Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs, 51276-51357 [06-7172]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 71, Number 167 (Tuesday, August 29, 2006)]
[Proposed Rules]
[Pages 51276-51357]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-7172]



[[Page 51275]]

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Part II





Department of Health and Human Services





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Food and Drug Administration



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21 CFR Parts 20, 201, 207, et al.



Requirements for Foreign and Domestic Establishment Registration and 
Listing for Human Drugs, Including Drugs that are Regulated Under a 
Biologics License Application, and Animal Drugs; Proposed Rule

Federal Register / Vol. 71, No. 167 / Tuesday, August 29, 2006 / 
Proposed Rules

[[Page 51276]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 20, 201, 207, 314, 330, 514, 515, 601, 607, 610, and 
1271

[Docket No. 2005N-0403]
RIN 0910-AA49


Requirements for Foreign and Domestic Establishment Registration 
and Listing for Human Drugs, Including Drugs that are Regulated Under a 
Biologics License Application, and Animal Drugs

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Proposed rule.

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SUMMARY:  The Food and Drug Administration (FDA) is proposing to amend 
its regulations governing drug establishment registration and drug 
listing. The proposed revisions would reorganize, consolidate, clarify, 
and modify current regulations concerning who must register 
establishments and list human drugs, human drugs that are also 
biological products (including vaccines and allergenic products), and/
or human cells, tissues, and cellular and tissue-based products (HCT/
Ps), and animal drugs. The proposal describes when and how to register 
and list and what information must be submitted for registration and 
listing. In addition, the proposal would make certain changes to the 
National Drug Code (NDC) system and would require the appropriate NDC 
number to appear on the labels for drugs subject to the listing 
requirements. The proposed regulations generally would require the 
electronic submission of all registration and most listing information. 
We (FDA) rely on establishment registration and drug listing 
information for administering many of our programs, such as 
postmarketing surveillance (including FDA inspections), bioterrorism, 
drug shortages and availability, and user fee assessments. We are 
taking this action to use the latest technology to improve our 
registration and listing system, which would further our goal of 
protecting the public health. We also believe that the conversion to an 
electronic system would make the registration and listing processes 
more efficient and effective for industry and us. We are also taking 
this action to support the implementation of, for example, the 
electronic prescribing provisions of the Medicare Prescription Drug, 
Improvement, and Modernization Act, our rulemaking requiring a bar code 
on certain drug products, and the DailyMed initiative.

DATES:  Submit written or electronic comments by November 27, 2006. 
Submit written comments on the information collection requirements by 
September 28, 2006 to OMB (see ADDRESSES). See section IX of this 
document for the proposed effective date and section X for the proposed 
compliance dates of a final rule based on this document.

ADDRESSES: You may submit comments, identified by Docket No. 2005N-0403 
and/RIN 0910-AA49, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following ways:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments.
     Agency Web site: https://www.fda.gov/dockets/ecomments. 
Follow the instructions for submitting comments on the agency Web site.
Written Submissions
Submit written submissions in the following ways:
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer 
accepting comments submitted to the agency by e-mail. FDA encourages 
you to continue to submit electronic comments by using the Federal 
eRulemaking Portal or the agency Web site, as described in the 
Electronic Submissions portion of this paragraph.
    Instructions: All submissions received must include the agency name 
and Docket No(s). and Regulatory Information Number (RIN) (if a RIN 
number has been assigned) for this rulemaking. All comments received 
may be posted without change to https://www.fda.gov/ohrms/dockets/
default.htm, 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 https://www.fda.gov/ohrms/dockets/default.htm 
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.
    Information Collection Provisions: Submit written comments on the 
information collection provisions to the Office of Information and 
Regulatory Affairs, Office of Management and Budget (OMB).To ensure 
that comments on the information collection are received, OMB 
recommends that written comments be faxed to the Office of Information 
and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: For information concerning drugs 
regulated by the Center for Drug Evaluation and Research (CDER): 
Herbert Gerstenzang or John W. Gardner, Center for Drug Evaluation and 
Research (HFD-330), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-8920, herbert.gerstenzang@fda.hhs.gov or 
john.gardner@fda.hhs.gov.
    For information concerning products regulated by the Center for 
Biologics Evaluation and Research (CBER): Valerie A. Butler, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
6210, valerie.butler@fda.hhs.gov.
    For information concerning animal drugs: Lowell Fried (HFV-212) or 
Isabel W. Pocurull (HFV-226), Center for Veterinary Medicine (CVM), 
Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 
301-827-7820 or 240-453-6853, lowell.fried@fda.hhs.gov or 
isabel.pocurull@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background
II. Summary of Current Registration and Listing Requirements
    A. Summary of Section 510 of the Act
    B. Summary of Current Registration and Listing Regulations
    1. Who Must Register and List Under Current Regulations?
    2. What Are the Current Registration Requirements?
    3. What Are the Current Listing Requirements?
    4. What Are the Current Requirements Associated With the Use of 
the NDC Number?
    5. Who Is Exempt from Registration and Listing Under Current 
Regulations and Who Is Not Covered by the Current Registration and 
Listing Requirements in 21 CFR part 207?
    6. Do Current Regulations Permit the Disclosure of Registration 
and Listing Information?
III. Highlights of the Proposed Rule
    A. Proposed Changes to the Current Registration and Listing 
Requirements

[[Page 51277]]

