[Federal Register Volume 64, Number 63 (Friday, April 2, 1999)]
[Proposed Rules]
[Pages 15944-15948]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-8159]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1
[Docket No. 98N-0583]
RIN 0910-AB16
Exports: Notification and Recordkeeping Requirements
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing new
regulations that would establish the notification and recordkeeping
requirements for persons exporting human drugs, biologics, devices,
animal drugs, food, and cosmetics that may not be marketed or sold in
the United States. These regulations would implement recent changes in
the statutory requirements applicable to certain exports, and would
also codify recordkeeping requirements for exports of products that
cannot be marketed or sold in the United States generally.
DATES: Submit written comments by June 16, 1999. Submit written
comments on the information collection requirements by May 3, 1999.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit written comments on the information
collection requirements to the Office of Information and Regulatory
Affairs, OMB, New Executive Office Bldg., 725 17th St. NW., rm. 10235,
Washington, DC 20502, Attn: Desk Officer for FDA.
FOR FURTHER INFORMATION CONTACT: Philip L. Chao, Office of Policy (HF-
23), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-827-3380.
SUPPLEMENTARY INFORMATION:
I. Introduction
Enacted and later amended in 1996, the FDA Export Reform and
Enhancement Act (Pub. L. 104-134, as amended by Pub. L. 104-180)
significantly changed the export requirements for unapproved human
drugs, biologics, devices, and animal drugs. For example, before the
law was enacted, most exports of unapproved new drug products could
only be made to the 21 countries then identified in section 802 of the
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 382), and
these exports were subject to numerous restrictions. The FDA Export
Reform and Enhancement Act amended section 802 of the act to allow,
among other things, the export of unapproved new human drugs to any
country in the world if the drug complies with the laws of the
importing country and has valid marketing authorization from any of the
following countries: Australia, Canada, Israel, Japan, New Zealand,
Switzerland, South Africa, and the countries in the European Union (EU)
and the European Economic Area (EEA) and certain other requirements are
met (see section 802(b)(1)(A) of the act). Currently, the EU countries
are Austria, Belgium, Denmark, Germany, Greece, Finland, France,
Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain, Sweden,
and the United Kingdom. The EEA countries are the EU countries,
Iceland, Liechtenstein, and Norway. The list of countries will expand
automatically if any country accedes to the EU or becomes a member of
the EEA. This provision of section 802 of the act also applies to the
export of certain devices that cannot be sold or marketed in the United
States.
The FDA Export Reform and Enhancement Act also modified the export
authority in section 801 of the act (21 U.S.C. 381). Before enactment
of the FDA Export Reform and Enhancement Act, section 801(e)(1) of the
act applied to the exportation of certain foods, drugs, devices, and
cosmetics. Products exported under section 801(e) of the act are not
considered adulterated or misbranded if the product intended for
export: (1) Meets the foreign purchaser's specifications, (2) is not in
conflict with the laws of the country to which it is being exported,
(3) is labeled on the outside of the shipping package that the product
is intended for export, and (4) is not sold or offered for sale in
domestic commerce (see section 801(e)(1) of the act). Additional
requirements apply to certain devices (see section 801(e)(2) of the
act). The FDA Export Reform and Enhancement Act extended these four
basic requirements to all exports under sections 801 and 802 of the
act, and to exports of partially processed biologics under section
351(h) of the Public Health Service Act (the PHS Act) (see section
801(e) and (f) of the act); section 802(f)(3) of the act; and section
351(h) of the PHS Act (42 U.S.C. 262(h))), and made section 801(e) of
the act the principal export authority for the exportation of
unapproved animal drugs other than animal drugs banned in the United
States. It also imposed additional labeling requirements on certain
exports of approved drugs (see section 801(f) of the act).
The FDA Export Reform and Enhancement Act also established
recordkeeping and notification requirements. Products exported under
section 802 of the act are subject to certain requirements under
section 802(f) and (g) of the act. Section 802(f) of the act prohibits
a drug or device from being exported under section 802 of the act if
it: (1) Does not conform with current good manufacturing practices, (2)
is adulterated under certain provisions in section 501 of the act (21
U.S.C. 351), (3) does not comply with section 801(e)(1) of the act, (4)
is the subject of a determination by FDA or the United States
Department of Agriculture (with respect to veterinary biologics) that
the probability of reimportation of the exported drug or device would
present an imminent hazard to the public health and safety of the
United States, (5) would present an imminent hazard to the public
health of the foreign country, (6) fails to comply with labeling
requirements in the country receiving the exported drug or device, or
(7) is not promoted in accordance with labeling requirements.
