I
104TH CONGRESS
2D SESSION
H. R. 3199
To amend the Federal Food, Drug, and Cosmetic Act and the Public Health
Service Act to facilitate the development and approval of new drugs
and biological products, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
MARCH 29, 1996
Mr. BURR (for himself, Mr. GREENWOOD, Mr. RICHARDSON, Mr. BILIRAKIS,
Mr. TOWNS, Mr. BARTON of Texas, Mr. HALL of Texas, Mr. KLUG, Ms.
ESHOO, Mr. UPTON, Mr. GORDON, Mr. BILBRAY, Mr. BREWSTER, Mr.
COBURN, Mr. DOOLEY of California, Mr. GANSKE, Mr. MCHALE, Mr.
OXLEY, Mr. PAYNE of Virginia, Mr. FIELDS of Texas, Mr. ROSE, Mr.
PAXON, Mr. HOLDEN, Mr. TAUZIN, Mr. SCHAEFER, Mr. FOX of Penn-
sylvania, Mr. FUNDERBURK, Mr. CAMPBELL, Mr. MCINTOSH, Mr. COX
of California, Mr. DREIER, Mr. HEINEMAN, Mr. WELDON of Florida, Mr.
SHAYS, Mr. HASTERT, Mr. NORWOOD, Mr. BURTON of Indiana, Mr.
FRAZER, Mr. STEARNS, Mr. FRISA, Mr. RAMSTAD, Mr. MARTINI, and
Ms. DUNN of Washington) introduced the following bill; which was re-
ferred to the Committee on Commerce
A BILL
To amend the Federal Food, Drug, and Cosmetic Act and
the Public Health Service Act to facilitate the develop-
ment and approval of new drugs and biological products,
and for other purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE, REFERENCE, AND TABLE OF
CONTENTS.
(a) SHORT TITLE.—This Act may be cited as the
‘‘Drug and Biological Products Reform Act of 1996’’.
(b) REFERENCE.—Whenever in this Act (other than
in sections 13 and 24) an amendment is expressed in
terms of an amendment to a section or other provision,
the reference shall be considered to be made to a section
or other provision of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 321) et seq.) except as otherwise
specified.
(c) TABLE OF CONTENTS.—The table of contents is
as follows:
Sec. 1. Short title, reference, and table of contents.
Sec. 2. FDA mission and annual report.
Sec. 3. Streamlining clinical research on drugs and biological products.
Sec. 4. The content and review of a new drug application.
Sec. 5. Effectiveness determination.
Sec. 6. Scientific review groups.
Sec. 7. Marketing approval.
Sec. 8. Accreditation of third parties.
Sec. 9. Dispute resolution.
Sec. 10. Good manufacturing practice inspections.
Sec. 11. Good manufacturing practices.
Sec. 12. Pilot and small scale manufacture.
Sec. 13. Manufacturing changes.
Sec. 14. Insulin and antibiotics.
Sec. 15. Nonprescription drugs.
Sec. 16. Information system.
Sec. 17. Environmental impact review.
Sec. 18. Application of State and Federal law to the practice of pharmacy
compounding.
Sec. 19. Harmonization.
Sec. 20. Use of scientific and medical information.
Sec. 21. Informal agency statements.
Sec. 22. Research and education; practice of medicine.
Sec. 23. Delegation of authority.
Sec. 24. Judicial review.
Sec. 25. Publication of notice of deviation.
Sec. 26. Biological products.
SEC. 2. FDA MISSION AND ANNUAL REPORT.
(a) MISSION.—Section 903 (21 U.S.C. 393) is
amended by redesignating subsections (b) and (c) as sub-
sections (c) and (d), respectively, and by adding after sub-
section (a) the following:
‘‘(b) MISSION.—The Food and Drug Administration
shall protect the public health and safety and promptly
and efficiently review and approve clinical research and
marketing of products in a manner that does not unduly
impede innovation or product availability. The Food and
Drug Administration shall participate with other countries
to reduce the burden of regulation, harmonize regulatory
requirements, and achieve appropriate reciprocal arrange-
ments.’’.
(b) ANNUAL REPORT.—Section 903 (21 U.S.C. 393),
as amended by subsection (a), is amended by adding at
the end the following:
‘‘(e) ANNUAL REPORT.—The Secretary shall, simul-
taneously with the submission each year of the budget for
the Food and Drug Administration, submit to the Com-
mittee on Commerce of the House of Representatives and
the Committee on Labor and Human Resources of the
Senate an annual report which shall—
‘‘(1) review the performance of the Food and
Drug Administration in meeting its mission and the
ucts with that of the most successful agencies per-
forming similar functions in other countries and
compare the resources used by such agencies.’’.
SEC. 3. STREAMLINING CLINICAL RESEARCH ON DRUGS
AND BIOLOGICAL PRODUCTS.
Section 505(i) (21 U.S.C. 355(i)) is amended by add-
ing ‘‘(1)’’ prior to the first sentence, by redesignating
paragraphs (1), (2), and (3) as subparagraphs (A), (B),
and (C), respectively, and by adding the following new
paragraphs at the end thereof:
‘‘(2) A clinical investigation of a new drug may begin
21 days after the Secretary has received from the sponsor
of the investigation a submission containing information
about the drug and the clinical investigation as follows:
The submission shall contain—
‘‘(A) adequate reports of basic information, cer-
tified by the applicant to be accurate reports, nec-
essary to assess the safety of the drug for use in
clinical investigation; and
‘‘(B) adequate information on the chemistry of
the drug, manufacturing of the drug, controls avail-
able for the drug, and primary data tabulations for
the drug from animal or human studies, except that
for phase I or phase II clinical investigations de-
tailed information shall not be required unless the
director of the office responsible for the review of
the drug makes a request within 21 days after the
submission regarding such detailed information in
writing and specifies the reasons for the request.
‘‘(3)(A) At any time, the Secretary may issue to the
sponsor of an investigation a clinical hold in writing pro-
hibiting the sponsor from conducting the investigation and
specifying the basis for the clinical hold. The Secretary
may issue a clinical hold upon a demonstration, based on
specific information available to the Secretary, that the
drug to be investigated represents an unreasonable risk
to the safety of the persons who are the subject of the
clinical investigation, taking into account the design of the
clinical investigation, the condition for which the drug is
to be investigated, and the health status of the subjects
involved.
‘‘(B) Any response from the sponsor of an investiga-
tion to the Secretary requesting that a clinical hold be re-
moved shall receive a decision, in writing and specifying
the reasons therefor, within 15 days after receipt of such
response or the clinical hold shall be deemed to be with-
drawn.
‘‘(4) As an alternative to the procedure established
in paragraph (2), a Phase I or Phase II clinical investiga-
tion may begin after an accredited institution has ap-
proved the investigation and the sponsor of the investiga-
tion has submitted to the Secretary a notification setting
forth the name and address of the sponsor, the identity
of the drug, and the uses of the drug that the sponsor
intends to investigate. Data and information developed
through such an investigation may be submitted in sup-
port of an application for approval of a new drug and shall
be considered by the Secretary to the same extent as data
and information developed through an investigation under
paragraph (2). Paragraph (3) shall apply to such an inves-
tigation. The Secretary shall establish by regulation the
requirements and qualifications that an accredited institu-
tion shall meet to be eligible to approve an investigation
for purposes of this paragraph.
‘‘(5) The Food and Drug Administration shall have
exclusive regulatory jurisdiction in the Department of
Health and Human Services over the use of a new drug
in any clinical investigation.’’.
SEC. 4. THE CONTENT AND REVIEW OF A NEW DRUG APPLI-
CATION.
(a) SECTION 505(b).—Section 505(b) (21 U.S.C.
