding of drugs for use in animals are articulated in two Compliance Policy
Guide (CPGs).CPG section 460.200 ["Pharmacy Compounding"], issued by FDA on
May 29, 2002 (see Notice of Availability, 67 Fed. Reg. 39,409 (June 7, 2002))
addresses the compounding of human drugs. (1The status of Section 503A of the
FDCA ["Pharmacy Compounding"] [21 U.S.C. § 353a] was addressed by the Supreme
Court in Thompson v. Western States Medical Center, 535 U.S. 357 (2002)) 'CPG
section 608.400 ["Compounding of Drugs for Use in Animals"], issued in revised form by
FDA's Center for Veterinary Medicine on July 8, 2003, addresses the compounding of
drugs for use in animals.
These CPGs identify factors that the Agency considers in deciding whether to initiate
enforcement action with respect to compounding. These factors help differentiate the
traditional practice of pharmacy compounding from the manufacture of unapproved new
drugs and unapproved new animal drugs. They further address compounding practices
that result in significant violations of the new drug, adulteration, or misbranding
provisions of the FDCA. As stated in the CPGs, the factors listed in the CPGs are not
intended to be exhaustive. See CPG section 460.200 ["Pharmacy Compounding"] ("The
. . . list of factors is not intended to be exhaustive .") and CPG section 608.400
["Compounding of Drugs for Use in Animals"j ("The . , . list of factors is not intended to
be all inclusive.")
B. CPG on Compounding of Human Drugs [CPG 460.200]
CPG 460.200 addresses the factors that the agency considers in determining whether
to exercise its enforcement discretion with respect to the, compounding of human drugs.
Some of the factors identified in the CPG on human compounding include considering
whether a firm
uses commercial scale manufacturing equipment or testing equipment for
compounding drug products;
compounds drugs that are copies, or essentially copies, of commercially available
FDA-approved drug products without a documented patient-specific medical need.
C. CPG on Compounding of Drugs for Use in Animals [CPG 608.400]
CPG 608.400 addresses the factors that the agency may consider in determining
whether to initiate regulatory action with respect to the illegal compounding of drugs for
use in animals. Some of the factors identified in this CPG include considering whether a
firm:
compounds drugs for use in animals where an approved new animal drug or approved
new human drug used as labeled or in conformity with Title 21 Code of Federal
Regulations Part 530 will, in the available dosage form and concentration,
appropriately treat the condition diagnosed;
compounds finished drugs from human or animal drugs that are not the subject of an
approved application, or from bulk drug substances, other than those specifically
addressed for regulatory discretion by the FDA, Center for Veterinary Medicine; or
uses commercial scale manufacturing equipment for compounding drug products
As discussed below, our inspection revealed the scope and nature of your activities are
clearly outside the bounds of traditional pharmacy practice and that these activities have
resulted in significant violations of the new animal drug provisions of the FDCA.
D. Inspectional Findings
As a result of our inspection of your firm, our findings include the following:
1. Your firm produces finished drug products that are essentially copies of commercially
available products, and your firm does not document a medical need for particular
patients for these versions of otherwise commercially available products. These
products include:
Enrofloxacin (veterinary)
Pyrimethamine/Sulfadiazine (veterinary)
Cyclosporine Ophthalmic (veterinary)
Altrenogest (veterinary)
Flunixin Meglumine (veterinary)
Ketoprofen (veterinary)
Acetic Acid 2% solution (human)
Dipyridamole 5 mg/mL injections (human)
DMSO (Dimethylsulfoxide) 50% aqueous solutions (human) EDTA (Edetate Disodium)
150 mg/mL injections (human) Estradiol Valerate Oil 10 mg/mL and 20 mg/mL injections
(human) Hyaluronidase 150 units/mL injections (human)
Isosulfan injections (human)
Lidocaine 2% surgical jelly (human)
Mesalamine 500 mg suppositories (human)
Mitomycin Ophthalmic solutions (human)
Naloxone HCI 1 mg/mL injections (human)
Progesterone in Oil 50 mg/mL injections (human)
Ranitidine 15 mg/mL solutions (human)
Sodium Tetradecyl Sulfate 3% injections (human)
Tacrolimus 0.1 % ointments (human)
Tinidazole 500 mg capsules (human)
2. Your facility and equipment are of a scale capable of producing large quantities of
products and are thus indicative of practice beyond traditional pharmacy compounding.