Section 802(g) of the act requires an exporter of a drug or device
under section 802(b)(1)(A) of the act to provide a ``simple
notification'' to the agency ``identifying the drug or device when the
exporter first begins to export such drug or device'' to any of the 25
countries identified in section 802(b)(1)(A) of the act. For exports to
other, nonlisted countries, section 802(g) of the act requires the
exporter to provide a simple notification ``identifying the drug or
device and the country to which such drug or device is being
exported.'' This section also requires persons export under any
provision of section 802 of the act to ``maintain records of all drugs
or devices exported and the countries to which they were exported.''
II. Description of the Proposed Rule
The proposed rule would amend 21 CFR part 1 to create a new
Sec. 1.101 entitled ``Notification and recordkeeping.''
Proposed Sec. 1.101(a) would describe the provision's scope as
covering notifications and records required for human drug, biologic,
device, animal drug, food, and cosmetic exports under
[[Page 15945]]
sections 801 or 802 of the act or section 351 of the PHS Act. In
general, the export provisions in sections 801 and 802 of the act and
section 351 of the PHS Act apply to persons exporting unapproved or
otherwise violative products, products approved in the United States
that will be used for unapproved uses in the foreign country, and
partially processed biologics. Products that meet all applicable
requirements of the act or the PHS Act for marketing and sale in the
United States and are exported for the same approved indications are
not subject to the export restrictions in sections 801 and 802 of the
act and section 351 of the PHS Act.
Proposed Sec. 1.101(b) would establish the recordkeeping
requirements for human drugs, biologics, devices, animal drugs, foods,
and cosmetics exported under or subject to section 801(e)(1) of the
act. These recordkeeping requirements are intended to facilitate an
evaluation of whether a person has complied with section 801(e)(1) of
the act, and would apply to all products exported under sections 801 or
802 of the act. For example, to demonstrate that the exported product
meets the foreign purchaser's specifications, proposed Sec. 1.101(b)(1)
would require records describing or listing the product specifications
requested by the foreign purchaser, including details about the product
(e.g., dosage strength, dosage form, purity, quality, operating
parameters, composition, etc.) and any manufacturing specifications
requested by the foreign purchaser (e.g., type of sterilization process
to be used, compliance with a particular manufacturing standard, etc.).
Proposed Sec. 1.101(b)(2) would require the exporter to maintain
documentation that demonstrates that the exported product does not
conflict with the importing country's laws, such as a letter from the
appropriate foreign government agency, department, or other authorized
body stating that the product has marketing approval from the foreign
government or does not conflict with that country's laws. The proposal
would not consider letters or other documents from nongovernmental
bodies or persons, such as company officials or attorneys in the
foreign country, to be satisfactory for this purpose. Proposed
Sec. 1.101(b)(3) would require the records to include copies of any
labels or labeling statements that are placed on the shipping packages
that show that the packages are intended for export. Statements such as
``For export only'' may be sufficient for this purpose. Proposed
Sec. 1.101(b)(4) would require records showing that the product is not
sold or offered for sale in the United States; these records could
pertain to the product, its labeling, and similar products sold in the
United States. Proposed Sec. 1.101(b) would require the records to be
maintained for at least 5 years from the date of exportation, and would
require that the records be made available to FDA, upon request, during
an inspection for review and copying.
