[Federal Register Volume 79, Number 103 (Thursday, May 29, 2014)]
[Rules and Regulations]
[Pages 30716-30721]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-12458]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1 and 16

[Docket No. FDA-2013-N-0365]


Administrative Detention of Drugs Intended for Human or Animal 
Use

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
implementing administrative detention authority with respect to drugs 
intended for human or animal use as authorized by amendments made to 
the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by the Food and 
Drug Administration Safety and Innovation Act (FDASIA). FDA's 
administrative detention authority with respect to drugs allows FDA to 
better protect the integrity of the drug supply chain. Specifically, 
FDA is able to administratively detain drugs encountered during an 
inspection that an authorized FDA representative conducting an 
inspection has reason to believe are adulterated or misbranded. This 
authority is intended to protect the public by preventing distribution 
or subsequent use of drugs encountered during inspections that are 
believed to be adulterated or misbranded, until FDA has had time to 
consider what action it should take concerning the drugs, and to 
initiate legal action, if appropriate.

DATES: This rule is effective June 30, 2014.

FOR FURTHER INFORMATION CONTACT: Charlotte Hinkle, Office of Regulatory 
Affairs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
32, Rm. 4343, Silver Spring, MD 20993-0002, 301-796-5300, 
[email protected].

SUPPLEMENTARY INFORMATION: 

Executive Summary

Purpose of the Regulatory Action

    FDA's administrative detention authority with respect to drugs 
intended for human or animal use allows FDA to better protect the 
integrity of the drug supply chain. Specifically, administrative 
detention is intended to protect the public by preventing distribution 
or subsequent use of drugs encountered during inspections that may be 
adulterated or misbranded, until FDA has had time to consider what 
action it should take concerning the drugs, and to initiate legal 
action, if appropriate. FDA already has the authority to 
administratively detain devices, tobacco, and foods that FDA has reason 
to believe are adulterated or misbranded.
    FDA is issuing this final rule under section 304(g) of the FD&C Act 
(21 U.S.C. 334(g)), as amended by section 709 of FDASIA, and section 
701 of the FD&C Act (21 U.S.C. 371). Section 304(g) of the FD&C Act 
also authorizes FDA to administratively detain devices and tobacco 
products.

Summary of the Major Provisions

    This final rule implements a regulation for the administrative 
detention of drugs. FDA is amending parts 1 and 16 (21 CFR parts 1 and 
16) to create an implementing rule for this authority. The changes set 
forth the procedures for detention of drugs believed to be adulterated 
or misbranded and amend the scope of FDA's part 16 regulatory hearing 
procedures to include the administrative detention of drugs.

Costs and Benefits

    The primary public health benefits from adoption of the final rule 
would be the value of the illnesses or deaths prevented because the 
Agency administratively detained a drug it has reason to believe is 
adulterated or misbranded; this benefit occurs only if the drug would 
not have been prevented from entering the market using one of the 
Agency's other enforcement tools. The estimated primary costs to FDA 
include marking or labeling the detained product and costs associated 
with appeals of detention orders. The Agency estimates the net annual 
social costs to be between $0 and $602,602.

I. Background

    In the Federal Register of July 15, 2013 (78 FR 42381), FDA 
proposed regulations to implement its new authority to administratively 
detain drugs that an authorized FDA representative conducting an 
inspection under section 704 of the FD&C Act (21 U.S.C. 374) has reason 
to believe are adulterated or misbranded. As discussed in the preamble 
to the proposed rule, on July 9, 2012, President Obama signed into law 
FDASIA (Public Law 112-144). Title VII of FDASIA provides FDA with 
important new authorities to help it better protect the integrity of 
the drug supply chain. One of those new authorities is section 709, 
which amends section 304(g) of the FD&C Act to provide FDA with 
administrative detention authority with respect to drugs. Section 
304(g) of the FD&C Act, as amended by FDASIA, provides FDA the same 
authority to detain drugs that section 304(g) already provides FDA with 
respect to devices and tobacco products. Once these implementing 
regulations with respect to drugs take effect, the amendments to 
section 304(g) of the FD&C Act will allow FDA to administratively 
detain drugs that an authorized FDA representative conducting an 
inspection under section 704 of the FD&C Act has reason to believe are 
adulterated or misbranded, until FDA has had time to consider what 
action it should take concerning the drugs, and to initiate legal 
action, if appropriate.