355(b)) is amended by adding at the end the following:
‘‘(4)(A) An application submitted under paragraph
(1) shall include adequate reports of clinical and pre-
clinical investigations on safety and effectiveness certified
by the applicant to be accurate and supported by tables
of the relevant data, and forms and tabulations related
to deaths and dropouts due to adverse reactions. The di-
rector of the office responsible for review of the drug may
request, in writing and specifying the reasons for the re-
quest for a particular application, the submission of spe-
cific primary data tabulations or case report forms or tab-
ulations for a specific investigation.
‘‘(B) The Secretary shall establish standards for the
review of applications submitted under paragraph (1) re-
lating to promptness, technical excellence, lack of bias and
conflict of interest, and a knowledge of regulatory and sci-
entific standards which shall apply equally to outside re-
viewers and to employees of the Secretary who review such
applications.
‘‘(C) Food and Drug Administration employees shall
meet with a sponsor of an investigation or an applicant
under an application submitted under paragraph (1) with-
in 30 days of any reasonable request for a meeting by the
sponsor or applicant for the purpose of reaching agree-
ment on the design and size of clinical trials. Minutes of
any such meeting shall be exchanged. Advice provided to
a sponsor or applicant at its request by a Food and Drug
Administration employee, which is reduced to writing and
made part of the administrative record by the sponsor or
applicant or by the Food and Drug Administration, re-
garding appropriate testing of a new drug shall not be
changed after such testing begins, except with the written
agreement of the sponsor or applicant or by a decision
in writing, after an informal hearing, by the director of
the office in which the drug is reviewed where such change
is needed because there is a demonstrated need to protect
the public health.
‘‘(D) The written decisions of the office responsible
for the review of a drug on all aspects of scientific and
medical matters relating to a new drug shall be binding
upon, and may not directly or indirectly be changed by,
the field personnel or the offices of compliance of the office
responsible for the review.
‘‘(E) No action by the office responsible for the re-
view of a drug on any matter relating to a new drug for
which an application has been submitted under paragraph
(1) may at any time, or under any circumstance other
than a demonstrable extraordinary circumstance, be de-
layed because of the unavailability of information from or
action by field personnel.’’.
(b) SECTION 735(7).—Section 735(7) is amended—
(1) by striking ‘‘applications for’’ and inserting
‘‘applications’’ and by inserting ‘‘for’’ after ‘‘(A)’’,
‘‘(B)’’, and ‘‘(C)’’;
(2) by striking ‘‘and’’ at the end of subpara-
graph (C),
(3) by striking the period at the end of sub-
paragraph (D) and inserting ‘‘, and’’, and
(4) by inserting the following after subpara-
graph (D):
‘‘(E) by outside organizations and individ-
uals.’’.
SEC. 5. EFFECTIVENESS DETERMINATION.
Section 505(d) (21 U.S.C. 355(d)) is amended—
(1) in the last sentence, by adding ‘‘one or
more’’ before ‘‘clinical investigations’’;
(2) by adding at the end the following: ‘‘For
purposes of the preceding sentence, a well-controlled
investigation shall only include methods of control
that are appropriate to the disease or condition for
which a drug is intended as prescribed, rec-
ommended, or suggested in its labeling. The Sec-
retary may waive the requirement to conduct any
well-controlled investigation, as defined in the pre-
ceding sentence.’’; and
(3) by inserting ‘‘(1)’’ after ‘‘(d)’’, by redesig-
nating clauses (1) through (6) as clauses (A)
through (F), by striking ‘‘(1) through (6)’’ and in-
serting ‘‘(A) through (F)’’, and by adding at the end
the following:
‘‘(2) For purposes of clause (E) of paragraph (1)—
‘‘(A) an application for a new drug for a serious
or life-threatening condition shall be considered to
have substantial evidence if it could be fairly and re-
sponsibly concluded by the experts referred to in
paragraph (1) that there is a reasonable likelihood
that the drug will be effective in a significant num-
ber of patients and that the risk from the drug is
no greater than the risk from the condition; and
‘‘(B) if an application has been submitted for a
new use of a previously approved new drug, such
drug shall be considered to have substantial evidence
by a demonstration that the new use is common
among clinicians experienced in the field and rep-
resents reasonable clinical practice based upon reli-
able clinical experience and confirmatory informa-
tion.
‘‘(3) For purposes of paragraph (1), the determina-
tion of effectiveness shall not include—
‘‘(A) relative effectiveness, unless the effective-
ness of the drug is explicitly compared in the label-
ing to the effectiveness of another drug;
‘‘(B) any potential use not explicitly included in
the labeling; and
‘‘(C) the cost-effectiveness of the drug as com-
pared to the cost-effectiveness of another drug un-
less the labeling explicitly includes a representation
about cost-effectiveness.’’.
SEC. 6. SCIENTIFIC ADVISORY PANELS.
Section 505 (21 U.S.C. 355) is amended by adding
at the end the following:
‘‘(n)(1) For the purpose of providing expert scientific
advice and recommendations to the Secretary regarding
a clinical investigation of a drug or biological product or
the approval for marketing of a drug or biological product
under section 505 or 506, the Secretary shall establish
panels of experts or use panels of experts established be-
fore the date of the enactment of this subsection, or both.
Scientific advisory panels shall consider scientific issues
and shall not include considerations of cost, economic as-
pects, comparative effectiveness, or legal matters.
‘‘(2) The Secretary may delegate the appointment
and oversight authority granted under section 904 to a
director of a center or successor entity within the Food
and Drug Administration.
‘‘(3) The Secretary shall appoint to each panel estab-
lished under paragraph (1) persons who are qualified by
training and experience to evaluate the safety and effec-
tiveness of the drugs and biological products to be referred
to the panel and who, to the extent feasible, possess skill
in the use of, or experience in, the development, manufac-
ture, or utilization of, such drugs or biological products.
The Secretary shall make appointments to each panel so
that each panel shall consist of members with adequately
diversified expertise in such fields as clinical and adminis-
trative medicine, engineering, biological and physical
sciences, and other related professions. In addition, each
panel shall include as nonvoting members a representative
of consumer interests and a representative of interests of
the drug and biological product manufacturing industry.
Scientific, trade, and consumer organizations shall be af-
forded an opportunity to nominate individuals for appoint-
ment to the panels. No individual who is in the regular
full-time employ of the United States and engaged in the
administration of this Act may be a member of any panel.
The Secretary shall designate one of the members of each
panel to serve as chairman thereof.
‘‘(4) Each member of a panel shall publically disclose
all conflicts of interest that member may have with the
work to be undertaken by the panel. No member of a panel
may vote on any matter where the member could gain fi-
nancially from the advice given to the Secretary. The Sec-
retary may grant a waiver of any conflict of interest upon
public disclosure of such conflict of interest if such waiver
contributes to the ability of a panel to contribute to the
public health, except that the Secretary may not grant a
waiver for a member of a panel when the member’s own
scientific work is involved.
‘‘(5) The Secretary shall provide education and train-
ing to each new panel member before such member partici-
pates in a panel’s activities. Such education and training
shall include a familiarization with certain requirements
under this Act and any related regulation of the Secretary
and the administrative process and procedures related to
panel meetings.
‘‘(6) Panel members (other than officers or employees
of the United States), while attending meetings or con-
ferences of a panel or otherwise engaged in its business,
shall be entitled to receive compensation at rates to be
fixed by the Secretary, but not at rates exceeding the daily
equivalent of the rate in effect for grade GS–18 of the
General Schedule, for each day so engaged, including trav-
eltime. While so serving away from their homes or regular
places of business, each member may be allowed travel ex-
penses (including per diem in lieu of subsistence) as au-
thorized by section 5703 of title 5, United States Code,
for persons in the Government service employed intermit-
tently.