    B. Promotion of Department of Health and Human Services Federal 
Health Information Technology Initiatives
IV. Description of the Proposed Rule
    A. General
    1. What Is the Purpose of Proposed Part 207?
    2. Who Would Part 207 Cover?
    3. Who Would Not Be Subject to Part 207?
    4. Who Would Be Exempt from Registration and Listing?
    5. What Definitions and Interpretations of Terms Would Apply to 
Part 207?
    B. Registration
    1. Who Would Be Required to Register?
    2. When Would Initial Registration Information Be Provided?
    3. What Information Would Be Required for Registration?
    4. What Are the Proposed Requirements for Reviewing and Updating 
Registration Information?
    C. The National Drug Code (NDC) Number: What is It? How is It 
Used? What Changes Are We Proposing?
    1. What Is the NDC Number?
    2. How Did NDC Numbers Originate? How Are They Used?
    3. What Changes Are We Proposing?
    4. How Do We Intend to Implement the NDC Number Changes?
    D. Listing
    1. Who Would Be Required to List Drugs?
    2. When Would Initial Listing Information Be Provided?
    3. What Listing Information Would Be Required?
    4. What Listing Information Would Be Required for Manufacturers?
    5. What Listing Information Would Be Required for Repackers and 
Relabelers?
    6. What Listing Information Would Be Required for Drug Product 
Salvagers Who are Not Repackers or Relabelers?
    7. What Additional Drug Listing Information May Be Required?
    8. What Are the Proposed Requirements for Reviewing and Updating 
Listing Information?
    E. Electronic Format
    1. How Would Registration and Listing Information Be Provided to 
FDA?
    2. What Was the Electronic Submission Pilot Project?
    3. How Would the Electronic Registration and Listing System 
Work?
    4. What Are the Proposed Requirements for the Submission of 
Content of Labeling in Electronic Format?
    5. Would the Proposal Require Electronic Submission of 
Advertisements and Other Labeling?
    6. What Guidance Documents Do We Intend To Issue on Providing 
Registration and Listing Information Electronically?
    7. How Would 21 CFR Part 11 Apply to the Electronic Submission 
of Registration and Listing Information?
    8. What Language Would Be Used to Provide Registration and 
Listing Information?
    9. Could the Electronic Format Requirements Be Waived?
    F. Miscellaneous
    1. What Are the Proposed Requirements for an Official Contact 
and a United States Agent?
    2. What Legal Status Is Conferred by Registration and Listing?
    3. What Registration and Listing Information Would Be Made 
Available for Public Disclosure?
    G. Conforming Actions
    1. Withdrawal from Sale of Drugs with Approved Marketing 
Applications
    2. Proposed Revisions to Other Regulations
    3. Compliance Verification Reports
V. Legal Authority
VI. Analysis of Economic Impacts
VII. Paperwork Reduction Act of 1995
VIII. Environmental Impact
IX. Proposed Effective Date
X. Proposed Compliance Dates
XI. Federalism
XII. Request for Comments
XIII. References

I. Background

    We originally published establishment registration regulations for 
human drugs, certain biological products, and animal drugs in the 
Federal Register of February 14, 1963 (28 FR 1457) (proposed rule) and 
April 3, 1963 (28 FR 3195) (final rule), and listing regulations for 
these drugs in the Federal Register of December 12, 1972 (37 FR 26431) 
(proposed rule) and March 7, 1973 (38 FR 6258) (final rule).
    We currently maintain a database containing the establishment 
registration and drug listing information submitted on paper to us. We 
rely on complete and accurate registration and listing information to 
accomplish a number of our statutory and regulatory objectives. For 
example, we use registration and listing information to:
     Identify the manufacturers, repackers, relabelers, and 
drug product salvagers of marketed drugs;\1\
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    \1\ ``Drug'' or ``drugs'' refers to human drugs, including drugs 
that are regulated under a biologics license application, and animal 
drugs (including Type A medicated articles), unless otherwise 
specifically stated. ``Drugs'' is defined in proposed Sec.  207.1 
and discussed in section IV.A.5 of this document. Biological 
products subject to proposed part 207 are described in proposed 
Sec.  207.9(c).
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     Identify the manufacturers, repackers, or relabelers of a 
specific drug or ingredient when that drug or ingredient is in short 
supply or is needed for a national emergency. This information helps us 
facilitate prompt drug shipment to the place where it is needed. For 
example, during a bioterrorism incident, we could use drug listing 
information to identify manufacturers, repackers, and relabelers of 
drugs that would be helpful in preventing or counteracting the deadly 
effects of biological weapons. With this information, we could 
facilitate prompt shipment of the drugs as needed;
     Facilitate the recall of drugs marketed by manufacturers, 
repackers, and relabelers;
     Identify and catalogue marketed drugs;
     Administer our postmarketing surveillance programs for 
drugs, including the drug surveillance sampling program that monitors 
the quality of the national drug supply;
     Identify drugs marketed in violation of the law;
     Schedule and plan inspections of registered establishments 
pursuant to section 704 of the Federal Food, Drug, and Cosmetic Act 
(the act) (21 U.S.C. 374); and
     Determine which marketed drugs are identical, related, or 
similar to drugs reviewed for effectiveness under the Drug Efficacy 
Study Implementation (DESI) program.
    We also rely on registration and listing information to help us 
comply with several other statutory provisions. We use the information 
to:
     Determine which entities are subject to establishment and 
product user fees under the prescription drug user fee program and the 
animal drug user fee program (21 U.S.C.379h and 379).
     Generate accurate estimates of the number of 
manufacturers, repackers, relabelers, and drug product salvagers and 
drugs that are affected by our rulemaking. These estimates help us 
assess the impact of our regulations on the regulated industry, which 
we are required to do under the Regulatory Flexibility Act (5 U.S.C. 
601-612), as amended by the Small Business Regulatory Enforcement 
Fairness Act (Public Law 104-121), the Unfunded Mandates Reform Act of 
1995 (2 U.S.C. 1501 et seq.), the Paperwork Reduction Act of 1995 (44 
U.S.C. 3501-3520), Executive Order 12866 (September 30, 1993), and the 
Congressional Review Act (section 251 of Public Law 104-121).
    Registration and listing information will continue to be used for 
all of the important public health purposes outlined above. Moreover, 
recent technological advances would allow us to enhance the usefulness 
of registration and listing information. Specifically, we are proposing 
that registration and listing information be submitted to us by using 
the electronic drug registration and listing system that we intend to 
develop. In addition to making the registration and listing process 
more efficient for industry, the electronic submission of registration 
and listing information would allow us to review and use such 
information more quickly and effectively in carrying out all of the

[[Page 51278]]

activities described above. Electronic submission of this information 
would also allow us to fully support the implementation of the 
provisions of the Medicare Prescription Drug, Improvement, and 
Modernization Act (Public Law 108-173) (Medicare Modernization Act), 
specifically the electronic prescribing provisions. In addition, 
electronic submission of registration and listing information would 
further the purpose of several statutes:
     The Public Health Security and Bioterrorism Preparedness 
and Response Act of 2002 (Public Law 107-188) (Bioterrorism Act) 
amended section 510(i) of the act (21 U.S.C. 360(i)) to require that 
foreign establishments submit, among other things, registration 
information electronically.
     The Medical Device User Fee and Modernization Act of 2002 
(Public Law 107-250) also amended section 510 of the act (at section 
510(p)) to explicitly give the Secretary of Health and Human Services 
(the Secretary) discretion to require the electronic submission of 
registration information, upon a finding that electronic receipt of 
such registration information is feasible, unless the Secretary grants 
a request for a waiver.
     The Government Paperwork Elimination Act of 1998 (Public 
Law 105-277, Title XVII) (GPEA) requires Federal agencies to give 
persons who are required to maintain, submit, or disclose information 
the option of doing so electronically when practicable as a substitute 
for paper, and to use electronic authentication (electronic signature) 
methods to verify the identity of the sender and the integrity of the 
electronic content.
    We believe that conversion to the electronic submission of 
registration and listing information will further the purpose of these 
laws and make the registration and listing processes more efficient and 
effective for industry and us.