Proposed Sec. 1.101(c) would establish recordkeeping requirements,
in addition to those required under proposed Sec. 1.101(b), for
partially processed biologics exported under section 351(h) of the PHS
Act. Proposed Sec. 1.101(c)(1) would require persons exporting a
partially processed biologic under section 351(h) of the PHS Act to
maintain records demonstrating that the product for export is a
partially processed biological product, that is, ``not in a form
applicable to the prevention, treatment, or cure of disease or injuries
of man.'' This may consist of evidence showing the product's need for
inactivation, fractionation, purification, or significant chemical
modification before it can be used in the formulation of a final
finished product for use outside the United States. Proposed
Sec. 1.101(c)(2) would require records to demonstrate that the product
was manufactured in conformity with applicable good manufacturing
practice requirements. Such records could include manufacturing records
that allow the partially processed biological product to be traced from
the assignment of a batch or lot numbering system at the U.S. firm,
temperature stability data for the product during conditions of
transit, and records of periodic checks of the capacity of shipping
containers. Proposed Sec. 1.101(c)(3) would require distribution
records of the exported partially processed biologics, while proposed
Sec. 1.101(c)(4) would require copies of all labeling that accompanies
the partially processed biological product for export, such as a
container label with the statement, ``Caution: For Further
Manufacturing Use Only,'' and any package insert. As in the case of
records under proposed Sec. 1.101(b), proposed Sec. 1.101(c) would
require these records to be maintained for at least 5 years from the
date of exportation and that the records be made available to FDA, upon
request, during an inspection for review and copying.
Proposed Sec. 1.101(d) would establish the notification
requirements for drugs, biologics, and devices exported under section
802 of the act. In brief, proposed Sec. 1.101(d)(1) would require
exporters to provide written notification to the agency that identifies
the article's name, identifies its generic name if the article is a
drug or the article's type if the product is a device, describes the
product's strength and dosage form (if the product is a drug or
biologic) or the product's model number (if the product is a device),
and identifies the country that is to receive the exported article.
Proposed Sec. 1.101(d)(2) would list the addresses to which the
notifications should be sent. However, these notification requirements
would not apply to investigational drugs or devices exported under
section 802(c) of the act. FDA published a final rule regarding
investigational device exports in the Federal Register of May 13, 1997
(62 FR 26228).
The proposed rule would require persons exporting a product in
anticipation of market authorization in a list country under section
802(d) of the act to comply with the notification requirements in
proposed Sec. 1.101(d)(1). This requirement would be consistent with an
interpretation of section 802(g) of the act that considers the nexus
between section 802(b)(1) and (d) of the act. Section 802(g) of the act
requires exporters of drugs, biologics, and devices to provide a simple
notification to the agency when they export a product to a listed
country or to an unlisted country under section 802(b)(1) of the act.
Section 802(b)(1) of the act permits exports when the drug, biologic,
or device has received market authorization in a listed country,
whereas section 802(d) of the act permits exports to a listed country
in anticipation of market authorization. A literal interpretation of
section 802(g) of the act would not require an exporter to notify FDA
when it shipped a product to a listed country in anticipation of market
authorization, but would instead require the exporter to notify FDA
when the exporter shipped the same product to the same country once it
receives market authorization. The agency has concluded that it would
be more simple and efficient, both for exporters and FDA, if exporters
notify FDA when they export a product in anticipation of market
authorization under section 802(d) of the act, rather than wait for
market authorization in the listed country and then notify FDA when the
product is exported under section 802(b)(1) of the act. This
interpretation is consistent with section 802 of the act as a whole, as
well as section 701(a) of the act (21 U.S.C. 371), which authorizes
regulations for the efficient enforcement of the act.
The agency acknowledges that, for exports to listed countries under
section 802(b)(1) of the act, section 802(g) of the
[[Page 15946]]
act requires the notification to identify only the drug, biologic, or
device being exported and does not expressly require the notification
to identify the country to which the drug, biologic, or device is being
exported. (In contrast, for drugs, biologics, or devices exported to
nonlisted countries under section 802 of the act, section 802(g) of the
act requires both identification of the exported product and the
country to which the product is being exported.) Nevertheless, FDA is
proposing to require that all export notifications under section 802(g)
of the act identify the product and the importing country. FDA is
taking this action because section 802(a)(2) of the act requires FDA to
notify the ``appropriate public health official'' in the foreign
country receiving an exported drug, biologic, or device if FDA
disapproves a marketing application for the drug, biologic, or device.
Additionally, section 802(f) of the act requires FDA to consult with
the ``appropriate public health official in the affected country'' in
the event that an exported drug, biologic, or device presents an
imminent hazard to the public health. Similar consultation obligations
exist if the product's labeling is not in accordance with the
requirements and conditions for use in the country in which the drug,
biologic, or device has valid marketing authorization and the country
to which the drug, biologic, or device is being exported or if the
drug, biologic, or device is not promoted in accordance with the
labeling requirements of section 802(f) of the act. Thus, to facilitate
these notifications and consultations with foreign officials
(particularly in the event that FDA disapproves a drug, biologic, or
device that has been exported, or the exported product presents an
imminent hazard to the public health of the receiving country), FDA
must know where the products have been exported. Consequently, proposed
Sec. 1.101(d)(1)(iv) would require all notifications to identify the
country or countries that are to receive the exported product.
