[Federal Register Volume 76, Number 42 (Thursday, March 3, 2011)]
[Notices]
[Pages 11794-11798]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-4703]
[[Page 11794]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0100]
Drugs for Human Use; Unapproved and Misbranded Oral Drugs Labeled
for Prescription Use and Offered for Relief of Symptoms of Cold, Cough,
or Allergy; Enforcement Action Dates
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing its
intention to take enforcement action against unapproved and misbranded
oral drug products that are labeled for prescription use and offered
for relief of symptoms of cold, cough, or allergy and persons who
manufacture or cause the manufacture of such products. These drug
products are marketed without approved applications, and many are
inappropriately labeled for use in infants and young children. These
drug products must obtain FDA approval of a new drug application (NDA)
or an abbreviated new drug application (ANDA), or comply with an FDA
over-the-counter (OTC) drug final monograph, before marketing.
DATES: This notice is effective March 3, 2011. For information about
enforcement dates, see SUPPLEMENTARY INFORMATION, section IV.
ADDRESSES: All communications in response to this notice should be
identified with Docket No. FDA-2011-N-0100 and directed to Sakineh
Walther, Division of New Drugs and Labeling Compliance, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 5242, Silver Spring, MD 20993-0002.
FOR FURTHER INFORMATION CONTACT: Sakineh Walther, Division of New Drugs
and Labeling Compliance, 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, e-mail:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
A. Cold, Cough, and Allergy Products Covered by This Notice
This Federal Register notice covers certain unapproved and
misbranded drug products that are available in oral form and labeled
for prescription use. These products are offered for relief of symptoms
relating to cold, cough, or allergy, and include antitussives,
expectorants, antihistamines, and nasal decongestants. This notice
covers extended-release,\1\ tannate, and immediate-release drug
products.
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\1\ The term ``extended-release'' is used in this document to
include all timed-release products, including products labeled as
``sustained-release,'' ``controlled-release,'' ``delayed-release,''
or ``long-acting.'' (See 21 CFR 310.502(a)(14).)
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B. Regulatory History of Products Covered by This Notice
Many of the drug products covered by this notice contain active
ingredients that were introduced into the marketplace without prior
review for effectiveness. When initially enacted in 1938, the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) required that FDA review
and approve ``new drugs'' for safety, but not effectiveness, before
they could legally be sold in interstate commerce.\2\ The FD&C Act made
it the sponsor's burden to show FDA that its drug was safe through the
submission of an NDA. Between 1938 and 1962, if a drug obtained
approval, FDA considered drugs that were identical, related, or similar
(IRS) \3\ to the approved drug to be ``covered'' by that approval, and
allowed those IRS drugs to be marketed without independent approval.
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\2\ A ``new drug'' is defined by the FD&C Act as a drug that is
not generally recognized, by experts qualified by scientific
training and experience to evaluate the safety and effectiveness of
drugs, as safe and effective for use under the conditions
prescribed, recommended, or suggested in its labeling (section 201
of the FD&C Act (21 U.S.C. 321(p)).
\3\ FDA's regulations at (21 CFR 310.6(b)(1)) provide: ``An
identical, related, or similar drug includes other brands,
potencies, dosage forms, salts, and esters of the same drug moiety
as well as of any drug moiety related in chemical structure or known
pharmacological properties.''
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In 1962, Congress amended the FD&C Act to require that new drugs be
proven effective for their labeled indications, as well as safe. This
amendment also required FDA to conduct a retrospective evaluation of
effectiveness for all drugs approved as safe between 1938 and 1962. FDA
contracted with the National Academy of Sciences/National Research
Council (NAS/NRC) to make an initial evaluation of the effectiveness of
over 3,400 products that had been approved only for safety between 1938
and 1962. The NAS/NRC reports for these drug products were submitted to
FDA in the late 1960s and early 1970s. The Agency reviewed and
reevaluated the reports and published its findings in Federal Register
notices. FDA's administrative implementation of the NAS/NRC reports was
called the Drug Efficacy Study Implementation (DESI). DESI covered the
approximately 3,400 products specifically reviewed by the NAS/NRC, as
well as the even larger number of IRS products that entered the market
without FDA approval.\4\ Many of the drug products covered by this
notice contain the same active ingredients as drug products that were
reviewed for effectiveness through the DESI process.