II. Summary of Current Registration and Listing Requirements

A. Summary of Section 510 of the Act

    Section 510(c) of the act requires every person upon first engaging 
in the ``manufacture, preparation, propagation, compounding, or 
processing'' of a drug in any establishment that he owns or operates in 
any State to immediately register his name and place of business and 
such establishment. Under section 510(a)(1) of the act, the term 
``manufacture, preparation, propagation, compounding, or processing'' 
must include ``repackaging or otherwise changing the container, 
wrapper, or labeling of any drug package * * * in furtherance of the 
distribution of the drug * * * from the original place of manufacture 
to the person who makes final delivery or sale to the ultimate consumer 
or user.'' Section 510(a)(2) of the act mandates that the term ``name'' 
include, among other things, the name of each partner of a partnership, 
and the name of each corporate officer and director of a corporation. 
An owner or operator of a registered establishment must also 
immediately register any additional establishment that he owns or 
operates in any State and in which he begins the ``manufacture, 
preparation, propagation, compounding, or processing'' of a drug 
(section 510(d) of the act). An owner or operator of any establishment 
that engages in these activities must register its establishment on or 
before December 31 of each year (section 510(b) of the act). Section 
510(i) of the act contains certain registration requirements pertaining 
to foreign establishments (e.g., submission of the name of each 
importer of a drug in the United States that is known to the 
establishment, submission of the name of each person who imports or 
offers for import a drug into the United States for purposes of 
importation). Section 510(g) of the act provides for certain exemptions 
from the registration requirements. In addition, section 510(p) of the 
act gives the Secretary discretion to require the electronic submission 
of registration information, upon a finding that electronic receipt of 
such registration information is feasible, unless the Secretary grants 
a request for a waiver.
    Section 510(j)(1) of the act requires that every person, at the 
time of registration, submit a list of all drugs that are being 
manufactured, prepared, propagated, compounded, or processed by him for 
commercial distribution and that have not been previously listed by 
him. This information must be submitted in the form and manner 
prescribed by the Secretary (section 510(j)(1) of the act). This 
listing information must be accompanied by, among other things, a copy 
of certain labeling and, in some cases, advertising for certain 
categories of drugs. Section 510(j)(2) of the act requires certain 
changes in listing information to be reported every June and December, 
including any material changes in information previously submitted 
under the listing provisions.
    Section 510(e) of the act permits the Secretary to assign a 
registration number to any person or any establishments registered 
under section 510 and a listing number to each drug or class of drugs 
listed under section 510(j) as long as the listing number is the same 
as that assigned pursuant to the National Drug Code. The disclosure 
provision in section 510(f) of the act requires the Secretary to make 
available for inspection any registration filed under section 510. 
Section 510(f) also provides that certain listing information must be 
exempt from disclosure unless the Secretary finds that such exemption 
would be inconsistent with protection of the public health.

B. Summary of Current Registration and Listing Regulations

1. Who Must Register and List Under Current Regulations?
    Under current part 207 (21 CFR part 207), with certain exceptions, 
owners or operators of establishments that engage in the manufacturing 
or processing of a drug or drugs must, in addition to other 
requirements, register their establishments and submit listing 
information for each of their drugs in commercial distribution.\2\ 
Notwithstanding certain exceptions, foreign drug establishments that 
manufacture, repack, or relabel a drug that is imported or offered for 
import into the United States must also comply with the registration 
and listing requirements. As explained in section IV.E of this 
document, all registration and listing information must currently be 
submitted to us using paper forms specified by us.
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    \2\``Drug or drugs'' includes drugs regulated under a BLA. For a 
description of biological products covered under proposed part 207, 
see proposed Sec.  207.9(c).
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2. What Are the Current Registration Requirements?
    Current requirements for registration include, among other things, 
the following provisions:
     Owners or operators of establishments entering into the 
manufacturing or processing of a drug or drugs must register their 
establishments within 5 days after beginning the manufacturing or 
processing of drugs at the establishments (Sec.  207.21(a)).
     If owners or operators of the establishments have not 
previously entered into such operations, then those owners or operators 
must register within 5 days after the submission of a new drug 
application (NDA), abbreviated new drug application (ANDA), new animal 
drug application (NADA), abbreviated new animal drug application 
(ANADA), medicated feed mill license application, or biologics license 
application (BLA) (Sec.  207.21(a)).

[[Page 51279]]