II. Overview of the Final Rule Including Changes to the Proposed Rule

A. Revisions to Part 1

    FDA is amending title 21 of the Code of Federal Regulations, part 1 
to create an implementing regulation for the administrative detention 
of drugs. The amendment to part 1 consists of one section, Sec.  1.980, 
under a new subpart, which is titled ``Subpart Q--Administrative 
Detention of Drugs Intended for Human or Animal Use.'' Section 1.980 
sets forth the procedures for the administrative detention of drugs 
encountered during an inspection that are believed to be adulterated or 
misbranded. The new regulation is closely modeled on the current 
regulation for the administrative detention of devices (21 CFR 800.55). 
There are minor differences from the device regulation, including 
updates to statutory references to refer to drugs instead of devices 
and changes to language to conform to current Federal Register 
requirements. Since FDA issued the proposed rule on administrative 
detention of drugs, FDA has issued other regulations in part 1, 
requiring reassignment of the section number within part 1. No other 
changes have been made to the substance of the proposed regulation. 
Other than renumbering the section, FDA is finalizing the implementing 
regulations as proposed.

B. Revisions to Part 16

    The amendment to part 16 is a technical change. This change amends 
a statement in Sec.  16.1 so that the scope of part 16 regulatory 
hearing procedures also will include administrative

[[Page 30717]]

detention authority with respect to drugs.

III. Comments on the Proposed Rule

    FDA received six comments in the docket for the July 15, 2013, 
proposed rule on administrative detention of drugs, three of which were 
responsive. However, after considering these comments, the Agency is 
not making any changes to the regulatory language included in the 
proposed rule. Relevant portions of the responsive comments are 
summarized and responded to in this document. The Agency did not 
consider nonresponsive comments in developing this final rule. To make 
it easier to identify comments and our responses, the word ``Comment,'' 
in parentheses, appears before the comment's description, and the word 
``Response,'' in parentheses, appears before our response. We have 
numbered each comment and response to help distinguish between 
different comments. Similar comments are grouped together under the 
same number. The number assigned to each comment is purely for 
organization purposes and does not signify the comment's value or 
importance or the order in which it was received. Comments addressing 
the proposed implementing regulation for the administrative detention 
of drugs and FDA's responses follow.

A. Standard for Administrative Detention Order

    In the proposed rule, FDA proposed that an administrative detention 
of drugs may be ordered when an authorized FDA representative, during 
an inspection under section 704 of the FD&C Act, has reason to believe 
that a drug is adulterated or misbranded. Two comments suggested the 
Agency modify the proposed standard for issuing an administrative 
detention order.
    (Comment 1) One commenter stated that the term ``adulteration'' is 
very broad and suggested that, to ensure that patients continue to have 
access to safe medications, the Agency should add an element of 
potential risk of public harm to the detention standard.
    (Response 1) The Agency does not have the authority to change the 
administrative detention standard, which is specified by statute. 
Section 304(g) of the FD&C Act provides, in relevant part: ``If during 
an inspection conducted under section 704 of a facility or vehicle, a 
drug which the officer or employee making the inspection has reason to 
believe is adulterated or misbranded is found in such facility or 
vehicle, such officer may order the drug detained (in accordance with 
regulations prescribed by the Secretary).'' Furthermore, we note that 
the terms ``adulterated'' and ``misbranded'' are well characterized by 
both the adulteration and misbranding provisions of the FD&C Act, its 
implementing regulations, and a substantial body of case law. For 
example, sections 501 and 502 of the FD&C Act (21 U.S.C. 351 and 352) 
provide criteria for determining whether a drug will be considered to 
be adulterated or misbranded, respectively. Because these terms are 
already well characterized, we do not believe it necessary or 
appropriate to further define or modify the meaning of these terms for 
the purposes of this rule.
    (Comment 2) One commenter suggested that the Agency should 
administratively detain shipments based on a pre-determined, justified 
level of suspicion, with an example that the Agency may wish to 
scrutinize more closely shipments that are not from a known shipper or 
known consignor.
    (Response 2) The commenter's reference to ``shipper and 
``consignor'' indicate that the commenter is confusing administrative 
detention of a drug during an inspection under section 304(g) of the 
FD&C Act with the process of reviewing imported products under section 
801(a) of the FD&C Act (21 U.S.C. 381). Under Sec.  1.94, when it 
appears to FDA that an imported article may be subject to refusal of 
admission under section 801(a) of the FD&C Act, FDA provides a notice 
of that fact to the owner or consignee and provides them with an 
opportunity to introduce testimony. This notice is commonly called a 
``Notice of Detention and Hearing'' (see, e.g., FDA Regulatory 
Procedures Manual, chapter 9, pp. 9-29) (Ref. 1) and is not related to 
administrative detention under section 304(g) of the FD&C Act.

