[Federal Register Volume 87, Number 28 (Thursday, February 10, 2022)]
[Notices]
[Pages 7840-7843]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-02801]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-1030]
Brenda K. Marmas: Final Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring
Brenda K. Marmas for a period of 5 years from importing or offering for
import any drug into the United States. FDA bases this order on a
finding that Ms. Marmas engaged in a pattern of importing or offering
for import misbranded drugs (i.e., in an amount, frequency, or dosage
that is inconsistent with her personal or household use) that are not
designated in an authorized electronic data interchange system as
products regulated by FDA. Ms. Marmas was given notice of the proposed
debarment and was given an opportunity to request a hearing to show why
she should not be debarred. As of December 12, 2021 (30 days after
receipt of the notice), Ms. Marmas had not responded. Ms. Marmas'
failure to respond and request a hearing constitutes a waiver of her
right to a hearing concerning this matter.
DATES: This order is applicable February 10, 2022.
ADDRESSES: Submit applications for termination of debarment to the
Dockets Management Staff, Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, or at https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of
Enforcement (ELEM-4029), Office of Strategic Planning and Operational
Policy, Office of Regulatory Affairs, Food and Drug Administration,
12420 Parklawn Dr., Rockville, MD 20857, 240 402-8743, or at
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(b)(1)(D) of the FD&C Act (21 U.S.C. 335a(b)(1)(D))
permits debarment of an individual from importing or offering for
import any drug into the United States if FDA finds, as required by
section 306(b)(3)(D) of the FD&C Act, that the individual has engaged
in a pattern of importing or offering for import misbranded drugs
(i.e., in an amount, frequency, or dosage that is inconsistent with
personal or household use by the importer), and the shipments are not
designated in an entry in an authorized electronic data exchange system
as products regulated by FDA.
After an investigation, FDA discovered that Ms. Marmas has engaged
in numerous instances of importing or offering for import misbranded
drugs; all the parcels containing the misbranded drugs serving as the
basis for this action, described in further detail below, were
intercepted by FDA at either the John F. Kennedy International Airport
(JFK), San Francisco International Airport (SFO), or Chicago
International Airport Mail Facilities (MF) and were addressed to Ms.
Marmas at an address connected to her.
On or about March 3, 2020, Ms. Marmas offered for import a parcel
intercepted and processed by FDA at JFK MF that was addressed to her.
This parcel contained multiple products. FDA determined that one of the
products contained in this parcel was 1,000 tablets of levofloxacin IP
and was a misbranded drug for a number of reasons: (1) The article was
determined to be a prescription drug but did not include the symbol
``Rx only'' on its label; (2) the article had been determined to lack
adequate directions for use; (3) the drug was not included in a list
required by section 510(j) of the FD&C Act (21 U.S.C. 360(j)); and (4)
the drug was manufactured, prepared, propagated, compounded, or
processed in an establishment not duly registered under section 510 of
the FD&C Act. FDA also determined that another product contained in
this parcel was 900 tablets of moxifloxacin hydrochloride and was a
misbranded drug for a number of reasons: (1) The article was determined
to be a prescription drug but did not include the symbol ``Rx only'' on
its label; (2) the article had been determined to lack adequate
directions for use; (3) the drug was not included in a list required by
section 510(j) of the FD&C Act; and (4) the drug was manufactured,
prepared, propagated, compounded, or processed in an establishment not
duly registered under section 510 of the FD&C Act. Both products were
refused entry on March 26, 2020.
[[Page 7841]]
On or about March 3, 2020, Ms. Marmas offered for import a parcel
intercepted and processed by FDA at JFK MF that was addressed to her.
This parcel contained multiple products. FDA determined that one of the
products contained in this parcel was 300 tablets of azithromycin IP
and was a misbranded drug because the article was determined to be a
prescription drug but did not include the symbol ``Rx only'' on its
label. FDA also determined that one of the products contained in this
parcel was 600 tablets of azithromycin IP and was a misbranded drug
because the article was determined to be a prescription drug but did
not include the symbol ``Rx only'' on its label. Both products were
refused entry on March 25, 2020.
On or about July 8, 2020, Ms. Marmas offered for import a parcel
intercepted and processed by FDA at SFO MF that was addressed to her.
FDA determined that the product contained in this parcel was 2,304
capsules of azithromycin 250 milligrams (mg) and was a misbranded drug
because the article was determined to be a prescription drug but did
not include the symbol ``Rx only'' on its label and the drug was not
included in a list required by section 510(j) of the FD&C Act. The
product was refused entry on August 5, 2020.
On or about July 17, 2020, Ms. Marmas offered for import a parcel
intercepted and processed by FDA at SFO MF that was addressed to her.