     Owners or operators of establishments that are required to 
register must renew their registration annually in accordance with the 
specified schedule (Sec.  207.21(a)). Changes in individual ownership, 
corporate or partnership structure, location, or drug-handling activity 
must be submitted as amendments to registration within 5 days of such 
changes (Sec.  207.26).
     We assign a permanent registration number to each 
registered establishment (Sec.  207.35).
     Private label distributors that do not otherwise 
manufacture or process drugs are not required to register; however, 
they must submit specified information to us to obtain a labeler code 
(Sec.  207.20(b)). Private label distributors are owners or operators 
of establishments not otherwise required to register under section 510 
of the act that distribute under their own label or trade name a drug 
manufactured or processed by a registered establishment.
3. What Are the Current Listing Requirements?
    Current requirements for listing include, among other things, the 
following provisions:
     Owners or operators of establishments must, at the time of 
registration, submit a list of every drug being manufactured or 
processed in commercial distribution at that time (Sec.  207.21(a)).
     Private label distributors that do not otherwise 
manufacture or process drugs are not required to list, but may elect to 
submit listing information directly to us (Sec.  207.20(b)). Currently, 
private label distributors that elect to submit listing information 
directly to us assume full responsibility for compliance with the 
requirements of part 207 (Sec.  207.20(b)). Owners or operators of 
establishments that are required to register and list must submit 
listing information to us on behalf of private label distributors that 
do not elect to submit listing information directly to us (Sec.  
207.20(b)).
     Drugs that may be subject to current listing requirements 
include bulk drug substances; finished dosage forms, whether 
prescription or over-the-counter (OTC) drugs; and Type A medicated 
articles (Sec.  207.25(b)).
     The required listing information submitted to us includes, 
but is not limited to:
    --The application number, if applicable,
    --Copies of current labeling as specified in current Sec.  
207.25(b) and, in some cases, a representative sampling of 
advertisements,
    --A quantitative listing of the active ingredient(s) (in some 
cases),
    --The NDC number, and
    --Any imprinting information (Sec.  207.25(b)).
     Owners or operators of establishments that are required to 
register must update their listing information every June and December 
or, at the discretion of the owner or operator, when the change occurs. 
Updated information must include, but is not limited to:
    --A list of each drug introduced by the registrant for commercial 
distribution that has not been included in any previously submitted 
list,
    --A list of all previously listed drugs for which commercial 
distribution has been discontinued,
    --A list of all drugs for which a notice of discontinuance was 
submitted and for which commercial distribution has resumed, and
    --Any material change, as defined under current Sec.  207.3(a)(3), 
in any information previously submitted (Sec.  207.30(a)).
4. What Are the Current Requirements Associated With the Use of the NDC 
Number?
    The NDC system is used, among other things, to assign a drug 
listing number to each drug or class of drugs.
     The NDC number currently consists of the labeler code, 
product code, and package code. We assign the labeler code, and, as 
stated in current regulations, ``establishments'' assign the product 
code and package code within certain parameters specified by us (Sec.  
207.35).
     Currently, we request, but not require, that the NDC 
number appear on all drug labels and labeling (Sec.  201.2 (21 CFR 
201.2), Sec.  207.35(b)(3)). However, drug products described in 
current Sec.  201.25(b) (21 CFR 201.25(b)) must have on the label a bar 
code that contains, at a minimum, the appropriate NDC number in a 
linear bar code that meets specified standards (Sec.  201.25).
     The current regulations specify both format and placement 
of the NDC number if the NDC number is included on drug labels and 
labeling (Sec.  207.35(b)(3)).
5. Who Is Exempt From Registration and Listing Under Current 
Regulations and Who Is Not Covered by the Current Registration and 
Listing Requirements in 21 CFR Part 207?
    Under current regulations, certain establishments are exempt from 
the registration and listing requirements. For example, practitioners 
who are licensed by law to prescribe or administer drugs and who 
manufacture or process drugs solely for use in their professional 
practice, and persons who manufacture or process drugs not for sale but 
solely for use in research, teaching, or chemical analysis are exempt 
from registration and listing requirements. Many of the exemptions in 
current Sec.  207.10 are also listed in section 510(g) of the act.
    The current regulations also describe those establishments that are 
not covered under part 207. Owners and operators of human blood and 
blood product establishments must register and list their products in 
accordance with part 607 (21 CFR part 607). However, such owners and 
operators who also manufacture or process other drug products at the 
same establishment must also register and list those drugs in 
accordance with part 207 (Sec.  207.7). Owners and operators of 
establishments that solely engage in the manufacture or processing of 
medical devices are not covered under part 207. However, such owners 
and operators must register and list their products in accordance with 
part 807.
6. Do Current Regulations Permit the Disclosure of Registration and 
Listing Information?
    The current regulations specify the registration and listing 
information submitted to us that is available for public disclosure 
(Sec.  207.37).

III. Highlights of the Proposed Rule

    This proposal would reorganize, consolidate, and modify the current 
registration and listing requirements. It would also assist us in 
promoting other important electronic health initiatives.

A. Proposed Changes to the Current Registration and Listing 
Requirements

    We are proposing many changes to the current registration and 
listing requirements. In section IV of this document, we discuss in 
detail these changes and the reasons for the changes. The most 
significant proposed changes to the current requirements are as 
follows:
     All registration information and most listing information 
would be provided to us electronically using the electronic drug 
registration and listing system that we intend to develop. (Currently, 
the information is submitted to us on paper forms.)
     The appropriate NDC number would be required, with certain 
exceptions, to appear on drug labels. The appropriate NDC number is the 
NDC number belonging to the manufacturer, repacker, or relabeler, that 
corresponds to the particular drug;

[[Page 51280]]

a repacker or relabeler would not be permitted to place an NDC number 
that corresponds to an original manufacturer on a repackaged or 
relabeled drug. Although the NDC number would not be required to appear 
on other drug labeling (that is, the prescription drug labeling or the 
package insert), the NDC number would need to accompany the submission 
of the other drug labeling. (Currently, we only request that the NDC 
number appear on drug labels and labeling. However, certain drug 
products must have on the label a bar code that contains, at a minimum, 
the appropriate NDC number (see Sec.  201.25).)
     All three sections of the NDC number--that is, the labeler 
code, product code, and package code--would be assigned prospectively 
by us to drugs that have not previously been assigned NDC numbers by a 
manufacturer, repacker, or relabeler. (Currently, we assign the labeler 
code, and the registered establishment or private label distributor 
assigns the product code and package code within certain parameters 
specified by us.) The labeler code assigned prospectively by us would 
be the same as the labeler code (or one of the labeler codes) used by 
the manufacturer, repacker, or relabeler on its currently marketed 
drugs.
     The NDC numbers currently assigned to drugs prior to the 
effective date of the rule would remain unchanged, provided those NDC 
numbers comply with the new regulations as finalized. FDA intends to 
validate that current NDC numbers comply with the new regulations as 
finalized. Manufacturers, repackers, and relabelers should review the 
information that they submitted to our registration and listing 
database to obtain an NDC number and update the information if 
necessary. They should complete their reviews and updates within 9 
months after a final rule's effective date. If, after the effective 
date of the final rule, there is a change in a drug (in accordance with 
proposed Sec.  207.33(f)), we would assign a new product code and 
package code to the newly changed drug, but the drug would keep the 
labeler code. If, after the effective date of the final rule, there is 
a change in a drug's packaging, we would assign a new package code to 
the drug, but the drug would keep the labeler code and the product 
code. (Currently, the registered establishment or private label 
distributor may assign the product and package codes within certain 
parameters specified by us.)
     Private label distributors would not be permitted to 
register or list under the proposed rule. (Currently, private label 
distributors submit certain information to request a labeler code and 
may list drugs. If the private label distributor elects not to submit 
drug listing information directly to us and to obtain a labeler code, 
the registered establishment must submit the drug listing information.) 
Manufacturers, repackers, relabelers, or drug product salvagers must 
submit drug listing information for those drugs they manufacture, 
repack, relabel, or salvage for a private label distributor.
     Drug product salvagers would, in addition to registering, 
be required to list the drugs they salvage, even if they do not repack 
or relabel the drugs. (Currently, drug product salvagers are required 
to register but not list.)
     The ``content of labeling'' as defined in proposed Sec.  
207.1 would be electronically submitted at the time of listing in a 
format that we can process, review, and archive. (Currently, all 
labeling required for listing is submitted in paper form.)