B. Notification of Detention Order

    In the proposed rule, FDA proposed that the detention order be 
issued in writing, in the form of a detention notice, signed by the 
authorized FDA representative who has reason to believe that the drugs 
are adulterated or misbranded, and issued to the owner, operator, or 
agent in charge of the place where the drugs are located. If the owner 
or the user of the drugs is different from the owner, operator, or 
agent in charge of the place where the drugs are detained, a copy of 
the detention order must be provided to the owner or user of the drugs 
if the owner's or user's identity can be readily determined. If 
detention of drugs in a vehicle or other carrier is ordered, a copy of 
the detention order must be provided to the shipper of record and the 
owner of the vehicle or other carrier, if their identities can be 
readily determined. An FDA representative issuing a detention order 
must label or mark the drugs with official FDA tags that include 
certain information.
    (Comment 3) One commenter requested that FDA immediately notify the 
party responsible (e.g., manufacturer or wholesaler) for the detained 
drug to enable drug owners to inform customers that their orders may be 
delayed as well as opened and checked by FDA.
    (Response 3) We believe that the notice requirements set forth in 
the proposed rule, which we are adopting, together with the requirement 
that FDA label or mark the drugs subject to the detention order, 
address the commenter's concerns regarding FDA notification of 
detention orders to the owner, operator, or agent in charge of the 
place where the drugs are located. Furthermore, if the owner or the 
user of the drugs is different from the owner, operator, or agent in 
charge of the place where the drugs are located, FDA also will provide 
a copy of the detention order to the owner or user of the drugs, if 
their identity can be readily determined. FDA expects such notification 
to be as timely as possible. The procedures FDA puts into place to 
implement this rule will address the notice requirements and help 
ensure that our investigators are appropriately educated and trained on 
the procedural requirements.

C. Appeals of Detention Orders

    In the proposed rule, FDA proposed that the person who would be 
entitled to claim the drugs, if seized, may appeal a detention order.
    (Comment 4) Two commenters suggested the Agency clarify that it is 
not the intent of the Agency to limit the manufacturer's ability to 
appeal a detention order.
    (Response 4) Who may appeal a detention order is determined by 
Federal statute. Section 304(g) of the FD&C Act specifies who may 
appeal a detention order: ``Any person who would be entitled to claim a 
device, drug, or tobacco product if it were seized under [304(a)] may 
appeal . . . a detention of such device, drug, or tobacco product. . 
.''.
    (Comment 5) One commenter expressed concern that a drug product 
subject to a detention order would be withheld from patients without 
due process, potentially creating a drug shortage.
    (Response 5) We believe that the detailed notice and appeals 
procedures set forth in the proposed rule, which

[[Page 30718]]

includes the opportunity for an informal hearing within 5 working days 
after the appeal is filed, satisfy the elements of due process. We 
appreciate the commenter's concern that an administrative detention 
could lead to a drug shortage and note that the Agency has an active 
drug shortages program. Preventing drug shortages has been, and 
continues to be, a top priority for FDA, and we take great efforts to 
address, prevent, and mitigate drug shortages. Yet in making regulatory 
and enforcement decisions, FDA not only is concerned with the potential 
for drug shortages, but also with the potential for harm to patients 
caused by an adulterated or misbranded drug entering into commerce.

