Rahim Shafa; Denial of Hearing; Final Debarment Order

Issuing agencies

Abstract

The Food and Drug Administration (FDA or Agency) is denying a request for a hearing submitted by Rahim Shafa (Dr. Shafa) and is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Dr. Shafa from providing services in any capacity to a person that has an approved or pending drug product application and debarring Dr. Shafa for 20 years from importing or offering for import any drug into the United States. FDA bases this order on the findings that Dr. Shafa was convicted of multiple felonies under Federal law that relate to the regulation of any drug product under the FD&C Act and the importation into the United States of any drug or controlled substance under the FD&C Act. FDA provided notice to Dr. Shafa of the proposed debarment and an opportunity to request a hearing. Dr. Shafa submitted a request for a hearing but failed to file with the Agency information and analyses sufficient to create a basis for a hearing.

Full Text

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<title>Federal Register, Volume 91 Issue 167 (Monday, August 31, 2026)</title>
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[Federal Register Volume 91, Number 167 (Monday, August 31, 2026)]
[Notices]
[Pages 55886-55890]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-17659]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2025-N-1599]


Rahim Shafa; Denial of Hearing; 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 denying a 
request for a hearing submitted by Rahim Shafa (Dr. Shafa) and is 
issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C 
Act) permanently debarring Dr. Shafa from providing services in any 
capacity to a person that has an approved or pending drug product 
application and debarring Dr. Shafa for 20 years from importing or 
offering for import any drug into the United States.

[[Page 55887]]

FDA bases this order on the findings that Dr. Shafa was convicted of 
multiple felonies under Federal law that relate to the regulation of 
any drug product under the FD&C Act and the importation into the United 
States of any drug or controlled substance under the FD&C Act. FDA 
provided notice to Dr. Shafa of the proposed debarment and an 
opportunity to request a hearing. Dr. Shafa submitted a request for a 
hearing but failed to file with the Agency information and analyses 
sufficient to create a basis for a hearing.

DATES: This order is applicable August 31, 2026.

ADDRESSES: Any application for termination of debarment by Dr. Shafa 
under section 306(d) of the FD&C Act (21 U.S.C. 335a(d)) (application) 
may be submitted 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

    Submit written/paper submissions as follows:
    <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-1599. An application will be placed in the docket and, unless 
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. If you do not wish your name and contact information to be made 
publicly available, you can provide this information on the cover sheet 
and not in the body of your application and you must identify this 
information as ``confidential.'' 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 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: Rachael Vieder Linowes, Office of 
Scientific Integrity, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 1, Rm. 4206, Silver Spring, Maryland 20993, 240-402-5931, 
<a href="/cdn-cgi/l/email-protection#9eccfffdf6fffbf2b0d2f7f0f1e9fbeddef8faffb0f6f6edb0f9f1e8"><span class="__cf_email__" data-cfemail="b4e6d5d7dcd5d1d89af8dddadbc3d1c7f4d2d0d59adcdcc79ad3dbc2">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(a)(2)(B) of the FD&C Act mandates permanent debarment 
of an individual from providing services in any capacity to a person 
that has an approved or pending drug product application if FDA finds 
that the individual has been convicted of a felony under Federal law 
for conduct relating to the regulation of drug products under the FD&C 
Act. Separately, section 306(b)(3)(C) of the FD&C Act permits FDA to 
debar an individual from importing or offering for import into the 
United States a drug if the Agency finds that the individual 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. 
On December 16, 2024, following a jury trial, the U.S. District Court 
for the District of Massachusetts entered a judgment against Dr. Shafa 
for multiple offenses, including the four felony convictions underlying 
the bases for these two debarments: three counts of importing 
merchandise contrary to law in violation of 18 U.S.C. 545, and one 
count of receiving and delivering a misbranded drug in violation of 
sections 301(c) and 303(a)(2) of the FD&C Act (21 U.S.C. 331(c) and 
333(a)(2)). On February 12, 2025, the court sentenced Dr. Shafa to 36 
months in Federal prison and restitution.
    By letter dated September 15, 2025 (hereafter ``Notice of 
Opportunity of Hearing'' or ``NOOH''), FDA's Office of Inspections and 
Investigations (OII) notified Dr. Shafa of a proposal to issue an order 
permanently debarring him from providing services in any capacity to a 
person with an approved or pending drug product application and 
debarring him for 20 years from importing or offering for import any 
drug into the United States. As explained in the NOOH, Dr. Shafa's 
convictions stemmed from his actions while he owned and operated Novel 
Psychopharmacology.
    As described in the NOOH, from on or before January 2008 to on or 
about January 2018, Dr. Shafa purchased disulfiram pellet implants, 
disulfiram injections, and naltrexone pellet implants from an overseas 
supplier and had them unlawfully shipped from Hong Kong to him on 
multiple occasions. The articles shipped to him were drugs under 
section 201(g)(1) of the FD&C Act (21 U.S.C. 321(g)(1)) in that they 
were intended to treat Dr. Shafa's patients for alcohol and opioid 
dependence. As stated in the NOOH, the drugs at issue were not FDA-
approved for these uses in the United States. As further outlined in 
the NOOH, Dr. Shafa agreed with the supplier that it would falsify the 
shipping documents to conceal the actual contents of the

