Distribution of Certain Drug Products by Registered Blood Establishments and Comprehensive Hemophilia Diagnostic Treatment Centers That Qualify as Health Care Entities; Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements and Administrative Procedures, 59496-59501 [E8-24050]
Download as PDF
<![CDATA[
59496
Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Rules and Regulations
FDC
No.
FDC date
State
City
Airport
07/10/08 ......
09/04/08 ......
MI .........
GQ .......
MANISTEE ......................
AGANA ............................
MANISTEE CO.–BLACKER ................
GUAM INTL .........................................
8/6401
8/6576
09/05/08
09/05/08
09/05/08
09/05/08
09/05/08
......
......
......
......
......
CO
CO
MT
MT
OR
........
........
........
........
........
DENVER .........................
DENVER .........................
BUTTE .............................
ANACONDA ....................
EUGENE .........................
ROCKY MOUNTAIN METROPOLITAN
ROCKY MOUNTAIN METROPOLITAN
BERT MOONEY ..................................
BOWMAN FIELD .................................
MAHLON SWEET FIELD ....................
8/6770
8/6771
8/6864
8/6866
8/6867
09/05/08
09/08/08
09/08/08
09/08/08
......
......
......
......
AK
KY
AR
AR
........
........
........
........
PERRYVILLE ..................
DANVILLE .......................
FORT SMITH ..................
FORT SMITH ..................
PERRYVILLE .......................................
STUART POWELL FIELD ...................
FORT SMITH RGNL ............................
FORT SMITH RGNL ............................
8/6868
8/7015
8/7062
8/7064
09/08/08 ......
09/08/08 ......
AR ........
AR ........
FORT SMITH ..................
FORT SMITH ..................
FORT SMITH RGNL ............................
FORT SMITH RGNL ............................
8/7065
8/7067
09/08/08 ......
09/08/08 ......
AR ........
AR ........
FORT SMITH ..................
FORT SMITH ..................
FORT SMITH RGNL ............................
FORT SMITH RGNL ............................
8/7068
8/7069
09/10/08
09/10/08
09/11/08
09/12/08
OK
CA
VA
LA
TULSA .............................
VAN NUYS ......................
DUBLIN ...........................
LAFAYETTE ....................
TULSA INTL .........................................
VAN NUYS ...........................................
NEW RIVER VALLEY ..........................
LAFAYETTE REGIONAL .....................
8/7352
8/7460
8/7673
8/7965
......
......
......
......
........
........
........
........
[FR Doc. E8–23916 Filed 10–8–08; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
regulations, among other things, restrict
the sale, purchase, or trade of, or the
offer to sell, purchase, or trade,
prescription drugs purchased by
hospitals and other health care entities.
This rule is effective November
10, 2008.
DATES:
Food and Drug Administration
FOR FURTHER INFORMATION CONTACT:
21 CFR Parts 203 and 205
[Docket No. FDA–2005–N–0345] (formerly
Docket No. 2005N–0428)
Distribution of Certain Drug Products
by Registered Blood Establishments
and Comprehensive Hemophilia
Diagnostic Treatment Centers That
Qualify as Health Care Entities;
Prescription Drug Marketing Act of
1987; Prescription Drug Amendments
of 1992; Policies, Requirements and
Administrative Procedures
AGENCY:
Food and Drug Administration,
HHS.
erowe on PROD1PC64 with RULES
ACTION:
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending its
regulations to allow certain registered
blood establishments and
comprehensive hemophilia diagnostic
treatment centers that are also health
care entities to distribute certain drug
products. The final rule amends limited
provisions of the regulations
implementing the Prescription Drug
Marketing Act of 1987 (PDMA), as
modified by the Prescription Drug
Amendments of 1992 (PDA). These
VerDate Aug<31>2005
15:31 Oct 08, 2008
Jkt 214001
Jennifer J. Ross, Center for Biologics
Evaluation and Research (HFM–10),
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448, 301–827–0372.
SUPPLEMENTARY INFORMATION:
I. Background
The PDMA (Public Law 100–293) was
enacted on April 22, 1988, and was
modified by the PDA (Public Law 102–
353) on August 26, 1992. The PDMA, as
modified, amended the Federal Food,
Drug, and Cosmetic Act (the act) to
establish restrictions and requirements
relating to various aspects of human
prescription drug marketing and
distribution. Among other things, the
PDMA prohibited, with certain
exceptions, the sale, purchase, or trade
(or offer to sell, purchase, or trade) of
any prescription drug that was
purchased by a hospital or other health
care entity. Section 503(c)(3)(A)(ii)(I) of
the act (21 U.S.C. 353(c)(3)(A)(ii)(I)).
Section 503(c)(3) also states that ‘‘[f]or
purposes of this paragraph, the term
‘entity’ does not include a wholesale
distributor of drugs or a retail pharmacy
licensed under State law * * *.’’
PO 00000
Frm 00018
Fmt 4700
Sfmt 4700
Subject
VOR RWY 27, ORIG
ILS OR LOC/DME RWY 6L,
AMDT 3B
GPS RWY 29L, ORIG–A
GPS RWY 29R, ORIG–A
ILS Y RWY 15, AMDT 6
VOR/DME OR GPS A, AMDT 1
ILS OR LOC/DME RWY 16L,
ORIG
RNAV (GPS) RWY 2, ORIG
LOC/DME RWY 30, AMDT 1A
RNAV (GPS) RWY 7, ORIG–B
VOR/DME OR TACAN RWY 7,
AMDT 11B
RNAV (GPS) RWY 25, ORIG–B
ILS OR LOC RWY 25, AMDT
21D
ILS OR LOC RWY 7, ORIG–B
VOR OR TACAN RWY 25,
AMDT 20G
ILS OR LOC RWY 18R, AMDT 7
ILS RWY 16R, AMDT 5A
ILS OR LOC RWY 6, AMDT 4A
TAKEOFF MINIMUMS AND (OBSTACLE) DEPARTURE PROCEDURES (ODP), AMDT 1
In the Federal Register of March 14,
1994 (59 FR 11842), we issued a
proposed rule to implement certain
provisions of the PDMA. The proposed
rule contained provisions on
prescription drug reimportation;
wholesale distribution of prescription
drugs by unauthorized distributors; the
resale of prescription drugs by hospitals,
health care entities, and charitable
institutions; and distribution of
prescription drug samples. After
consideration of comments, we issued a
final rule in the Federal Register of
December 3, 1999 (64 FR 67720) (the
December 1999 final rule), with an
effective date of December 4, 2000.