Specifically, your facility contains [redacted]rooms used for production, including raw
material storage, weighing, and [redacted] sterile suites. Equipment contained within
these processing rooms is capable of producing large quantities of drug products. For
example, the [redacted] encapsulator is capable of producing [redacted] capsules per
hour and the [redacted] Mixer has a capacity of [redacted]. This manufacturing
equipment produces large quantities of drugs, including lot sizes of drugs that are
inconsistent with traditional pharmacy compounding. Examples of lot sizes produced by
your firm include, but are not limited to:
Diethylstilbestrol 1 mg capsule - [redacted] capsules (veterinary or human)
Dipyrone 500 mg/ml injection [redacted] (veterinary)
Flunixin Meglumine paste 1.5 mg/30 ml - [redacted] (veterinary)
Girseofulvin 2.5 gm/10 gm packet - [redacted] packets (veterinary)
17-alpha Hydroxyprogesterone Caproate injection - [redacted]
(veterinary or human)
Lidocaine 2% jelly 1000 ml - [redacted] (human)
Your firm purports to be a compounding pharmacy. But our inspection revealed that
your firm engages in activities that fall outside the traditional practice of pharmacy
compounding of drugs. We base this conclusion on the factors in CPG 460.200, and
CPG 608.400 including the factors identified above. Your firm is engaged in the large scale
manufacturing of unapproved drugs, including copies of commercially available
FDA-approved drugs, which raises safety concerns and poses a significant threat to the
new drug approval process of the FDCA.
E. Violations of the FDCA
Based on the foregoing findings, your firm and the drugs that your firm produces violate
the following provisions of the FDCA:
1. Unapproved New Drugs Under Section 505 of the FDCA f21 U.S. C.S 3551
The human drug products produced by your firm are unapproved new drugs within the
meaning of section 505 of the FDCA [21 U.S.C. § 355] and may not be introduced into
interstate commerce without an FDA-approved drug application.
2. Misbranded Drugs Under Section 502ffl(1 ) of the FDCA T21 U.S.C. S352(f)(1)l
Your human and animal drug products are 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
use. These products are not exempt from section 502(f)(1) under 21 C.F.R. § 201.115
because they are new drugs within the meaning of section 201 (p) of the FDCA [21
U.S.C. § 321 (p)], or new animal drugs within the meaning of section 201 (v) of the FDCA
[21 U.S.C. § 321 (v)], and they lack approved applications filed pursuant to sections 505
or 512 of the FDCA [21 U.S.C. §§ 355 and 360b].
3. Adulterated Animal Drugs Under Section 501 a 5 of the FDCA T21 U.S.C. § 351(a)(5)!
The animal drugs that you compound from bulk active pharmaceutical ingredients (bulk
APIs) are unsafe within the meaning of section 512 of the Act (21 U.S.C. § 360b) since
they are not the subject of approved New Animal Drug Applications. Assuch, they are
adulterated under section 501(a)(5) of the Act (21 U.S.C. § 351(a)(5)). Sections
512(a)(4) and (5) of the Act (21 U.S.C. §§ 360b(a)(4) and (5)), and their implementing
regulations, allow some extralabel use of approved animal and human drugs, including
compounding from approved animal and human drugs. These provisions, however,
apply only to approved drugs and do not permit compounding from bulk APIs (see 21
C.F.R.§ 530.13(a)).'
4. Misbranded Drugs Under Section 502(o) of the FDCA 121 U.S.C. § 352(0)1
The human and animal drugs produced by your firm are misbranded under section
502(o) of the FDCA [21 U.S.C. § 352(o)] in that they are manufactured in an
establishment not duly registered under section 510 of the FDCA [21 U.S.C. § 360], and
the drugs have not been listed as required by section 510(j) ofthe FDCA [21 U.S.C. §
3600)]. Your facility is not exempt from registration and drug listing under section 510(g)
of the FDCA [21 U.S.C. § 360(g)] or 21 C.F.R. § 207.10.
Wenote that it is also your responsibility to assure that you comply with current Good
Manufacturing Practice (GMP) as delineated in 21 C.F.R. Parts 210 and 211. Future
inspections will assess your compliance with these regulations.
F. Conclusion
The above violations are not intended to be an all-inclusive list of deficiencies. You
should take prompt action to correct these deviations. Failure to promptly correct these
deviations may result in additional regulatory action without further notice, including
seizure of your products or injunction against you or your firm. Federal agencies are
routinely advised of the issuance of warning letters so that they may take this
information into account when considering the award of government contracts.
Please notify this office in writing within 15 working days of receipt of this letter of any
steps you will take to correct the noted violations, including an explanation of each step
being taken to prevent the recurrence of similar violations. If corrective action cannot be
completed within 15 working days, please state the reason for the delay and the time
frame within which the correction will be completed.
You should address your reply to this letter to the U.S. Food and Drug Administration,
New Jersey District, 10Waterview Boulevard, 3rd Floor, Parsippany, New Jersey
07054, Attn: Sarah A. Delia Fave, Compliance Officer.
Sincerely,
IS/
Douglas I. Ellsworth
District Director
New Jersey District
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
Silver Spring, MD 20993-0002
June 29, 2012
George J. Malmberg, R.Ph.
President and CEO
Wedgewood Pharmacy
405 Heron Drive #200
Swedesboro, NJ 08085
Dear Mr. Malmberg:
This letter concerns the information that appears on your website regarding Wedgewood
Pharmacy's compounding of 17-hydroxyprogesterone caproate (HC). HC is the active
ingredient in Makena, which, as you know, the Foodand Drug Administration (FDA)
approved in February 2011 for the reduction of the risk of certain preterm births in
women who have had at least one prior preterm birth.