‘‘(7) The Secretary shall take whatever action is nec-
essary to ensure that regular meetings are held by sci-
entific advisory panels, at appropriate intervals and for a
sufficient length of time, so that any matter to be reviewed
by any such panel shall be presented to the panel not more
than 60 days after the matter is ready for review by the
panel. The meetings shall occur not less than 6 times each
year unless there are compelling reasons for fewer meet-
ings. Such meetings shall be held with the physical pres-
ence of panel members at least 3 times each calendar year.
Other meetings of the panel may be held using electronic
communication to convene the meeting.
‘‘(8)(A) All persons, including employees of the Sec-
retary, shall have the same rights and responsibilities re-
garding—
‘‘(i) the submission of data and information to,
and contact and discussion with, a scientific advisory
panel;
‘‘(ii) the participation of the persons at meet-
ings of the panel; and
‘‘(iii) access to data and information submitted
to a scientific advisory panel (except for data and in-
formation that are not available for public disclosure
under section 552 of title 5, United States Code).
‘‘(B) In a case in which a scientific advisory panel
reviews an application submitted under section 505 or 506
(including a petition, notification, or other similar re-
quest), all related data and information that are not avail-
able for public disclosure under section 552 of title 5,
United States Code, shall be exchanged between the appli-
cant and the Food and Drug Administration at the time
the data and information are submitted to such panel but
shall not otherwise be publicly disclosed.
‘‘(C) Any meetings of a scientific advisory panel shall
provide adequate time for initial presentations and for re-
sponse to any differing views and shall encourage free and
open participation by all interested persons.
‘‘(9) Within 30 days after the date a scientific advi-
sory panel makes its conclusions and recommendations on
any matter under review by the panel, the Food and Drug
Administration official responsible for the matter shall re-
view the conclusions and recommendations of the panel,
shall make a final decision on the matter, and shall notify
the affected persons of the decision in writing and, if the
decision differs from the conclusions and recommendations
of the panel, shall include the reasons for the difference.
‘‘(10) A scientific advisory panel under this sub-
section shall not be subject to the annual chartering and
annual report requirements of the Federal Advisory Com-
mittee Act. Such a panel shall make an annual report of
its activities to the Secretary.’’.
SEC. 7. MARKETING APPROVAL.
Section 505(b) (21 U.S.C. 355(b)), as amended by
section 4(a), is amended—
(1) in the first sentence of paragraph (1), by
inserting immediately after ‘‘the Secretary’’ the fol-
lowing: ‘‘or may file such application with a person
authorized to review applications for marketing ap-
proval under section 712’’; and
(2) by adding after paragraph (4) the following:
‘‘(5)(A) The scope of review responsibilities of accred-
ited persons authorized to conduct reviews of marketing
approval applications under section 712 shall include the
review of applications to determine whether there is a rea-
sonable assurance that a drug is safe and effective under
the conditions prescribed, recommended, or suggested in
the proposed labeling. The review shall be conducted under
the standards and requirements of this Act applicable to
reviews by the Secretary. Prior to 60 days before the end
of the period prescribed by subsection (c), the accredited
person shall submit a report of its review to the Secretary
and its recommendations. Recommendations to the Sec-
retary shall specify whether an application should be ap-
proved or denied and shall state the basis for the rec-
ommendation.
‘‘(B) The recommendation of the accredited person
shall be deemed to be approved by the Secretary unless
the Secretary finds that there is a reasonable probability
that the drug is not safe or effective. Upon receipt of the
recommendation from an accredited person to approve or
deny an application, the Secretary shall evaluate the rec-
ommendation within 60 days of such receipt. In the event
that the Secretary makes such a finding, the Secretary
shall provide a detailed explanation of the basis of the dif-
ference.’’.
SEC. 8. ACCREDITATION OF THIRD PARTIES.
(a) AMENDMENT.—Subchapter A of chapter VII is
amended by adding at the end the following:
‘‘SEC. 712. ACCREDITED PERSONS.
‘‘(a) IN GENERAL.—The Secretary shall, within 180
days of the date of the enactment of this section, by regu-
lation establish procedures for the accreditation of persons
for the purposes of—
‘‘(1) 
reviewing 
applications 
under 
section
505(b) or 506, providing written reviews to the Sec-
retary for the Secretary’s consideration, and making
recommendations on whether or not such applica-
tions should be approved; and
‘‘(2) conducting good manufacturing practice
inspections to determine the conformance of a facil-
ity with regulations promulgated under sections
501(a)(2), 505(d)(3), and 520(f).
‘‘(b) ACCREDITATION.—
‘‘(1) PROGRAMS.—The Secretary shall provide
for such accreditation through programs adminis-
tered by government agencies or by other qualified
organizations.
‘‘(2) IMPLEMENTATION.—The Secretary may
designate one or more qualified non-government or-
ganizations to implement such programs. Such orga-
nizations shall implement such programs from fees
charged to applicants for accreditation.
‘‘(3) QUALIFICATIONS.—An accredited person
shall meet the following requirements:
‘‘(A) Such person shall be an independent
organization which is not owned or controlled
by manufacturer, supplier or vendor of drugs
and which has no organizational, material, or
financial affiliation with such a manufacturer,
supplier, or vendor.
‘‘(B) Such person shall be a legally con-
stituted entity permitted to conduct the activi-
ties for which it seeks accreditation.
‘‘(C) Such person shall not engage in the
development, manufacture, promotion, or sale
of drugs.
‘‘(D) Such person shall be operated in ac-
cordance with generally accepted professional
and ethical business practices and shall agree in
writing that as a minimum it will—
‘‘(i) certify that reported information
accurately reflects data reviewed;
‘‘(ii) limit work to that for which com-
petence and capacity are available;
‘‘(iii) 
treat 
information 
received,
records, reports, and recommendations as
proprietary information; and
‘‘(iv) promptly respond and attempt to
resolve complaints regarding its activities
for which it is accredited.’’.
(b) CONFORMING AMENDMENT.—Section 301 (21
U.S.C. 321) is amended by redesignating the second para-
graph (u) as paragraph (v) and by adding after that para-
graph the following:
‘‘(w) in the case of a drug, device, or food—
‘‘(A) the submission of a report or rec-
ommendation by a person accredited under section
712 that is false or misleading in any material re-
spect;
‘‘(B) the disclosure by a person accredited
under section 712 of confidential commerical infor-
mation or any trade secret without the express writ-
ten consent of the person who submitted such infor-
mation or secret to such person; or
‘‘(C) the receipt by a person accredited under
section 712 of a bribe in any form or the doing of
any corrupt act by such person associated with a re-
sponsibility delegated to such person under this
Act.’’.
SEC. 9. DISPUTE RESOLUTION.
Chapter V, as amended by section 14(b)(1), is
amended by adding after section 506 the following:
‘‘DISPUTE RESOLUTION
‘‘SEC. 507. (a) At any time before the issuance of
the notice under section 505(c)(1)(B) or an exemption for
investigational use under section 505(i) for a drug subject
to section 505 or 506, the applicant may, in writing, notify
the Secretary that an impasse exists in the review of the
application for a drug under section 505(b) or the submis-
sion for such an exemption with respect to a specifically
identified issue.
‘‘(b) On receipt of the notification from the applicant,
the Secretary shall refer the disputed issue—
‘‘(1) to an existing (as of the date of the notifi-
cation) scientific advisory panel having expertise re-
lated to the issue;
‘‘(2) to a special Government employee, as de-
fined in section 202(a) of title 18, United States
Code, or to a non-governmental person qualified to
mediate or arbitrate the substance of such impasse
who is acceptable to the Secretary and the applicant.