After publication of the December
1999 final rule, we received many
comments on, and held several meetings
to discuss the implications of, the final
regulations for registered blood
establishments that distribute bloodderived products and provide limited
health care services to hospitals and
patients. According to comments,
implementing the December 1999 final
rule as published would interfere with
longstanding relationships between
blood centers and other health care
providers such as hospitals and
hemophilia treatment centers.
Section 203.20(a) (21 CFR 203.20(a))
of the December 1999 final rule stated,
in relevant part, that no person may sell,
purchase, or trade, or offer to sell,
purchase, or trade any prescription drug
that was purchased by a health care
entity. ‘‘Health care entity,’’ in turn, was
defined in § 203.3(q) (21 CFR 203.3(q))
E:\FR\FM\09OCR1.SGM
09OCR1
Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Rules and Regulations
as any person that provides diagnostic,
medical, surgical, or dental treatment, or
chronic or rehabilitative care, but did
not include any retail pharmacy or
wholesale distributor. That definition
specifically stated that ‘‘[a] person
cannot simultaneously be a ‘health care
entity’ and a retail pharmacy or
wholesale distributor.’’
Thus, under the December 1999 final
rule as written, blood establishments
and hemophilia treatment centers
functioning as health care entities
would be prohibited from engaging in
wholesale distribution of prescription
drugs except for blood and blood
components intended for transfusion,
which are exempted from the
regulations under § 203.1 (21 CFR 203.1)
(see also 21 CFR 203.22(g)). As
discussed in the preamble to the
December 1999 final rule (64 FR 67720
at 67725 to 67727), blood derivatives are
not blood components and were
therefore subject to this prohibition on
wholesale distribution. Therefore, under
the December 1999 final rule, a blood
establishment or a hemophilia treatment
center could not generally resell blood
derivatives to entities other than
consumers or patients and
simultaneously provide health care,
such as medical services associated with
those products. Examples of blood
derivatives that are prescription drugs
include, but are not limited to, albumin,
antihemophilic factor, Coagulation
Factor IX, alpha-1 proteinase inhibitor,
and immune globulin.
On May 3, 2000, we delayed until
October 1, 2001, the effective date of
several provisions of the December 1999
final rule and reopened the
administrative record (65 FR 25639). In
the Federal Register of March 1, 2001
(66 FR 12850), we announced our
decision to further delay until April 1,
2002, the applicability of § 203.3(q)
(definition of ‘‘health care entity’’) to the
wholesale distribution of blood
derivatives by health care entities.
Further delays of effective dates
followed until December 1, 2008, to give
us additional time to consider whether
regulatory changes were appropriate
and, if so, to initiate such changes (67
FR 6645, February 13, 2002; 68 FR 4912,
January 31, 2003; 69 FR 8105, February
23, 2004; 71 FR 66108, November 13,
2006).
In the Federal Register of February 1,
2006 (71 FR 5200), we published a
proposed rule (the February 2006
proposal) to amend § 203.22, which
59497
excludes certain activities from the sales
restrictions in § 203.20. As proposed,
§ 203.22 would have provided a limited
exclusion for registered blood
establishments that qualify as health
care entities. The February 2006
proposal, as a result, would have
allowed certain registered blood
establishments that qualify as health
care entities to distribute blood
derivatives. The proposal sought
information about the functions of
registered blood establishments to assist
us in determining whether further
modification of the December 1999 final
rule would be warranted in the interest
of public health. We also requested
comments on whether the proposal
should be expanded to allow registered
blood establishments that also provide
health care services to distribute drugs
other than blood derivatives that might
be used to treat blood disorders. In
addition, we sought comment on
whether hemophilia treatment centers
should be included within the scope of
the exclusion.
After reviewing the comments on the
February 2006 proposal, we have made
several changes to the rule, as described
in the following table:
TABLE 1.—PRINCIPAL CHANGES BETWEEN THE PROPOSED AND FINAL RULE
Proposed Rule
Final Rule
Exclusion applies to a registered blood establishment that qualifies as a health care entity, as long as all of the health care services that the establishment provides are related to its activities as a registered blood establishment or the health care services
consist of collecting, processing, storing, or administering human hematopoietic stem/
progenitor cells or performing diagnostic testing of specimens provided that these
specimens are tested together with routine donor testing.
Exclusion would apply to the sale, purchase, or trade
of, or the offer to sell, purchase, or trade any blood
derivative.
Exclusion applies to the sale, purchase, or trade of, or the offer to sell, purchase, or
trade any: (1) Drug indicated for a bleeding or clotting disorder, or anemia; (2) blood
collection container approved under section 505 of the act; or (3) drug that is a blood
derivative (or a recombinant or synthetic form of a blood derivative).
Exclusion did not apply to hemophilia treatment centers.
erowe on PROD1PC64 with RULES
Exclusion would apply to a registered blood establishment that qualifies as a health care entity, as
long as all of the health care services that it provides are related to its activities as a registered
blood establishment.
