
[Federal Register Volume 79, Number 87 (Tuesday, May 6, 2014)]
[Proposed Rules]
[Pages 25758-25763]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-10304]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2014-N-0504]


Administrative Destruction of Certain Drugs Refused Admission to 
the United States

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is proposing 
a regulation to implement its authority to destroy a drug valued at 
$2,500 or less (or such higher amount as the Secretary of the Treasury 
may set by regulation) that has been refused admission into the United 
States under the Federal Food, Drug, and Cosmetic Act (FD&C Act), by 
providing to the owner or consignee notice and an opportunity to appear 
and introduce testimony to the Agency prior to the destruction. The 
proposed regulation is authorized by amendments made to the FD&C Act by 
the Food and Drug

[[Page 25759]]

Administration Safety and Innovation Act (FDASIA). Once finalized, this 
proposed regulation will allow FDA to better protect the public health 
by providing an administrative process for the destruction of certain 
refused drugs, thus increasing the integrity of the drug supply chain.

DATES: Submit either electronic or written comments on the proposed 
rule by July 7, 2014.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2014-
N-0504, by any of the following methods.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper submissions): 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name 
and Docket No. FDA-2014-N-0504 for this rulemaking. All comments 
received may be posted without change to http://www.regulations.gov, 
including any personal information provided. For additional information 
on submitting comments, see the ``Comments'' heading of the 
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number(s), found in brackets in the heading of this document, 
into the ``Search'' box and follow the prompts and/or go to the 
Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852.

FOR FURTHER INFORMATION CONTACT: Ann M. Metayer, Office of Regulatory 
Affairs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
32, Rm. 4338, Silver Spring, MD 20993-0002, 301-796-3324, 
FDASIAImplementationORA@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

Executive Summary

Purpose of the Proposed Rule

    The proposed rule would provide the owner or consignee of a drug 
that has been refused admission into the United States, and that is 
valued at $2,500 or less (or such higher amount as the Secretary of the 
Treasury may set by regulation) with (1) written notice that FDA 
intends to destroy the drug and (2) an opportunity to present testimony 
to the Agency before the drug is destroyed. In 2012, Congress amended 
section 801(a) of the FD&C Act (21 U.S.C. 381(a)) to provide FDA with 
the authority to destroy these refused drugs without providing the 
owner or consignee with the opportunity to export the drug. Congress 
directed FDA to issue regulations that provide the drug's owner or 
consignee with notice and an opportunity to present testimony to the 
Agency prior to the drug's destruction. (Section 708 of FDASIA (Pub. L. 
112-144).) This provision, as well as section 701 of the FD&C Act (21 
U.S.C. 371), provide the legal authority for this proposed rule.

Summary of the Major Provisions of the Proposed Regulatory Action

    This proposed rule would provide the owner or consignee of a drug 
that has been refused admission into the United States under section 
801(a) of the FD&C Act, and that is valued at $2,500 or less (or such 
higher amount as the Secretary of the Treasury may set by regulation) 
with (1) written notice that FDA intends to destroy the drug and (2) 
notice and an opportunity to present testimony to the Agency before the 
drug is destroyed.
    FDA proposes to amend part 1 (21 CFR part 1) by expanding the scope 
of Sec.  1.94 (21 CFR 1.94). Currently this regulation provides the 
owner or consignee of an FDA-regulated product offered for import into 
the United States with notice and opportunity to present testimony to 
the Agency prior to refusal of admission of the product. The proposed 
rule would expand the scope of Sec.  1.94 to provide an owner or 
consignee with notice and opportunity to present testimony to the 
Agency prior to the destruction of certain refused drugs.

Costs and Benefits

    The primary public health benefit from adoption of the proposed 
rule would be the value of the illnesses and deaths avoided because FDA 
destroyed a drug valued at $2,500 or less (or such higher amount as the 
Secretary of the Treasury may set by regulation) that posed a public 
health risk. This benefit accrues whenever the Agency's other 
enforcement tools would not have prevented a drug that does not comply 
with the requirements of the FD&C Act (violative drug) from entering 
the U.S. market. The estimated primary costs of the proposed rule, if 
finalized, include the additional costs to destroy a violative drug. 
The Agency estimates the quantifiable net annual social benefit of the 
proposed rule to range between $228,000 and $618,000.