‘‘(c) The applicant and representatives of the Sec-
retary may consult with the panel, special Government em-
ployee, or non-governmental person on the matter re-
ferred. The panel, special Governmental employee, or non-
governmental person shall submit to the Secretary and the
applicant a report containing recommendations (including
a statement of reasons for the recommendations) regard-
ing the matter not later than 60 days after the date of
the referral, or not later than 90 days after the date of
the referral if the panel, special Governmental employee,
or non-governmental person considers the additional 30
days to be necessary. Not later than 30 days after the
date of receiving the report, the Secretary shall, in writing,
confirm or modify the recommendations received, provid-
ing reasons and reference to data before the panel, special
Governmental employee, or non-governmental person for
any modification. If the Secretary fails to act on such a
recommendation within 30 days of its receipt, the rec-
ommendation of the panel, special Government employee,
or non-governmental person shall be deemed to be the rec-
ommendation of the Secretary.
‘‘(d) The Federal Advisory Committee Act shall not
apply to any scientific advisory panel acting under this
section.’’.
SEC. 10. GOOD MANUFACTURING PRACTICE INSPECTIONS.
(a) Section 704 (21 U.S.C. 374) is amended—
(1) in subsection (a)(1), by inserting ‘‘, or an
accredited person to conduct good manufacturing
practice inspections under section 712’’ after ‘‘Sec-
retary’’;
(2) in subsection (a)(3), by inserting ‘‘, or an
accredited organization or individual under section
712,’’ after ‘‘employee’’;
(3) in subsection (b), by inserting ‘‘, or an ac-
credited person under section 712,’’ after ‘‘em-
ployee’’;
(4) in subsection (b), by inserting ‘‘(1)’’ after
‘‘(b)’’, by redesignating clauses (1) and (2) as
clauses (A) and (B), respectively, and by adding at
the end the following:
‘‘(2) The Secretary shall provide, at least 10 days
from the date of presentation of the report of conditions
or practices identified in paragraph (1), for the person re-
ceiving such report to respond. The Secretary shall take
no regulatory action against a person or article identified
in such a report until completing a review of such response
which is timely submitted to the Secretary, except the Sec-
retary may take immediate action when the Secretary
finds that there is a reasonable probability that a drug
intended for human use would cause serious, adverse
health consequences or death or that any regulated article
could present an unreasonable and substantial risk of in-
jury or illness to the public health. The Secretary shall
provide to the regulated person, within 30 days of receiv-
ing a response to the report identified in paragraph (1),
a written detailed assessment of the response.
‘‘(3) At the time an accredited person completes an
inspection under the authority of this section and section
712, such person shall identify in writing to the person
subject to the inspection each condition or practice ob-
served during such inspection which suggests a deviation
from requirements of this Act. However, such accredited
person shall immediately submit to the Secretary the find-
ings of the inspection when the drug to which such find-
ings relate is intended for human use and presents a rea-
sonable probability that such drug would cause serious,
adverse health consequences or death or that such drug
could present an unreasonable and substantial risk of in-
jury or illness to the public unless the person subject to
the inspection—
‘‘(A) immediately ceases distribution of the
drug;
‘‘(B) immediately notifies health professionals
and drug user facilities to instruct such professionals
and facilities to cease use of the drug; and
‘‘(C) immediately undertakes all corrections
identified by the accredited person.
When such compliance is complete, the accredited person
shall provide the inspected person a certification of compli-
ance which includes the dates of inspections, a statement
that the inspected facility is in compliance with the re-
quirements of section 520(f), the date the compliance was
achieved at the facility, and the signature of the accredited
person attesting to the finding that the inspected facility
is in good manufacturing practices compliance as defined
by such section. When an accredited person has certified
compliance with good manufacturing practices require-
ments and provided the Secretary with a copy of the cer-
tification within 10 days of its being made, the Secretary
may not perform a good manufacturing practices inspec-
tion of the person subject to an inspection for a period
of 2 years after the date of the certification unless justified
by good cause.’’; and
(5) in subsection (c), by striking ‘‘or employee’’
and inserting ‘‘, employee, or accredited person’’;
(6) in subsection (e), by striking ‘‘or employee’’
each place it occurs and inserting ‘‘, employee, or ac-
credited person’’; and
(7) by adding at the end the following:
‘‘(f) Persons duly designated by the Secretary to con-
duct inspections under this section shall not request any
information not permitted under subsections (a) and (e)
unless such person states with specificity and in writing
the identification of the information subject to the request,
the reason for the request, and that the written request
seeks to obtain information not required to be produced
under this section. Such request shall not include informa-
tion related to sales (other than distribution), personnel,
or pricing data.’’.
SEC. 11. GOOD MANUFACTURING PRACTICES.
(a) AMENDMENT.—Section 501(a) (21 U.S.C.
351(a)) is amended—
(1) 
by 
striking 
‘‘(a)(1)’’ 
and 
inserting
‘‘(a)(1)(A)’’;
(2) by redesignating subclauses (A) and (B) in
clauses (2) and (4) as subclauses (i) and (ii), respec-
tively; and
(3) by redesignating clauses (2) through (6) as
clauses (B) through (F), respectively;
(4) by adding at the end the following:
‘‘(2) All chemistry, manufacturing, and controls
which comply with an approved new drug application
under section 505 or an approved drug application under
section 506 or with the opinion of an appropriate official
in the component of the Food and Drug Administration
responsible for the review of such chemistry, manufactur-
ing, or controls and which is reduced to writing and made
part of the administrative record shall be deemed to com-
ply with current good manufacturing practice. The Sec-
retary shall not take action to delay or prevent the manu-
facture or marketing of a drug under section 505 or 506
for failure to conform to current good manufacturing
practice unless there is reasonable probability of actual
harm to the public health or the Secretary determines in
writing, after an informal hearing, that the drug is—
‘‘(A) not bioequivalent,
‘‘(B) deviates from the specifications for the
drug established in the approved new drug applica-
tion from the specifications for the drug established
by the manufacturer,
‘‘(C) lacks adequate assurance that it will meet
the represented sterility, or
‘‘(D) has been rendered unsafe or ineffective.’’.
(b) CONFORMING AMENDMENTS.—
(1) SECTION
303.—Section 303(g)(1)(B)(iii)
(21 U.S.C. 333(g)(1)(B)(iii)) is amended by striking
‘‘501(a)(2)(A)’’ and inserting ‘‘501(a)(1)(B)(i)’’.
(2) SECTION
304.—Section 304(d)(1) (21
U.S.C. 
334(d)(1)) 
is 
amended 
by 
striking
‘‘501(a)(3)’’ and inserting ‘‘501(a)(1)(C)’’.
(3) SECTION
512.—Section 512(a)(1) (21
U.S.C. 
360c(a)(1)) 
is 
amended 
by 
striking
‘‘501(a)(5)’’ and inserting ‘‘501(a)(1)(E)’’, section
512(a)(2) (21 U.S.C. 360c(a)(2)) is amended by
striking ‘‘501(a)(6)’’ and inserting ‘‘501(a)(1)(F)’’,
and section 512(a)(3) (21 U.S.C. 360c(a)(3)) is
amended by striking ‘‘501(a)(5) or (6)’’ and insert-
ing ‘‘501(a)(1)(E) or 501(a)(1)(F)’’.
(4) SECTION 721.—Section 721(a) (21 U.S.C
379e(a)) is amended by striking ‘‘501(a)(4)’’ and in-
serting ‘‘501(a)(1)(D)’’.
(5) SECTION 802.—Sections 802(b)(1)(D) and
802(f)(1)(B) (21 U.S.C.382(b)(1)(D),382(f)(1)(B))
are each amended by striking ‘‘(a)(1), (a)(2)(A),
(a)(3)’’ 
and 
inserting 
‘‘(a)(1)(A), 
(a)(1)(B)(i),
(a)(1)(C)’’ .