Exclusion applies to the sale, purchase, or trade of, or the offer to sell, purchase, or
trade, by a comprehensive hemophilia diagnostic treatment center that is receiving a
grant under section 501(a)(2) of the Social Security Act and that qualifies as a health
care entity, any drug indicated for a bleeding or clotting disorder, or anemia, or any
drug that is a blood derivative (or a recombinant or synthetic form of a blood derivative).
We describe and respond to the
comments on the February 2006
proposal in section II of this document.
We grouped into comment categories
those comments with similar types of
issues. To make it easier to identify the
comment category and our response, the
word ‘‘Comment,’’ in parentheses, will
appear before the comment category’s
description, and the word ‘‘Response,’’
in parentheses, will appear before our
response. We have also numbered each
comment category to help distinguish
VerDate Aug<31>2005
15:31 Oct 08, 2008
Jkt 214001
between different comment types. The
number assigned to each comment
category is purely for organizational
purposes and does not signify the
comment category’s value or importance
or the order in which a particular
comment was received.
II. Comments on the February 2006
Proposal
We received several types of
comments on the proposed rule.
PO 00000
Frm 00019
Fmt 4700
Sfmt 4700
(Comment 1) Some comments
requested that the exclusion be
expanded to allow registered blood
establishments to distribute other drugs,
in addition to blood derivatives, that are
used to treat bleeding disorders.
According to the comments, a number
of blood centers in effect act as regional
centers of transfusion medicine and as
part of their core blood-related mission
also supply their hospital customers
with certain blood-related products that
are not blood derivatives. Further, the
E:\FR\FM\09OCR1.SGM
09OCR1
erowe on PROD1PC64 with RULES
59498
Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Rules and Regulations
comments maintained that the current
system is cost-effective whereby blood
centers offer community hospitals the
full range of blood-related products and
trained personnel and expertise in
handling those products. The comments
contended that patients also benefit
from blood centers’ commitment to
maintaining an adequate supply of
blood-related products.
(Response) We agree that the
exclusion should be expanded to allow
registered blood establishments to
distribute certain drugs in addition to
blood derivatives and therefore have
modified the final rule to include within
the scope of the exclusion any:
• Drug indicated for a bleeding
disorder,
• Drug indicated for a clotting
disorder,
• Drug indicated for anemia,
• Blood collection container
approved under section 505 of the act
(21 U.S.C. 355), and
• Drug that is a blood derivative (or
a recombinant or synthetic form of a
blood derivative).
(Comment 2) One comment stated
that some blood centers, as part of their
core blood-related mission, also supply
their hospital customers with certain
blood-related products not derived from
human blood. For example, blood
centers distribute recombinant
erythropoietin, which is used to
stimulate the production of red blood
cells.
(Response) Under the final rule as
revised, drugs indicated for anemia,
such as erythropoiesis-stimulating
agents, are subject to the exclusion in
§ 203.22(h).
(Comment 3) One comment, through
a survey of blood centers, described
drugs other than blood derivatives
distributed by some blood centers.
These drugs included TRASYLOL
(aprotinin injection), STIMATE nasal
spray (desmopressin acetate nasal
spray), tetanus and diphtheria (Td)
vaccine, and the rabies vaccines
RABAVERT and IMOVAX.
(Response) The manufacturer of
TRASYLOL (aprotinin) is removing the
drug from the U.S. market due to safety
concerns and therefore at this time
access to TRASYLOL is limited to
investigational use of the drug according
to the procedures described in a special
treatment protocol. Desmopressin
acetate injection is indicated for
treatment of certain types of blood
disorders such as Hemophilia A and
von Willebrand’s disease (Type I). It is
therefore included in the § 203.22(h)
exclusion for any drug indicated for a
bleeding or clotting disorder, or anemia.
Desmopressin acetate nasal spray,
VerDate Aug<31>2005
15:31 Oct 08, 2008
Jkt 214001
however, is not indicated for a bleeding
or clotting disorder, or anemia, and it is
not a blood derivative (or a recombinant
or synthetic form of a blood derivative),
and therefore is not included within the
exclusion in § 203.22(h).
Tetanus and diphtheria (Td) vaccine
and rabies vaccines are not included
within the exclusion in § 203.22(h)
because they are not indicated for a
bleeding or clotting disorder, or anemia,
and they are not blood derivatives (or
recombinant or synthetic forms of blood
derivatives). Therefore, the further
distribution by a registered blood
establishment of Td vaccine and rabies
vaccines is prohibited by § 203.20.
(Comment 4) One comment stated
that as biotechnology advances,
additional, partial substitutes for human
blood are expected to become available.
For example, the comment noted that
hemoglobin-based oxygen carriers
derived from bovine blood are in
development. Blood centers would
logically be involved in the supply
chain of such drug products.
(Response) We agree that flexibility is
needed to provide for the potential
future development of drugs, such as
blood substitutes, that would be used to
treat bleeding disorders. For purposes of
this discussion, the use of the term
‘‘blood substitute’’ refers to products
such as hemoglobin-based oxygen
carriers, which may partially or
transitionally replace the function of
blood elements. Our intent is that the
exclusions in § 203.22(h) and (i) could
apply to a blood substitute product that
might be licensed or approved in the
future.
(Comment 5) One comment suggested
that hemophilia treatment centers
should be included within the scope of
the exclusion. According to the
comment, hemophilia treatment centers
currently play a critical role in the
distribution of clotting factor to ensure
the appropriate care of persons with
hemophilia and related bleeding
disorders. Thus, prohibiting hemophilia
treatment centers from distributing
clotting factor would have a tremendous
detrimental effect on access to care for
patients with hemophilia and related
bleeding disorders.