I. Background and Legal Authority

    On July 9, 2012, President Obama signed FDASIA into law. Title VII 
of FDASIA provides FDA with important new authorities to help the 
Agency better protect the integrity of the drug supply chain. One of 
those new authorities is in section 708, which amends section 801(a) of 
the FD&C Act, to provide FDA with the authority to use an 
administrative procedure to destroy a drug valued at $2,500 or less (or 
such higher amount as the Secretary of the Treasury may set by 
regulation) that was not brought into compliance as described in 
section 801(b) of the FD&C Act and was refused admission into the 
United States. Section 708 of FDASIA authorizes FDA to use this new 
administrative procedure without offering the owner or consignee the 
opportunity to export the drug. Section 708 further provides that FDA 
will store and, as applicable, dispose of the drug that the Agency 
intends to destroy. The drug's owner or consignee is liable for FDA's 
storage and disposal costs pursuant to section 801(c) of the FD&C Act.
    FDA is issuing this proposed rule to implement section 708 of 
FDASIA. That provision directs FDA to issue regulations that provide 
the owner or consignee of a drug valued at $2,500 or less (or such 
higher amount as the Secretary of the Treasury may set by regulation) 
that has been refused admission with notice and an opportunity to 
introduce testimony to the Agency prior to the destruction of the drug. 
The provision further states that this process may be combined with the 
notice and opportunity to appear before FDA and introduce testimony on 
the admissibility of the drug under section 801(a) of the FD&C Act, as 
long as appropriate notice is provided to the owner or consignee. FDA 
is also issuing this proposed rule under section 701(b) of the FD&C 
Act, which authorizes regulations for the efficient enforcement of 
section 801 of the FD&C Act.
    A drug that is imported or offered for import is subject to refusal 
of admission under section 801(a) of the FD&C Act if, among other 
reasons, it is or appears to be adulterated, misbranded, or unapproved 
in violation of section 505 of the FD&C Act (21 U.S.C. 355). Under 
current regulation Sec.  1.94, FDA issues a notice of the Agency's 
intention to refuse a drug to the owner or consignee, as defined in 
Sec.  1.83, stating the reasons for the intended refusal. If the 
article is

[[Page 25760]]