D. Movement of Detained Drugs

    In the proposed rule, FDA proposed that, except as provided, no 
person may move a detained drug within or from the place where they 
were ordered detained until FDA terminates the detention or the 
detention period expires, whichever occurs first.
    (Comment 6) Two commenters noted that administrative detention 
regulations should provide sufficient flexibility for movement in order 
to preserve product integrity during the detention process.
    (Response 6) FDA believes that Sec.  1.980(h)(3)(i) provides the 
flexibility sufficient to preserve product quality and integrity during 
an administrative detention. Paragraph (h)(3) states that an authorized 
FDA representative ``may approve, in writing, the movement of detained 
drugs for any of the following purposes: (i) To prevent interference 
with an establishment's operation or harm to the drugs.''

E. Notification of Detention Termination

    In the proposed rule, FDA proposed that, if FDA decides to 
terminate a detention or when the determination period expires, 
whichever occurs first, an FDA representative authorized to terminate a 
detention will issue a detention termination notice releasing the drugs 
to any person who received the original detention order or that 
person's representative and will remove, or authorize in writing the 
removal of, the required labels or tags.
    (Comment 7) One commenter suggested adding language that FDA will 
notify, by telephone or other means of rapid communication, the person 
who received the original detention order or that person's 
representative of the detention notification.
    (Response 7) We understand the concern raised by the commenter but 
do not believe that the notification of detention requirements should 
be revised to require notification by telephone or other means of rapid 
communication. As a general matter, current Agency practice with regard 
to administrative detentions is to concurrently notify the person who 
received the original detention order, or that person's representative, 
of the detention termination when a detention termination notice is 
sent by mail. We will consider incorporating such notification 
processes into Agency procedures to implement administrative detentions 
for drugs.

F. Enforcement Concerns

    (Comment 8) One commenter expressed concern regarding the potential 
for variability of enforcement among FDA's investigators, particularly 
regarding potential adulteration charges under section 501(j) of the 
FD&C Act.
    (Response 8) The authorities granted to FDA in Title VII of FDASIA, 
including the authority to enforce the prohibition against delaying, 
denying, limiting, or refusing an inspection under section 707 of 
FDASIA, are a comprehensive package, intended to enhance FDA's 
oversight of the global drug supply chain. Implementation of these new 
authorities will include measures to help ensure that our investigators 
are appropriately educated and trained on the new legal authorities and 
implementing procedures.

G. Foreign Inspections

    (Comment 9) One commenter suggested that FDA highlight the intent 
and manner in which the Agency intends to collaborate with foreign 
governments to apply administrative detention authority abroad.
    (Response 9) We appreciate this comment; however, the focus of this 
rule is not on our enforcement implementation, but on the process by 
which administrative detention of drugs occurs. If, in the future, we 
determine that administrative detention authority with respect to drugs 
has a unique application, we will evaluate what guidance or other 
information we will need to issue to help ensure transparency.

H. Harmonization With European Union Legislation

    (Comment 10) One commenter suggested that to support global 
harmonization, FDA harmonize the administrative detention of drugs to 
the highest possible degree with the European Union Falsified Medicines 
Directive (EU Directive 2011/62).
    (Response 10) FDA appreciates the comment. We do harmonize with 
legislation of our foreign regulatory counterparts to the extent 
possible and practicable. In 2011, the European Union (EU) Council 
issued the Falsified Medicines Directive in an effort to strengthen the 
EU's ability to detect falsified medicines and prevent their entry into 
the legitimate supply chain by adding new requirements in four main 
areas: Safety features, supply chain and good distribution practices, 
active pharmaceutical ingredients, and Internet sales (Ref. 2). This EU 
legislation, however, does not address administrative detention of 
drugs.

IV. Legal Authority

    FDA is issuing this final rule under sections 304(g) and 701 of the 
FD&C Act and section 709 of FDASIA. Section 709 of FDASIA provides FDA 
authority to issue regulations regarding administrative detention 
authority with respect to drugs. Section 304(g) of the FD&C Act 
includes FDA's administrative detention authority with respect to 
drugs. The final rule is necessary for efficient enforcement of the 
FD&C Act.