(Response) We agree. We recognize
the role of hemophilia treatment centers
in ensuring the appropriate care of
persons with hemophilia and related
bleeding disorders. We have revised
§ 203.22(i) to exclude from the sales
restrictions in § 203.20 the sale,
purchase, or trade of, or the offer to sell,
purchase, or trade, by a comprehensive
hemophilia diagnostic treatment center
that is receiving a grant under section
PO 00000
Frm 00020
Fmt 4700
Sfmt 4700
501(a)(2) of the Social Security Act1 and
that qualifies as a health care entity, any
drug indicated for a bleeding or clotting
disorder, or anemia; or any drug that is
a blood derivative (or a recombinant or
synthetic form of a blood derivative).
(Comment 6) One comment stated
that certain registered blood
establishments can also be hemophilia
treatment centers. According to the
comment, at least two federally funded
hemophilia treatment centers are also
registered blood establishments. The
comment expressed concern that, if
these entities provide health care
services unrelated to their activities as
a registered blood establishment, they
would not be eligible for the exclusion.
The comment suggested the final rule
should clarify that the health care
services provided by a registered blood
establishment that is also a hemophilia
treatment center should be considered
related to its activities as a registered
blood establishment. The routine
distribution of clotting factor by such an
establishment would be prohibited if it
were determined that the services it
provides to persons with hemophilia are
not considered related to its activities as
a registered blood establishment.
(Response) We agree with the issue
presented in this comment and have
modified the final rule to add an
exclusion (§ 203.22(i)) for
comprehensive hemophilia diagnostic
treatment centers receiving a grant
under section 501(a)(2) of the Social
Security Act. This exclusion does not
require that the services provided by a
comprehensive hemophilia diagnostic
treatment center be related to its
activities as a registered blood
establishment. Thus, a comprehensive
hemophilia diagnostic treatment center
that is also a registered blood
establishment may utilize the exclusion
in § 203.22(i).
(Comment 7) One comment expressed
concern that because blood centers also
distribute blood bags containing
anticoagulant, the presence of
anticoagulants in the blood bags makes
these products drugs and therefore
subjects the blood bags to the provisions
of the PDMA.
(Response) We agree with the concern
expressed in this comment. A blood bag
that contains an anticoagulant is
regulated under the drug authorities. We
do not want to interfere with current
practices and potentially create
1 Comprehensive hemophilia diagnostic treatment
centers receive funding, as part of the National
Hemophilia Program, through grants administered
by the Department of Health and Human Services
Health Resources and Services Administration
under the authority provided in section 501(a)(2) of
the Social Security Act (42 U.S.C. 701(a)(2)).
E:\FR\FM\09OCR1.SGM
09OCR1
erowe on PROD1PC64 with RULES
Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Rules and Regulations
shortages of products collected in blood
bags. Therefore, any blood collection
container approved under section 505 of
the act (i.e., a blood bag containing an
anticoagulant) is included in the
exclusion in § 203.22(h).
(Comment 8) Some comments
suggested the reference to ‘‘blood
derivatives’’ should be modified to
clarify that the exclusions cover all
antihemophilic factor, both recombinant
and plasma-derived.
(Response) We agree with these
comments and have modified the
exclusions in § 203.22(h) and (i) to
clarify that the exclusions extend to
recombinant or synthetic forms of blood
derivatives.
(Comment 9) Some comments
suggested the exclusion in § 203.22
should be broadened to include
registered blood establishments that
qualify as health care entities, as long as
any health care services they provide
are predominantly related to their
activities as a registered blood
establishment.
(Response) We believe that the
substitution of the word
‘‘predominantly’’ for ‘‘all’’ in the phrase
referring to the health care services that
a registered blood establishment
provides would make the provision too
broad and would not provide the
protections intended in the PDMA.
However, we recognize that certain
blood establishments, due to their
specialized medical expertise, routinely
collect, store and administer human
hematopoietic stem/progenitor cells and
conduct diagnostic testing of specimens
concurrently with specimens
undergoing routine donor testing. Our
intent is to not interfere with the current
practice of blood establishments to
provide these specialized health care
services. Therefore, instead of replacing
‘‘all’’ with ‘‘predominantly,’’ we
extended the exclusion in § 203.22(h) to
those registered blood establishments
that collect, process, store, or administer
human hematopoietic stem/progenitor
cells or perform diagnostic testing of
specimens provided that these
specimens are tested together with
specimens undergoing routine donor
testing. Thus, a registered blood
establishment that provides any health
care services unrelated to its activities
as a registered blood establishment is
not eligible for the exclusion provided
in the rule unless the unrelated health
care services consist of collecting,
processing, storing, or administering
human hematopoietic stem/progenitor
cells or performing diagnostic testing of
specimens provided these specimens
are tested together with specimens
undergoing routine donor testing.
VerDate Aug<31>2005
15:31 Oct 08, 2008
Jkt 214001
Examples of health care services that
we view as related to registered blood
establishments’ activities and that
would therefore allow these
establishments to utilize the exclusion
in § 203.22(h) include: Therapeutic
hemapheresis, therapeutic
phlebotomies, plasma exchange,
transfusion services, and ordinary donor
screening activities for donor suitability
(e.g., measuring a donor’s temperature,
blood pressure, and hematocrit or
hemoglobin). We also consider
preventive health care services intended
to maintain a healthy donor population,
such as administering influenza virus
vaccines and testing the levels of
prostate specific antigen and cholesterol
in potential donors, to be related
activities.
An example of a health care service
that would prevent a registered blood
establishment from utilizing the
exclusion in § 203.22(h) is
administering to a patient antibiotics
intended to treat a respiratory infection
unrelated to transfusion medicine. If a
registered blood establishment engages
in this activity, the establishment would
not be permitted to distribute any drug
indicated for a bleeding or clotting
disorder, or anemia, any blood
collection container approved under
section 505 of the act, or any drug that
is a blood derivative (or a recombinant
or synthetic form of a blood derivative).
