Notice2026-03252
Sherrie R. McCain: Final Debarment Order
Primary source
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Published
February 19, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Sherrie R. McCain 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. McCain was convicted of a felony under Federal law for introduction into interstate commerce of a misbranded drug. The factual basis supporting Ms. McCain's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Ms. McCain 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 April 17, 2025 (30 days after receipt of the notice), Ms. McCain had not responded. Ms. McCain's failure to respond and request a hearing constitutes a waiver of her right to a hearing concerning this matter.
Full Text
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<title>Federal Register, Volume 91 Issue 33 (Thursday, February 19, 2026)</title>
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[Federal Register Volume 91, Number 33 (Thursday, February 19, 2026)]
[Notices]
[Pages 8003-8005]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-03252]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0309]
Sherrie R. McCain: Final Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C
Act) debarring Sherrie R. McCain 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. McCain was convicted of a felony under
Federal law for introduction into interstate commerce of a misbranded
drug. The factual basis supporting Ms. McCain's conviction, as
described below, is conduct relating to the importation into the United
States of a drug or controlled substance. Ms. McCain 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 April 17, 2025
(30 days after receipt of the notice), Ms. McCain had not responded.
Ms. McCain's 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 19, 2026.
ADDRESSES: Any application by Ms. McCain for termination of debarment
under section 306(d)(1) of the FD&C Act (21 U.S.C. 335a(d)(1)) may be
submitted at any time as follows:
Electronic Submissions
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. An application
submitted electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a> will be posted to the docket unchanged. Because
your application will be made public, you are solely responsible for
ensuring that your application does not include any confidential
information that you or a third party may not wish to be posted, such
as medical information, your or anyone else's Social Security number,
or confidential business information, such as a manufacturing process.
Please note that if you include your name, contact information, or
other information that identifies you in the body of your application,
that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit an application with confidential
information that you do not wish to be made available to the public,
submit the application as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For a written/paper application submitted to the Dockets
Management Staff, FDA will post your application, as well as any
attachments, except for information submitted, marked, and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All applications must include the Docket No. FDA-
2025-N-0309. Received applications will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit an application with
confidential information that you do not wish to be made publicly
available, submit your application only as a written/paper submission.
You should submit two copies total. One copy will include the
information you claim to be confidential with a heading or cover note
that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The
Agency will review this copy, including the claimed confidential
information, in its consideration of your application. The second copy,
which will have the claimed confidential information redacted/blacked
out, will be available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Submit both copies to the Dockets Management
Staff. Any information marked as ``confidential'' will not be disclosed
except in accordance with 21 CFR 10.20 and other applicable disclosure
law. For more information about FDA's posting of comments to public
dockets, see 80 FR 56469, September 18, 2015, or access
[[Page 8004]]
the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
and insert the docket number, found in brackets in the heading of this
document, into the ``Search'' box and follow the prompts and/or go to
the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852 between 9 a.m. and 4 p.m., Monday through Friday, 240-402-
7500. Publicly available submissions may be seen in the docket.
FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of Field
Enforcement, Office of Field Regulatory Operations, Office of
Inspections and Investigations, Food and Drug Administration, at 240-
402-8743, or <a href="/cdn-cgi/l/email-protection#1c78797e7d6e717972686f5c7a787d3274746f327b736a"><span class="__cf_email__" data-cfemail="ec88898e8d9e818982989fac8a888dc284849fc28b839a">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(b)(1)(D) of the FD&C Act 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)(C) of the
FD&C Act, that the individual has been convicted of a felony for
conduct relating to the importation into the United States of any drug
or controlled substance.
On October 24, 2024, Ms. McCain was convicted as defined in section
306(l)(1) of the FD&C Act in the U.S. District Court for the Northern
District of Alabama when the court accepted her plea of guilty and
entered judgment against her for the felony offense of introduction
into interstate commerce of a misbranded drug in violation of 21 U.S.C.
331(a) and 333(a)(2) (sections 301(a) and 303(a)(2) of the FD&C Act).
The underlying facts supporting the conviction are as follows:
As contained in the Information, and in the Plea Agreement from her
case, between in and around December 2017 until in or around July 2021,
Ms. McCain received foreign unapproved prescription drugs at her
residence in Alabama. On or about September 5, 2019, U.S. Customs and
Border Protection (CBP) agents seized at a border port a package
containing approximately 4,000 prescription Tramadol pills and
approximately 2,000 prescription Carisoprodol pills that was addressed
to Ms. McCain at her residence in Alabama. Subsequent to the seizure,
law enforcement executed a search warrant at Ms. McCain's residence.
