[Federal Register Volume 85, Number 54 (Thursday, March 19, 2020)]
[Notices]
[Pages 15792-15794]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05715]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-3608]


Stephen Kalinoski: Final Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is issuing an 
order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
permanently debarring Stephen Kalinoski from providing services in any 
capacity to a person that has an approved or pending drug product 
application. FDA bases this order on a finding that Mr. Kalinoski was 
convicted of a felony for conduct that relates to the regulation of a 
drug product under the FD&C Act. Mr. Kalinoski was given notice of the 
proposed permanent debarment and an opportunity to request a hearing 
within the timeframe prescribed by regulation. Mr. Kalinoski failed to 
respond. Mr. Kalinoski's failure to request a hearing within the 
prescribed timeframe

[[Page 15793]]

constitutes a waiver of his right to a hearing concerning this action.

DATES: This order is applicable March 19, 2020.

ADDRESSES: Submit applications for special termination of debarment to 
the Dockets Management Staff (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of 
Enforcement, Office of Strategic Planning and Operational Policy, 
Office of Regulatory Affairs, Food and Drug Administration, 12420 
Parklawn Dr., Rockville, MD 20857, [email protected], or 240-402-
8743.

SUPPLEMENTARY INFORMATION: 

I. Background

    Section 306(a)(2)(B) of the FD&C Act (21 U.S.C. 335a(a)(2)(B)) 
requires debarment of an individual if FDA finds that the individual 
has been convicted of a felony under Federal law for conduct relating 
to the regulation of any drug product under the FD&C Act. On July 14, 
2017, Mr. Kalinoski entered a plea of guilty to one count of conspiracy 
to commit wire fraud, a felony offense, in violation of 18 U.S.C. 371, 
and on December 19, 2017, judgment was entered against Mr. Kalinoski in 
the U.S. District Court for the Eastern District of New York.
    The factual basis for this conviction is as follows: Mr. Kalinoski 
was the director of pharmacy and registered pharmacist in charge at Med 
Prep Consulting, Inc. (Med Prep), a medical drug repackager located and 
incorporated in New Jersey in 1994. Med Prep manufactured, repackaged, 
processed, packed, labeled, held, compounded, and distributed various 
drug products, including pain management medications, anesthesia and 
operating room drugs, and oncology and dialysis drugs. Mr. Kalinoski 
worked at Med Prep from approximately 2003 to its closing in the summer 
of 2013 and was in charge of repackaging and compounding operations and 
other drug-processing activities.
    Between approximately January 2007 and April 2013, Mr. Kalinoski 
knowingly and intentionally conspired with other individuals to devise 
a scheme and artifice to defraud healthcare providers and to obtain 
money and property from them by means of materially false and 
fraudulent pretenses, representations, and promises, and for the 
purpose of executing such scheme and artifice, and attempting to do so, 
to transmit and cause to be transmitted, by means of wire communication 
in interstate commerce, writings, signs, signals, pictures, and sounds.
    Specifically, during this time period, Mr. Kalinoski conspired with 
others to introduce and introduced, or caused the introduction of, 
adulterated and misbranded drugs into interstate commerce, all with the 
intent to defraud and mislead healthcare providers. The adulterated 
drugs Mr. Kalinoski introduced or caused to be introduced into 
interstate commerce were adulterated because they were prepared, 
packed, and held under insanitary conditions and because the drugs 
consisted in whole or in part of a filthy, putrid, and decomposed 
substance. The misbranded drugs Mr. Kalinoski introduced or caused to 
be introduced in interstate commerce were misbranded because the drugs 
were dangerous to health when used as labeled and because the labeling 
on the drugs regarding use by dates and the strength of the ingredients 
were false and misleading. Mr. Kalinoski assured healthcare providers 
that they were receiving drug products from Med Prep that were produced 
in full compliance with the law, were compounded and packaged in 