Without this limit on the types of health
care services that may be provided, we
are concerned the rule would encourage
hospitals and other health care entities
to register as blood establishments
strictly to take advantage of this
exclusion.
(Comment 10) One comment
suggested the exclusion should extend
to any distribution of drug products
used in cellular and related biological
therapies.
(Response) The reference to cellular
and related biological therapy products
goes beyond the scope of the proposed
rule. Therefore, we decline to
incorporate these products into the
exclusions as part of this final rule.
III. Description of the Final Rule
This document modifies part 203 (21
CFR part 203) to allow a registered
blood establishment2 that provides
2 Establishment is defined as ‘‘a place of business
under one management at one general physical
location. The term includes, among others, human
blood and plasma donor centers, blood banks,
transfusion services, other blood product
manufacturers and independent laboratories that
engage in quality control and testing for registered
blood product establishments’’ (21 CFR 607.3(c)).
Owners or operators of establishments that engage
in the manufacturing of blood products are required
to register as described in 21 CFR 607.7(a).
PO 00000
Frm 00021
Fmt 4700
Sfmt 4700
59499
certain health care services3 and that
also distributes certain drugs, to
continue in both capacities. The
distribution of these drug products,
however, is permitted under this rule
only if ‘‘all of the health care services
that the [registered blood] establishment
provides are related to its activities as a
registered blood establishment or the
health care services consist of
collecting, processing, storing, or
administering human hematopoietic
stem/progenitor cells or performing
diagnostic testing of specimens
provided that these specimens are tested
together with specimens undergoing
routine donor testing.’’ This document
also modifies part 203 to allow certain
hemophilia treatment centers4 that
provide health care services and that
also distribute certain drugs to continue
in both capacities.
The final rule amends § 203.22, which
contains exclusions from the sales
restrictions in § 203.20. New paragraph
(h) provides a limited exclusion for
certain registered blood establishments
that also qualify as health care entities.
Under the exclusion, the sales
restrictions in § 203.20 would not apply
to the sale, purchase, or trade of (or the
offer to sell, purchase, or trade) any: (1)
Drug indicated for a bleeding or clotting
disorder, or anemia; or (2) blood
collection container approved under
section 505 of the act; or (3) drug that
is a blood derivative (or a recombinant
or synthetic form of a blood derivative),
by a registered blood establishment that
qualifies as a health care entity as long
as all of the health care services that the
establishment provides are related to its
activities as a registered blood
establishment or the health care services
consist of collecting, processing, storing,
or administering human hematopoietic
stem/progenitor cells or performing
diagnostic testing of specimens
provided that these specimens are tested
together with specimens undergoing
routine donor testing.
For a registered blood establishment
located within a hospital, such as a
blood bank or transfusion service, we
consider the registered blood
establishment to be that part of the
hospital that functions as a registered
blood establishment and, for the
purposes of this final rule, to be
3 Health care services are provided by a health
care entity defined in relevant part in § 203.3(q) as
‘‘any person that provides diagnostic, medical,
surgical, or dental treatment, or chronic or
rehabilitative care, but does not include any retail
pharmacy or any wholesale distributor.’’
4 The exclusion in the final rule extends to
comprehensive hemophilia diagnostic treatment
centers receiving grants under section 501(a)(2) of
the Social Security Act.
E:\FR\FM\09OCR1.SGM
09OCR1
erowe on PROD1PC64 with RULES
59500
Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Rules and Regulations
included in the § 203.22(h) exclusion. If,
however, on a case-by-case basis, the
facts show that a registered blood
establishment located in a hospital is
taking advantage of the exclusion but is
providing health care services beyond
those specified in § 203.22(h), then that
registered blood establishment is in
violation of this final rule and the
PDMA and may be subject to
administrative or regulatory action, or
criminal prosecution, for any such
violation.
New § 203.22(i) provides a limited
exclusion for certain hemophilia
treatment centers that qualify as health
care entities. Under the exclusion, the
sales restrictions in § 203.20 would not
apply to the sale, purchase, or trade of
(or the offer to sell, purchase, or trade)
any drug indicated for a bleeding or
clotting disorder, or anemia, or any drug
that is a blood derivative (or a
recombinant or synthetic form or a
blood derivative), by a comprehensive
hemophilia diagnostic treatment center
that is receiving a grant under section
501(a)(2) of the Social Security Act and
that qualifies as a health care entity.
The exclusions in § 203.22(h) and (i)
are intended to allow for the sale,
purchase, trade of (or offer to sell,
purchase, or trade) drugs related to the
hematological needs of a patient related
to bleeding, anemia, or hematological
replacement therapies. These drugs
include clotting factors such as Factor
VIII, Factor IX, and von Willebrand
Factor used to treat hemophilic
disorders; pharmaceuticals such as
tranexamic acid used to prevent
bleeding from clot lysis; and,
erythropoiesis stimulating agents used
to treat anemia. Examples of drugs that
are blood derivatives, which are
included in the exclusions, are immune
globulins, coagulation proteins, and
human serum albumin. Recombinant
and synthetic forms of blood
derivatives, such as coagulation proteins
and antihemophilic clotting factor, are
also included in the exclusions. In
addition, blood bags containing
anticoagulant are covered by the
exclusion’s provision for blood
collection containers approved under
section 505 of the act.
The exclusions in § 203.22(h) and (i)
apply only to a registered blood
establishment (§ 203.22(h)) or a
comprehensive hemophilia diagnostic
treatment center (§ 203.22(i)), and not to
other entities. These exclusions are
narrow and apply only to certain
registered blood establishments and
comprehensive hemophilia diagnostic
treatment centers that qualify as health
care entities and that meet other specific
criteria. These exclusions do not exempt
VerDate Aug<31>2005
15:31 Oct 08, 2008
Jkt 214001
The agency has determined under 21
CFR 25.30 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.
a significant economic impact on a
substantial number of small entities.