B. Promotion of the Department of Health and Human Services (DHHS) 
Federal Health Information Technology Initiatives

    The proposal would allow us to provide important support for the 
full implementation of the electronic prescription provisions of the 
Medicare Modernization Act. The proposal would also support other 
initiatives, described in section IV.C.2 of this document, including 
DHHS Federal Health Information Technology initiatives. The proposal 
would result in an up-to-date NDC number system, in which we assign the 
NDC number, providing for accurate, unique, and unambiguous NDC numbers 
for each drug. This would allow electronic systems to reliably and 
consistently link the NDC number to the appropriate drug labeling 
through another DHHS health information technology initiative, 
Structured Product Labeling (SPL). The drug labeling would supply the 
drug ingredient and other information necessary to support the 
development of the standards for medication terminology necessary for 
electronic prescribing. Other initiatives supported by this proposal, 
including bar coding for drugs, are discussed in section IV.C.2 of this 
document.

IV. Description of the Proposed Rule

    We are proposing to reorganize, consolidate, clarify, and modify 
the regulations in part 207. As a result, we have revised and 
recodified some provisions, added new provisions, and eliminated 
others. The following description of the proposed rule describes both 
new provisions and changes to existing regulations.

A. General

1. What Is the Purpose of Proposed Part 207?
    We are proposing to add new Sec.  207.5 to explicitly state the 
purpose of part 207, as set forth in the legislative history of the 
Drug Amendments of 1962 and the Drug Listing Act of 1972.
     Establishment registration information helps us to 
identify who is manufacturing, repacking, relabeling, or salvaging 
drugs and where those operations are being performed. As explained in 
Senate Report No. 1744, ``drugs should not be on the market unless 
[FDA] knows who is making them, and where they are being made. This 
will help stop illicit and substandard manufacturers who do not follow 
the methods or establish the controls called for by good manufacturing 
practice'' (1962 U.S.C.C.A.N. 2884, 2889). Knowing where drugs are 
being made is even more important today because it would increase the 
Nation's ability to prepare for and respond effectively to bioterrorism 
and other public health emergencies.
     Drug listing information gives us a current inventory of 
marketed drugs. As stated in Senate Report No. 92-924, ``[t]he 
effective enforcement of the drug provisions of the [a]ct requires the 
ready availability of a current inventory of all marketed drugs'' (1972 
U.S.C.C.A.N. 2963, 2964). Moreover, the intent of drug listing is to 
provide us ``with an effective means of surveillance'' (Id. at 2965). 
Both establishment registration and drug listing information facilitate 
our implementation and enforcement of the act and are used for many 
important public health purposes. In addition, this information will 
help us better respond to emergencies (for example, we will be in a 
better position to effectively facilitate recalls should there be such 
a need).
2. Who Would Part 207 Cover?
    We are proposing to add new Sec.  207.9 to explain that part 207 
would apply to the following.
     Domestic manufacturers, domestic repackers, domestic 
relabelers, and domestic drug product salvagers, unless they are exempt 
under section 510(g) of the act or proposed Sec.  207.13. The terms 
``domestic manufacturers,'' ``domestic repackers,'' ``domestic 
relabelers,'' and ``domestic drug product salvagers'' are defined in 
proposed Sec.  207.1 and are explained in section IV.A.5 of this 
document. Proposed Sec.  207.9 does not

[[Page 51281]]

change the scope of current part 207. Domestic manufacturers, domestic 
repackers, domestic relabelers, and domestic drug product salvagers 
would be covered under proposed part 207 whether or not the drugs they 
manufacture, repack, relabel, or salvage enter interstate commerce. 
Section 510(b) and (c) of the act refer to an establishment ``in any 
State.'' Congress's intention for section 510 of the act to apply to 
drugs both in interstate and intrastate commerce is stated in section 
301 of Public Law 82-781, in part, as follows: ``[T]he products of all 
[establishments in which drugs are manufactured, prepared, propagated, 
compounded, or processed] are likely to enter the channels of 
interstate commerce and directly affect such commerce; and * * * the 
regulation of interstate commerce in drugs without provision for 
registration and inspection of establishments that may be engaged only 
in intrastate commerce in such drugs would discriminate against and 
depress interstate commerce in such drugs, and adversely burden, 
obstruct, and affect such interstate commerce.''\3\ Accordingly, we are 
proposing to add to proposed Sec.  207.9 the clause ``regardless of 
whether their drugs enter interstate commerce'' to reflect this 
congressional finding. The phrase ``Drug products * * * must be listed 
whether or not the output of such establishments or any particular drug 
so listed enters interstate commerce'' is already included in current 
Sec.  207.20(a).
---------------------------------------------------------------------------

    \3\See footnote 1 of section 510 of the act.
---------------------------------------------------------------------------