During the execution of the search warrant, law enforcement found
approximately 27,950 foreign unapproved prescription drug pills along
with shipping and repackaging material. The shipping material found at
her residence listed the description of contents as ``Candy and
Merchandise'' and ``Hair Care Product Set.'' These labels were
inconsistent with the actual contents of the packages, which were
prescription drug pills.
After the execution of the state search warrant on or about
September 10, 2019, Ms. McCain was interviewed by law enforcement.
During that interview, Ms. McCain stated than an individual with
initials S.M. shipped the pills to her and provided her with a list of
orders to fill. Ms. McCain stated that once the pills arrived at her
residence, she would repackage and ship them to various individuals
across the United States. A review of the evidence seized at her home
showed Ms. McCain had shipped numerous packages to individuals in more
than 25 states within the last two years. For her part in the shipping
operation, Ms. McCain received on a weekly basis between $200 and
$2,000. Ms. McCain also received packages addressed to different
aliases that were variations of her actual name on shipping labels.
Specifically, law enforcement discovered a shipping label dated
September 13, 2019, addressed to ``Sherri Mohan,'' as well as a
shipping label dated March 31, 2021, addressed to Renee McCain.
On or about June 23, 2021, CBP agents seized at a border port a
package containing approximately 2,000 prescription Alprazolam pills
that were addressed to Ms. McCain at her residence in Alabama. On or
about July 13, 2021, Ms. McCain was again interviewed by law
enforcement. Ms. McCain told agents that individuals from India
contacted her approximately six to eight months after the search
warrant was executed at her residence in September 2019 and asked her
to continue shipping foreign pills for them. Ms. McCain told agents
that she received three to four foreign packages containing foreign
drugs. Ms. McCain said she would remove the blister packs from the box,
repackage them, and then ship them to customers. Ms. McCain said she
would use the U.S. Postal Service to ship the drugs. Ms. McCain said
the reason she started to repackage and ship the foreign prescription
drugs again was for the money. Ms. McCain told agents that she knew at
the time what she was doing was illegal. Ms. McCain showed the agents
images, texts, and emails on her iPhone that corroborated her illegal
conduct. Ms. McCain also provided consent for law enforcement to search
her residence. During that search, law enforcement found approximately
3,600 foreign unapproved prescription drug pills, including
Carisoprodol, Tramadol, Sildenafil Citrate, Gabapentin, Pregabalin, and
Ephedrine. During the search, law enforcement also found shipping boxes
and labels. Ms. McCain would repackage foreign prescription drugs in
her home and then provide them to customers without a valid
prescription written by a licensed practitioner. The drugs Ms. McCain
shipped included 180 Carisoprodol pills, 180 Gabapentin pills, 90
Tramadol pills, and 180 Gabapentin pills. In total, between in or
around December 2017 and in or around July 2021, Ms. McCain shipped
misbranded drugs to individuals in approximately 25 different states
outside of Alabama.
FDA sent Ms. McCain, by certified mail, on March 10, 2025, a notice
proposing to debar her for a 5-year period from importing or offering
for import any drug into the United States. The proposal was based on a
finding under section 306(b)(3)(C) of the FD&C Act that Ms. McCain's
felony conviction under Federal law for introduction into interstate
commerce of a misbranded drug in violation of 21 U.S.C. 331(a) and
333(a)(2) (sections 301(a) and 303(a)(2) of the FD&C Act), was for
conduct relating to the importation of any drug or controlled substance
into the United States because Ms. McCain illegally received foreign
unapproved prescription drugs which she repackaged and sent out to
consumers throughout the U.S. In proposing a debarment period, FDA
weighed the considerations set forth in section 306(c)(3) of the FD&C
Act that the Agency considered applicable to Ms. McCain's offense and
concluded that the offense warranted the imposition of a 5-year period
of debarment.
The proposal informed Ms. McCain of the proposed debarment and
offered her an opportunity to request a hearing, providing her 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. McCain received the proposal and notice of opportunity for
a hearing on March 18, 2025. Ms. McCain 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 Division of Field Enforcement Director, Office of
Inspections and Investigations, under
[[Page 8005]]
section 306(b)(3)(C) of the FD&C Act, under authority delegated to the
Director, Division of Enforcement, finds that Ms. Sherrie R. McCain has
been convicted of a felony under Federal law for conduct relating to
the importation into the United States of any drug or controlled
substance. FDA finds that the offense 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. McCain is debarred for a
period of 5 years from importing or offering for import any drug into
the United States, effective (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 Ms. McCain is a prohibited act.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-03252 Filed 2-18-26; 8:45 am]
BILLING CODE 4164-01-P
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