Yourwebsite includes a press release Wedgewood Pharmacy issued on March 30, 2011,
which interprets a statement issued by FDA the same day.' In the press release, titled
"With FDAgreen light, Wedgewood Pharmacy continues to compound 17P
(hydroxyprogesterone caproate)", Wedgewood Pharmacy acknowledged that"Under
normal circumstances, compounding pharmacies muststop making a prescription drug
when the same drug is manufactured as a commercial product." However, Wedgewood
Pharmacy interpreted FDA's March 30, 2011, statement on Makena as "allowing]
compounding pharmacies to continue" compounding hydroxyprogesterone caproate, and
stated that it would"continue to prepare and dispense 1ml, 5ml and 10ml multi-dose vials
of 17P (Hydroxyprogesterone Caproate)." Wedgewood Pharmacy's press statement also
explained that"for patients with certain sensitivities, forwhom the use of Wedgewood
Pharmacy's regular formulation of 17P is contraindicated, the company also will provide
a preservative-free 17-alpha hydroxyprogesterone caproate, 250mg/ml, in single-dose
vials." In addition, your website includes a statementtitled "FDA's Review of
Compounded 17P Finds NoSafety or Purity Issues for Enforcement Policy Change,"
which states that "the FDA found no reason to change its enforcement policies regarding
compounded Hydroxyprogesterone Caproate."
Weare writing to ensure that Wedgewood Pharmacy is not operating under the
misimpression that there is a "green light" to compound large volumes of copies of
Makena. On June 15, 2012, FDA updated the March 30, 2011, statement on
compounded versions of hydroxyprogesterone caproate. That statement explained:
1http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm249025.htm (March 30,2011).
Page 2
Compounding largevolumes of drugs that are copies of FDA-approved
drugs circumvents important public health requirements, including the
Federal Food, Drug, and Cosmetic Act's drug approval provisions.
Consumers and health professionals rely on the Act's evidence-based drug
approval process to ensure that drugs are safeand effective. For that
reason, one factor that the agency considers in determining whether a
drug may be compounded is whether the prescribing practitioner has
determined that a compounded product is necessary for the particular
patient and would provide a significant difference for the patient as
compared to the FDA-approved commercially available drug product.
(emphasis added).
The statement also emphasized thatFDA is "applying its normal enforcement policies for
compounded drugs to compounded hydroxyprogesterone caproate," and that the
"compounding of any drug, including hydroxyprogesterone caproate, should not exceed
the scope oftraditional pharmacy compounding." Acomplete copy ofthe statement is
available on FDA's website at
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm308546.htm.
As we explained in our October 31, 2006, Warning Letter to you, "[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 massproduced
product, ordiluted dosages for children." The information on your website
indicates that you compound copies of the commercially available product as well as a
preservative-free formulation for patients unable to tolerate the product that contains the
preservative. You should be aware that FDA does not view compounding large volumes
of drugs that are copies of FDA-approved drugs as traditional pharmacy compounding.
The compounding of copies of commercially available drugs is addressed in both section
503A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 353a) andthe Agency's
compliance policy guide (CPG) on pharmacy compounding (CPG Sec. 460.200). For a
drug to satisfy the conditions in section 503A, a pharmacist may "not compound
regularly or in inordinate amounts (as defined by the Secretary) any drug products that
are essentially copies of a commercially available drug product." 21 U.S.C.
§353a(b)(l)(D). Similarly, the CPG identifies factors that the Agency considers in
deciding whether to initiate enforcement action with respect to compounding. One of the
factors listed in the CPG is "Compounding drug products that are commercially available
in the marketplace or that are essentially copies of commercially available FDA-approved
2As you know, the Fifth and Ninth Circuit Courts of Appeals have reached different conclusions regarding
whether section 503A is invalid or remains in effect. Compare Western States Med Or. v. Shalala, 238
F.3d 1090 (9th Cir. 2001) (holding that the solicitation and advertising prohibitions in section 503A are an
impermissible regulation of commercial speech and that those provisions are unconstitutional and cannot be
severed from the rest of section 503A, causing all of section 503Ato be invalid); with Medical Ctr. Pharm.
v. Mukasey, 536 F.3d 383 (5th Cir. 2008) (compounded drugs are "new drugs" and "new animal drugs"
within the meaning oftheAct and therefore are subject to regulation by the FDA, and the advertising
prohibitions in section 503A previously found to be unconstitutional can be severed from section 503A,
leaving the remaining parts of that section valid and effective).
Page 3
drug products. In certain circumstances, it may be appropriate for a pharmacist to
compound a small quantity of a drug that is only slightly different than an FDA-approved
drug that is commercially available. In these circumstances, FDA will consider whether
there is documentation of the medical need for the particular variation of the compound
for the particular patient." CPG Sec. 460.200 at 4-5.
As stated above, FDA does not consider compounding large volumes of copies, or what
are essentially copies, of any approved commercially available drug to fall within the
scope of traditional pharmacy practice. A Pharmacy that engages in such compounding
may be subject to enforcement action.
CC:
Diana Amador Toro
Director, New Jersey District
Sincerely,
Kathleen R. Anderson, Pharm.D.
Director (acting), Office of Unapproved Drugs and
Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
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