     Foreign manufacturers, foreign repackers, foreign 
relabelers, and foreign drug product salvagers, unless they are exempt 
under proposed Sec.  207.13(c) through (h). Foreign manufacturers, 
foreign repackers, foreign relabelers, and foreign drug product 
salvagers are currently required to register, and foreign 
manufacturers, foreign repackers, and foreign relabelers are currently 
required to submit listing information in accordance with section 510 
of the act and Sec.  207.40. The terms ``foreign manufacturers,'' 
``foreign repackers,'' ``foreign relabelers,'' and ``foreign drug 
product salvagers'' are defined in proposed Sec.  207.1 and explained 
in section IV.A.5 of this document.
    An increased number of foreign manufacturers, foreign repackers, 
foreign relabelers, and foreign drug product salvagers may be required 
to comply with registration and/or listing requirements because we are 
proposing, as explained in section IV.A.4 of this document, to revoke 
certain provisions of current Sec.  207.40(a) and (b). We are proposing 
to revoke the exemption in current Sec.  207.40(a) relating to foreign 
establishments whose drugs enter a foreign trade zone and are re-
exported from the foreign trade zone without having entered U.S. 
commerce. We are also proposing to revoke, in part, current Sec.  
207.40(b), which allows for a component of a drug imported under 
section 801(d)(3) of the act (21 U.S.C. 381(d)(3)) to be imported or 
offered for import into the United States even if the component is not 
listed and manufactured, prepared, propagated, compounded, or processed 
at a registered foreign establishment. We are proposing to eliminate 
these two exemptions in current Sec.  207.40(a) and (b) from the 
registration and listing requirements in light of certain statutory 
changes that have occurred since the publication of the final rule on 
foreign establishment registration and listing. Those changes include 
enactment of the Bioterrorism Act, which reflects Congress' desire to 
increase the Nation's ability to prepare for and respond effectively to 
bioterrorism and other public health emergencies.
     Manufacturers of drugs regulated under a BLA, as follows:
    Manufacturers of drugs regulated under a BLA including, but not 
limited to: (1) Plasma derivatives such as albumin, Immune Globulin, 
Factor VIII and Factor IX, and recombinant versions of plasma 
derivatives or animal derived plasma derivatives; (2) vaccines; (3) 
allergenic products; (4) bulk product substances such as fractionation 
intermediates or pastes; and (5) therapeutic biological products.
    Establishments solely engaged in the manufacture, as defined in 
Sec.  1271.3(e) (21 CFR 1271.3(e)), of HCT/Ps, as defined in Sec.  
1271.3(d), that, under Sec.  1271.20, are also drugs regulated under 
section 351 of the Public Health Service Act (PHS Act) or section 505 
of the act. Proposed Sec.  207.9(c)(2) would direct these 
establishments to register and list those HCT/Ps with CBER by following 
the procedures described in subpart B of part 1271 (21 CFR part 1271) 
instead of the procedures for registration and listing described in 
part 207. Proposed Sec.  207.9(c)(2) is similar to current Sec.  
207.20(f), which we propose to revoke and replace with proposed Sec.  
207.9(c)(2).
    We are also explaining the relationship between the requirements 
for HCT/Ps in part 207 and part 1271 of this chapter. We have 
implemented, in part 1271, a comprehensive, risk-based regulatory 
approach for HCT/Ps. Under this approach, some HCT/Ps are regulated 
solely under section 361 of the PHS Act (42 U.S.C. 264) and the 
regulations in part 1271; other HCT/Ps are also subject to regulation 
as drugs or devices under the act and to premarket application or 
notification requirements (submissions may include BLAs, NDAs, or 
device PMAs, product development protocols, or 510(k) applications).
    Current Sec.  207.20(f) also states that the additional listing 
information requirements in current Sec.  207.31 are applicable to HCT/
Ps registered in accordance with the procedures in part 1271, subpart B 
if they are also drugs regulated under a BLA and/or the act. We are 
proposing to revoke current Sec.  207.31 and move several of its 
requirements to other sections of the proposed rule (see discussion in 
sections IV.C and IV.D of this document). Consistent with the 
provisions in current Sec.  207.20(f), the requirements will continue 
to apply to HCT/Ps that, under Sec.  1271.20, are also drugs regulated 
under a BLA or section 505 of the act.
    In addition, proposed Sec.  207.9(c)(2) would require the 
submission of information not currently required for HCT/Ps under part 
207, although the submission of such information has been required for 
drug products that are not HCT/Ps. For example, proposed Sec.  
207.9(c)(2) would require establishments to submit the NDC number, as 
described in proposed Sec. Sec.  207.49(a), 207.53(a), and 
207.54(b)(1), and the route of administration, as described in proposed 
Sec.  207.49(b). Under these provisions, such HCT/P establishments 
would not be required to register and list with both CBER and CDER. 
Rather, we envision that establishments will register with CBER, and 
then will be asked to provide additional information as required under 
part 207. We will manage our databases so that both CBER and CDER have 
use of the registration and listing information provided. The concept 
is that there will be a link in place when the establishment 
electronically accesses the electronic registration and listing system 
at https://www.fda.gov/cber/tissue/tisreg.htm for tissue registration. 
This will allow access to the drug database fields to fill in the 
additional information such as the NDC number. If the establishment 
enters that it manufactures a licensed biologic, this will trigger the 
link. At the current time, there is only one such product.
3. Who Would Not Be Subject to Part 207?
    Proposed Sec.  207.9 also describes two categories of 
establishments that would not be subject to part 207:
     Owners and operators of human blood and blood product

[[Page 51282]]