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\4\ Section 310.6(b)(2)) provides that when qualified experts
determine that the findings in a DESI notice are applicable to an
IRS drug, that IRS drug is affected by the DESI notice.
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All drugs covered by the DESI review are ``new drugs'' under the
FD&C Act. If FDA's final DESI determination classifies a drug product
as ineffective for one or more indications, that drug product and those
IRS to it can no longer be marketed for such indications and are
subject to enforcement action as unapproved new drugs. If FDA's final
DESI determination classifies a drug product as effective for one or
more of its labeled indications, the drug, and those IRS to it, can be
marketed for such indications, provided each product is the subject of
an application approved for safety and effectiveness. Those drug
products with NDAs approved before 1962 for safety therefore require
approved supplements to their original applications if found effective
under DESI; IRS drug products require an approved NDA or ANDA, as
appropriate. Furthermore, labeling for these drug products may contain
only those indications for which the DESI review found the product
effective unless the firm marketing the product has received approval
for additional indication(s).
In the early 1970s, FDA granted temporary exemptions from the time
limits established for completing certain phases of the DESI program
for certain oral prescription drugs offered for relief of cold, cough,
allergy, and related symptoms (38 FR 34481, December 14, 1973). The
exemptions were granted because of the close relationship between these
prescription drugs and OTC drugs, which were subject to the ongoing OTC
drug review. (See 21 CFR part 330.) Postponement of final evaluations
of these DESI prescription products enabled the Agency to consider the
recommendations of the OTC review panel in addition to any evidence
submitted by NDA holders and other parties in response to various DESI
notices covering relevant products.
II. Safety Concerns With Unapproved New Drugs
Because marketed unapproved new drug products have not been through
[[Page 11795]]
FDA's approval process, there may be safety risks associated with them.
Some unapproved product labeling omits or modifies safety warnings or
other information that is important to ensure safe use, such as drug
interactions or potential adverse experiences. FDA is particularly
concerned about pediatric labeling for these unapproved products. Some
of the unapproved products covered by this notice are labeled and
marketed for use in children as young as 1 month of age. Without
reviewing applications for these products, FDA has no way to assess the
scientific support, if any, for the use of these products in pediatric
populations.
FDA also has concerns regarding the manufacturing processes for
unapproved new drugs and changes in the formulations of these products.
When new drugs are marketed without FDA approval, FDA does not have an
opportunity, prior to product marketing, to determine whether the
manufacturing process for the drugs is adequate to ensure that they are
of suitable quality. Additionally, there is no opportunity prior to
marketing for FDA to review and approve proprietary names to minimize
potential safety issues caused by product name confusion. In fact, FDA
has received reports of name confusion associated with unapproved
prescription products covered by this notice. Look-alike and sound-
alike similarities between product names may contribute to medication
errors and adverse events.
Similarly, the new drug approval requirement allows the Agency to
evaluate proposed changes to approved product formulations to ensure
that such modifications meet FDA standards for safety and effectiveness
and to ensure that formulation changes are accompanied, as necessary,
by appropriate changes in product proprietary names or labeling, or
other measures that may be warranted to minimize confusion and risks to
patients. Modifications of product formulations that are not made under
FDA's drug approval process thus pose an increased risk of confusing
healthcare practitioners and causing harm to consumers, such as
underdose or overdose, particularly in pediatric patients.
Finally, FDA has specific safety concerns about the products
covered by this notice that are marketed as extended-release products.