[[Page 55888]]

packages of disulfiram pellet implants, disulfiram injections, and 
naltrexone pellet implants sent to him. The contents of the packages 
Dr. Shafa's supplier used included descriptions such as ``plastic beads 
in plastic tubes'' and listed values below the actual value of the 
drugs. Knowing that the actual contents of the packages had been 
concealed, Dr. Shafa accepted the packages the supplier sent containing 
the disulfiram pellet implants, disulfiram injections, and naltrexone 
pellet implants. Dr. Shafa then administered the drugs to patients. 
Several of Dr. Shafa's patients experienced complications from the 
procedures or did not find the drugs effective. Despite reports of 
complications and complaints of ineffectiveness, Dr. Shafa continued to 
administer the unapproved drugs to patients.
    The NOOH explained that the proposed permanent mandatory debarment 
from providing services to a person with an approved or pending drug 
application was based on his felony convictions and that the conduct 
underlying the convictions related to the regulation of drug products 
under the FD&C Act. The NOOH explained that the proposed 20-year 
permissive debarment related to drug importation was also based on his 
felony convictions and that the conduct underlying the convictions 
related to the importation of drugs into the United States. The NOOH 
explained that the maximum period of debarment from drug importation 
for an individual subject to permissive debarment for a felony under 
section 306(c)(2)(A)(iii) of the FD&C Act is 5 years and that the 
debarment periods may run consecutively or concurrently.
    The NOOH also outlined findings concerning the three relevant 
factors that OII considered in determining the appropriateness and 
period of debarment from drug importation under section 306(b)(1)(D) of 
the FD&C Act, as provided in section 306(c)(3): (1) the nature and 
seriousness of any offense involved, (2) the nature and extent of 
voluntary steps to mitigate the impact on the public of any offense 
involved, and (3) prior convictions under the FD&C Act or under other 
Acts involving matters within the jurisdiction of FDA. OII found that 
the nature and seriousness of the offenses and the nature and extent of 
voluntary steps to mitigate the effect on the public are unfavorable 
considerations for Dr. Shafa. OII found the lack of prior convictions 
involving matters within FDA jurisdiction as a favorable consideration 
for Dr. Shafa. OII concluded that the facts supporting the unfavorable 
factors outweigh those supporting the favorable factor, thereby 
warranting a 20-year debarment from drug importation, 5 years for each 
conviction to run consecutively. The NOOH also provided Dr. Shafa with 
an opportunity for him to request a hearing under section 306(i) of the 
FD&C Act and part 12 (21 CFR part 12).
    In response to the NOOH, in a letter dated October 2, 2025, Dr. 
Shafa requested a stay ``of any proceeding'' due to an appeal of his 
convictions. On October 6, 2025, Dr. Shafa submitted a timely hearing 
request and notice of appearance. Dr. Shafa reiterated that he was 
requesting a hearing ``following the fulfillment of my litigation, 
appeal process, and completion of my sentencing.'' On November 19, 
2025, the Director of the Office of Scientific Integrity (OSI Director) 
denied Dr. Shafa's request to stay the matter and gave Dr. Shafa until 
December 19, 2025, to submit analyses and information in support of his 
hearing request. On December 10, 2025, Dr. Shafa submitted additional 
information.\1\ Dr. Shafa's response challenges the proposed debarments 
on the grounds that he was wrongfully accused and convicted of the 
offenses at issue and that he has appealed his convictions. 
Additionally, Dr. Shafa contends that there are material factual 
disputes concerning the circumstances of his convictions, the medical 
necessity of the procedures identified in the NOOH, and 
``irregularities that affected the outcome.''
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    \1\ Dr. Shafa submitted supplemental information by letter dated 
December 29, 2025. This letter, which FDA marked received on January 
9, 2026, was untimely as information offered in support of the 
hearing request because it was received after the December 19, 2025, 
deadline for submitting such information. Furthermore, even if the 
OSI Director were to consider the letter, none of the information 
contained therein raises a material factual issue suitable for a 
hearing.
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    Under the authority delegated to him by the Commissioner of Food 
and Drugs, the OSI Director has considered Dr. Shafa's request for a 
hearing. Hearings are granted only if there is a genuine and 
substantial issue of fact. A request for a hearing may not rest on mere 
allegations or denials but must present specific facts showing that 
there is a genuine and substantial issue of fact that justifies a 
hearing. Hearings will not be granted on issues of policy or law, on 
mere allegations, denials or general descriptions of positions and 
contentions, or on data and information insufficient to justify the 
factual determination urged (see Sec.  12.24(b)).