sent by international mail, FDA generally considers the addressee of 
the parcel to be the owner or consignee. If this notice is to an 
individual who is importing a drug for personal use, it is issued 
consistent with the requirements of section 801(g) of the FD&C Act. The 
owner or consignee is given an opportunity to appear before the Agency 
and introduce testimony orally or in writing on why the drug should not 
be refused admission into the United States. The owner or consignee can 
also submit an application for authorization to recondition the drug to 
bring it into compliance with the FD&C Act or to render it other than a 
food, drug, device, or cosmetic. If, after providing the owner or 
consignee with notice and opportunity to present testimony, FDA 
determines that the drug should be refused admission, a notice of such 
refusal is issued to the owner or consignee.
    The majority of refused drug products subject to FDA's new 
destruction authority come into the United States via an International 
Mail Facility (IMF) or an express courier hub. Parcels that come into 
the United States via an IMF are routed by the United States Postal 
Service (USPS) to Customs and Border Protection (CBP). CBP interdicts 
certain drug shipments and turns them over to FDA for examination and a 
determination of admission under the FD&C Act. Some of these parcels 
may include one or more drugs that are unapproved, adulterated and/or 
misbranded, including counterfeit drugs and drugs that purport to be 
dietary supplements. USPS estimated that the average daily number of 
parcels that came into the United States via international mail from 
November 1, 2011, to October 31, 2012, was nearly 1.2 million (Ref. 1). 
It is estimated that the number of such parcels which contain drugs 
that enter the United States each year through the IMFs is between 20 
million and 100 million.
    Operation Safeguard is a multiagency initiative to target illicit 
imports of prescription drugs. In total, from fiscal years 2010 through 
2012, FDA examined nearly 45,000 shipments and CBP seized more than 
14,000 illicit shipments of prescription drugs during Operation 
Safeguard, with international mail shipments constituting the majority 
of the shipments that were seized (Ref. 1). Despite these efforts, the 
high volume of inbound international mail shipments has strained 
limited Federal resources at the IMFs making it extremely difficult to 
interdict all incoming shipments of violative drugs.
    Violative drugs pose a serious public health threat to consumers in 
the United States because they might not contain the active ingredient 
that patients need for the treatment of their disease; they might have 
too much or too little of an active ingredient; they might contain the 
wrong active ingredient; and/or they might contain toxic ingredients. 
For certain classes of drugs (e.g. antibiotics), these quality problems 
can also increase the likelihood of drug resistance (Ref. 2). By taking 
these drugs, consumers may be harmed directly by exposure to unsafe 
drugs or they may be harmed because they are prevented from getting the 
appropriate dose or strength of medications they need. Adverse events 
due to these violative drugs are underreported. Patients taking 
ineffective drugs may die or suffer the adverse effects of the 
underlying disease, making it difficult to detect or attribute these 
consequences to the violative drug (Ref. 3).
    FDA has issued several warnings about counterfeit and unapproved 
drugs, including warnings issued in 2012 and 2013 about counterfeit 
versions of the cancer medicines AVASTIN and ALTUZAN (bevacizumab) 
approved for marketing outside of the United States, that were 
purchased by medical practices in the United States. Certain 
counterfeit versions of these drugs did not contain the active 
pharmaceutical ingredient, (bevacizumab), which may have resulted in 
patients not receiving needed therapy (Ref. 4). In July 2013, a British 
citizen was sentenced to 18 months in prison for distributing 
adulterated cancer drugs and selling a counterfeit version of ALTUZAN 
that was obtained from Turkey to physicians in the United States (Ref. 
5). As of December 2013, FDA has issued over 1500 letters to medical 
practices in the United States to educate them about risky buying 
practices and to warn them about counterfeit and unapproved drugs in 
U.S. distribution. FDA publishes warnings about counterfeit medications 
on its Web site at http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/CounterfeitMedicine/default.htm.
    Many violative drugs are purchased by U.S. consumers over the 
Internet. In July 2013, the Government Accountability Office (GAO) 
issued a report on rogue Internet pharmacies. In its report, GAO 
defined a rogue Internet pharmacy as a fraudulent enterprise that 
operates in violation of Federal and/or State law, offers cheap drugs 
for sale without a prescription that meets Federal and State 
requirements, or operates without a pharmacy license in the United 
States. These rogue pharmacies may also operate in violation of laws 
relating to fraud, money laundering and/or intellectual property 
rights. Rogue Internet pharmacies operate Web sites that may look 
professional and legitimate, but in reality are often marketplaces for 
unapproved, adulterated and/or misbranded drugs (Ref. 6). According to 
the GAO report, LegitScript, an online pharmacy verification service 
that assesses the legitimacy of Internet pharmacies, determined that 
there were over 34,000 active rogue Internet pharmacies as of April 
2013 (Ref. 7).
    FDA has received a number of reports of adverse events resulting 
from the purchase of violative drugs over the internet. For example, 
FDA received reports from several consumers who ordered the FDA-
approved drugs AMBIEN, XANAX, LEXAPRO, or ATIVAN over the Internet but 
instead received products containing haloperidol (the active 
pharmaceutical ingredient in the FDA-approved antipsychotic drug 
HALDOL). These consumers required emergency medical treatment for 
symptoms such as difficulty in breathing, muscle spasms, and muscle 
stiffness--all drug reactions associated with this powerful 
antipsychotic (Ref. 8). In May 2012, FDA warned consumers about a 
counterfeit version of ADDERALL (a drug used to treat attention deficit 
hyperactivity disorders and narcolepsy) containing the wrong active 
pharmaceutical ingredients, that was being purchased on the Internet 
(Ref. 9).
    Some drugs that are represented and sold as dietary supplements can 
also present a significant public health risk. For example, some 
purported dietary supplements actually contain hidden or deceptively 
labeled active pharmaceutical ingredients, some at levels much higher 
than those found in drug products that are the subject of approved 
applications. Such products, especially when taken without physician 
supervision, can cause harm and have been associated with serious 
adverse events. Some purported dietary supplements, although they may 
not contain harmful ingredients, present a significant indirect public 
health risk because they are promoted to prevent or treat serious 
diseases but have not been proven safe and effective for that purpose. 
Instead of seeing a doctor for diagnosis and treatment, na[iuml]ve 
consumers may rely on such unproven remedies and may even substitute 
them for doctor-prescribed medications that have been approved by FDA 
based on proof of safety and effectiveness.
    Approximately 60 percent of the Class I drug recalls for fiscal 
years 2007 through 2013 involved drugs purported

