[Federal Register Volume 87, Number 133 (Wednesday, July 13, 2022)]
[Notices]
[Pages 41725-41727]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-14899]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food And Drug Administration

[Docket No. FDA-2021-N-1322]


Kris A. Hampton-Bey II: 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 
Kris A. Hampton-Bey II 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 Mr. Hampton-Bey II engaged in a pattern of 
importing or offering for import misbranded drugs (i.e. in an amount, 
frequency, or dosage that is inconsistent with his personal or 
household use) that are not designated in an authorized electronic data 
interchange system as products regulated by FDA. Mr. Hampton-Bey II was 
given notice of the proposed debarment and was given an opportunity to 
request a hearing to show why he should not be debarred. As of May 8, 
2022 (30 days after receipt of the notice), Mr. Hampton-Bey II had not 
responded. Mr. Hampton-Bey II's failure to respond and request a 
hearing constitutes a waiver of his right to a hearing concerning this 
matter.

DATES: This order is applicable July 13, 2022.

ADDRESSES: Submit applications for termination of debarment to the 
Dockets Management Staff, Food and Drug Administration, 5630 Fishers 
Lane, Rm.

[[Page 41726]]

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 adulterated or 
misbranded drugs (i.e. in an amount, frequency, or dosage that is 
inconsistent with personal or household use by the importer) that are 
not designated in an entry in an authorized electronic data interchange 
system as products regulated by FDA.
    After an investigation, FDA discovered that Mr. Hampton-Bey II 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 Newark or Chicago 
International Mail Facilities (IMF) and were addressed to Mr. Hampton-
Bey II at an address connected to him.
    On or about March 11, 2019, Mr. Hampton-Bey II offered for import a 
parcel intercepted and processed by FDA at the Chicago IMF and which 
was addressed to him. FDA determined that the product contained in this 
parcel was 550 tablets of sildenafil citrate 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 because the article 
was determined to lack adequate directions for use. The product was 
refused entry on April 8, 2019.
    On or about June 25, 2019, Mr. Hampton-Bey II offered for import 
two parcels intercepted and processed by FDA at the Chicago IMF and 
which were addressed to him. FDA determined that the product contained 
in the first parcel was 850 tablets of Sildenafil Tabs 100 MG and was a 
misbranded drug because the article was determined to lack adequate 
directions for use and 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 product contained in the second parcel 
was 850 tablets of Sildenafil 100 MG Tabs and was a misbranded drug 
because the article was determined to lack adequate directions for use 
and 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 July 17, 2019.
    On or about August 19, 2019, Mr. Hampton-Bey II offered for import 
a parcel intercepted and processed by FDA at the Chicago IMF and which 
was addressed to him. FDA determined that the product contained in this 
parcel was 900 tablets of Sildenafil Tabs 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'' on its label and because the 
article was determined to lack adequate directions for use. The product 
was refused entry on September 12, 2019.
    On or about December 28, 2020, Mr. Hampton-Bey II offered for 
import a parcel intercepted and processed by FDA at the Chicago IMF and 
which was addressed to him. FDA determined that the product contained 
in this parcel was 870 tablets of Sildenafil Tabs 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'' on its label and 
because the article was determined to be a drug that was not included 
in a list required by section 510(j) of the FD&C Act (21 U.S.C. 
360(j)). The product was refused entry on January 19, 2021.
    On or about December 29, 2020, Mr. Hampton-Bey II offered for 
import a parcel intercepted and processed by FDA at the Chicago IMF and 
which was addressed to him. FDA determined that the product contained 
in this parcel was 870 tablets of sildenafil citrate 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 January 21, 2021.
    On or about December 29, 2020, Mr. Hampton-Bey II offered for 
import a parcel intercepted and processed by FDA at the Chicago IMF and 
which was addressed to him. FDA determined that the product contained 
in this parcel was 870 tablets of sildenafil citrate and was a 
misbranded drug because the article was determined to lack adequate 
directions for use. The product was refused entry on January 22, 2021.
    On or about January 5, 2021, Mr. Hampton-Bey II offered for import 
a parcel intercepted and processed by FDA at the Chicago IMF and which 
was addressed to him. FDA determined that the product contained in this 
parcel was 870 tablets of sildenafil and was a misbranded drug because 
the article was determined to lack adequate directions for use and 
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 February 5, 2021.
    On or about January 6, 2021, Mr. Hampton-Bey II offered for import 
a parcel intercepted and processed by FDA at the Chicago IMF and which 
was addressed to him. FDA determined that the product contained in this 
parcel was 870 tablets of Sildenafil Tablets 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'' on its label and 
because the article had been determined to lack adequate directions for 
use. The product was refused entry on February 1, 2021.
    On or about January 7, 2021, Mr. Hampton-Bey II offered for import 
a parcel intercepted and processed by FDA at the Chicago IMF and which 
was addressed to him. FDA determined that the first product contained 
in this parcel was 850 tablets of sildenafil citrate 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 
because the article had been determined to lack adequate directions for 
use. FDA determined that the second product contained in this parcel 
was 10 tablets of sildenafil citrate tablets 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 because the article 
had been determined to lack adequate directions for use. Both products 
were refused entry on February 3, 2021.
    On or about March 4, 2021, Mr. Hampton-Bey II offered for import a 
parcel intercepted and processed by FDA at the Chicago IMF and which 
was addressed to him. FDA determined that the product contained in this 
parcel was 87 tablets of sildenafil tablets and was a misbranded drug 
because the article was determined: (1) to be a prescription drug but 
did not include the symbol ``Rx only'' on its label; (2) not to bear a 
label containing the name and place of business of the manufacturer, 
packer, or distributor; (3) to be a drug that was not included in a 
list required by section 510(j) of the FD&C Act; and (4) to be a drug 
that was manufactured, prepared, propagated, compounded, or processed 
in an establishment not duly registered under section 510 of the FD&C 
Act. The