Many of these products contain amounts of active ingredients that could
pose safety risks if the same amount of active ingredient were
contained in an immediate-release dosage form. Without prior review of
applications for these products, there is no assurance that the firms
that market these products have established appropriate specifications
for release of the active ingredients or that the products are properly
formulated and manufactured to release their active ingredients to an
extent and at a rate that is both safe and effective.
III. Legal Status of Products Identified in This Notice
A. Extended-Release Products
Some of the products covered by this notice are sold as extended-
release products. Since 1959, FDA has concluded that all products in
extended-release dosage forms are new drugs requiring approved NDAs or
ANDAs before being marketed (24 FR 3756, May 9, 1959). Agency review of
individual applications for extended-release products is needed to
ensure that the finished product releases its active ingredient to an
extent and at a rate that is both safe, with a predictable and
controlled release of the dose, and effective, sustaining the intended
effect over the entire dosing interval. Firms submitting applications
are required to establish appropriate release specifications supported
by clinical evidence, along with data showing that the finished product
as manufactured by the firm releases its active ingredient according to
those specifications.
The Agency's determination that all products in timed-release
dosage form are new drugs requiring approved applications is codified
at 21 CFR 310.502(a)(14). Approval of an NDA under section 505(b) of
the FD&C Act (21 U.S.C. 355(b)) or an ANDA under section 505(j) of the
FD&C Act is required as a condition for marketing all such products.
The unapproved extended-release drug products subject to this
notice are all labeled for prescription use. Prescription drugs are
defined under section 503(b)(1)(A) of the FD&C Act (21 U.S.C.
353(b)(1)(A)) as drugs that, because of toxicity or other potentially
harmful effect, are not safe to use except under the supervision of a
practitioner licensed by law to administer such drugs.\5\ A drug that
is labeled as a prescription drug but does not meet the definition of
``prescription drug'' under section 503(b)(1)(A) of the FD&C Act is
misbranded under section 503(b)(4)(B) of the FD&C Act (21 U.S.C.
353(b)(4)(B)). Thus, if an extended-release drug covered by this notice
is labeled as a prescription product, but does not meet the definition
in section 503(b)(1)(A) of the FD&C Act, it is misbranded under section
503(b)(4)(B) of the FD&C Act. If an extended-release drug subject to
this notice actually meets the definition of ``prescription drug''
under 503(b)(1)(A), it is misbranded under section 502(f)(1) of the
FD&C Act (21 U.S.C. 352(f)(1)), in that it fails to bear adequate
directions for use. An approved prescription drug can satisfy the
``adequate directions for use'' requirement if it bears the NDA-
approved labeling (Sec. Sec. 201.100(c)(2) and 201.115 (21 CFR
201.100(c)(2) and 201.115)). Because the unapproved prescription
extended-release drug products covered by this notice do not have
approved applications with approved labeling, they fail to bear
``adequate directions for use,'' and are misbranded under section
502(f)(1) of the FD&C Act.
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\5\ The definition of ``prescription drug'' also includes a drug
that is limited by an approved application to use under the
professional supervision of a licensed practitioner (21 U.S.C.
353(b)(1)(B)). This prong of the definition obviously does not apply
to the unapproved extended-release drug products covered by this
notice.
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B. Tannates
Some of the products covered by this notice contain active
ingredients that are in tannate salt form (tannate drugs). FDA has
reviewed the publicly available scientific literature on these
ingredients, and has determined that unapproved oral drugs labeled for
prescription use and offered for relief of symptoms of cold, cough, or
allergy that contain the following ingredients are not generally
recognized as safe and effective (GRASE): Brompheniramine tannate;
carbetapentane tannate; carbinoxamine tannate; chlorpheniramine
tannate; dexbrompheniramine tannate; dexchlorpheniramine tannate;
dextromethorphan tannate; diphenhydramine tannate; ephedrine tannate;
phenylephrine tannate; pseudoephedrine tannate; pyrilamine tannate; and
triprolidine tannate. Therefore, products containing these ingredients
are new drugs within the meaning of section 201(p) of the FD&C Act, and
require approved NDAs or ANDAs before marketing.