This parcel contained multiple products. FDA determined that one of the
products contained in this parcel was 300 tablets of amoxicillin 875 mg
and was a misbranded drug for multiple reasons: (1) The article was
determined to be a prescription drug but did not include the symbol
``Rx only'' on its label; (2) the article had been determined to lack
adequate directions for use; and (3) the drug was not included in a
list required by section 510(j) of the FD&C Act. FDA also determined
that one of the products contained in this parcel was 1,400 capsules of
clindamycin 300 mg and was a misbranded drug because the article had
been determined to lack adequate directions for use and the drug was
not included in a list required by section 510(j) of the FD&C Act. Both
products were refused entry on September 23, 2020.
On or about July 17, 2020, Ms. Marmas offered for import a parcel
intercepted and processed by FDA at SFO MF that was addressed to her.
This parcel contained multiple products. FDA determined that one of the
products contained in this parcel was 84 tablets of azithromycin 250 mg
and was a misbranded drug for multiple reasons: (1) The article was
determined to be a prescription drug but did not include the symbol
``Rx only'' on its label; (2) the article had been determined to lack
adequate directions for use; and (3) the drug was not included in a
list required by section 510(j) of the FD&C Act. FDA also determined
that one of the products contained in this parcel was 1,800 capsules of
clindamycin 150 mg and was a misbranded drug because the article had
been determined to lack adequate directions for use and because the
drug was not included in a list required by section 510(j) of the FD&C
Act. FDA also determined that one of the products contained in this
parcel was 500 tablets of roxithromycin 150 mg and was a misbranded
drug because the article had been determined to lack adequate
directions for use and because the drug was not included in a list
required by section 510(j) of the FD&C Act. All three products were
refused entry on September 23, 2020.
On or about July 21, 2020, Ms. Marmas offered for import a parcel
intercepted and processed by FDA at SFO MF that was addressed to her.
FDA determined that the product contained in this parcel was 2,520
capsules of fluconazole 200 mg and was a misbranded drug because the
drug was manufactured, prepared, propagated, compounded, or processed
in an establishment not duly registered under section 510 of the FD&C
Act and because the drug was not included in a list required by section
510(j) of the FD&C Act. The product was refused entry on August 17,
2020.
On or about July 30, 2020, Ms. Marmas offered for import a parcel
intercepted and processed by FDA at SFO MF that was addressed to her.
FDA determined that the product contained in this parcel was 2,000
capsules of doxycycline hyclate 100 mg and was a misbranded drug
because the article was determined to be a prescription drug but did
not include the symbol ``Rx only.'' The product was refused entry on
October 5, 2020.
On or about July 30, 2020, Ms. Marmas offered for import a parcel
intercepted and processed by FDA at SFO MF that was addressed to her.
This parcel contained multiple products. FDA determined that one of the
products contained in this parcel was 500 capsules of amoxicillin
trihydrate 500 mg and was a misbranded drug for multiple reasons: (1)
The article was determined to be a prescription drug but did not
include the symbol ``Rx only'' on its label; (2) the article had been
determined to lack adequate directions for use; and (3) the drug was
not included in a list required by section 510(j) of the FD&C Act. FDA
determined that one of the other products contained in this parcel was
2,000 capsules of clindamycin 300 mg and was a misbranded drug because
the article had been determined to lack adequate directions for use and
because the drug was not included in a list required by section 510(j)
of the FD&C Act. FDA determined that one of the other products
contained in this parcel was 300 tablets of amoxicillin/clavulanic acid
875 mg/125 mg and was a misbranded drug for multiple reasons: (1) The
article was determined to be a prescription drug but did not include
the symbol ``Rx only'' on its label; (2) the article had been
determined to lack adequate directions for use; and (3) the drug was
not included in a list required by section 510(j) of the FD&C Act. All
three products were refused entry on October 9, 2020.
On or about July 31, 2020, Ms. Marmas offered for import a parcel
intercepted and processed by FDA at SFO MF that was addressed to her.
This parcel contained multiple products. FDA determined that one of the
products contained in this parcel was 576 capsules of azithromycin 250
mg and was a misbranded drug because the article was determined to be a
prescription drug but did not include the symbol ``Rx only'' on its
label and the article had been determined to lack adequate directions
for use. FDA determined that the other product contained in this parcel
was 1,600 tablets of clarithromycin 500 mg and was a misbranded drug
because the article was determined to be a prescription drug but did
not include the symbol ``Rx only'' on its label. Both products were
refused entry on September 4, 2020.