II. Analysis

    As an initial matter, Dr. Shafa challenges his proposed debarment 
under sections 306(a)(2)(B) and 306(b)(3)(C) of the FD&C Act by 
contending, ``I was wrongfully accused[,] and my conviction is under 
appeal.'' Pursuant to section 306(l) of the FD&C Act, however, a person 
is deemed to have been convicted of a criminal offense when a judgment 
of conviction has been entered against the person by a Federal or State 
court, regardless of whether there is an appeal pending. Dr. Shafa does 
not dispute that the U.S. District Court for the District of 
Massachusetts entered the judgment of convictions underlying the 
proposals to debar him. Under section 306(l) of the FD&C Act, a pending 
appeal is not a ground for postponing either ruling on a hearing 
request or conducting a hearing on a proposed debarment. If Dr. Shafa's 
appeal ultimately results in the convictions being overturned, he may 
seek termination of his debarment (see section 306(d)(B)(ii) of the 
FD&C Act).
    Dr. Shafa further maintains that ``an evidentiary hearing is 
required [for] debarment.'' Under Sec.  12.24(b), however, FDA may deny 
a hearing request if there are no factual issues suitable for a 
hearing. ``FDA may deny a request for a hearing unless `the [hearing 
request] . . . identif[ies] a material issue of fact''' (Vanda Pharms., 
Inc. v. U.S. FDA, 150 F.4th 563, 573 (D.C. Cir. 2025) (quoting Am. 
Cyanamid Co. v. FDA, 606 F.2d 1307, 1314 (D.C. Cir. 1979)) and citing 
Sec.  12.24(b); see also Costle v. Pacific Legal Found., 445 U.S. 198, 
214 (1980) (a party seeking a hearing is required to meet a ``threshold 
burden of tendering evidence suggesting the need for a hearing''), 
reh'g denied, 446 U.S. 947 (1980), citing Weinberger v. Hynson, 
Westcott & Dunning, Inc., 412 U.S. 609, 620-21 (1973); Pineapple 
Growers Ass'n v. FDA, 673 F.2d 1083, 1085-86 (9th Cir. 1982) (holding 
that no hearing is necessary unless ``material issues of fact'' have 
been raised)).
    In support of his hearing request, Dr. Shafa nonetheless contends 
that there are four areas in which there are material factual disputes: 
(1) ``whether the alleged conduct constitutes willful wrongdoing,'' (2) 
whether the medical procedures and drugs used performed to clinical 
standards, (3) whether evidence exists that undermined the proceeding, 
such as ``clear determining exculpatory evidence,'' and (4) whether the 
purchase of implants was strictly for patients' personal use and 
compatible with personal importation law. Additionally, Dr. Shafa 
states that he has maintained all required continuing medical

[[Page 55889]]

education requirements and that he has never had disciplinary 
proceedings against him by the Massachusetts Board of Medicine for his 
medical practice.