SEC. 12. PILOT AND SMALL SCALE MANUFACTURE.
Section 505(c) (21 U.S.C. 355(c)) is amended by
adding at the end thereof the following:
‘‘(4) A new drug manufactured in a pilot or other
small facility may be used to demonstrate the safety and
effectiveness of the drug and to obtain approval prior to
scaling up to a larger facility, unless the Secretary dem-
onstrates in writing and specifying in detail the reasons,
after an informal hearing, that a full scale production fa-
cility is necessary to ensure the safety or effectiveness of
the drug.’’.
SEC. 13. MANUFACTURING CHANGES.
Chapter VII (21 U.S.C. 371 et seq.) is amended by
adding at the end thereof the following:
‘‘SUBCHAPTER D—MANUFACTURING CHANGES
‘‘SEC. 740. MANUFACTURING CHANGES.
‘‘(a) IN GENERAL.—A change in the manufacture of
a new drug, biological product, new animal drug, blood,
or blood component shall be made in accordance with this
section.
‘‘(b) DRUG AND BIOLOGICAL PRODUCT.—A change
in the manufacture of a new drug or a biological product
that is the subject of a monograph in an official compen-
dium, a biological product that can be adequately charac-
terized by chemical, physical, or biological means, or a new
animal drug, blood, or blood component shall require—
‘‘(1) validation; and
‘‘(2)(A) if there is no change in the approved
qualitative and quantitative formulation or in the
approved release specifications, or if there is a
change in the approved qualitative or quantitative
formula or in the approved release specifications of
a type permitted by the Secretary by regulation, may
be made at any time and shall be reported annually
to the Secretary; and
‘‘(B) for any other change, shall require com-
pletion of an appropriate study demonstrating
equivalence according to criteria established by the
Secretary (unless such requirement is waived by the
Secretary), may be made at any time, and shall be
reported to the Secretary through a supplement or
amendment submitted at the time the change is
made.
‘‘(c) BIOLOGICAL PRODUCT NOT SUBJECT
TO
A
MONOGRAPH.—A change in the manufacture of a biologi-
cal product that is not the subject of a monograph in an
official compendium and cannot be adequately character-
ized by chemical, physical, or biological means shall re-
quire validation and—
‘‘(1) if the change relates solely to a modifica-
tion of the manufacturing facility or change in per-
sonnel, with no change in the approved manufactur-
ing process or release specifications, may be made at
any time and shall be reported annually to the Sec-
retary; and
‘‘(2) for any other change, shall require comple-
tion of a bioassay or other appropriate study dem-
onstrating equivalence according to criteria estab-
lished by the Secretary (unless such requirement is
waived by the Secretary), may be made at any time,
and shall be reported to the Secretary through an
amendment submitted at the time the change is
made.
‘‘(d) SPECIAL DETERMINATION FOR A BIOLOGICAL
PRODUCT.—A determination shall be made prior to ap-
proval of a biological product under section 506 whether
the product can be adequately characterized for purposes
of this subsection. With respect to biological products ap-
proved prior to the date of enactment of the Drug and
Biological Products Reform Act of 1996, the determina-
tion shall be made within 90 days after the date of enact-
ment of such Act. Any determination under this sub-
section is subject to change based upon new scientific in-
formation.’’.
SEC. 14. INSULIN AND ANTIBIOTICS.
(a) CERTIFICATION OF DRUGS CONTAINING INSU-
LIN.—
(1) AMENDMENT.—Section 506 (21 U.S.C.
356) is repealed.
(2) CONFORMING AMENDMENTS.—
(A) Sections 301(i)(1) and 301(j)(1) (21
U.S.C. 321(i)(1), 321(j)(1)) are each amended
by striking ‘‘506, 507,’’.
(B) Section 501(k) (21 U.S.C. 351(k)) is
repealed
(C) Section 502(k) (21 U.S.C. 352(k) is
repealed.
(D) 
Sections 
510(j)(1)(A) 
and
510(j)(1)(D) 
(21 
U.S.C. 
360(j)(1)(A),
360(j)(1)(D)) are each amended by striking
‘‘506, 507,’’.
(E) Section 8126(h)(2) of title 38, United
States Code, is amended by inserting ‘‘or’’ at
the end of subparagraph (B), by striking ‘‘; or’’
at the end of subparagraph (C) and inserting a
period, and by striking subparagraph (D).
(F) Section 1927(k)(2) of the Social Secu-
rity Act (42 U.S.C. 1396r–8(k)(2)) is amended
by striking ‘‘; and’’ at the end of subparagraph
(B) and inserting a period and by striking sub-
paragraph (C).
(b) CERTIFICATION OF ANTIBIOTICS.—
(1) AMENDMENT.—Section 507 (21 U.S.C.
357), as in effect on the date of the enactment of
this Act, is repealed.
(2) CONFORMING AMENDMENTS.—
(A) Section 201(aa) (21 U.S.C. 321(aa)) is
amended by striking out ‘‘or 507’’, section
201(dd) (21 U.S.C. 321(dd)) is amended by
striking ‘‘507,’’, and sections 201(ff)(2)(B) and
201(ff)(3) (21 U.S.C. 321(ff)(2)(B), 321(ff)(3))
are each amended by striking ‘‘, certified as an
antibiotic under section 507,’’.
(B) Section 301(e) (21 U.S.C. 331(e)) is
amended by striking ‘‘507(d) or (g),’’.
(C) Sections 301(i)(1) and 301(j) (21
U.S.C. 321(i)(1), 321(j)) are each amended by
striking ‘‘507,’’.
(D) Section 306(d)(4)(B)(ii) (21 U.S.C.
335a(d)(4)(B)(ii)) is amended by striking ‘‘or
507’’.
(E) Section 502 (21 U.S.C. 352) is
amended by striking subsection (l).
(F) Section 510(j)(1)(D) (21 U.S.C.
360(j)(1)(D)) is amended by striking ‘‘507,’’.
(G) Section 520(l) is amended by striking
paragraph (4) and by striking ‘‘or Antibiotic
Drugs’’ in the subsection heading.
(H) Section 525(a) (21 U.S.C. 360aa(a))
is amended by inserting ‘‘or’’ at the end of
paragraph (1), by striking paragraph (2), and
by redesignating paragraph (3) as paragraph
(2).
(I) Section 525(a) (21 U.S.C. 360aa(a)) is
amended by striking ‘‘, certification of such
drug for such disease or condition under section
507,’’.
(J) Section 526(a)(1) (21 U.S.C. 360bb) is
amended by striking ‘‘the submission of an ap-
plication for certification of the drug under sec-
tion 507,’’, by inserting ‘‘or’’ at the end of sub-
paragraph (A), by striking subparagraph (B),
and by redesignating subparagraph (C) as sub-
paragraph (B).
(K) Section 526(b) (21 U.S.C. 360bb(b))
is amended by striking ‘‘, a certificate was is-
sued for the drug under section 507,’’ each time
it appears and by striking ‘‘, approval of an ap-
plication for certification under section 507,’’.
(L) Section 527(a) (21 U.S.C. 360cc(a)) is
amended by inserting ‘‘or’’ at the end of para-
graph (1), by striking paragraph (2), by redes-
ignating paragraph (3) as paragraph (2), and
by striking ‘‘, issue another certificate under
section 507,’’.
(M) Section 527(b) (21 U.S.C. 360cc(b))
is amended by striking ‘‘, if a certification is is-
sued under section 507 for such a drug,’’, and
‘‘, of the issuance of the certification under sec-
tion 507,’’.
(N) Section 704(a)(1) (21 U.S.C. 374) is
amended by striking ‘‘, section 507 (d) or (g)’’.