[[Page 25761]]

to be dietary supplements. (Class I drug recalls involve public health 
threats for which there is a reasonable probability that the use of or 
exposure to a drug will cause serious adverse health consequences or 
death.) Many of the drugs being unlawfully marketed as dietary 
supplements are imported into the United States via IMFs and express 
courier hubs.
    Currently, drugs that have been refused admission into the United 
States under section 801(a) of the FD&C Act are destroyed unless they 
are exported within 90 days. Certain illegal drugs may also be 
destroyed if they are seized and condemned under FDA's seizure 
authority, section 304 of the FD&C Act (21 U.S.C. 334), or if they are 
seized and forfeited under CBP's seizure and forfeiture authority, such 
as 19 U.S.C. 1595a(c). Drugs that are imported via an IMF which are 
refused are sent back to the USPS for export. There is currently little 
deterrence to prevent sellers from sending violative drugs or resending 
previously refused drugs into the United States via the IMFs. Drugs 
refused admission into the United States might be subsequently offered 
for re-importation by unscrupulous sellers who choose to circumvent the 
import regulatory systems. In fact, some of the parcels returned by 
USPS have been resubmitted for entry into the United States by the 
sender, with the sticker indicating prior refusal by FDA still attached 
and visible. Under this proposed rule, FDA will be better able to 
prevent such re-importation by having an administrative mechanism for 
destroying a drug valued at $2,500 or less (or such higher amount as 
the Secretary of the Treasury may set by regulation) that has been 
refused admission.

II. Proposed Changes to Current Regulations

A. Proposed Revisions to Part 1

    FDA proposes to amend part 1 to create an implementing regulation 
for the administrative destruction of refused drugs. The proposed 
amendment to part 1 consists of amendments to Sec.  1.94.

B. Principal Features of the Proposed Rule

    Section 708 of FDASIA authorizes the Agency to destroy certain 
drugs that have already been refused admission under section 801(a) of 
the FD&C Act after the owner or consignee receives notice and an 
opportunity to present testimony before the Agency prior to 
destruction. The proposed rule allows FDA to provide two separate 
notices and hearings--one for refusal of admission and one for 
destruction of a refused drug product--or to combine both notices and 
hearings into one notice and proceeding. Whether the determinations 
occur separately or in one combined proceeding, the determination of 
refusal and the determination regarding destruction of a drug will be 
made separately by the Agency as the findings are separate and 
distinct. As with refusal of admission, FDA plans to specify 
operational details of its process for destruction by guidance, 
operating guidelines, or similar means. For example, the proposed rule 
says the notice will specify a time period for introducing testimony 
regarding destruction, which may be adjusted upon timely request giving 
reasonable grounds, and FDA could explain the time period it would 
typically provide. The operational details could also include the 
format of the notice and which FDA officials are authorized to make the 
decision as to whether to destroy a particular drug.
    As noted, a drug is subject to refusal of admission if, among other 
reasons, it is or appears to be adulterated, misbranded, or unapproved 
in violation of section 505 of the FD&C Act. FDA intends to exercise 
its new authority under section 708 of FDASIA to take the further step 
of destroying a drug only in situations where, after providing the 
owner or consignee with the opportunity to introduce testimony, the 
Agency has made a determination that the drug is adulterated, 
misbranded, or unapproved in violation of section 505.

III. Effective Date

    FDA intends that the effective date of the new requirements will be 
30 days after publication of a final rule in the Federal Register. 
Section 708 of FDASIA states that FDA's new authority under section 
801(a) of the FD&C Act shall not take effect until FDA issues a final 
regulation, and section 708 of FDASIA requires FDA to ``publish the 
final regulation not less than 30 days before the regulation's 
effective date.''