Section 202(a) of the Unfunded
Mandates Reform Act of 1995 requires
that agencies prepare a written
statement, which includes an
assessment of anticipated costs and
benefits, before proposing ‘‘any rule that
includes any Federal mandate that may
result in the expenditure by State, local,
and tribal governments, in the aggregate,
or by the private sector, of $100,000,000
or more (adjusted annually for inflation)
in any one year.’’ The current threshold
after adjustment for inflation is $130
million, using the most current (2007)
Implicit Price Deflator for the Gross
Domestic Product. FDA does not expect
this final rule to result in any 1-year
expenditure that would meet or exceed
this amount.
VI. Federalism
List of Subjects
FDA has analyzed this final rule in
accordance with the principles set forth
in Executive Order 13132. FDA has
determined that the rule does not
contain policies that have substantial
direct effects on the States, on the
relationship between the National
Government and the States, or on the
distribution of power and
responsibilities among the various
levels of government. Accordingly, the
agency has concluded that the rule does
not contain policies that have
federalism implications as defined in
the Executive order and, consequently,
a federalism summary impact statement
is not required.
21 CFR Part 203
any person or entity from the other
requirements in part 203 Prescription
Drug Marketing .
IV. Paperwork Reduction Act of 1995
This final rule contains no collections
of information. Therefore, clearance by
the Office of Management and Budget
under the Paperwork Reduction Act of
1995 (44 U.S.C. 3501–3520) (PRA) is not
required.
V. Environmental Impact
VII. Analysis of Impacts
FDA has examined the impacts of the
final rule under Executive Order 12866
and the Regulatory Flexibility Act (5
U.S.C. 601–612), and the Unfunded
Mandates Reform Act of 1995 (Public
Law 104–4). 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 net benefits
(including potential economic,
environmental, public health and safety,
and other advantages; distributive
impacts; and equity). The agency
believes that this final rule is not a
significant regulatory action under the
Executive order.
The Regulatory Flexibility Act
requires agencies to analyze regulatory
options that would minimize any
significant impact of a rule on small
entities. Because this rule proposes a
narrow revision that is intended to
maintain the status quo, the agency
certifies that the final rule will not have
PO 00000
Frm 00022
Fmt 4700
Sfmt 4700
Labeling, Prescription drugs,
Reporting and recordkeeping
requirements, Warehouses.
21 CFR Part 205
Intergovernmental relations,
Prescription drugs, Reporting and
recordkeeping requirements, Security
measures, Warehouses.
■ Therefore, under the Federal Food,
Drug, and Cosmetic Act and under the
authority delegated to the Commissioner
of Food and Drugs, 21 CFR parts 203
and 205 are amended as follows:
PART 203—PRESCRIPTION DRUG
MARKETING
1. The authority citation for 21 CFR
part 203 continues to read as follows:
■
Authority: 21 U.S.C. 331, 333, 351, 352,
353, 360, 371, 374, 381.
2. Section 203.3 is amended by
revising paragraph (q) to read as follows:
■
§ 203.3
Definitions.
*
*
*
*
*
(q) Health care entity means any
person that provides diagnostic,
medical, surgical, or dental treatment, or
chronic or rehabilitative care, but does
not include any retail pharmacy or any
wholesale distributor. Except as
provided in § 203.22(h) and (i), a person
cannot simultaneously be a ‘‘health care
entity’’ and a retail pharmacy or
wholesale distributor.
*
*
*
*
*
■ 3. Section 203.22 is amended by
adding paragraphs (h) and (i) to read as
follows:
§ 203.22
*
E:\FR\FM\09OCR1.SGM
*
Exclusions.
*
09OCR1
*
*
Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Rules and Regulations
(h) The sale, purchase, or trade of, or
the offer to sell, purchase, or trade, by
a registered blood establishment that
qualifies as a health care entity any:
(1) Drug indicated for a bleeding or
clotting disorder, or anemia;
(2) Blood collection container
approved under section 505 of the act;
or
(3) Drug that is a blood derivative (or
a recombinant or synthetic form of a
blood derivative); as long as all of the
health care services that the
establishment provides are related to its
activities as a registered blood
establishment or the health care services
consist of collecting, processing, storing,
or administering human hematopoietic
stem/progenitor cells or performing
diagnostic testing of specimens
provided that these specimens are tested
together with specimens undergoing
routine donor testing. Blood
establishments relying on the exclusion
in this paragraph must satisfy all other
requirements of the act and this part
applicable to a wholesale distributor or
retail pharmacy.
(i) The sale, purchase, or trade of, or
the offer to sell, purchase, or trade, by
a comprehensive hemophilia diagnostic
treatment center that is receiving a grant
under section 501(a)(2) of the Social
Security Act and that qualifies as a
health care entity, any drug indicated
for a bleeding or clotting disorder, or
anemia, or any drug that is a blood
derivative (or a recombinant or
synthetic form of a blood derivative).
Comprehensive hemophilia diagnostic
treatment centers relying on the
exclusion in this paragraph must satisfy
all other requirements of the act and this
part applicable to a wholesale
distributor or retail pharmacy.
