Notice2022-14899
Kris A. Hampton-Bey II: Final Debarment Order
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 13, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 133 (Wednesday, July 13, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 133 (Wednesday, July 13, 2022)]
[Notices]
[Pages 41725-41727]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-14899]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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#bbdfded9dac9d6ded5cfc8fbdddfda95d3d3c895dcd4cd"><span class="__cf_email__" data-cfemail="b3d7d6d1d2c1ded6ddc7c0f3d5d7d29ddbdbc09dd4dcc5">[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 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 <a href="http://www.regulations.gov">http://www.regulations.gov</a> 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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on July 13, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.