FDA, however, invites comment on possible alternatives to this
notification requirement that would satisfy the consultation,
notification, and recordkeeping obligations and requirements in section
802 of the act. The agency is especially interested in alternatives
that would reduce the paperwork burden, such as electronic submissions
and recordkeeping or periodic notifications (e.g., monthly, quarterly,
etc.), and the details of such alternatives.
Proposed Sec. 1.101(e) would establish additional recordkeeping
requirements for exported drugs, biologics, and devices subject to
section 802(g) of the act. These records would include, but not be
limited to, records concerning the product's name; its generic name if
the product is a drug or a biologic or the type of device if the
product is a device; a description of its strength and dosage form and
the product's lot or control number (if the product is a drug or
biologic) or the product's model number (if the product is a device);
the consignee's name and address; and the date on which the product was
exported and the quantity of product exported. The proposal would
require these records to be kept at the site from which the products
were exported and be maintained for 5 years after the date of
exportation. The proposal would require that these records be made
readily available for review and copying by FDA during an inspection,
and these records would be in addition to those records required under
proposed Sec. 1.101(b).
III. 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.
IV. Paperwork Reduction Act of 1995
This proposed rule contains information collection requirements
which are subject to review by the Office of Management and Budget
(OMB) under the Paperwork Reduction Act of 1995 (the PRA). The title,
description, and respondent description of the information collection
requirements are shown as follows, with an estimate of the annual
reporting and recordkeeping burden. Included in the estimate is the
time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing
the collection of information.
Title: Exports: Notification and Recordkeeping Requirements.
Description: The proposed rule would establish the notification and
recordkeeping requirements for persons exporting a human drug,
biologic, device, animal drug, food, or cosmetic under section 801(e)
or 802 of the act or section 351(h) of the PHS Act.
Description of Respondents: Businesses.
Table 1.--Estimated Annual Reporting and Recordkeeping Burden1
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Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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1.101(b) 316 2.8 885 1 885
1.101(c) 8 2 16 2 32
1.101(d) 244 2.4 586 1 586
1.101(e) 175 3.3 578 2 1,156
Total 2,659
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The estimates are based on the number of notifications received by
the relevant FDA centers in 1996 or 1997 (depending on the last year
for which figures were available) as well as consultations with
industry sources.
As required by section 3507(d) of the PRA, FDA has submitted a copy
of this proposed rule to OMB for its review of these previously
approved information collection requirements. The agency solicits
comments on the information collection requirements in order to: (1)
Evaluate whether the proposed collection of information is necessary
for the proper performance of the functions of the agency, including
whether the information will have practical utility; (2) evaluate the
accuracy of the agency's estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used; (3) enhance the quality, utility, and clarity of
the information to be collected; and (4) minimize the burden of the
collection of information on those
[[Page 15947]]
who are to respond, including through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of reports.
V. Analysis of Impacts
FDA has examined the impacts of this proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354).
Executive Order 12866 directs agencies to assess all costs and benefits
of available regulatory alternatives and, when regulation is necessary,
to select regulatory approaches that maximize new benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes this
proposed rule is consistent with the regulatory philosophy and the
principles identified in the Executive Order. In addition, the proposed
rule is a significant regulatory action as defined in the Executive
Order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant economic impact
of a rule on small entities. The proposed rule will not have a
significant economic impact on a substantial number of small entities,
but FDA has conducted an initial regulatory flexibility analysis to
ensure that impacts on small entities were assessed and to alert any
potentially impacted small entities to the opportunity to submit
comments to FDA.
The proposed rule would implement the notification and
recordkeeping aspects of the FDA Export Reform and Enhancement Act. The
proposal requires firms that export unapproved new drugs, biologics,
and devices under section 802 to notify FDA. The notification would
identify the product being exported (name and description) and the
product's destination. The proposal would also require firms that
export human drugs, biologics, devices, animal drugs, foods, and
cosmetics to maintain records demonstrating their compliance with the
statutory requirements in sections 801(e) or 802 of the act or section
351(h) of the PHS Act (whichever is applicable).