compliance with chapter 797 of the United States Pharmacopeia (USP 797) 
and would be safe for patients. Mr. Kalinoski also told healthcare 
providers that the beyond use dates that Mr. Kalinoski assigned to 
sterile drug products were supported by sterility testing that 
satisfied the requirements of USP 797. These representations were made 
in, among other places, quarterly reports that were sent by email to 
healthcare providers and on Med Prep's website. Mr. Kalinoski did not 
inform healthcare providers of failures to comply with USP 797 and 
basic sterility practices, and breaches of aseptic technique in Med 
Prep's cleanroom, which occurred repeatedly at Med Prep's facility.
    By engaging in this conduct, Mr. Kalinoski violated Federal and 
State law applicable to drug preparation and created serious risks for 
patients who were being treated for cancer and other illnesses. Mr. 
Kalinoski misrepresented the quality of Med Prep's drug processing and 
repackaging operation to increase market share, and he engaged in 
substandard practices to save money and increase his profits. Relying 
on these misrepresentations and omissions, healthcare providers paid 
Med Prep approximately $34,970,881 for its services between 
approximately 2007 and 2012.
    Based on his conviction, FDA sent Mr. Kalinoski by certified mail 
on September 27, 2019, a notice proposing to permanently debar him from 
providing services in any capacity to a person that has an approved or 
pending drug product application. The proposal was based on a finding, 
under section 306(a)(2)(B) of the FD&C Act, that Mr. Kalinoski was 
convicted, as set forth in section 306(l)(1) of the FD&C Act, of a 
felony under Federal law for conduct relating to the regulation of a 
drug product under the FD&C Act. The proposal also offered Mr. 
Kalinoski 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 file a timely request for a hearing 
constituted a waiver of the opportunity for a hearing and of any 
contentions concerning this action. Mr. Kalinoski received the proposal 
on October 3, 2019. Mr. Kalinoski did not request a hearing and has, 
therefore, waived his opportunity for a hearing and 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(a)(2)(b) of the FD&C Act, under 
authority delegated to the Assistant Commissioner, finds that Stephen 
Kalinoski has been convicted of a felony under Federal law for conduct 
relating to the regulation of a drug product under the FD&C Act.
    As a result of the foregoing finding, Stephen Kalinoski is 
permanently debarred from providing services in any capacity to a 
person with an approved or pending drug product application under 
sections 505, 512, or 802 of the FD&C Act (21 U.S.C. 355, 360b, or 
382), or under section 351 of the Public Health Service Act (42 U.S.C. 
262), applicable (see DATES) (see sections 201(dd) and 306(c)(1)(B) and 
(c)(2)(A)(ii) of the FD&C Act (21 U.S.C. 321(dd) and 335a(c)(1)(B) and 
(c)(2)(A)(ii)). Any person with an approved or pending drug product 
application who knowingly employs or retains as a consultant or 
contractor, or otherwise uses in any capacity the services of Stephen 
Kalinoski during his debarment, will be subject to civil money 
penalties (section 307(a)(6) of the FD&C Act (21 U.S.C. 335b(a)(6))). 
If Mr. Kalinoski provides services in any capacity to a person with an 
approved or pending drug product application during his period of 
debarment, he will be subject to civil money penalties (section 
307(a)(7) of the FD&C Act). In addition, FDA will not accept or review 
any abbreviated new drug applications from Mr. Kalinoski during his 
period of

[[Page 15794]]

debarment (section 306(c)(1)(B) of the FD&C Act).
    Any application by Mr. Kalinoski for special termination of 
debarment under section 306(d)(4) of the FD&C Act should be identified 
with Docket No. FDA-2019-N-3608 and sent to the Dockets Management 
Staff (see ADDRESSES). All such submissions are to be filed in one 
copy. The public availability of information in these submissions is 
governed by 21 CFR 10.20.
    Publicly available submissions may be seen in the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: March 13, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-05715 Filed 3-18-20; 8:45 am]
 BILLING CODE 4164-01-P