The unapproved tannate drug products subject to this notice are all
labeled for prescription use. Prescription drugs are defined under
section 503(b)(1)(A) of the FD&C Act as drugs that, because of toxicity
or other potentially harmful effect, are not safe to use except under
the supervision of a practitioner licensed by law to administer such
drugs.\6\ A drug that is
[[Page 11796]]
labeled as a prescription drug but does not meet the definition of
``prescription drug'' under section 503(b)(1)(A) of the FD&C Act is
misbranded under section 503(b)(4)(B) of the FD&C Act. Thus, if a
tannate drug covered by this notice is labeled as a prescription
product, but does not meet the definition in section 503(b)(1)(A) of
the FD&C Act, it is misbranded under section 503(b)(4)(B) of the FD&C
Act. If a tannate drug covered by this notice actually meets the
definition of ``prescription drug,'' it is misbranded under section
502(f)(1) of the FD&C Act, in that it fails to bear adequate directions
for use. An approved prescription drug can satisfy the ``adequate
directions for use'' requirement if it bears the NDA-approved labeling
(21 CFR 201.100(c)(2) and 201.115). Because the unapproved prescription
tannate drug products covered by this notice do not have approved
applications with approved labeling, they fail to bear ``adequate
directions for use,'' and are misbranded under section 502(f)(1) of the
FD&C Act.
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\6\ The definition of ``prescription drug'' also includes a drug
that is limited by an approved application to use under the
professional supervision of a licensed practitioner (21 U.S.C.
353(b)(1)(B)). This prong of the definition obviously does not apply
to the unapproved tannate drug products covered by this notice.
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C. Immediate-Release Products
The remaining unapproved oral products covered by this notice are
immediate-release products labeled for prescription use and offered for
relief of symptoms associated with cold, cough, or allergy. The
immediate-release products fall into the following three categories:
1. Drugs Inappropriately Labeled for Prescription Use
A small number of the immediate-release products covered by this
notice conform to the requirements of the final OTC monograph at 21 CFR
part 341, ``Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic
Drug Products for Over-the-Counter Human Use'' (the final OTC Cold
Cough monograph), except that they are labeled for prescription use
only. Section 503(b)(1) of the FD&C Act establishes the definition of a
``prescription drug.'' Drug products that do not meet the definition of
a prescription drug but are labeled for prescription use are misbranded
under section 503(b)(4)(B) of the FD&C Act. If these drugs conform to
the requirements of the final OTC Cold Cough monograph, they are not
new drugs and they do not require an approved NDA or ANDA in order to
be legally marketed OTC.\7\
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\7\ In addition to any other applicable requirements, firms that
manufacture OTC drugs must comply with the labeling requirements at
21 CFR 201.66.
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2. Drugs Containing Ingredients Included in the Final OTC Cold Cough
Monograph But Labeled With Nonconforming Indications or Dosing Regimens
The majority of the immediate-release products covered by this
notice are labeled for prescription use and contain ingredients that
are included in the final OTC Cold Cough monograph, but have
indications, dosing regimens, or both, that are inconsistent with that
monograph. FDA has reviewed the indications and dosing regimens (dosing
intervals and dosage amounts) in the labeling of over 300 such
products, and has reviewed the publicly available scientific literature
for studies of these products.\8\ In no case did FDA find literature
sufficient to support a determination that one of these products was
GRASE for relief of symptoms of cold, cough, or allergy. Therefore,
these products are all ``new drugs'' within the meaning of section
201(p) of the FD&C Act, that require approved NDAs or ANDAs before
marketing.
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\8\ The over 300 products reviewed by FDA represent all products
in this category that FDA was able to identify.