(O) Section 735(1) (21 U.S.C. 379g(1)(C))
is amended by inserting ‘‘or’’ at the end of sub-
paragraph (B), by striking subparagraph (C),
and by redesignating subparagraph (D) as sub-
paragraph (C).
(P) Sections 5(b)(1)(A) and 5(b)(1)(B) of
the 
Orphan 
Drug 
Act 
(21 
U.S.C.
360ee(b)(1)(A), 
360ee(b)(1)(B)) 
are 
each
amended by striking ‘‘or 507’’.
(Q) Section 28(b)(2)(A)(ii)(II) of the In-
ternal Revenue Code of 1986 is amended by
striking ‘‘or 507’’.
(R) Section 156(f)(4)(B) of title 35,
United States Code, is amended by striking
‘‘507,’’ each place it occurs.
(S) Section 1927(k)(2)(A)(i) of the Social
Security 
Act 
(42 
U.S.C. 
1396r–
8(k)(2)(A)(ii)(II)) is amended by striking ‘‘or
507’’.
(c) EXPORTATION.—Section 802 (21 U.S.C. 382) is
amended by adding at the end thereof the following:
‘‘(h) EXPORTATION OF INSULIN AND ANTIBIOTICS.—
Insulin and antibiotics may be exported without regard to
the requirements in this section if the insulin and anti-
biotics meet the requirements in section 801(e)(1).’’.
SEC. 15. NONPRESCRIPTION DRUGS.
Chapter V is amended by adding after section 510
(21 U.S.C. 360) the following:
‘‘NONPRESCRIPTION DRUGS
‘‘SEC. 511. All applications or petitions requesting
that 
a 
drug 
be 
switched 
from 
prescription 
to
nonprescription status and all other matters relating to
nonprescription drugs shall be reviewed and acted upon
solely by a single office in the Center for Drug Evaluation
and Research or a successor entity, and that office shall
report directly to the Director of the Center. A single sci-
entific advisory panel may provide conclusions and rec-
ommendations regarding any such matter.’’.
SEC. 16. INFORMATION SYSTEM.
Chapter IX, as amended by section 9, is amended by
adding at the end the following:
‘‘SEC. 907. INFORMATION SYSTEM.
‘‘The Secretary shall establish and maintain an infor-
mation system to track the status and progress of each
application or submission (including a petition, notifica-
tion, or other similar form of request) submitted to the
Food and Drug Administration requesting agency action.
The system shall permit access by the applicant.’’.
SEC. 17. ENVIRONMENTAL IMPACT REVIEW.
Chapter VII, as amended by section 13, is amended
by adding at the end the following:
‘‘SUBCHAPTER E—ENVIRONMENTAL IMPACT REVIEW
‘‘SEC. 745. ENVIRONMENTAL IMPACT REVIEW.
‘‘No action by the Secretary pursuant to this Act
shall require, with respect to an action to be taken by the
Secretary, the preparation of an environmental impact
statement under the National Environmental Policy Act
of 1969 or an environmental assessment unless the Sec-
retary demonstrates that—
‘‘(1) because of extraordinary circumstances the
action will have a significant effect on the human
environment; and
‘‘(2) the consideration of such significant effect
on the human environment will directly affect the
Secretary’s decision on the action.’’.
SEC. 18. APPLICATION OF FEDERAL LAW TO THE PRACTICE
OF PHARMACY COMPOUNDING.
Section 503 (21 U.S.C. 353) is amended by adding
at the end the following:
‘‘(h)(1) Sections 501(a)(1)(B)(ii), 501(f), 501(h),
502(f)(1), 502(l), 502(o), 502(s), 502(t), 505, 506, and
510 and sections 510 through 520 shall not apply to a
drug that is compounded by a licensed pharmacist on the
order of a licensed physician.
‘‘(2) No provision of this Act shall apply to a bulk
drug product or other drug, including an imported product
drug, that is intended for use by a licensed pharmacist
in compounding a drug or device on the order of a licensed
physician, except to the extent that the provision relates
directly to the quality, purity, or identity of such drug.’’.
SEC. 19. HARMONIZATION.
Section 803 (21 U.S.C. 383) is amended by adding
at the end the following:
‘‘(c)(1) The Secretary shall regularly and continu-
ously participate in meetings with other countries to dis-
cuss methods and approaches to reduce the burden of reg-
ulation, harmonize regulatory requirements, and seek ap-
propriate reciprocal arrangements. The Secretary shall,
within 180 days of the date of enactment of this sub-
section, make public a plan that establishes a framework
for achieving mutual recognition of good manufacturing
practices.
‘‘(2) The Secretary shall report to the Committee on
Commerce of the House of Representatives and the Com-
mittee on Labor and Human Resources of the Senate at
least 60 days before executing any bilateral or multilateral
agreement under paragraph (1).’’.
SEC. 20. USE OF SCIENTIFIC AND MEDICAL INFORMATION.
Section 502(f) (21 U.S.C. 352(f)) is amended by add-
ing at the end the following: ‘‘The dissemination of medi-
cal texts, articles from peer-reviewed scientific publica-
tions, information from Federal Government agencies, and
presentations at medical and scientific meetings shall not
form a basis to require adequate directions for use under
clause (1) or information for use (or the equivalent there-
of) under any exemption to clause (1) and shall not form
a basis to require the filing of a report required under
section 510(k) or the filing of an application under section
505 or 515 unless such person, in addition to disseminat-
ing the above-referenced information, encourages the un-
approved use of a legally marketed drug or device through
labeling, advertising, or other means of promotion. Mere
knowledge that a legally available drug or device is used
by licensed practitioners for the treatment or diagnosis of
diseases or conditions in individual patients shall not form
a basis to require adequate directions for use under clause
(1), or information for use (or the equivalent thereof)
under any exemption to clause (1), and shall not form a
basis to require either the filing of a notification required
under section 510(k) or an application under section 505
or 515. The Secretary shall not consider the dissemination
of medical texts, articles from peer review scientific publi-
cations, information from Federal Government agencies,
presentations at medical and scientific meetings, and dis-
plays at trade shows relating to a drug or device which
is not approved for marketing or investigational use within
the meaning of section 505(i) or 520(g) to be activities
prohibited under published regulations of the Secretary
unless the sponsor of an investigation for the drug or de-
vice, or an agent of such sponsor, in addition to the afore-
mentioned activities encourages the use of a drug or de-
vice.’’.
SEC. 21. INFORMAL AGENCY STATEMENTS.
Section 701 (21 U.S.C. 371) is amended by adding
at the end the following:
‘‘(h)(1) The Secretary shall not rely upon informal
agency statements, including guidance documents, policy
statements, points to consider documents, or any other
statements that have not been promulgated in accordance
with the rulemaking requirements of chapter V of title 5,
United States Code, to require any action be taken to sat-
isfy a requirement of this Act.
‘‘(2) The Secretary shall publish notice in the Federal
Register of the availability to the public of each type of
statement identified in paragraph (1). Additionally, the
Secretary shall undertake to make available all such state-
ments by electronic or other similar means.’’.
SEC. 22. EDUCATION AND RESEARCH; PRACTICE OF MEDI-
CINE.
Chapter IX, as amended by section 16, is amended
by adding at the end the following:
‘‘SEC. 908. EDUCATION AND RESEARCH.
‘‘(a) EDUCATION.—The Secretary shall conduct
training and education programs for the employees of the
Food and Drug Administration relating to the regulatory
responsibilities and policies established by this Act, includ-
ing programs for scientific training, administrative process
and procedure, and integrity issues.
‘‘(b) RESEARCH.—The Secretary, acting through the
Food and Drug Administration, may conduct or contract
for scientific research only if it is directly related to the
implementation of this Act.
‘‘SEC. 909. PRACTICE OF MEDICINE.
