
[Federal Register Volume 78, Number 135 (Monday, July 15, 2013)]
[Proposed Rules]
[Pages 42381-42386]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-16843]



[[Page 42381]]

Vol. 78

Monday,

No. 135

July 15, 2013

Part IV





Department of Health and Human Services





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 Food and Drug Administration





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21 CFR Parts 1 and 16





Administrative Detention of Drugs Intended for Human or Animal Use; 
Draft Guidance for Industry on Circumstances That Constitute Delaying, 
Denying, Limiting, or Refusing a Drug Inspection; Availability; 
Proposed Rule and Notice

  Federal Register / Vol. 78 , No. 135 / Monday, July 15, 2013 / 
Proposed Rules  

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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: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing a 
regulation to implement 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). Once 
the applicable regulation is finalized, FDA's administrative detention 
authority with respect to drugs will allow FDA to better protect the 
integrity of the drug supply chain. Specifically, FDA will be able to 
administratively detain drugs encountered during an inspection that an 
officer or employee 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: Submit either electronic or written comments on the proposed 
rule by September 13, 2013.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2013-
N-0365, 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 or CD-ROM 
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-2013-N-0365. 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: Charlotte Hinkle, Office of Regulatory 
Affairs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
32, Rm. 4345, Silver Spring, MD 20993-0002, 301-796-5300, 
FDASIAImplementationORA@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

Executive Summary

Purpose of the Regulatory Action

    FDA's administrative detention authority with respect to drugs 
intended for human or animal use will allow 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 proposed rule under section 304(g) of the FD&C 
Act, as amended by section 709 of FDASIA, and section 701 of the FD&C 
Act (21 U.S.C. 334(g) and 371). Section 304(g) also authorizes FDA to 
administratively detain devices and tobacco products.

Summary of the Major Provisions

    This notice contains a proposed rule regarding the administrative 
detention of drugs. FDA proposes to amend parts 1 and 16 (21 CFR parts 
1 and 16) to create an implementing rule for this authority. The 
proposed 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 proposed 
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 $591,480.

I. Background

    On July 9, 2012, President Obama signed the Food and Drug 
Administration Safety and Innovation Act (FDASIA, Pub. L. 112-144) into 
law. 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 (21 U.S.C. 334(g)) 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 implementing regulations with respect to 
drugs are finalized, the amendments to section 304(g) of the FD&C Act 
will take effect, allowing FDA to administratively detain drugs that an 
officer or employee conducting an inspection under section 704 of the 
FD&C Act has reason to believe are adulterated or misbranded.
    FDA's administrative detention authority with respect to drugs will 
allow FDA to drive safety and quality through the drug supply chain. 
Use of this authority 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.
    Section 709 of FDASIA requires the Secretary to ``consult with 
stakeholders, including manufacturers of drugs'' before issuing 
implementing regulations. Section 709 of FDASIA also requires FDA to 
issue a notice of proposed rulemaking that includes the proposed 
regulation and provides a period of at least 60 days for comments on 
the proposed regulation. Finally,

[[Page 42383]]

section 709 of FDASIA states that FDA must ``publish the final 
regulation not less than 30 days before the regulation's effective 
date'' and states that FDA must issue regulations no later than 2 years 
after enactment of FDASIA.
    On April 9, 2013, FDA published a document in the Federal Register 
that opened a 30-day public docket to solicit input from all relevant 
stakeholders regarding FDA's issuance of regulations for the 
administrative detention of drugs (78 FR 21085). The docket was 
intended to ensure that stakeholders had an opportunity to provide 
comments before FDA issued proposed regulations on administrative 
detention with respect to drugs and to ensure that such information 
submitted to FDA was available to all interested persons in a timely 
fashion.
    The 30-day public docket closed on May 9, 2013. FDA received one 
responsive, non-substantive comment. The Agency did not consider 
nonresponsive comments in developing this proposed rule. FDA notes that 
this announcement regarding the proposed rule also solicits input from 
all relevant stakeholders before FDA issues final regulations to 
implement its administrative detention authority with respect to drugs. 
FDA modeled the proposed regulations for the administrative detention 
of drugs on the existing regulations covering administrative detention 
of devices (see 21 CFR 800.55). FDA did so because of identical 
statutory authority underlying the regulations (21 U.S.C. 334(g)).

II. Proposed Changes to Current Regulations

A. Proposed Revisions to Part 1

    FDA proposes to amend part 1 (21 CFR part 1) to create an 
implementing regulation for the administrative detention of drugs. The 
proposed amendment to part 1 consists of one section, Sec.  1.501, 
under a new subpart, which is titled ``Subpart L--Administrative 
Detention of Drugs Intended for Human or Animal Use.'' Proposed Sec.  
1.501 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.

B. Proposed Revisions to Part 16

    The proposed 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 will also include administrative 
detention authority with respect to drugs.

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 709 of FDASIA states that FDA's new authority under section 
304(g) of the FD&C Act shall not take effect until FDA issues a final 
regulation, and section 709 requires FDA to ``publish the final 
regulation not less than 30 days before the regulation's effective 
date.'' Finally, section 709 of FDASIA requires that no later than 2 
years after enactment of FDASIA, regulations to implement 
administrative detention authority with respect to drugs must be 
issued. Therefore, FDA intends to issue the final rule for 
administrative detention authority with respect to drugs by July 9, 
2014, with an effective date for the final rule no later than August 8, 
2014.

IV. Legal Authority

    FDA is issuing this proposed 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 proposed rule is necessary for efficient enforcement of the 
FD&C Act.

V. 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 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 
proposed 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 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 to result in any 1-year expenditure that would meet or 
exceed this amount.
    The primary public health benefits from adoption of the proposed 
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 
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 the 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 $591,480. The present 
discounted value over 20 years would be in the range of $0 to 
$8,799,729 at a 3 percent discount rate and in the range of $0 to 
$6,266,148 at a 7 percent discount rate.

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    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 proposed 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 Initial Regulatory Flexibility Analysis, as required 
under the Regulatory Flexibility Act.

VI. Paperwork Reduction Act of 1995

    FDA concludes that the requirements proposed 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)).

VII. 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.

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. 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.

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, it is proposed that 21 CFR parts 1 and 
16 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. Add subpart L, consisting of Sec.  1.501, to read as follows:

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


Sec.  1.501  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 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;

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    (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 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)(1) Movement of detained drugs. 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.

[[Page 42386]]

    (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 the 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
3. 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
4. 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 1.501(g) of this 
chapter). * * *

    Dated: July 10, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-16843 Filed 7-12-13; 8:45 am]
BILLING CODE 4160-01-P


