[Federal Register Volume 86, Number 92 (Friday, May 14, 2021)]
[Notices]
[Pages 26523-26524]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10249]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-2047]


Rick Shepard: 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 
Rick Shepard 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. Shepard was convicted of one felony count under 
Federal law for conspiracy to import and introduce misbranded drugs 
into interstate commerce. The factual basis supporting Mr. Shepard's 
conviction is conduct relating to the importation into the United 
States of a drug or controlled substance. Mr. Shepard 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 February 14, 2021 
(30 days after receipt of the notice), Mr. Shepard had not responded. 
His failure to respond and request a hearing constitutes a waiver of 
his right to a hearing concerning this matter.

DATES: This order is applicable May 14, 2021.

ADDRESSES: Submit applications for termination of debarment to the 
Dockets Management Staff (HFA-305), 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 (ELEM-4029), Division 
of Enforcement, 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 the FDA finds, as required by 
section 306(b)(3)(C) of the FD&C, 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 September 14, 
2020, Mr. Shepard was convicted, as defined in section 306(l)(1) of the 
FD&C Act, in the U.S. District Court for the District of Kansas, when 
the court entered judgment against him for the offense of ``Conspiracy 
to Import and Introducing Misbranded Drugs into Interstate Commerce, a 
Class D Felony'' in violation of 18 U.S.C. 371.
    FDA's finding that debarment is appropriate is based on the felony 
conviction referenced herein. The factual basis for this conviction is 
as follows: As contained in the Plea Agreement in Mr. Shepard's case, 
filed on January 27, 2020, Mr. Shepard owned, controlled, and operated 
Epic Products, LLC (Epic), a Kansas Limited Liability Company, from 
approximately October 2013 until at least April 2018. Epic was engaged 
in wholesaling of products under the labeled name ``Euphoric'' that 
were marketed as ``all-natural, herbal supplements for male 
enhancement.'' Euphoric's label made no mention of tadalafil and 
sildenafil citrate. However, Mr. Shepard knew that Euphoric contained 
tadalafil and sildenafil citrate because he imported these drugs, 
repacked them, and sold them under the Euphoric label. Specifically, 
Mr. Shepard purchased in bulk from suppliers in China capsules 
containing tadalafil and sildenafil citrate that he had delivered to 
mail and packing stores on the east coast before forwarding them to his 
address in Kansas.
    Sildenafil citrate is the active ingredient in Pfizer, Inc.'s FDA-
approved erectile dysfunction drug, VIAGRA. Likewise, tadalafil is the 
active ingredient in Eli Lilly & Company's FDA-approved erectile 
dysfunction drug, CIALIS. Once Mr. Shepard received the bulk capsules, 
he repackaged them and applied his Euphoric label. Mr. Shepard then 
sold these capsules in novelty stores in Kansas, Missouri, and 
Colorado. Throughout this entire scheme, Mr. Shepard did not possess a 
valid wholesale drug distribution license, a valid pharmacy license, or 
a license to prescribe prescription drugs. Finally, from January 2012 
to September 2017, Mr. Shepard deposited $1.8 million into his business 
account.
    As a result of this conviction, FDA sent Mr. Shepard, by certified 
mail on December 21, 2020, a notice proposing to debar him 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 Mr. Shepard's felony conviction for one felony 
count under Federal law, for the offense of ``Conspiracy to Import And 
Introducing Misbranded Drugs into Interstate Commerce, a Class D 
Felony,'' was for conduct relating to the importation into the United 
States of any drug or controlled substance because he illegally 
imported, repackaged, and introduced misbranded tadalafil and 
sildenafil capsules into interstate commerce.
    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. Shepard's offense and concluded that this felony 
offense warranted the imposition of a 5-year period of debarment. The 
proposal informed Mr. Shepard of the proposed debarment and offered him 
an opportunity to request a hearing, providing him 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. Shepard received the proposal and notice of opportunity for 
a hearing on January 15, 2021. He 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

[[Page 26524]]

306(b)(3)(C) of the FD&C Act, under authority delegated to the 
Assistant Commissioner, finds that Mr. Rick Shepard 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, Mr. Shepard 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 or controlled substance by, 
with the assistance of, or at the direction of Mr. Shepard is a 
prohibited act.
    Any application by Mr. Shepard for termination of debarment under 
section 306(d)(1) of the FD&C Act should be identified with Docket No. 
FDA-2020-N-2047 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 https://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: May 11, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-10249 Filed 5-13-21; 8:45 am]
BILLING CODE 4164-01-P