[[Page 41727]]

product was refused entry on April 5, 2021.
    On or about March 17, 2021, Mr. Hampton-Bey II offered for import a 
parcel intercepted and processed by FDA at the Newark IMF and which was 
addressed to him. FDA determined that the product contained in this 
parcel was 364 tablets of BEGMA-100 Sildenafil Citrate Tablets 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'' on its 
label. The product was refused entry on April 23, 2021.
    On or about March 24, 2021, Mr. Hampton-Bey II offered for import a 
parcel intercepted and processed by FDA at the Chicago IMF and which 
was addressed to him. FDA determined that the product contained in this 
parcel was 870 tablets of sildenafil citrate 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 April 19, 2021.
    On or about April 20, 2021, Mr. Hampton-Bey II offered for import a 
parcel intercepted and processed by FDA at the Chicago IMF and which 
was addressed to him. FDA determined that the product contained in this 
parcel was 800 tablets of Sildenafil 100 MG Tablets and was a 
misbranded drug because the article was determined to be a drug that 
was not included in a list required by section 510(j) of the FD&C Act. 
The product was refused entry on May 11, 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 his 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 Mr. Hampton-Bey II, by certified mail on April 
4, 2022, a notice proposing to debar him 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 Mr. Hampton-Bey II's pattern of conduct and concluded 
that his conduct warranted the imposition of a 5-year period of 
debarment.
    The proposal informed Mr. Hampton-Bey II of the proposed debarment 
and offered him 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 him that failure to request a hearing constituted a waiver 
of the opportunity for a hearing and of any contentions concerning this 
action. Mr. Hampton-Bey II received the proposal and notice of 
opportunity for a hearing on April 8, 2022. Mr. Hampton-Bey II failed 
to request a hearing within the timeframe prescribed by regulation and 
has, therefore, waived his opportunity for a hearing and waived any 
contentions concerning his 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 Mr. Kris 
A. Hampton-Bey II 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 his 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, Mr. Hampton-Bey II 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 by, with the 
assistance of, or at the direction of Mr. Hampton-Bey II is a 
prohibited act.
    Any application by Mr. Hampton-Bey II for termination of debarment 
under section 306(d)(1) of the FD&C Act should be identified with 
Docket No. FDA-2021-N-1322 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, 240-402-7500.

    Dated: July 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-14899 Filed 7-12-22; 8:45 am]
BILLING CODE 4164-01-P