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The unapproved immediate-release drug products subject to this
notice that contain ingredients that are included in the final OTC Cold
Cough monograph, but with indications, dosing regimens, or both, that
are inconsistent with that monograph, are all labeled for prescription
use. Prescription drugs are defined under section 503(b)(1)(A) of the
FD&C Act as drugs that, because of toxicity or other potentially
harmful effect, are not safe to use except under the supervision of a
practitioner licensed by law to administer such drugs.\9\ A drug that
is labeled as a prescription drug but does not meet the definition of
``prescription drug'' under section 503(b)(1)(A) of the FD&C Act is
misbranded under section 503(b)(4)(B) of the FD&C Act. Thus, if an
immediate-release drug covered by this notice is labeled as a
prescription product, but does not meet the definition in section
503(b)(1)(A), it is misbranded under section 503(b)(4)(B). If an
immediate-release drug covered by this notice does meet the definition
of ``prescription drug'' in 503(b)(1)(A), it is misbranded under
section 502(f)(1) of the FD&C Act, in that it fails to bear adequate
directions for use. An approved prescription drug can satisfy the
``adequate directions for use'' requirement if it bears the NDA-
approved labeling (Sec. Sec. 201.100(c)(2) and 201.115). Because the
unapproved prescription immediate-release drug products subject to this
notice that contain ingredients that are included in the final OTC Cold
Cough monograph, but with indications, dosing regimens, or both, that
are inconsistent with that monograph, do not have approved applications
with approved labeling, they fail to bear ``adequate directions for
use,'' and are misbranded under section 502(f)(1).
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\9\ The definition of ``prescription drug'' also includes a drug
that is limited by an approved application to use under the
professional supervision of a licensed practitioner (21 U.S.C.
353(b)(1)(B)). This prong of the definition obviously does not apply
to the unapproved immediate-release drug products subject to this
notice and containing ingredients that are included in the final OTC
Cold Cough monograph, but with indications, dosing regimens, or
both, that are inconsistent with that monograph.
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3. Drugs Containing Ingredients Not Included in the Final OTC Cold
Cough Monograph
The remaining immediate-release products covered by this notice are
labeled for prescription use and contain active ingredients that are
not included in the final OTC Cold Cough monograph. FDA has reviewed
the publicly available scientific literature on these ingredients, and
has determined that the products covered by this notice and offered for
relief of symptoms of cold, cough, or allergy that contain the
following ingredients are not GRASE: Atropine; carbetapentane;
cyproheptadine; dyphylline; hyoscyamine; methscopolamine nitrate;
phenyltoloxamine; potassium guaiacosulfonate; promethazine; and
scopolamine. Therefore, products covered by this notice containing
these ingredients and marketed for relief of symptoms of cold, cough,
or allergy are new drugs within the meaning of section 201(p) of the
FD&C Act, and require approved NDAs or ANDAs prior to marketing.
The unapproved immediate-release drug products that are subject to
this notice and that contain active ingredients not included in the
final OTC Cold Cough monograph are all labeled for prescription use.
Prescription drugs are defined under section 503(b)(1)(A) of the FD&C
Act as drugs that, because of toxicity or other potentially harmful
effect, are not safe to use except under the supervision of a
practitioner licensed by law to administer such drugs.\10\ A drug that
is
[[Page 11797]]
labeled as a prescription drug but does not meet the definition of
``prescription drug'' under section 503(b)(1)(A) is misbranded under
section 503(b)(4)(B) of the FD&C Act. Thus, if an immediate-release
drug covered by this notice is labeled as a prescription product, but
does not meet the definition in section 503(b)(1)(A), it is misbranded
under section 503(b)(4)(B). If a drug covered by this notice meets the
definition of ``prescription drug'' in 503(b)(1)(A), it is misbranded
under section 502(f)(1) of the FD&C Act, in that it fails to bear
adequate directions for use. An approved prescription drug can satisfy
the ``adequate directions for use'' requirement if it bears the NDA-
approved labeling (Sec. Sec. 201.100(c)(2) and 201.115). Because the
unapproved prescription immediate-release drug products covered by this
notice that contain active ingredients not included in the final OTC
Cold Cough monograph do not have approved applications with approved
labeling, they fail to bear ``adequate directions for use,'' and are
misbranded under section 502(f)(1) of the FD&C Act.
