[Federal Register Volume 76, Number 183 (Wednesday, September 21, 2011)]
[Rules and Regulations]
[Pages 58398-58399]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-24316]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter I

[Docket No. FDA-2011-D-0633]


Revised Guidance on Marketed Unapproved Drugs; Compliance Policy 
Guide Sec. 440.100; Marketed New Drugs Without Approved NDAs or ANDAs; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of compliance policy guide.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a revised guidance entitled ``Marketed Unapproved 
Drugs--Compliance Policy Guide Sec. 440.100, Marketed New Drugs Without 
Approved NDAs or ANDAs'' (CPG 440.100). CPG 440.100 describes how FDA 
intends to exercise its enforcement discretion with regard to drug 
products marketed in the United States that do not have required FDA 
approval for marketing. CPG 440.100 has been revised to state that the 
enforcement priorities and potential exercise of enforcement discretion 
discussed in the CPG apply only to unapproved new drug products that 
are being commercially used or sold as of September 19, 2011. All 
unapproved new drugs introduced onto the market after that date are 
subject to immediate enforcement action at any time, without prior 
notice and without regard to the enforcement priorities set forth in 
CPG 440.100.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed 
adhesive label to assist that office in processing your requests. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Sakineh Walther, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 5242, Silver Spring, MD 20993-0002, 301-
796-3349.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a revised guidance entitled 
``Marketed Unapproved Drugs--Compliance Policy Guide Sec. 440.100, 
Marketed New Drugs Without Approved NDAs or ANDAs''. This CPG is being 
issued consistent with FDA's good guidance practices (GGP) regulation 
(Sec.  10.115 (21 CFR 10.115)). This CPG is being implemented without 
prior public comment because the Agency has determined that prior 
public participation is not feasible or appropriate (Sec.  
10.115(g)(2)). The Agency made this determination because, in light of 
the fact that revised CPG 440.100 establishes the date after which the 
enforcement priorities and potential exercise of enforcement discretion 
discussed in it do not apply to newly introduced unapproved drugs, 
delayed implementation of revised CPG 440.100 would provide an 
incentive for manufacturers to rush new unapproved drugs to market 
during the comment and finalization period, in order to be subject to 
enforcement priorities that may be perceived as more advantageous to 
extended marketing of illegal, unapproved drug products. The potential 
increase in marketing of new unapproved drugs raises public health 
concerns; because unapproved drug products have not been approved by 
FDA for safety, effectiveness, and quality, patients may be at greater 
risk when using unapproved drug products than when using FDA-approved 
drug products. In light of the concerns about potential increased 
marketing of new unapproved drugs, FDA has determined that it is not 
appropriate to seek comment before implementing revised CPG 440.100. 
Although CPG 440.100 is immediately in effect, it remains subject to 
comment in accordance with the Agency's GGP regulation.
    Under the Federal Food, Drug, and Cosmetic Act, drug products that 
require approval must obtain that approval prior to introduction into 
interstate commerce (see 21 U.S.C. 355). Manufacturers and distributors 
of products that enter the market without complying with these long-
standing statutory requirements are acting in violation of the law. In 
June 2006, FDA announced a new drug safety initiative to remove 
unapproved drugs from the market. As part of the Unapproved Drugs 
Initiative, FDA issued a final CPG entitled ``Marketed Unapproved 
Drugs--Compliance Policy Guide Sec. 440.100, Marketed New Drugs Without 
Approved NDAs or ANDAs'' (CPG 440.100) (see 71 FR 33466, June 9, 2006). 
CPG 440.100 describes how FDA intends to exercise its enforcement 
discretion regarding currently marketed unapproved new drugs. CPG 
440.100 describes six categories of unapproved drug products that are 
the Agency's highest enforcement priorities, and the circumstances in 
which the Agency intends to bring enforcement actions consistent with 
those priorities. FDA has initiated 17 actions against unapproved new 
drugs under the Unapproved Drugs Initiative and engaged in significant 
outreach to manufacturers, distributors, consumers and prescribers 
under this Initiative, resulting in the removal of over a thousand 
unapproved new drugs from the market (see http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ucm238675.htm).
    Despite both the long-standing statutory requirement that new drugs 
must obtain approval prior to marketing (21 U.S.C. 355) and FDA's 
outreach efforts under the Marketed Unapproved Drugs Initiative, FDA is 
aware that unapproved new drugs have continued to come onto the market 
after the issuance of the 2006 CPG. In some cases, these unapproved new 
drugs come onto the market to compete with other unapproved new drugs 
that are already on the market. In other cases, unapproved new drugs 
are introduced to the market when a manufacturer perceives that there 
may be an ``opportunity'' to gain a share of the market after actions 
taken by FDA, including enforcement actions that remove similar 
unapproved new drugs from the market. In either case, FDA must expend 
additional scarce resources to address unapproved products in 
situations where manufacturers and distributors have had ample notice 
that the products they are introducing onto

[[Page 58399]]

the market cannot be legally marketed without approval.
    To address this situation, FDA is revising CPG 440.100 to make 
clear that unapproved new drugs introduced onto the market after 
September 19, 2011 are subject to enforcement action at any time, 
without prior notice and without regard to the enforcement priorities 
set forth in CPG 440.100 for unapproved new drugs marketed prior to 
September 19, 2011. The revision to CPG 440.100 excludes from the 
enforcement priorities set forth in the guidance the manufacture and 
marketing of newly introduced unapproved drugs.
    This guidance represents the Agency's current thinking on its 
enforcement priorities with respect to new drugs marketed without 
approved new drug applications or abbreviated new drug applications. It 
does not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. An alternative approach may be used 
if such approach satisfies the requirements of the applicable statutes 
and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: September 16, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
 [FR Doc. 2011-24316 Filed 9-19-11; 12:30 pm]
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