FDA's initial determination that the rule will not have a
significant economic impact on a substantial number of small entities
is based on the estimated reporting and recordkeeping costs for the
rule. Industry sources suggest that an average notification under the
rule would require 1 hour to prepare and that the average wage is $30
per hour. Combining this information with information from FDA's export
records (which suggest approximately 2.4 exports per firm), an
exporting firm's notification cost would be $72 ($30 x 2.4).
FDA's export records also suggest that the average number of
records varies (depending on the product involved) from 2.8 to 5.1
records per firm. Industry sources project the average recordkeeping
cost to be $100 per record, so the recordkeeping cost per firm ranges
from $280 for firms exporting products that are subject only to section
801(e) of the act to $510 for firms exporting products under section
802 of the act and to $480 for firms exporting products under section
351(h) of the PHS Act.
Thus, because the estimated proposed notification and recordkeeping
costs are low, the proposed rule, if finalized, should not have a
significant economic impact on a substantial number of small entities.
FDA considered alternatives that would require less information to
be retained in the required records. For example, one alternative would
be to require the notification to provide only the product's name and
destination. However, because drug products may vary in dosage strength
and size and yet still share the same name, a notice that merely named
the product would not be sufficiently revealing to inform FDA about the
exported drug. Another alternative would be to shorten the
recordkeeping period, but because FDA's inspection resources have a
wide range of obligations, from factory inspections to examining
imports, a shorter time period would increase the likelihood of records
being lost or destroyed before FDA could inspect an exporting firm.
The Unfunded Mandates Reform Act (Pub. L. 104-114) requires that
agencies prepare an assessment of anticipated costs and benefits before
proposing any rule that may result in an expenditure in any 1 year by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100 million or more (adjusted annually for
inflation). FDA estimates that the total recordkeeping costs for
industry under the proposed rule would be $207,300. This estimate is
based on a projected 2,073 records per year, multiplied by an industry
cost of $100 per record. The total estimated reporting cost to industry
is $17,580. This estimate is derived from the estimated total burden
hours for reports (586) multiplied by a wage of $30 per hour per
report. Because these expenditures will not result in a 1-year
expenditure of $100 million or more, FDA is not required to perform a
cost-benefit analysis under the Unfunded Mandates Reform Act.
VI. Requests for Comments
Interested persons may, on or before June 16, 1999, submit to the
Dockets Management Branch (address above) written comments regarding
this proposal. Two copies of any comments are to be submitted, except
that individuals may submit one copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. Received comments may be seen in the office above between 9
a.m. and 4 p.m., Monday through Friday. Organizations and individuals
desiring to submit comments on the information collection requirements
should direct them to the Office of Information and Regulatory Affairs
(address above).
List of Subjects in 21 CFR Part 1
Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling,
Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 1 be amended as follows:
PART 1--GENERAL ENFORCEMENT REGULATIONS
1. The authority citation for 21 CFR part 1 is revised to read as
follows:
Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 343, 352,
355, 360b, 362, 371, 374, 381, 382, 393; 42 U.S.C. 216, 241, 243,
262, 264.
2. Section 1.101 is added to subpart E to read as follows:
Sec. 1.101 Notification and recordkeeping.
(a) Scope. This section pertains to notifications and records
required for human drug, biologic, device, animal drug, food, and
cosmetic exports under sections 801 or 802 of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C. 381 and 382) or section 351 of
the Public Health Service Act (42 U.S.C. 262) .
(b) Recordkeeping requirements for human drugs, biologics, devices,
animal drugs, foods, and cosmetics exported under or subject to section
801(e)(1) of the act. Persons exporting an article under section
801(e)(1) of the act or an article otherwise subject to section
801(e)(1) of the act shall maintain records as enumerated in paragraphs
(b)(1) through (b)(4) of this section demonstrating that the product
meets the requirements of section 801(e)(1) of the act. Such records
shall be
[[Page 15948]]
maintained for at least 5 years from the date of exportation. The
records shall be made available to the Food and Drug Administration
(FDA), upon request, during an inspection for review and copying by
FDA.