A. There Are No Genuine and Substantial Issues of Fact Warranting a 
Hearing on Whether Dr. Shafa Is Subject to Debarment Under Sections 
306(a)(2)(B) and 306(b)(3)(C) of the FD&C Act

    Under section 306(a)(2)(B) of the FD&C Act, an individual convicted 
of a Federal felony for conduct relating to the regulation of drug 
products under the FD&C Act is subject to permanent debarment. Further, 
section 306(b)(3)(C) of the FD&C Act authorizes FDA to debar an 
individual from importing or offering for import into the United States 
a drug if the Agency finds that the individual 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. The relevant 
factual considerations as to whether Dr. Shafa is subject to debarment 
under these provisions are whether he was convicted of a felony under 
Federal law and whether the conduct underlying the convictions related 
to the regulation of drug products and the importation into the United 
States of any drug or controlled substance.
    As explained in the NOOH, Dr. Shafa was convicted of three counts 
of importing merchandise contrary to law in violation of 18 U.S.C. 545 
and one count of receiving and delivering a misbranded drug in 
violation of section 301(c) and 303(a)(2) of the FD&C Act. Dr. Shafa 
does not deny that he was, in fact, convicted of those violations. As 
explained above, Dr. Shafa's appeal of those convictions does not 
affect whether he is currently subject to debarment. Furthermore, there 
is no genuine and substantial issue of fact as to whether the conduct 
underlying the convictions related to both the regulation of drug 
products and the importation of drug products into the United States. 
As described in the NOOH, the conduct underlying Dr. Shafa's 
convictions included his coordinating the shipment of unapproved and 
misbranded drugs into the United States and the falsification of the 
labeling to conceal the actual contents of the shipments. The criminal 
proceedings further establish that Dr. Shafa administered the 
unapproved and misbranded drugs to patients. The conduct underlying Dr. 
Shafa's felony convictions thus relates to both the regulation of drug 
products and the importation of drugs into the United States.
    In short, there is no dispute as to whether Dr. Shafa's four felony 
convictions and underlying conduct relate to both the regulation of 
drug products under the FD&C Act and the importation of drugs into the 
United States. Therefore, Dr. Shafa has failed to justify a hearing on 
whether he is subject to debarment under either section 306(a)(2)(B) or 
306(b)(3)(C) of the FD&C Act.

B. There Is No Genuine and Substantial Issue of Fact Warranting a 
Hearing Regarding the Proposed Permissive Debarment

    Having determined that Dr. Shafa is subject to mandatory debarment 
under section 306(a)(2)(B) of the FD&C Act and permissive debarment 
under section 306(b)(3)(C) of the FD&C Act, FDA then must determine the 
debarment period for the permissive debarment.
    In considering the appropriateness and period of proposed debarment 
relating to the importation into the United States of a drug or 
controlled substance, FDA considers the factors outlined in section 
306(c)(3) of the FD&C Act where applicable. As explained above, OII 
determined that the applicable factors for the appropriateness and 
period of Dr. Shafa's debarment, as provided in section 306(c)(3) of 
the FD&C Act were (1) the nature and seriousness of any offense 
involved; (2) the nature and extent of voluntary steps to mitigate the 
impact on the public of any offense involved; and (3) prior convictions 
under the FD&C Act or under other Acts involving matters within the 
jurisdiction of FDA. Given these considerations, OII proposed that Dr. 
Shafa be debarred for a total of 20 years from importing drugs or 
offering drugs for import into the United States, by imposing a period 
of 5 years for each conviction and running those periods consecutively.
    Dr. Shafa does not specifically address the factors underpinning 
the proposed total debarment period of 20 years; however, FDA construes 
several of his arguments as attempts to mitigate the nature and 
seriousness of his offense under section 306(c)(3)(A) of the FD&C Act. 
In arguing that he should not be debarred from importing drugs into the 
United States on the basis of his felony convictions, Dr. Shafa 
contends that he did not act with an intent to defraud. He also argues, 
in essence, that his purchase of the drugs in question was consistent 
with FDA's exercise of enforcement discretion as to personal 
importation law. Dr. Shafa further contends that he complied with 
reporting his medical procedures to the Massachusetts Board of Medicine 
and that the board never levied any restrictions or penalties regarding 
the procedure or his use of the implants. He also states that ``The 
District Administration Law Hearing . . . on behalf of the Medical 
Board of Massachusetts'' found that his practice was compatible with 
``Standard Care'' medical practice.
    Dr. Shafa's felony convictions under 18 U.S.C. 545 required the 
jury to find that he ``fraudulently or knowingly, with intent to 
defraud the United States'' smuggled merchandise into the country, and 
his conviction under section 303(a)(2) of the FD&C Act required the 
jury to find that he violated section 301(c) of the FD&C Act ``with an 
intent to defraud or mislead.'' Indeed, the criminal proceedings 
established that Dr. Shafa coordinated shipping unapproved and 
misbranded drugs into the United States and concealing their identity 
through false and misleading shipping documents and that he then 
administered the drugs to patients. His claim that he did not act with 
an intent to defraud thus does not raise a material factual dispute 
suitable for a hearing given the evidence adduced at trial and the 
elements of the offenses for his convictions. Furthermore, as OII 
stated in the NOOH, the drugs in question posed significant risks to 
Dr. Shafa's patients because they had not been reviewed by FDA for 
safety, effectiveness, or quality and thus determined to be safe and 
effective for their intended uses. The deceptive conduct underlying Dr. 
Shafa's convictions--which is not in dispute and involved concealing 
the identity of such drug products from the government--was 
sufficiently egregious to warrant OII's conclusion that the nature and 
seriousness of Dr. Shafa's offenses constitute an unfavorable 
consideration under section 306(c)(3)(A) of the FD&C Act. Dr. Shafa's 
arguments regarding FDA's personal importation policy and his medical 
practice simply fail to counter OII's conclusion regarding the nature 
and seriousness of his offenses under section 306(c)(3)(A) of the FD&C 
Act to a degree sufficient to raise a genuine and substantial issue of 
fact with respect to that consideration. Therefore, the OSI Director 
treats this consideration as unfavorable.
    In the NOOH, OII stated that it was unaware of any steps Dr. Shafa 
took to mitigate the impact on the public of his actions. Dr. Shafa has 
not presented any information or analysis addressing this factor; 
therefore, he failed to raise a genuine and substantial issue of fact 
with respect to the nature and extent of