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\10\ The definition of ``prescription drug'' also includes a
drug that is limited by an approved application to use under the
professional supervision of a licensed practitioner (21 U.S.C.
353(b)(1)(B)). This prong of the definition obviously does not apply
to the unapproved immediate-release drug products covered by this
notice that contain active ingredients not included in the final OTC
Cold Cough monograph.
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IV. Notice of Enforcement Action
Although not required to do so by the Administrative Procedure Act,
the FD&C Act, or any rules issued under its authority, or for any other
legal reason, FDA is providing this notice to persons \11\ who are
marketing unapproved and misbranded oral drug products labeled for
prescription use and offered for relief of symptoms relating to cold,
cough, or allergy that the Agency intends to take enforcement action
against such products and those who manufacture them or cause them to
be manufactured or shipped in interstate commerce.
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\11\ A ``person'' includes individuals, partnerships,
corporations, and associations (21 U.S.C. 321(e)).
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Manufacturing or shipping the drug products covered by this notice
can result in enforcement action, including seizure, injunction, or
other judicial or administrative proceeding. Consistent with policies
described in the Agency's guidance entitled ``Marketed Unapproved
Drugs--Compliance Policy Guide'' (the Marketed Unapproved Drugs CPG)
(http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070290.pdf), the
Agency does not expect to issue a warning letter or any other further
warning to firms marketing drug products covered by this notice prior
to taking enforcement action. The Agency also reminds firms that, as
stated in the Marketed Unapproved Drugs CPG, any unapproved drug
marketed without a required approved application is subject to Agency
enforcement action at any time. The issuance of this notice does not in
any way obligate the Agency to issue similar notices or any notice in
the future regarding marketed unapproved drugs.\12\
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\12\ The Agency's general approach for dealing with these
products in an orderly manner is spelled out in the Marketed
Unapproved Drugs CPG. That CPG, however, provides notice that any
product that is being marketed illegally, and the persons
responsible for causing the illegal marketing of the product, are
subject to FDA enforcement action at any time.
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As described in the Marketed Unapproved Drugs CPG, the Agency may,
at its discretion, identify a period of time during which the Agency
does not intend to initiate an enforcement action against a currently
marketed unapproved drug solely on the ground that it lacks an approved
application under section 505 of the FD&C Act. With respect to drug
products covered by this notice, the Agency intends to exercise its
enforcement discretion for only a limited period of time because there
are safety issues with respect to the products covered by this notice
and numerous marketed products that have approved applications or
comply with the applicable OTC drug final monograph are offered to
treat symptoms relating to cold, cough, and allergy. Therefore, the
Agency intends to implement this notice as follows.
For the effective date of this notice, see the DATES section of
this document. FDA intends to take enforcement action against any drug
product covered by this notice that is not listed with the Agency in
full compliance with section 510 of the FD&C Act (21 U.S.C. 360) before
March 2, 2011, and is manufactured, shipped, or otherwise introduced or
delivered for introduction into interstate commerce by any person on or
after March 3, 2011. FDA also intends to take enforcement action
against any drug product covered by this notice that is listed with FDA
in full compliance with section 510 of the FD&C Act but is not being
commercially used or sold \13\ in the United States on March 2, 2011
and that is manufactured, shipped, or otherwise introduced or delivered
for introduction into interstate commerce by any person on or after
March 3, 2011.
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\13\ For purposes of this notice, the term ``commercially used
or sold'' means that the product has been used in a business or
activity involving retail or wholesale marketing and/or sale.