IV. Analysis of Impacts (Summary of the Initial Regulatory Impact 
Analysis)

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612) and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety, and other advantages; distributive impacts; and 
equity). The Agency believes that this proposed rule, if finalized, 
would not be an economically significant regulatory action as defined 
by Executive Order 12866.
    If a rule has a significant economic impact on a substantial number 
of small businesses, the Regulatory Flexibility Act requires Agencies 
to analyze regulatory alternatives that would minimize any significant 
impact of a rule on small entities. As further explained in this 
section, FDA has determined that this proposed rule, if finalized, 
would not have a significant economic impact on a substantial number of 
small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that Agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
state, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $141 million, using the most current (2012) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
proposed rule, if finalized, to result in any 1-year expenditure that 
would meet or exceed this amount.
    The primary public health benefit from adoption of the proposed 
rule would be the value of the illnesses or deaths avoided because the 
Agency destroyed a refused drug valued at $2,500 or less (or such 
higher amount as the Secretary of the Treasury may set by regulation) 
that posed a public health risk. Additionally, the proposed rule may 
benefit firms through increases in sales, brand value, and investment 
in research and development if the destroyed drug is a counterfeit or 
an otherwise falsified version of an approved drug. The threat of 
destruction may also have a deterrent effect resulting in a reduction 
in the amount of violative drugs shipped into the United States in the 
future. These benefits accrue whenever the Agency's other enforcement 
tools would not have prevented a violative drug from entering the U.S. 
market. The current procedure whereby a drug refused admission might be 
exported does not ensure that the drug would not be imported into the 
United States in the future.
    The estimated primary costs to FDA include the additional costs 
associated with destroying a refused drug. Our

[[Page 25762]]

estimates of the primary costs assume that all refused drugs valued at 
$2,500 or less (or such higher amount as the Secretary of the Treasury 
may set by regulation) would be destroyed (estimated 12,100 
destructions performed each year), that FDA would contract with another 
Government agency or private firm to destroy the drug, and the notice 
and hearing process for destruction would likely be combined with the 
notice and hearing process for refusals. Based on an assumed 12,100 
administrative destructions performed each year, the Agency estimates 
the quantifiable net annual social benefit of the proposed rule, if 
finalized, to be between $228,000 and $618,000. The present discounted 
value of the quantifiable net social benefit over 20 years would be in 
the range of $3,386,000 to $9,169,000 at a 3 percent discount rate and 
in the range of $2,411,000 to $6,529,000 at a 7 percent discount rate.
    FDA has examined the economic implications of the proposed rule as 
required by the Regulatory Flexibility Act. If a rule will have a 
significant economic impact on a substantial number of small entities, 
the Regulatory Flexibility Act requires agencies to analyze regulatory 
options that would lessen the economic effect of the rule on small 
entities. In the proposed rule, small entities will bear costs to the 
extent that they are responsible for the violative product. The number 
of expected destructions per year along with the very small value per 
event implies that this burden would not be significant, so we find 
that this proposed rule, if finalized, would not have a significant 
economic impact on a substantial number of small entities. This 
analysis, together with other relevant sections of this document, 
serves as the Initial Regulatory Flexibility Analysis, as required 
under the Regulatory Flexibility Act.
    The full discussion of economic impacts is available in docket FDA-
2014-N-0504 and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm# (Ref. 10).

V. Paperwork Reduction Act of 1995

    FDA concludes that the requirements contained in this proposed rule 
are not subject to review by the Office of Management and Budget 
because they do not constitute a ``collection of information'' under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3518(c)(1)(B)(ii)).

VI. Federalism

    FDA has analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. FDA has determined that 
the proposed rule, if finalized, would not contain policies that would 
have substantial direct effects on the States, on the relationship 
between the National Government and the States, or on the distribution 
of power and responsibilities among the various levels of government. 
Accordingly, the Agency tentatively concludes that the proposed rule 
does not contain policies that have federalism implications as defined 
in the Executive order and, consequently, a federalism summary impact 
statement is not required.

VII. Environmental Impact

    The Agency has determined under 21 CFR 25.30(h) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

VIII. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of 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, and will be posted to the docket at http://www.regulations.gov.

IX. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday. 
(FDA has verified the Web site addresses, but FDA is not responsible 
for any subsequent changes to the Web sites after this document 
publishes in the Federal Register.)