PART 205—GUIDELINES FOR STATE
LICENSING OF WHOLESALE
PRESCRIPTION DRUG DISTRIBUTORS
4. The authority citation for 21 CFR
part 205 continues to read as follows:
■
Definitions.
erowe on PROD1PC64 with RULES
*
*
*
*
(h) Health care entity means any
person that provides diagnostic,
medical, surgical, or dental treatment, or
chronic or rehabilitative care, but does
not include any retail pharmacy or any
wholesale distributor. Except as
provided in § 203.22(h) and (i) of this
chapter, a person cannot simultaneously
VerDate Aug<31>2005
15:31 Oct 08, 2008
Jkt 214001
BILLING CODE 4160–01–S
Correction of Publication
Accordingly, 26 CFR part 1 is
corrected by making the following
correcting amendment:
■
PART 1—INCOME TAXES
Paragraph 1. The authority citation
for part 1 continues to read, in part, as
follows:
■
Authority: 26 U.S.C. 7805 * * *
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 1
[TD 8073]
Income, Excise, and Estate and Gift
Taxes; Effective Dates and Other
Issues Arising Under the Employee
Benefit Provisions of the Tax Reform
Act of 1984; Correction
Internal Revenue Service (IRS),
Treasury.
ACTION: Correcting amendment.
AGENCY:
SUMMARY: This document contains a
correction to temporary regulations (TD
8073) that were published in the
Federal Register on Tuesday, February
4, 1986 (51 FR 4312) relating to effective
dates and certain other issues arising
under sections 91, 223, and 511–561 of
the Tax Reform Act of 1984. This action
is necessary because of changes to the
applicable tax law made by the Tax
Reform Act of 1984. The temporary
regulations will affect qualified
employee benefit plans, welfare benefit
funds and employees receiving benefits
through such plans.
DATES: This correction is effective
October 9, 2008, and is applicable after
December 31, 1985.
FOR FURTHER INFORMATION CONTACT:
Melissa A. D’Ambrose, (202) 622–6080
(not a toll-free number).
SUPPLEMENTARY INFORMATION:
The temporary regulations that are the
subject of this document are under
sections 72, 79, 125, 133, 402, 404, 419,
461, 463, 505, 512, and 1042 of the
Internal Revenue Code.
5. Section 205.3 is amended by
revising paragraph (h) to read as
follows:
■
*
Dated: October 3, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–24050 Filed 10–8–08; 8:45 am]
Background
Authority: 21 U.S.C. 351, 352, 353, 371,
374.
§ 205.3
be a ‘‘health care entity’’ and a retail
pharmacy or wholesale distributor.
59501
Need for Correction
As published, temporary regulations
(TD 8073) contain an error that may
prove to be misleading and is in need
of clarification.
List of Subjects in 26 CFR Part 1
Income taxes, Reporting and
recordkeeping requirements.
PO 00000
Frm 00023
Fmt 4700
Sfmt 4700
Par. 2. Section 1.512(a)–5T A–3: (b) is
amended by revising the second
sentence to read as follows:
■
§ 1.512(a)–5T Questions and answers
relating to the unrelated business taxable
income of organizations described in
paragraphs (9), (17) or (20) of section 501(c)
(temporary).
*
*
*
*
*
A–3: * * *
(b) * * * For purposes of section
512(a)(3)(B), member contributions
include both employee contributions
and employer contributions to the
VEBA, SUB, or GLSO.
*
*
*
*
*
LaNita Van Dyke,
Chief, Publications and Regulations Branch,
Legal Processing Division, Associate Chief
Counsel (Procedure and Administration).
[FR Doc. E8–23917 Filed 10–8–08; 8:45 am]
BILLING CODE 4830–01–P
DEPARTMENT OF DEFENSE
Office of the Secretary
[DOD–2007–OS–0025]
RIN 0790–AI08
32 CFR Part 112
Indebtedness of Military Personnel
Department of Defense.
Final rule.
AGENCY:
ACTION:
SUMMARY: This part contains uniform
Department of Defense policies for
indebtedness of military personnel. This
updated rule contains editorial changes
only as required for internal Department
of Defense mandated reconsideration
every five years.
DATES: Effective Date: This rule is
effective November 10, 2008.
FOR FURTHER INFORMATION CONTACT:
Lieutenant Colonel Tom Williams,
Office of the Deputy Under Secretary of
Defense for Program Integration, 4000
Defense Pentagon, Washington, DC
20301–4000.
SUPPLEMENTARY INFORMATION: The
proposed rule was published on April
17, 2007 at 72 FR 19136. One editorial
E:\FR\FM\09OCR1.SGM
09OCR1
]]>Agencies
[Federal Register Volume 73, Number 197 (Thursday, October 9, 2008)]
[Rules and Regulations]
[Pages 59496-59501]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-24050]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 203 and 205
[Docket No. FDA-2005-N-0345] (formerly Docket No. 2005N-0428)
Distribution of Certain Drug Products by Registered Blood
Establishments and Comprehensive Hemophilia Diagnostic Treatment
Centers That Qualify as Health Care Entities; Prescription Drug
Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies,
Requirements and Administrative Procedures
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending its
regulations to allow certain registered blood establishments and
comprehensive hemophilia diagnostic treatment centers that are also
health care entities to distribute certain drug products. The final
rule amends limited provisions of the regulations implementing the
Prescription Drug Marketing Act of 1987 (PDMA), as modified by the
Prescription Drug Amendments of 1992 (PDA). These regulations, among
other things, restrict the sale, purchase, or trade of, or the offer to
sell, purchase, or trade, prescription drugs purchased by hospitals and
other health care entities.
DATES: This rule is effective November 10, 2008.
FOR FURTHER INFORMATION CONTACT: Jennifer J. Ross, Center for Biologics
Evaluation and Research (HFM-10), Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-0372.
SUPPLEMENTARY INFORMATION:
I. Background
The PDMA (Public Law 100-293) was enacted on April 22, 1988, and
was modified by the PDA (Public Law 102-353) on August 26, 1992. The
PDMA, as modified, amended the Federal Food, Drug, and Cosmetic Act
(the act) to establish restrictions and requirements relating to
various aspects of human prescription drug marketing and distribution.