establishments. This proposed rule does not apply to owners and 
operators of human blood and blood product establishments unless they 
manufacture any of the products listed in proposed Sec.  207.9(c)(1)(i) 
and (c)(1)(iv). If the owners and operators of human blood and blood 
product establishments manufacture any of those products, then they 
must register and list under part 207. Establishments that collect or 
process whole blood and blood products as well as establishments 
involved in the testing of whole blood and blood products would 
register and list under part 607. For purposes of this proposal, blood 
and blood products consist of human whole blood, plasma, or serum or 
any product derived from human whole blood, plasma, or serum, and the 
term includes biological products regulated as licensed devices. 
Manufacturers of licensed devices and manufacturers of licensed 
biological components used in a licensed device would register and list 
under part 607. This exclusion is consistent with current Sec.  
207.7(a) and would not apply to owners and operators of human blood and 
blood product establishments who also manufacture other drugs.
     Establishments that solely manufacture, prepare, 
propagate, compound, assemble, or process medical devices. 
Establishment registration and device listing regulations for such 
establishments and initial importers of devices, including in vitro 
diagnostic products, are codified in part 807. Establishments that 
manufacture, prepare, propagate, compound, assemble, or process medical 
devices, and also manufacture, prepare, propagate, compound, or process 
drugs, are subject to part 207 for drugs and part 807 for devices.
    As a result of these proposed revisions clarifying the scope of 
part 207, proposed Sec.  207.9 includes the provisions in current Sec.  
207.7 that explain the applicability of part 207 to human blood and 
blood products and medical devices. We are also proposing to revoke 
related provisions that set forth addresses in the Center for Devices 
and Radiological Health (CDRH) and CBER for submitting registration and 
listing information, and provisions that specify the appropriate forms 
for submitting such information.
4. Who Would Be Exempt From Registration and Listing?
    Section 510(g) of the act and current Sec.  207.10 provide for 
exemptions from registration and drug listing requirements. Proposed 
Sec.  207.13 contains certain changes to some of the exemptions in 
current Sec.  207.10, as discussed in the first part of this section. 
Proposed Sec.  207.13 also incorporates without change some exemptions 
from current Sec.  207.10, as discussed at the end of this section.
    The introductory paragraph of proposed Sec.  207.13, largely 
consistent with current Sec.  207.10, states that, except as provided 
in proposed Sec.  207.13(i), the classes of persons listed in proposed 
Sec.  207.13 are exempt from registration and drug listing under 
section 510(g) of the act, or because we have found, under section 
510(g)(5) of the act, that their registration is not necessary for the 
protection of the public health. We are proposing to add the phrase 
``except as provided in proposed Sec.  207.13(i)'' to indicate that 
even though the classes of persons identified in paragraphs (a) through 
(h) are exempt from registration and drug listing, if such persons 
engage in activities as set forth in paragraph (i), the exemption does 
not apply and they are required nonetheless to register and list. We 
are also proposing to include in the introductory paragraph a sentence 
clarifying that the exemption under proposed Sec.  207.13 would not 
provide exemptions from other provisions of the act or regulations. For 
example, persons that do not have to register establishments and list 
drugs are still subject to the adulteration and misbranding provisions 
under sections 501 and 502 of the act (21 U.S.C. 351 and 352) and also 
may be subject to the new drug approval requirements under section 505 
of the act (21 U.S.C. 355) or new animal drug approval requirements 
under section 512 of the act (21 U.S.C. 360b). We may inspect their 
establishments in accordance with section 704 of the act and the 
current good manufacturing practice requirements. We are proposing to 
add the clarifying sentence because in the past some manufacturers, 
repackers, relabelers, and drug product salvagers that were exempt from 
registration and listing requirements incorrectly believed these 
provisions provided exemptions from other provisions of the act and 
regulations. Accordingly, we are proposing to add this sentence to 
remedy any confusion on this point.
    a. Pharmacies--The current exemption for pharmacies is codified at 
Sec.  207.10(a). The proposed rule would revise and clarify the 
exemption, and would move it to Sec.  207.13(a). Except as noted in the 
discussion below, proposed Sec.  207.13(a) is generally consistent with 
current Sec.  207.10(a).
    Under proposed Sec.  207.13(a), pharmacies would be exempt from the 
registration and listing requirements if they: Operate in conformance 
with all applicable local laws regulating the practice of pharmacy, 
including all applicable local laws regulating the dispensing of 
prescription drugs; regularly engage in dispensing prescription drugs 
upon prescription of practitioners licensed by law to administer these 
drugs to patients under their professional care; and do not manufacture 
(as defined in proposed Sec.  207.1), repack, or relabel drugs for sale 
other than in the regular course of the practice of pharmacy, including 
dispensing and selling drugs at retail.
    Additional language has been added to proposed Sec.  
207.13(a)(1)(i) and (a)(1)(ii) to more closely track the language in 
section 510(g)(1) of the act. In addition, proposed Sec.  207.13(a) 
does not include language that is in current Sec.  207.10(a) that 
provides that the supplying of prescription drugs to a practitioner 
licensed to administer the drugs for use in the course of the 
practitioner's professional practice or to other pharmacies to meet 
temporary inventory shortages are not acts that require pharmacies to 
register. We are deleting this language because it is not necessary. 
Pharmacies that engage in such activities would be exempt from 
registration if they fulfill the following requirements: Operate in 
conformance with all applicable local laws regulating the practice of 
pharmacy, including all applicable local laws regulating dispensing of 
prescription drugs (proposed Sec.  207.13(a)(1)(i)); regularly engage 
in dispensing prescription drugs upon prescription of practitioners 
licensed by law to administer these drugs to patients under their 
professional care (proposed Sec.  207.13(a)(1)(ii)); and do not 
manufacture (as defined in Sec.  207.1), repack, or relabel drugs for 
sale other than in the regular course of the practice of pharmacy, 
including dispensing and selling drugs at retail (proposed Sec.  
207.13(a)(1)(iii)).
    Proposed Sec.  207.13(a)(2) clarifies that pharmacies may 
potentially qualify for the exemption in proposed Sec.  207.13(a) only 
if they are located in any State as defined in section 201(a)(l) of the 
act (21 U.S.C. 321) (that is, any State or Territory of the United 
States, the District of Columbia, and the Commonwealth of Puerto Rico). 
This proposed provision is currently located in the introductory 
paragraph in current Sec.  207.10. We believe it would be more clear to 
place this provision in proposed Sec.  207.13(a)(2). This aspect of the 
proposed provision is consistent with current Sec. Sec.  207.10 and 
207.40.
    b. Hospitals, clinics, other health care entities, and public 
health agencies--The current exemption for hospitals, clinics, and 
public health agencies is

[[Page 51283]]