V. Analysis of Impacts (Summary of the Regulatory Impact Analysis)

    FDA has examined the impacts of the final 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 (Public 
Law 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 final rule 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. FDA has determined that this final 
rule 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

[[Page 30719]]

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 (2013) Implicit Price Deflator for the Gross Domestic 
Product. FDA does not expect this final rule to result in any 1-year 
expenditure that would meet or exceed this amount.
    The primary public health benefits from adoption of the final rule 
would be the value of the illnesses or deaths prevented because the 
Agency administratively detained a drug it has reason to believe is 
adulterated or misbranded; this benefit occurs only if the drug would 
not have been prevented from entering the market using one of the 
Agency's other enforcement tools. There may also be benefits from 
deterrence if administrative detention increases the likelihood that 
misbranded or adulterated products will not be marketed in the future.
    The estimated primary costs to FDA include marking or labeling the 
detained product and costs associated with appeals of detention orders. 
However, other costs, such as loss in market value of a detained drug, 
may be incurred if FDA revokes the detention order on appeal. Given the 
history of administrative detention use with medical devices and foods, 
the likelihood is low of FDA issuing a detention order that is later 
revoked on appeal.
    We estimate the annual costs using a range of 0 to 20 
administrative detentions performed each year. The Agency estimates the 
net annual social costs to be between $0 and $602,602. The present 
discounted value over 20 years would be in the range of $0 to 
$8,965,196 at a 3 percent discount rate and in the range of $0 to 
$6,383,974 at a 7 percent discount rate.
    FDA has examined the economic implications of the final 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. We find that this final rule 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 Final Regulatory Flexibility Analysis, as required under 
the Regulatory Flexibility Act.
    The full discussion of economic impacts is available in docket FDA-
2013-N-0365 and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm (Ref. 3).

VI. Paperwork Reduction Act of 1995

    This final rule contains no collection of information under the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3518(c)(1)(B)(ii)). 
Therefore, clearance by the Office of Management and Budget is not 
required under the Paperwork Reduction Act of 1995.

VII. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that 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 has concluded 
that the 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.

VIII. 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.

IX. References

    The following references have been placed on display in the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday, 
and are available electronically at http://www.regulations.gov. (FDA 
has verified the Web site address, but FDA is not responsible for any 
subsequent changes to the Web site after this document publishes in the 
Federal Register.)
    1. FDA Regulatory Procedures Manual, chapter 9, pp. 9-29.
    2. ``Directive 2011/62/EU of the European Parliament and of the 
Council of 8 June 2011 amending Directive 2011/83/EC on the Community 
code relating to medicinal products for human use, as regards the 
prevention of the entry into the legal supply chain of falsified 
medicinal products,'' Official Journal of the European Union, January 
7, 2011, available at http://ec.europa.eu/health/files/eudralex/vol-1/dir_2011_62/dir_2011_62_en.pdf.
    3. Final Regulatory Impact Analysis, Final Regulatory Flexibility 
Analysis, and Unfunded Mandates Reform Act Analysis for Administrative 
Detention of Drugs Intended for Human or Animal Use, available at 
http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

List of Subjects

21 CFR Part 1

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

21 CFR Part 16

    Administrative practice and procedure.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and the 
Public Health Service Act, and under authority delegated to the 
Commissioner of Food and Drugs, 21 CFR parts 1 and 16 are 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.

Subparts L-P--[Added and Reserved]

0
2. Add and reserve subparts L through P.
0
3. Add subpart Q, consisting of Sec.  1.980, to read as follows:

Subpart Q--Administrative Detention of Drugs Intended for Human or 
Animal Use


Sec.  1.980  Administrative detention of drugs.