On or about August 13, 2020, Ms. Marmas offered for import a parcel
intercepted and processed by FDA at SFO MF that was addressed to her.
FDA determined that the product contained in this parcel was 2,860
capsules of doxycycline hyclate 100 mg and was a misbranded drug
because the article was determined to be a prescription drug but did
not include the symbol ``Rx only.'' The product was refused entry on
October 6, 2020.
On or about September 30, 2020, Ms. Marmas offered for import a
parcel intercepted and processed by FDA at Chicago International
Airport MF that was addressed to her. FDA determined that the product
contained in this parcel was 1,000 tablets of amoxycillin and potassium
clavulanate IP and was a misbranded drug because the drug was
manufactured, prepared, propagated,
[[Page 7842]]
compounded, or processed in an establishment not duly registered under
section 510 of the FD&C Act and because the drug was not included in a
list required by section 510(j) of the FD&C Act. The product was
refused entry on October 26, 2020.
On or about October 2, 2020, Ms. Marmas offered for import a parcel
intercepted and processed by FDA at JFK MF that was addressed to her.
This parcel contained multiple products. FDA determined that one of the
products contained in this parcel was 230 tablets of LQUIN levofloxacin
and was a misbranded drug because the article was determined to be a
prescription drug but did not include the symbol ``Rx only'' on its
label and the article had been determined to lack adequate directions
for use. FDA determined that the other product contained in this parcel
was 129 tablets of AZICIP azithromycin and was a misbranded drug
because the article was determined to be a prescription drug but did
not include the symbol ``Rx only'' on its label and the article had
been determined to lack adequate directions for use. Both products were
refused entry on October 28, 2020.
On or about October 16, 2020, Ms. Marmas offered for import a
parcel intercepted and processed by FDA at Chicago International
Airport MF that was addressed to her. This parcel contained multiple
products. FDA determined that one of the products contained in this
parcel was 1,500 capsules of amoxicillin and was a misbranded drug for
multiple reasons: (1) The required label or labeling was determined to
not be in English in violation of Sec. 201.15(c)(1) (21 CFR
201.15(c)(1)); (2) the article had been determined to lack adequate
directions for use; (3) the drug was not included in a list required by
section 510(j) of the FD&C Act; (4) the drug was manufactured,
prepared, propagated, compounded, or processed in an establishment not
duly registered under section 510 of the FD&C Act; and (5) the article
was determined to be a prescription drug but did not include the symbol
``Rx only'' on its label. FDA determined that the other product
contained in this parcel was 1,600 tablets of FLOXCIPRO 250
ciprofloxacin and was a misbranded drug for multiple reasons: (1) The
required label or labeling was determined to not be in English in
violation of Sec. 201.15(c)(1); (2) the article had been determined to
lack adequate directions for use; (3) the drug was not included in a
list required by section 510(j) of the FD&C Act; (4) the drug was
manufactured, prepared, propagated, compounded, or processed in an
establishment not duly registered under section 510 of the FD&C Act;
and (5) the article was determined to be a prescription drug but did
not include the symbol ``Rx only'' on its label. Both products were
refused entry on December 3, 2020.
On or about November 16, 2020, Ms. Marmas offered for import a
parcel intercepted and processed by FDA at JFK MF that was addressed to
her. This parcel contained multiple products. FDA determined that one
of the products contained in this parcel was 300 tablets of AZICIP
azithromycin and was a misbranded drug because the article was
determined to be a prescription drug but did not include the symbol
``Rx only'' on its label. FDA determined that the other product
contained in this parcel was 1,000 tablets of CIPRODAC ciprofloxacin
and was a misbranded drug because the article was determined to be a
prescription drug but did not include the symbol ``Rx only'' on its
label. Both products were refused entry on December 10, 2020.
On or about December 15, 2020, Ms. Marmas offered for import a
parcel intercepted and processed by FDA at JFK MF that was addressed to
her. This parcel contained multiple products. FDA determined that one
of the products contained in this parcel was 1,000 capsules of
cephalexin IP 500 mg (CEPHADEX 500) and was a misbranded drug as the
article was determined to be a prescription drug but did not include
the symbol ``Rx only'' on its label. FDA determined that one of the
products contained in this parcel was 30 capsules of vancomycin
hydrochloride IP 250 mg (VANLID 250) and was a misbranded drug as the
article was determined to be a prescription drug but did not include
the symbol ``Rx only'' on its label. FDA determined that one of the
other products contained in this parcel was 250 tablets of trimethoprim
and sulphamethoxazole IP (BACTRIM DS) and was a misbranded drug as the
article was determined to be a prescription drug but did not include
the symbol ``Rx only'' on its label. All three products were refused
entry on January 19, 2021.