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However, for drug products covered by this notice that are
commercially used or sold in the United States, have a National Drug
Code (NDC) number listed with FDA, and are in full compliance with
section 510 of the FD&C Act before March 2, 2011 (``currently marketed
and listed''), the Agency intends to exercise its enforcement
discretion as follows. FDA intends to initiate enforcement action
against any currently marketed and listed product covered by this
notice that is manufactured on or after June 1, 2011 or that is shipped
on or after August 30, 2011.\14\ Further, FDA intends to take
enforcement action against any person who manufactures or ships such
products after these dates. Any person who has submitted or submits an
application for a drug product covered by this notice but has not
received approval must comply with this notice.
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\14\ If FDA finds it necessary to take enforcement action
against a product covered by this notice, the agency may take action
relating to all of the defendant's other violations of the FD&C Act
at the same time. For example, if a firm continues to manufacture or
market a product covered by this notice after the applicable
enforcement date has passed, to preserve limited agency resources,
FDA may take enforcement action relating to all of the firm's
unapproved drugs that require applications at the same time. (See,
e.g., United States v. Sage Pharmaceuticals, 210 F.3d 475, 479-480
(5th Cir. 2000) (permitting the Agency to combine all violations of
the act in one proceeding, rather than taking action against
multiple violations of the act in ``piecemeal fashion'').)
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The Agency, however, does not intend to exercise its enforcement
discretion as outlined previously if the following apply: (1) A
manufacturer or distributor of drug products covered by this notice is
violating other provisions of the FD&C Act, including, but not limited
to, violations related to FDA's current good manufacturing practices,
adverse drug event reporting, labeling or misbranding requirements
other than those identified in this notice or (2) it appears that a
firm, in response to this notice, increases its manufacture or
interstate shipment of drug products covered by this notice above its
usual volume during these periods.
Nothing in this notice, including FDA's intent to exercise its
enforcement discretion, alters any person's liability or obligations in
any other enforcement action, or precludes the Agency from initiating
or proceeding with enforcement action in connection with any other
alleged violation of the FD&C Act, whether or not related to a drug
product covered by this notice. Similarly, a person who is or becomes
enjoined from marketing unapproved or misbranded drugs may not resume
marketing of such products based on FDA's exercise of enforcement
discretion that is set forth in this notice.
Drug manufacturers and distributors should be aware that the Agency
is exercising its enforcement discretion as described previously only
in regard to
[[Page 11798]]
drug products covered by this notice that are marketed under an NDC
number listed with the Agency in full compliance with section 510 of
the FD&C Act before March 2, 2011. As previously stated, drug products
covered by this notice that are currently marketed but not listed with
the Agency on the date of this notice must, as of the effective date of
this notice, have approved applications prior to their shipment in
interstate commerce. Moreover, any person or firm that has submitted or
submits an application but has yet to receive approval for such
products is still responsible for full compliance with this notice.
V. Discontinued Products
Some firms may have previously discontinued the manufacturing or
distribution of products covered by this notice without removing them
from the listing of their products under section 510(j) of the FD&C
Act. Other firms may discontinue manufacturing or marketing listed
products in response to this notice. Firms that wish to notify the
Agency of product discontinuation should send a letter, signed by the
firm's chief executive officer, fully identifying the discontinued
product(s), including NDC number(s), and stating that the product(s)
has (have) been discontinued. The letter should be sent to Sakineh
Walther (see ADDRESSES). Firms should also update the listing of their
products under section 510(j) of the FD&C Act to reflect
discontinuation of products covered by this notice. FDA plans to rely
on its existing records, including its drug listing records, or other
available information when it targets violations for enforcement
action.
This notice is issued under the Federal Food, Drug, and Cosmetic
Act (sections 502 and 505 (21 U.S.C. 352 and 355)) and under authority
delegated to the Assistant Commissioner for Policy under section
1410.21 of the FDA Staff Manual Guide.
Dated: February 22, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-4703 Filed 3-2-11; 8:45 am]
BILLING CODE 4160-01-P