[Federal Register Volume 87, Number 141 (Monday, July 25, 2022)]
[Notices]
[Pages 44128-44129]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-15795]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-1156]


Kenneth Zipperer: 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 
Kenneth Zipperer 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. Zipperer was convicted of one felony count under 
Federal law relevant to these debarment proceedings for mail fraud. The 
factual basis supporting Mr. Zipperer's conviction, as described below, 
is conduct relating to the importation into the United States of a drug 
or controlled substance. Mr. Zipperer 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 March 30, 2022 (30 days after receipt 
of the notice), Mr. Zipperer had not responded. Mr. Zipperer'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 25, 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 
[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)(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 September 9, 2021, Mr. Zipperer was convicted, as defined in 
section 306(l)(1) of FD&C Act, in the U.S. District Court for the 
Western District of Wisconsin, when the court entered judgment against 
him for two offenses, one of which is relevant to these debarment 
proceedings: the offense of mail fraud, in violation of 18 U.S.C. 1341. 
FDA's finding that debarment is appropriate is based on the felony 
conviction referenced herein. The factual basis for this conviction is 
as follows: Mr. Zipperer acknowledged in his plea and sentencing 
hearing on September 9, 2021, that he owned and operated Zipperer 
Financial LLC where he worked as an insurance broker selling Medicare 
insurance policies to elderly individuals. Mr. Zipperer imported, via 
U.S. mail, foreign-sourced prescription drugs from an internet pharmacy 
company in India using the website ``www.alldaychemist.com.'' The 
packages mailed from this pharmacy contained the return address of 
Derric Wood in Delhi, India, and Mr. Zipperer had these packages 
shipped to a P.O. Box he rented for Zipperer Financial LLC. Mr. 
Zipperer imported many of the foreign-sourced prescription drugs in 
wholesale quantities and broke down the bulk shipments and repackaged 
them into retail quantities for his individual clients. Mr. Zipperer 
distributed many of these foreign-sourced prescription medications to 
his clients in person, though he had no valid wholesale distribution 
license, pharmacy license, or license to prescribe prescription drugs.
    Further, as Mr. Zipperer acknowledged in his plea and sentencing 
hearing on September 9, 2021, the prescription drugs Mr. Zipperer 
distributed to his clients were misbranded because they were foreign-
sourced versions of various prescription drugs that were not approved 
by FDA for use in the United States and were dispensed to consumers 
without a valid prescription of a practitioner licensed by law to 
administer such drugs. The drugs were therefore misbranded because they 
did not contain adequate directions for use. Mr. Zipperer imported 
these misbranded prescription drugs in boxes containing customs 
declaration forms affixed outside the box that falsely declared that 
the contents were personal supply medications.
    As a result of this conviction, FDA sent Mr. Zipperer, by certified 
mail, on February 14, 2022, 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. Zipperer's felony conviction for 
mail fraud, in violation of 18 U.S.C. 1341, was for conduct relating to 
the importation into the United States of any drug or controlled 
substance because he illegally imported misbranded prescription drugs 
and then distributed those drugs, unlawfully, to consumers. 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. Zipperer's offense and concluded that the offense warranted the 
imposition of a 5-year period of debarment.
    The proposal informed Mr. Zipperer 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. Zipperer received the proposal and

[[Page 44129]]

notice of opportunity for a hearing on February 28, 2022. Mr. Zipperer 
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)(C) of the FD&C Act, under 
authority delegated to the Assistant Commissioner, finds that Mr. 
Kenneth Zipperer 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. Zipperer 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. Zipperer is a 
prohibited act.
    Any application by Mr. Zipperer for termination of debarment under 
section 306(d)(1) of the FD&C Act should be identified with Docket No. 
FDA-2021-N-1156 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: July 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-15795 Filed 7-22-22; 8:45 am]
BILLING CODE 4164-01-P