‘‘Nothing in this Act shall be construed to limit or
interfere with the authority of a health care practitioner,
licensed by law to administer drugs and devices, to pre-
scribe or administer any legally marketed drug or device
to a patient for any condition or disease within a legiti-
mate health care practitioner-patient relationship.’’.
SEC. 23. DELEGATION OF AUTHORITY.
Section 903 (21 U.S.C. 393), as amended by section
2(b), is amended by adding at the end the following:
‘‘(f) DELEGATION OF AUTHORITY.—The reference in
sections 505(b)(4)(A), 505(b)(4)(C), 505(i)(2)(B), and
505(n)(1) to the authority of a specific official or position
in the Food and Drug Administration to perform a par-
ticular function is an authority which shall be only exer-
cised by such official or individual in such position and
the authority to exercise such authority may not be dele-
gated.’’.
SEC. 24. JUDICIAL REVIEW.
Section 505(h) (21 U.S.C. 355(h)) is amended to
read as follows:
‘‘(h)(1) Not later than 30 days after—
‘‘(A) any written decision respecting any aspect
of an investigational new drug; or
‘‘(B) any written decision respecting any aspect
of an application, petition, or notification for mar-
keting review or approval for a drug under this sec-
tion;
any person adversely affected by such decision, notice, or
warning may file a petition with the United States Court
of Appeals for the District of Columbia or for the circuit
wherein such person resides or such person has a principal
place of business for judicial review of such decision, no-
tice, or warning. A copy of the petition shall be transmit-
ted by the clerk of the court to the Secretary or other
officer designated by the Secretary for that purpose. The
Secretary shall file in the court the record of the proceed-
ings on which the Secretary based the Secretary’s decision,
notice, or warning as provided in section 2112 of title 28,
United States Code. For purposes of this subsection, the
term ‘‘record’’ means all notices and other matter pub-
lished in the Federal Register with respect to the decision,
notice, or warning reviewed, all information submitted to
the Secretary with respect to such decision, notice, or
warning, proceedings of any scientific advisory panel with
respect to such decision, notice, or warning, any hearing
held with respect to such decision, notice, or warning, and
any other information identified by the Secretary, in the
administrative proceeding held with respect to such deci-
sion, notice, or warning as being relevant to such regula-
tion or order.
‘‘(2) If the petitioner applies to the court for leave
to adduce additional data, views, or arguments respecting
the decision, notice, or warning being reviewed and shows
to the satisfaction of the court that such additional data,
views, or arguments are material and that there were rea-
sonable grounds for the petitioner’s failure to adduce such
data, views, or arguments in the proceedings before the
Secretary, the court may order the Secretary to provide
additional opportunity for the oral presentation of data,
views, or arguments and for written submissions. The Sec-
retary may modify the Secretary’s findings, or make new
findings by reason of the additional data, views, or argu-
ments so taken and shall file with the court such modified
or new findings, and the Secretary’s recommendation, if
any, for the modification or setting aside of the decision,
notice, or warning being reviewed, with the return of such
additional data, views, or arguments.
‘‘(3) Upon the filing of the petition under paragraph
(1) for judicial review of a decision, notice, or warning,
the court shall have jurisdiction to review the decision, no-
tice, or warning in accordance with chapter 7 of title 5,
United States Code, and to grant appropriate relief, in-
cluding interim relief, as provided in such chapter.
‘‘(4) The judgment of the court affirming or setting
aside, in whole or in part, any decision, notice, or warning
shall be final, subject to review by the Supreme Court of
the United States upon certiorari or certification, as pro-
vided in section 1254 of title 28 of the United States Code.
‘‘(5) The remedies provided for in this subsection
shall be in addition to and not in lieu of any other rem-
edies provided by law.
‘‘(6) To facilitate judicial review under this sub-
section or under any other provision of law of a decision,
notice, or warning issued under this section, each such de-
cision, notice, or warning shall contain a statement of the
reasons for its issuance and the basis, in the record of
the proceedings held in connection with its issuance, for
its issuance.’’.
SEC. 25. PUBLICATION OF NOTICE OF DEVIATION.
Section 705 (21 U.S.C 375) is amended by adding
at the end the following:
‘‘(c) The Secretary may make public or communicate
to any person outside the Food and Drug Administration
any information regarding a notice which informs a regu-
lated person of a purported deviation from a requirement
of this Act only after the Secretary has completed the in-
vestigation of such deviation.’’.
SEC. 26. BIOLOGICAL PRODUCTS.
(a) DEFINITIONS.—
(1) BIOLOGICAL PRODUCT AND TISSUE.—Sec-
tion 201 (21 U.S.C. 321) is amended by adding at
the end the following:
‘‘(gg) The term ‘biological product’ means a virus,
therapeutic serum, toxin, antitoxin, vaccine, allergenic
product, derivative of blood and blood components, or
analogous product, or arsphenamine or its derivatives, in-
tended for use in the diagnosis, cure, mitigation, treat-
ment, or prevention of a disease or physiologic condition
in man, but does not include blood, blood components, or-
gans, eyes, milk, or human tissue. A biological product is
a drug within the meaning of paragraph (g) but is not
a new drug within the meaning of paragraph (p).
‘‘(hh) The term ‘human tissue’ means a collection of
human cells which are intended for use in the diagnosis,
cure, mitigation, treatment, or prevention of a disease or
physiological condition in man or for the augmentation of
a natural bodily function. Human tissue may be combined
with biologically inactive substances and subjected to any
form of processing before use subject to operating stand-
ards established under section 506(a)(2)(A). Human tis-
sue achieves its primary intended purposes through struc-
tural support or cellular function and not systemic action.
Human tissue is not a drug or device and does not include
blood, blood components, organs, or milk.’’.
(2) BLOOD, BLOOD
COMPONENTS, ORGANS,
MILK, OR HUMAN TISSUE.—Section 201(g)(1) (21
U.S.C 321(g)(1)) is amended by adding at the end
the following: ‘‘Blood, a blood component, an organ,
milk, or human tissue is not a drug.’’.
(3) 
DEVICE.—Section 
201(h) 
(21 
U.S.C.
321(h)) is amended by adding at the end the follow-
ing: ‘‘Computer software developed by, modified by,
and used in a human tissue establishment shall not
be subject to any premarket clearance requirement
under this Act but such software shall be validated
to demonstrate that it achieves its intended purpose
before use and it shall be subject to the good manu-
facturing requirements of this Act.’’.
(b) REGULATION
OF
BIOLOGICAL
PRODUCTS.—
Chapter V, as amended by section 14, is amended by add-
ing after section 505 the following:
‘‘BIOLOGICAL PRODUCTS
‘‘SEC. 506. (a) No person shall introduce or deliver
for introduction into interstate commerce a biological
product unless an approval of a product license application
filed pursuant to this section is effective with respect to
such product and the biological product meets the good
manufacturing 
practice 
requirement 
of 
section
501(a)(1)(B)(ii).
‘‘(b) A product license application for a biological
product shall—
‘‘(1) contain the information that is required
for a new drug under the second sentence of section
505(b)(1);
‘‘(2) be subject to the procedures and standards
established for a new drug in sections 505(c)(1),
505(d), 505(e), 505(f), 505(g), and 505(h) but not
the standards of sections 505(d)(6) and 505(e)(4);
‘‘(3) be subject to the provisions for an inves-
tigational new drug in section 505(i);
‘‘(4) be subject to the requirements for a new
drug established in section 505(k); and
‘‘(5) in the case of a derivative of blood and
blood components, apply to all facilities of the appli-
cant that are licensed under subsection (c).