On or about April 23, 2021, Ms. Marmas offered for import a parcel
intercepted and processed by FDA at JFK MF that was addressed to her.
This parcel contained multiple products. FDA determined that one of the
products contained in this parcel was 1,000 capsules of RESTECLIN 500
(tetracycline) and was a misbranded drug as the article was determined
to be a prescription drug but did not include the symbol ``Rx only'' on
its label. FDA determined that one of the products contained in this
parcel was 400 tablets of RIFAGUR 400 (rifaximin) and was a misbranded
drug as the article was determined to be a prescription drug but did
not include the symbol ``Rx only'' on its label. Both products were
refused entry on May 18, 2021.
On or about May 26, 2021, Ms. Marmas offered for import a parcel
intercepted and processed by FDA at JFK MF that was addressed to her.
This parcel contained multiple products. FDA determined that one of the
products contained in this parcel was 500 tablets of amoxycillin and
potassium clavulanate IP and was a misbranded drug because the article
was determined to be a prescription drug but did not include the symbol
``Rx only'' on its label. The product was refused entry on June 25,
2021. FDA determined that the other product contained in this parcel
was 300 tablets of azithromycin IP 500 mg and was a misbranded drug
because the article was determined to be a prescription drug but did
not include the symbol ``Rx only'' on its label. This product was
refused entry on June 24, 2021.
On or about July 15, 2021, Ms. Marmas offered for import a parcel
intercepted and processed by FDA at Chicago International Airport MF
that was addressed to her. FDA determined that the product contained in
this parcel was 500 tablets of amoxycillin and potassium clavulanate
IP; CIPMOX CV-625 and was a misbranded drug because the article had
been determined to lack adequate directions for use and because the
drug was not included in a list required by section 510(j) of the FD&C
Act. The product was refused entry on August 13, 2021.
As a result of this pattern of importing or offering for import
misbranded drugs (i.e., in an amount, frequency, or dosage that is
inconsistent with her personal or household use) that are not
designated in an authorized electronic data interchange system as
products regulated by FDA, in accordance with section 306(b)(3)(D) of
the FD&C Act, FDA sent Ms. Marmas, by certified mail on November 3,
2021, a notice proposing to debar her for a 5-year period from
importing or offering for import any drug into the United States.
In proposing a debarment period, FDA weighed the considerations set
forth in section 306(c)(3) of the FD&C Act that it considered
applicable to Ms. Marmas' pattern of conduct and concluded that her
conduct warranted the imposition of a 5-year period of debarment.
The proposal informed Ms. Marmas of the proposed debarment and
offered her
[[Page 7843]]
an opportunity to request a hearing, providing 30 days from the date of
receipt of the letter in which to file the request, and advised her
that failure to request a hearing constituted a waiver of the
opportunity for a hearing and of any contentions concerning this
action. Ms. Marmas received the proposal and notice of opportunity for
a hearing on November 12, 2021. Ms. Marmas failed to request a hearing
within the timeframe prescribed by regulation and has, therefore,
waived her opportunity for a hearing and waived any contentions
concerning her debarment. (21 CFR part 12).
II. Findings and Order
Therefore, the Assistant Commissioner, Office of Human and Animal
Food Operations, under section 306(b)(3)(D) of the FD&C Act, under
authority delegated to the Assistant Commissioner, finds that Ms.
Brenda K. Marmas has engaged in a pattern of importing or offering for
import misbranded drugs (i.e., in an amount, frequency, or dosage that
is inconsistent with her personal or household use) that are not
designated in an authorized electronic data interchange system as
products regulated by FDA. FDA finds that this pattern of conduct
should be accorded a debarment period of 5 years as provided by section
306(c)(2)(A)(iii) of the FD&C Act.
As a result of the foregoing finding, Ms. Marmas is debarred for a
period of 5 years from importing or offering for import any drug into
the United States, applicable (see DATES). Pursuant to section 301(cc)
of the FD&C Act (21 U.S.C. 331(cc)), the importing or offering for
import into the United States of any drug or controlled substance by,
with the assistance of, or at the direction of Ms. Marmas is a
prohibited act.
Any application by Ms. Marmas for termination of debarment under
section 306(d)(1) of the FD&C Act should be identified with Docket No.
FDA-2021-N-1030 and sent to the Dockets Management Staff (see
ADDRESSES). The public availability of information in these submissions
is governed by 21 CFR 10.20(j).
Publicly available submissions will be placed in the docket and
will be viewable at http://www.regulations.gov or at the Dockets
Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: February 3, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-02801 Filed 2-9-22; 8:45 am]
BILLING CODE 4164-01-P