[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 
<a href="/cdn-cgi/l/email-protection#0c68696e6d7e616962787f4c6a686d2264647f226b637a"><span class="__cf_email__" data-cfemail="3e5a5b5c5f4c535b504a4d7e585a5f1056564d10595148">[email protected]</span></a>.

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


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