1. Government Accountability Office. ``Internet Pharmacies: Federal 
Agencies and States Face Challenges Combating Rogue Sites, 
Particularly Those Abroad,'' (GAO-13-560), p. 29, 2013. http://www.gao.gov/products/GAO-13-560.
2. U.S. Food and Drug Administration. ``Remarks as Delivered of 
Margaret A. Hamburg, M.D., Commissioner of Food and Drugs, 
Partnership for Safe Medicines Interchange,'' 2010. http://www.fda.gov/downloads/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/CounterfeitMedicine/UCM235240.pdf.
3. Institute of Medicine. ``Countering the Problem of Falsified and 
Substandard Drugs.'' Washington, DC: The National Academies Press, 
p. 57, 2013. http://books.nap.edu/openbook.php?record_id=18272.
4. U.S. Food and Drug Administration. ``Health Care Provider Alert: 
Another Counterfeit Cancer Medicine Found in the United States,'' 
2013. http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/CounterfeitMedicine/ucm338283.htm.
5. Department of Justice, United States Attorney's Office for the 
Eastern District of Missouri. ``English Citizen Sentenced for 
Distributing Adulterated and Counterfeit Cancer Drugs,'' 2013. 
http://www.justice.gov/usao/moe/news/2013/july/taylor_richard.html.
6. Government Accountability Office. ``Internet Pharmacies: Federal 
Agencies and States Face Challenges Combating Rogue Sites, 
Particularly Those Abroad,'' (GAO-13-560), What GAO Found, 2013. 
http://www.gao.gov/products/GAO-13-560.
7. Id., p. 14.
8. U.S. Food and Drug Administration. ``The Possible Dangers of 
Buying Drugs Over the Internet,'' 2011. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048396.htm.
9. U.S. Food and Drug Administration. ``FDA Warns Consumers about 
Counterfeit Version of Teva's Adderall,'' 2011. http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm305932.htm.
10. U.S. Food and Drug Administration. ``Preliminary Regulatory 
Impact Analysis, Initial Regulatory Flexibility Analysis, and 
Unfunded Mandates Reform Act Analysis for Administrative Destruction 
of Certain Drugs Refused Admission to the United States,'' 2014. 
http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm#.

List of Subjects in 21 CFR Part 1

    Cosmetics, Drugs, Exports, Food Labeling, Imports, Labeling, 
Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, and 
under authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR part 1 be amended as follows:

PART 1--GENERAL ENFORCEMENT REGULATIONS

0
1. The authority citation for 21 CFR part 1 is revised to read as 
follows:

    Authority: 15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 
1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 343, 350c, 
350d, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 374, 
381, 382, 387, 387a, 387c, 393; 42 U.S.C. 216, 241, 243, 262, 264.

0
2. Revise Sec.  1.94 to read as follows:

[[Page 25763]]

Sec.  1.94  Hearing on refusal of admission or destruction.

    (a) If it appears that the article may be subject to refusal of 
admission, or that the article is a drug that may be subject to 
destruction under section 801(a) of the Federal Food, Drug, and 
Cosmetic Act, the district director shall give the owner or consignee a 
written notice to that effect, stating the reasons therefor. The notice 
shall specify a place and a period of time during which the owner or 
consignee shall have an opportunity to introduce testimony. Upon timely 
request giving reasonable grounds therefor, such time and place may be 
changed. Such testimony shall be confined to matters relevant to the 
admissibility or destruction of the article, and may be introduced 
orally or in writing.
    (b) If such owner or consignee submits or indicates his or her 
intention to submit an application for authorization to relabel or 
perform other action to bring the article into compliance with the 
Federal Food, Drug, and Cosmetic Act or to render it other than a food, 
drug, device, or cosmetic, such testimony shall include evidence in 
support of such application. If such application is not submitted at or 
prior to the hearing on refusal of admission, the district director 
shall specify a time limit, reasonable in the light of the 
circumstances, for filing such application.
    (c) If the article is a drug that may be subject to destruction 
under section 801(a) of the Federal Food, Drug, and Cosmetic Act, the 
district director may give the owner or consignee a single written 
notice that provides the notice on refusal of admission and the notice 
on destruction of an article described in paragraph (a) of this 
section. The district director may also combine the hearing on refusal 
of admission with the hearing on destruction of the article described 
in paragraph (a) of this section into a single proceeding.

    Dated: April 30, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-10304 Filed 5-5-14; 8:45 am]
BILLING CODE 4160-01-P