[[Page 55890]]

voluntary steps to mitigate the impact on the public. Consistent with 
OII's findings in the NOOH, the OSI Director will thus treat this 
consideration as unfavorable.
    Based on the undisputed record, a 20-year debarment period is 
appropriate. Although it is undisputed that Dr. Shafa has no previous 
criminal convictions related to matters within the jurisdiction of FDA, 
this single favorable factor does not counterbalance the nature and 
seriousness of his offense and lack of voluntary steps promptly taken 
to mitigate the impact of his offense on the public. Therefore, the OSI 
Director concurs with OII's conclusion that ``the facts supporting the 
unfavorable factors outweigh those supporting the favorable factor and 
therefore warrants the imposition of a twenty-year period of debarment, 
five years for each conviction.''

III. Findings and Order

    Therefore, under section 306(a)(2)(B) of the FD&C Act and authority 
delegated to him by the Commissioner of Food and Drugs, the OSI 
Director finds that Dr. Shafa has been convicted of a felony under 
Federal law for conduct relating to the regulation of drug products 
under the FD&C Act. The OSI Director also finds that Dr. Shafa 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 
and is subject to debarment as set forth in section 306(b)(3)(C) of the 
FD&C Act. The OSI Director considered the applicable factors listed in 
section 306(c)(3) of the FD&C Act and determined, based on the 
undisputed record before him, that debarring Dr. Shafa for 20 years 
from importing or offering for import into the United States any drugs 
is appropriate.
    As a result of the foregoing findings, Dr. Shafa 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), effective August 
31, 2026 (see 21 U.S.C. 335a(c)(1)(B) and (c)(2)(A)(ii) and 21 U.S.C. 
321(dd)). Any person with an approved or pending drug product 
application, who knowingly uses the services of Dr. Shafa, in any 
capacity during his period of 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 Dr. Shafa, during his period of debarment, provides services in any 
capacity to a person with an approved or pending drug product 
application, 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 submitted by or with the 
assistance of Dr. Shafa during his period of debarment (section 
306(c)(1)(B) of the FD&C Act).
    Additionally, as a result of the foregoing findings, Dr. Shafa is 
debarred for a period of 20 years from importing or offering for import 
any drug into the United States, effective August 31, 2026. Pursuant to 
section 301(cc) of the FD&C Act, the importing or offering for import 
into the United States of any drug by, with the assistance of, or at 
the direction of Dr. Shafa, is a prohibited act.

George M. Warren,
Director, Office of Scientific Integrity.
[FR Doc. 2026-17659 Filed 8-28-26; 8:45 am]
BILLING CODE 4164-01-P


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