codified at Sec.  207.10(b). The proposed exemption is generally 
consistent with current Sec.  207.10(b), except for the addition of 
``other health care entities'' and other mostly minor revisions and 
clarifications, as described below. The proposed exemption would move 
to Sec.  207.13(b).
    Hospitals, clinics, other health care entities, and public health 
agencies are exempt, under proposed Sec.  207.13(b), from the 
registration and listing requirements if they: Operate establishments 
in conformance with all applicable local laws regulating the practice 
of pharmacy and medicine, including all applicable local laws 
regulating the dispensing of prescription drugs; regularly engage in 
dispensing prescription drugs, other than human blood or blood 
products, upon prescription of practitioners licensed by law to 
administer these drugs to patients under their professional care; and 
do not manufacture (as defined in proposed Sec.  207.1), repack, or 
relabel drugs other than in the regular course of the practice of 
pharmacy, including dispensing.
    The exemption in proposed Sec.  207.13(b) would be limited to 
hospitals, clinics, other health care entities, and public health 
agencies located in any State as defined in section 201(a)(1) of the 
act. The proposed provision requiring that such facilities be located 
in any State is currently located in the introductory paragraph in 
current Sec.  207.10. We believe it would be more clear to place this 
provision in proposed Sec.  207.13(b)(2). This proposed provision 
(except with respect to BLA holders and the clarification with respect 
to positron emission tomography (PET) drugs) is generally consistent 
with current Sec. Sec.  207.10 and 207.40.
    We are proposing to add ``other health care entities'' to this 
exemption because we are aware that other health care entities besides 
hospitals, clinics, and public health agencies (such as skilled nursing 
facilities) lawfully provide medical care and dispense drugs and 
logically are similarly situated to hospitals, clinics, and public 
health agencies for purposes of exempting them from registration and 
listing, if they meet the statutory and regulatory requirements.
    We are also proposing to add language to proposed Sec.  207.13(b) 
to make the exemption more consistent with the pharmacy exemption in 
proposed Sec.  207.13(a). For example, we are proposing to add language 
to proposed Sec.  207.13(b)(1)(i) so that this exemption also 
specifically requires compliance with all applicable laws regulating 
dispensing of prescription drugs, as is required by proposed Sec.  
207.13(a)(1)(i). We are similarly proposing to add Sec.  
207.13(b)(1)(iii) to be consistent with proposed Sec.  
207.13(a)(1)(iii), although in proposed Sec.  207.13(b)(1)(iii) we have 
not included the terms ``for sale'' or ``selling drugs at retail'' 
since this language is appropriate for retail pharmacies relying on the 
exemption provided by proposed Sec.  207.13(a), but not for hospitals, 
clinics, other health care entities, and public health agencies relying 
on the exemption provided by proposed Sec.  207.13(b).
    We believe that the exemption for hospitals, clinics, other health 
care entities, and public health agencies provided in proposed Sec.  
207.13(b)(2) should be relied upon by pharmacies within these health 
care entities that dispense drugs to patients receiving care in the 
health care entities and that meet the requirements of the exemption, 
but should not be relied upon by retail pharmacies located within these 
health care entities. Retail pharmacies should rely upon the exemption 
in proposed Sec.  207.13(a) if they meet the requirements of that 
proposed provision.
    c. Persons who manufacture, repack, relabel, or salvage certain 
medicated feeds--Although we are proposing to reorganize and clarify 
the exemption for persons who manufacture, repack, relabel, or salvage 
certain medicated feeds, we are not proposing to change the substance 
of the exemption. Under proposed Sec.  207.13(f), persons who 
manufacture, repack, relabel, or salvage Type B or Type C medicated 
feeds, except for manufacturers, repackers, relabelers, or drug product 
salvagers of Type B or Type C medicated feeds made from Category II, 
Type A medicated articles, are exempt from registration. This exemption 
would not apply to persons who would otherwise be required to register 
(such as manufacturers, repackers, relabelers, or drug product 
salvagers of certain free-choice feeds, as defined in 21 CFR 510.455, 
or certain liquid feeds, as defined in 21 CFR 558.5, where the 
specifications and/or formulas are not published and a feed mill 
license is required). Proposed Sec.  207.13(f) also clarifies that all 
manufacturers, repackers, relabelers, or drug product salvagers of Type 
B or Type C medicated feeds would be exempt from listing.
    d. The current exemptions for foreign trade zones and drugs 
imported under section 801(d)(3) of the act would be revoked--In 2001, 
we issued a final rule on foreign establishment registration and 
listing (66 FR 59138, November 27, 2001). The regulation created two 
exemptions in Sec.  207.40:
     Under current Sec.  207.40(a), a foreign establishment is 
not required to comply with the registration and listing requirements 
if its drug enters a foreign trade zone and is re-exported from that 
foreign trade zone without having entered U.S. commerce. We created 
this exemption as part of the final rule on foreign establishment 
registration and listing because registering such foreign 
establishments or listing drugs that were confined to a foreign trade 
zone--and were therefore not introduced into domestic commerce--was not 
considered necessary for the protection of the public health (see 66 FR 
59138 at 59139 and 59140).
     Current Sec.  207.40(b), which states that no drug may be 
imported or offered for import into the United States unless the drug 
is listed and manufactured, prepared, propagated, compounded, or 
processed at a registered foreign establishment, also states that this 
prohibition does not apply to components of drugs imported under 
section 801(d)(3) of the act. Section 801(d)(3) of the act, as it 
existed before June 2002, allowed persons to import unapproved or 
otherwise noncompliant articles (such as drug components) provided that 
the imported articles were further processed or incorporated into 
products and exported or, if not used, the imported articles were 
destroyed or exported. The provision in Sec.  207.40(b) reflected the 
fact that, at the time, section 801(d)(3) of the act imposed very few 
restrictions on the admission of drug components that are imported into 
the United States for further processing or incorporation into a 
product that will be exported from the United States (66 FR 59138 at 
59148).
    Given the additional level of import restrictions imposed by the 
Bioterrorism Act, and the underlying security concerns that led to the 
Bioterrorism Act's adoption, we are proposing to eliminate these two 
exemptions in current Sec.  207.40(a) and (b) from the registration and 
listing requirements. In particular, sections 321 and 322 of the 
Bioterrorism Act, which affected foreign establishment registration by 
amending sections 510 and 801 (among other provisions) of the act, 
suggest that Congress intended the information requirements for foreign 
establishments and imported products to be comprehensive, and that 
Congress regarded the information it was requiring to be important to 
its goal in increasing the Nation's ability to prepare for and respond 
effectively to bioterrorism and other public health emergencies. This, 
in turn, suggests to

[[Page 51284]]

FDA that the exceptions from the registration and listing requirements 
are therefore no longer appropriate.
    The Bioterrorism Act affected foreign establishment registration, 
in relevant part, by amending sections 510(i) and 801 of the act:
     To require, as part of an establishment's registration, 
the name of each importer of the drug that is known to the 
establishment and the name of each person who imports or offers to 
import the drug into the United States; and
     To provide that we may refuse admission of a product and, 
if the product is refused admission, that the product shall be held at 
the port of entry until a statement regarding the foreign 
establishment's registration is submitted to us.
    The amendment to section 510(i) of the act reflects a determination 
on the part of Congress that a foreign establishment shipping drugs to 
the United States should provide additional information in its 
registration (that is, information about importers and persons who 
import or offer for import). FDA is concerned that if a foreign 
establishment is not subject to this establishment registration 
requirement--either by virtue of importing into a foreign trade zone or 
by importing components under section 801(d)(3) of the act--it would 
allow some importers and persons who import or offer for import to go 
undetected, thereby creating an unnecessary vulnerability in Congress' 
system of requiring this information.
    The amendment to section 801(o) of the act reflects a determination 
that establishment registration and drug listing information is 
important enough that, if it is lacking at the time the article is 
offered for import, the article may be refused admission (and, if 
refused, shall be held at the port of entry). FDA is concerned that if 
a foreign establishment is exempt from the registration and listing 
requirements--either by virtue of importing into a foreign trade zone 
or by importing components under section 801(d)(3) of the act--FDA 
would be unable to rely on amended sections 510(i) and 801 of the act 
to require that imported products be held at the port of entry to the 
United States or to prevent such product's delivery to the importer or 
consignee. This situation would stand in the way of implementing 
Congress' apparent intent that this information be a prerequisite for 
entry of the imported product into the United States.
    We believe that removing the exception to the registration and 
listing requirements for products entering foreign trade zones and for 
products imported under section 801(d)(3) of the act is consistent with 
Congress' desire to increase the Nation's ability to prepare for and 
respond effectively to bioterrorism and other public health emergencies 
by requiring foreign establishments to provide more, rather than less, 
information for imported products.
    The Bioterrorism Act also revised section 801(d)(3) of the act, in 
part, by:
     Requiring importers to identify the manufacturers of the 
imported drug component, and each processor, packer, distributor, or 
other entity that had possession of the article from the manufacturer 
to the importer;
     Requiring certificates of analysis to accompany most 
imported articles; and
     Giving us the ability to refuse admission to the United 
States if we determine there is credible evidence or information 
indicating that the article is not