(1) Records demonstrating that the product meets the foreign
purchaser's specifications. Such records shall include descriptions or
lists of product specifications requested by the foreign purchaser,
such as product details (e.g., dosage strength, dosage form, purity,
quality, operating parameters, composition, etc.) and manufacturing
specifications requested by the foreign purchaser (e.g., type of
sterilization process to be used, compliance with a particular
manufacturing standard, etc.);
(2) Records demonstrating that the product does not conflict with
the laws of the importing country, such as a letter from an appropriate
foreign government agency, department, or other authorized body stating
that the product has marketing approval from the foreign government or
does not conflict with that country's laws. Letters or other documents
from nongovernmental bodies or persons, such as company officials or
attorneys in the foreign country, are not acceptable. If the letter or
other document from the foreign government is not in English, the
person exporting the article must have an English-language translation
of that document or be prepared to translate the document into English
at the time of any FDA inspection;
(3) Records demonstrating that the product is labeled on the
outside of the shipping package that it is intended for export,
including copies of any labels or labeling statements, such as ``For
export only,'' that are placed on the shipping packages; and
(4) Records demonstrating that the product is not sold or offered
for sale in the United States, such as documentation concerning the
product, its labeling, and similar products sold in the United States.
(c) Additional recordkeeping requirements for partially processed
biologics exported under section 351(h) of the Public Health Service
Act. In addition to the requirements in paragraph (b) of this section,
persons exporting a partially processed biologic under section 351(h)
of the Public Health Service Act shall maintain, for at least 5 years
from the date of exportation and make available to FDA, upon request,
during an inspection for review and copying by FDA, the following
records:
(1) Records demonstrating that the product for export is a
partially processed biological product and not in a form applicable to
the prevention, treatment, or cure of diseases or injuries of man;
(2) Records that demonstrate that the partially processed
biological product was manufactured in conformity with current good
manufacturing practice requirements;
(3) Distribution records of the exported partially processed
biological products; and
(4) Copies of all labeling that accompanies the exported partially
processed biological product, such as a container label with the
statement, ``Caution: For Further Manufacturing Use Only'' and any
package insert.
(d) Notification requirements for drugs, biologics, and devices
exported under section 802 of the Federal Food, Drug, and Cosmetic Act.
(1) Persons exporting a human drug, biologic, or device under section
802 of the Federal Food, Drug, and Cosmetic Act, other than a drug or a
device for investigational use exported under section 802(c) of the
Federal Food, Drug, and Cosmetic Act, shall provide written
notification to the Food and Drug Administration. The notification
shall identify:
(i) The product's name;
(ii) If the product is a drug or biologic, the product's generic
name or, if the product is a device, the type of device;
(iii) If the product is a drug or biologic, a description of the
product's strength and dosage form or, if the product is a device, the
product's model number; and
(iv) The country that is to receive the exported article.
(2) The notification shall be sent to the following addresses:
(i) For biological drug products and devices regulated by the
Center for Biologics Evaluation and Research--Division of Case
Management (HFM-610), Office of Compliance, Center for Biologics
Evaluation and Research, Food and Drug Administration, 1401 Rockville
Pike, rm. 200N, Rockville, MD 20852-1448;
(ii) For human drug products--Division of Labeling and
Nonprescription Drug Compliance (HFD-310), Center for Drug Evaluation
and Research, Food and Drug Administration, 7520 Standish Pl.,
Rockville, MD 20855-2737;
(iii) For devices--Division of Program Operations (HFZ-305), Center
for Devices and Radiological Health, Food and Drug Administration, 2094
Gaither Rd., Rockville, MD 20850.
(e) Recordkeeping requirements for products subject to section
802(g) of the act. (1) Any person exporting a product under any
provision of section 802 of the act shall maintain records of all
drugs, biologics, and devices exported and the countries to which the
products were exported. In addition to the requirements in paragraph
(b) of this section, such records include, but are not limited to, the
following:
(i) The product's name;
(ii) If the product is a drug or biologic, the product's generic
name or, if the product is a device, the type of device;
(iii) If the product is a drug or biologic, a description of its
strength and dosage form and the product's lot or control number or, if
the product is a device, the product's model number;
(iv) The consignee's name and address; and
(v) The date on which the product was exported and the quantity of
product exported.
(2) These records shall be kept at the site from which the products
were exported and be maintained at least 5 years after the date of
exportation. The records shall be made available to FDA, upon request,
during an inspection for review and copying by FDA.
Dated: December 23, 1998.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 99-8159 Filed 4-1-99; 8:45 am]
BILLING CODE 4160-01-F