    (a) General. This section sets forth the procedures for detention 
of drugs believed to be adulterated or misbranded. Administrative 
detention is intended to protect the public by preventing distribution 
or use of drugs encountered during inspections that may be adulterated 
or misbranded, until the Food and Drug Administration (FDA) has had 
time to consider what action it should take concerning the drugs, and 
to initiate legal action, if appropriate. Drugs that FDA orders 
detained may not be used, moved, altered, or tampered with in any 
manner by any person during the detention period, except as authorized 
under paragraph (h) of this section, until FDA

[[Page 30720]]

terminates the detention order under paragraph (j) of this section, or 
the detention period expires, whichever occurs first.
    (b) Criteria for ordering detention. Administrative detention of 
drugs may be ordered in accordance with this section when an authorized 
FDA representative, during an inspection under section 704 of the 
Federal Food, Drug, and Cosmetic Act, has reason to believe that a 
drug, as defined in section 201(g) of the Federal Food, Drug, and 
Cosmetic Act, is adulterated or misbranded.
    (c) Detention period. The detention is to be for a reasonable 
period that may not exceed 20 calendar days after the detention order 
is issued, unless the FDA District Director in whose district the drugs 
are located determines that a greater period is required to seize the 
drugs, to institute injunction proceedings, or to evaluate the need for 
legal action, in which case the District Director may authorize 
detention for 10 additional calendar days. The additional 10-calendar-
day detention period may be ordered at the time the detention order is 
issued or at any time thereafter. The entire detention period may not 
exceed 30 calendar days, except when the detention period is extended 
under paragraph (g)(6) of this section. An authorized FDA 
representative may, in accordance with paragraph (j) of this section, 
terminate a detention before the expiration of the detention period.
    (d) Issuance of detention order. (1) The detention order must be 
issued in writing, in the form of a detention notice, signed by the 
authorized FDA representative who has reason to believe that the drugs 
are adulterated or misbranded, and issued to the owner, operator, or 
agent in charge of the place where the drugs are located. If the owner 
or the user of the drugs is different from the owner, operator, or 
agent in charge of the place where the drugs are detained, a copy of 
the detention order must be provided to the owner or user of the drugs 
if the owner's or user's identity can be readily determined.
    (2) If detention of drugs in a vehicle or other carrier is ordered, 
a copy of the detention order must be provided to the shipper of record 
and the owner of the vehicle or other carrier, if their identities can 
be readily determined.
    (3) The detention order must include the following information:
    (i) A statement that the drugs identified in the order are detained 
for the period shown;
    (ii) A brief, general statement of the reasons for the detention;
    (iii) The location of the drugs;
    (iv) A statement that these drugs are not to be used, moved, 
altered, or tampered with in any manner during that period, except as 
permitted under paragraph (h) of this section, without the written 
permission of an authorized FDA representative;
    (v) Identification of the detained drugs;
    (vi) The detention order number;
    (vii) The date and hour of the detention order;
    (viii) The period of the detention;
    (ix) The text of section 304(g) of the Federal Food, Drug, and 
Cosmetic Act and paragraphs (g)(1) and (g)(2) of this section;
    (x) A statement that any informal hearing on an appeal of a 
detention order must be conducted as a regulatory hearing under part 16 
of this chapter, with certain exceptions described in paragraph (g)(3) 
of this section; and
    (xi) The location and telephone number of the FDA district office 
and the name of the FDA District Director.