Within 2 years of the date of enactment of this section
the Secretary shall harmonize the regulations governing
product license applications with the regulations governing
new drug applications filed pursuant to section 505(b)(1)
and the regulations governing good manufacturing prac-
tices promulgated under section 501(a)(1)(B)(ii). If the
Secretary fails to implement such harmonization within 2
years, the regulations governing product license applica-
tions shall be null and void and all biological products shall
be subject to the regulations governing new drug applica-
tions filed pursuant to section 505(b)(1). The amendments
made to section 505 by the Drug Price Competition and
Patent Term Restoration Act of 1984 shall not apply to
biological products.
‘‘(c)(1) No person shall introduce or deliver for intro-
duction into interstate commerce blood or blood compo-
nents unless an approval of a product license application
filed pursuant to this section is effective with respect to
such product. Blood and blood components intended for
use in the diagnosis, cure, mitigation, treatment, or pre-
vention of a disease or physiologic condition in man shall
be subject to—
‘‘(A) performance standards for safety, purity,
and where applicable, potency,
‘‘(B) good manufacturing practices, and
‘‘(C) labeling,
established by regulations promulgated by the Secretary,
and shall be obtained and processed only in facilities li-
censed by the Secretary.
‘‘(2) Licensed establishments shall be subject to in-
spection under section 704. During such an inspection the
Secretary shall have access to or copies of patient and
donor names and other donor identifying information
when such access is critical to public health. Such an in-
spection may be conducted by nonprofit membership orga-
nizations that meet requirements established by the Sec-
retary for individuals and organizations accredited by the
Secretary under section 712.
‘‘(3)(A) The Secretary shall by regulation establish
the requirements that a facility or a group of facilities
within one corporate entity shall meet to be eligible to be
licensed under a single facility license to obtain and proc-
ess a specific set of blood and blood components.
‘‘(B) Within 90 days after the Secretary receives an
application for a license under this subsection from a facil-
ity, the Secretary shall review the application and may in-
spect the facility to determine compliance with the require-
ments established under this subsection. Such inspection
may be conducted by non-profit organizations that meet
requirements established by the Secretary or by persons
accredited by the Secretary under section 712. Within
such 90 days, the Secretary shall grant a license or shall
deny a license and specify in writing the reasons for the
denial and the requirements that must be met to obtain
a license.
‘‘(C) The Secretary may at any time revoke or sus-
pend a license in accordance with this paragraph for fail-
ure to comply with the requirements established under this
subsection as follows:
‘‘(i) The license may be immediately suspended
with an informal hearing to follow if the Secretary
demonstrates that the deficiencies identified con-
stitute an immediate danger of serious adverse
health consequences or death.
‘‘(ii) Before revoking a license, the Secretary
shall provide the facility in writing a list of specific
deficiencies that must be corrected in order to retain
the license and shall provide 30 days for a written
response and for correction of the deficiencies. If the
facility fails to provide an adequate response or to
make a correction, the Secretary shall provide the
opportunity for an informal hearing. Such hearing
shall be held within 30 days of the receipt of the
written response.
‘‘(iii) The revocation or suspension of any li-
cense shall not prevent the continued use of any
blood or blood component which has left the control
of the licensee unless the Secretary determines, as
part of the revocation or suspension order, that such
use represents an actual harm to the public health.
‘‘(4) Blood and blood components are not biological
products, drugs, devices, or human tissue. Computer soft-
ware developed by, modified by, and used in a blood or
blood component establishment shall not be subject to any
premarket clearance requirement under this Act but such
software shall be validated to demonstrate that it achieves
its intended purpose before use and it shall be subject to
the good manufacturing requirements of this Act.
‘‘(5) Blood components and derivatives of blood and
blood components intended for use as a blood test or in
the diagnosis of disease are devices and are not drugs, bio-
logical products, or human tissue.
‘‘(d)(1) Human tissue shall be subject to regulation
under this subsection only if the Secretary demonstrates,
in writing published in the Federal Register and after a
hearing before the Commissioner, that voluntary regula-
tion under generally accepted scientific standards is inad-
equate to protect the public health with respect to any par-
ticular type of human tissue or human tissue generally.
‘‘(2)(A) Based upon such a demonstration, the Sec-
retary may establish by regulation operating standards for
the safety of human tissue and may require human tissue
to be processed only in an establishment registered in ac-
cordance with the procedures established for drugs under
section 510.
‘‘(B) The operating standards authorized under this
paragraph shall be limited to the following general require-
ments for the recovery, processing, storage, and shipment
of human tissue:
‘‘(i) Requirements for universal infection con-
trol designs to prevent transmission of disease.
‘‘(ii) Good processing practices that assure the
safety, maintenance of structure, and preservation of
original cellular function of tissue.
‘‘(iii) Labeling requirements for the identifica-
tion of the type of tissue, the addition of any foreign
substance, and information needed to permit tracing.
‘‘(C) Registered establishments shall be subject to in-
spection under section 704. During such an inspection the
Secretary shall have access to or copies of patient and
donor names and other donor identifying information
when such access is critical to public health as defined in
regulations to be promulgated by the Secretary for par-
ticular types of tissue. Such inspection may be conducted
by nonprofit membership organizations that meet require-
ments established by the Secretary for individuals and or-
ganizations accredited by the Secretary under section 712.
‘‘(3) The requirements established under paragraph
(2) shall not apply to human tissue not stored for a signifi-
cant period or not significantly processed.
‘‘(e) The Secretary may take action to enforce the
requirements of good manufacturing practice for blood,
blood components, and good operating standards for
human tissue in the same manner as is done for drugs.’’.
(c) TRANSITION.—The requirements of the interim
regulation promulgated by the Secretary of Health and
Human Services on December 1993, shall remain in effect
for a period of 18 months after the date of the enactment
of this section so that the Secretary may have an oppor-
tunity to establish general controls for tissue pursuant to
section 506(d)(1)(A) of the Federal Food, Drug, and Cos-
metic Act. The Secretary shall not regulate eyes until such
time that the Secretary makes a finding under section
506(d)(1)(A) of such Act that voluntary regulation under
generally accepted standards is inadequate to protect the
public health.
(d) CONFORMING AMENDMENTS.—
(1) SECTION
301(d).—Section 301(d) (21
U.S.C. 331(d)) is amended by striking ‘‘or 505’’ and
inserting ‘‘, 505, or 506’’.
(2) 
SECTION
301(e).—Section 
301(e) 
(21
U.S.C. 331(e)) is amended by inserting after ‘‘(k),’’
the following: ‘‘506(b),’’.
(3) SECTION
301.—Section 301 (21 U.S.C.
331), as amended by section 8(b), is amended by
adding after paragraph (w) the following:
‘‘(x) The failure of blood, blood component, or human
tissue to comply with any applicable requirement estab-
lished under section 506.’’.
(4) SECTION 501.—Section 501 (21 U.S.C. 351)
is amended by adding at the end the following:
‘‘(j) If it is a biological product, blood, blood compo-
nent, or human tissue and it does not comply with any
applicable requirement established under section 506.’’.
(5) SECTION 351.—Section 351 of the Public
Health Service Act (42 U.S.C. 262) is amended by
striking the section heading and ‘‘SEC. 351.’’ and
subsections (a) through (d)(1) and (e) through (g)
of such section 351 are repealed.
(6) SECTION
351.—Subsection (d)(2) of such
section 351 is redesignated as subsection (g) of sec-
tion 511.
(7) MULTIPLE
SECTIONS.—Sections 525(a),
526(a)(1), 
526(a)(1)(C), 
526(b)(1), 
526(b)(2),
527(a), 527(b), 735(1)(D), 735(3), 735(6)(D),
802(a)(1)(B), 
802(b)(1)(A)(ii)(II), 
802(b)(1)(C),
802(c)(1)(C), 802(d)(3), 802(d)(4), and 902(c) (21
U.S.C. 360aa(a), 360bb(a)(1), (a)(1)(C), (b)(1),