    (e) Approval of detention order. A detention order, before 
issuance, must be approved by the FDA District Director in whose 
district the drugs are located. If prior written approval is not 
feasible, prior oral approval must be obtained and confirmed by written 
memorandum within FDA as soon as possible.
    (f) Labeling or marking a detained drug. An FDA representative 
issuing a detention order under paragraph (d) of this section must 
label or mark the drugs with official FDA tags that include the 
following information:
    (1) A statement that the drugs are detained by the U.S. Government 
in accordance with section 304(g) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 334(g)).
    (2) A statement that the drugs must not be used, moved, altered, or 
tampered with in any manner for the period shown, without the written 
permission of an authorized FDA representative, except as authorized in 
paragraph (h) of this section.
    (3) A statement that the violation of a detention order or the 
removal or alteration of the tag is punishable by fine or imprisonment 
or both (section 303 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 333)).
    (4) The detention order number, the date and hour of the detention 
order, the detention period, and the name of the FDA representative who 
issued the detention order.
    (g) Appeal of a detention order. (1) A person who would be entitled 
to claim the drugs, if seized, may appeal a detention order. Any appeal 
must be submitted in writing to the FDA District Director in whose 
district the drugs are located within 5 working days of receipt of a 
detention order. If the appeal includes a request for an informal 
hearing, as defined in section 201(x) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321(x)), the appellant must request either that 
a hearing be held within 5 working days after the appeal is filed or 
that the hearing be held at a later date, which must not be later than 
20 calendar days after receipt of a detention order.
    (2) The appellant of a detention order must state the ownership or 
proprietary interest the appellant has in the detained drugs. If the 
detained drugs are located at a place other than an establishment owned 
or operated by the appellant, the appellant must include documents 
showing that the appellant would have legitimate authority to claim the 
drugs if seized.
    (3) Any informal hearing on an appeal of a detention order must be 
conducted as a regulatory hearing under regulation in accordance with 
part 16 of this chapter, except that:
    (i) The detention order under paragraph (d) of this section, rather 
than the notice under Sec.  16.22(a) of this chapter, provides notice 
of opportunity for a hearing under this section and is part of the 
administrative record of the regulatory hearing under Sec.  16.80(a) of 
this chapter;
    (ii) A request for a hearing under this section should be addressed 
to the FDA District Director;
    (iii) The last sentence of Sec.  16.24(e) of this chapter, stating 
that a hearing may not be required to be held at a time less than 2 
working days after receipt of the request for a hearing, does not apply 
to a hearing under this section;
    (iv) Paragraph (g)(4) of this section, rather than Sec.  16.42(a) 
of this chapter, describes the FDA employees, i.e., regional food and 
drug directors, who preside at hearings under this section.
    (4) The presiding officer of a regulatory hearing on an appeal of a 
detention order, who also must decide the appeal, must be a regional 
food and drug director (i.e., a director of an FDA regional office 
listed in part 5, subpart M of this chapter) who is permitted by Sec.  
16.42(a) of this chapter to preside over the hearing.
    (5) If the appellant requests a regulatory hearing and requests 
that the hearing be held within 5 working days after the appeal is 
filed, the presiding officer must, within 5 working days, hold the 
hearing and render a decision affirming or revoking the detention.
    (6) If the appellant requests a regulatory hearing and requests 
that the hearing be held at a date later than

[[Page 30721]]

within 5 working days after the appeal is filed, but not later than 20 
calendar days after receipt of a detention order, the presiding officer 
must hold the hearing at a date agreed upon by FDA and the appellant. 
The presiding officer must decide whether to affirm or revoke the 
detention within 5 working days after the conclusion of the hearing. 
The detention period extends to the date of the decision even if the 5-
working-day period for making the decision extends beyond the otherwise 
applicable 20-calendar-day or 30-calendar-day detention period.
    (7) If the appellant appeals the detention order but does not 
request a regulatory hearing, the presiding officer must render a 
decision on the appeal, affirming or revoking the detention within 5 
working days after the filing of the appeal.
    (8) If the presiding officer affirms a detention order, the drugs 
continue to be detained until FDA terminates the detention under 
paragraph (j) of this section or the detention period expires, 
whichever occurs first.
    (9) If the presiding officer revokes a detention order, FDA must 
terminate the detention under paragraph (j) of this section.
    (h) Movement of detained drugs. (1) Except as provided in this 
paragraph, no person may move detained drugs within or from the place 
where they have been ordered detained until FDA terminates the 
detention under paragraph (j) of this section or the detention period 
expires, whichever occurs first.
    (2) If detained drugs are not in final form for shipment, the 
manufacturer may move them within the establishment where they are 
detained to complete the work needed to put them in final form. As soon 
as the drugs are moved for this purpose, the individual responsible for 
their movement must orally notify the FDA representative who issued the 
detention order, or another responsible district office official, of 
the movement of the drugs. As soon as the drugs are put in final form, 
they must be segregated from other drugs, and the individual 
responsible for their movement must orally notify the FDA 
representative who issued the detention order, or another responsible 
district office official, of their new location. The drugs put in final 
form must not be moved further without FDA approval.
    (3) The FDA representative who issued the detention order, or 
another responsible district office official, may approve, in writing, 
the movement of detained drugs for any of the following purposes:
    (i) To prevent interference with an establishment's operations or 
harm to the drugs;
    (ii) To destroy the drugs;
    (iii) To bring the drugs into compliance;
    (iv) For any other purpose that the FDA representative who issued 
the detention order, or other responsible district office official, 
believes is appropriate in the case.
    (4) If an FDA representative approves the movement of detained 
drugs under paragraph (h)(3) of this section, the detained drugs must 
remain segregated from other drugs and the person responsible for their 
movement must immediately orally notify the official who approved the 
movement of the drugs, or another responsible FDA district office 
official, of the new location of the detained drugs.
    (5) Unless otherwise permitted by the FDA representative who is 
notified of, or who approves, the movement of drugs under this 
paragraph, the required tags must accompany the drugs during and after 
movement and must remain with the drugs until FDA terminates the 
detention or the detention period expires, whichever occurs first.
    (i) Actions involving adulterated or misbranded drugs. If FDA 
determines that the detained drugs, including any that have been put in 
final form, are adulterated or misbranded, or both, it may initiate 
legal action against the drugs or the responsible individuals, or both, 
or request that the drugs be destroyed or otherwise brought into 
compliance with the Federal Food, Drug, and Cosmetic Act under FDA's 
supervision.
    (j) Detention termination. If FDA decides to terminate a detention 
or when the detention period expires, whichever occurs first, an FDA 
representative authorized to terminate a detention will issue a 
detention termination notice releasing the drugs to any person who 
received the original detention order or that person's representative 
and will remove, or authorize in writing the removal of, the required 
labels or tags.
    (k) Recordkeeping requirements. (1) After issuance of a detention 
order under paragraph (d) of this section, the owner, operator, or 
agent in charge of any factory, warehouse, other establishment, or 
consulting laboratory where detained drugs are manufactured, processed, 
packed, or held, must have, or establish, and maintain adequate records 
relating to how the detained drugs may have become adulterated or 
misbranded, records on any distribution of the drugs before and after 
the detention period, records on the correlation of any in-process 
detained drugs that are put in final form under paragraph (h) of this 
section to the completed drugs, records of any changes in, or 
processing of, the drugs permitted under the detention order, and 
records of any other movement under paragraph (h) of this section. 
Records required under this paragraph must be provided to FDA on 
request for review and copying. Any FDA request for access to records 
required under this paragraph must be made at a reasonable time, must 
state the reason or purpose for the request, and must identify to the 
fullest extent practicable the information or type of information 
sought in the records to which access is requested.
    (2) Records required under this paragraph must be maintained for a 
maximum period of 2 years after the issuance of the detention order or 
for such other shorter period as FDA directs. When FDA terminates the 
detention or when the detention period expires, whichever occurs first, 
FDA will advise all persons required under this paragraph to keep 
records concerning that detention whether further recordkeeping is 
required for the remainder of the 2-year, or shorter, period. FDA 
ordinarily will not require further recordkeeping if the Agency 
determines that the drugs are not adulterated or misbranded or that 
recordkeeping is not necessary to protect the public health, unless the 
records are required under other regulations in this chapter (e.g., the 
good manufacturing practice regulation in part 211 of this chapter).

PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

0
4. The authority citation for 21 CFR part 16 is revised to read as 
follows:

    Authority: 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394, 
467F, 679, 821, 1034; 42 U.S.C. 201-262, 263b, 364.

0
5. Revise the first sentence of Sec.  16.1 paragraph (b)(1) to read as 
follows:


Sec.  16.1  Scope.

* * * * *
    (b) * * *
    (1) Statutory provisions: Section 304(g) of the act relating to the 
administrative detention of devices and drugs (see Sec. Sec.  800.55(g) 
and 1.980(g) of this chapter).
* * * * *

    Dated: May 23, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-12458 Filed 5-28-14; 8:45 am]
BILLING CODE 4160-01-P