Among other things, the PDMA prohibited, with certain exceptions, the
sale, purchase, or trade (or offer to sell, purchase, or trade) of any
prescription drug that was purchased by a hospital or other health care
entity. Section 503(c)(3)(A)(ii)(I) of the act (21 U.S.C.
353(c)(3)(A)(ii)(I)). Section 503(c)(3) also states that ``[f]or
purposes of this paragraph, the term `entity' does not include a
wholesale distributor of drugs or a retail pharmacy licensed under
State law * * *.''
In the Federal Register of March 14, 1994 (59 FR 11842), we issued
a proposed rule to implement certain provisions of the PDMA. The
proposed rule contained provisions on prescription drug reimportation;
wholesale distribution of prescription drugs by unauthorized
distributors; the resale of prescription drugs by hospitals, health
care entities, and charitable institutions; and distribution of
prescription drug samples. After consideration of comments, we issued a
final rule in the Federal Register of December 3, 1999 (64 FR 67720)
(the December 1999 final rule), with an effective date of December 4,
2000.
After publication of the December 1999 final rule, we received many
comments on, and held several meetings to discuss the implications of,
the final regulations for registered blood establishments that
distribute blood-derived products and provide limited health care
services to hospitals and patients. According to comments, implementing
the December 1999 final rule as published would interfere with
longstanding relationships between blood centers and other health care
providers such as hospitals and hemophilia treatment centers.
Section 203.20(a) (21 CFR 203.20(a)) of the December 1999 final
rule stated, in relevant part, that no person may sell, purchase, or
trade, or offer to sell, purchase, or trade any prescription drug that
was purchased by a health care entity. ``Health care entity,'' in turn,
was defined in Sec. 203.3(q) (21 CFR 203.3(q))
[[Page 59497]]
as any person that provides diagnostic, medical, surgical, or dental
treatment, or chronic or rehabilitative care, but did not include any
retail pharmacy or wholesale distributor. That definition specifically
stated that ``[a] person cannot simultaneously be a `health care
entity' and a retail pharmacy or wholesale distributor.''
Thus, under the December 1999 final rule as written, blood
establishments and hemophilia treatment centers functioning as health
care entities would be prohibited from engaging in wholesale
distribution of prescription drugs except for blood and blood
components intended for transfusion, which are exempted from the
regulations under Sec. 203.1 (21 CFR 203.1) (see also 21 CFR
203.22(g)). As discussed in the preamble to the December 1999 final
rule (64 FR 67720 at 67725 to 67727), blood derivatives are not blood
components and were therefore subject to this prohibition on wholesale
distribution. Therefore, under the December 1999 final rule, a blood
establishment or a hemophilia treatment center could not generally
resell blood derivatives to entities other than consumers or patients
and simultaneously provide health care, such as medical services
associated with those products. Examples of blood derivatives that are
prescription drugs include, but are not limited to, albumin,
antihemophilic factor, Coagulation Factor IX, alpha-1 proteinase
inhibitor, and immune globulin.
On May 3, 2000, we delayed until October 1, 2001, the effective
date of several provisions of the December 1999 final rule and reopened
the administrative record (65 FR 25639). In the Federal Register of
March 1, 2001 (66 FR 12850), we announced our decision to further delay
until April 1, 2002, the applicability of Sec. 203.3(q) (definition of
``health care entity'') to the wholesale distribution of blood
derivatives by health care entities. Further delays of effective dates
followed until December 1, 2008, to give us additional time to consider
whether regulatory changes were appropriate and, if so, to initiate
such changes (67 FR 6645, February 13, 2002; 68 FR 4912, January 31,
2003; 69 FR 8105, February 23, 2004; 71 FR 66108, November 13, 2006).
In the Federal Register of February 1, 2006 (71 FR 5200), we
published a proposed rule (the February 2006 proposal) to amend Sec.
203.22, which excludes certain activities from the sales restrictions
in Sec. 203.20. As proposed, Sec. 203.22 would have provided a
limited exclusion for registered blood establishments that qualify as
health care entities. The February 2006 proposal, as a result, would
have allowed certain registered blood establishments that qualify as
health care entities to distribute blood derivatives. The proposal
sought information about the functions of registered blood
establishments to assist us in determining whether further modification
of the December 1999 final rule would be warranted in the interest of
public health. We also requested comments on whether the proposal
should be expanded to allow registered blood establishments that also
provide health care services to distribute drugs other than blood
derivatives that might be used to treat blood disorders. In addition,
we sought comment on whether hemophilia treatment centers should be
included within the scope of the exclusion.
After reviewing the comments on the February 2006 proposal, we have
made several changes to the rule, as described in the following table:
Table 1.--Principal Changes Between the Proposed and Final Rule
------------------------------------------------------------------------
Proposed Rule Final Rule
------------------------------------------------------------------------
Exclusion would apply to a Exclusion applies to a registered blood
registered blood establishment that qualifies as a health
establishment that care entity, as long as all of the health
qualifies as a health care care services that the establishment
entity, as long as all of provides are related to its activities as
the health care services a registered blood establishment or the
that it provides are health care services consist of
related to its activities collecting, processing, storing, or
as a registered blood administering human hematopoietic stem/
establishment. progenitor cells or performing diagnostic
testing of specimens provided that these
specimens are tested together with routine
donor testing.
------------------------------------------------------------------------
Exclusion would apply to Exclusion applies to the sale, purchase, or
the sale, purchase, or trade of, or the offer to sell, purchase,
trade of, or the offer to or trade any: (1) Drug indicated for a
sell, purchase, or trade bleeding or clotting disorder, or anemia;
any blood derivative. (2) blood collection container approved
under section 505 of the act; or (3) drug
that is a blood derivative (or a
recombinant or synthetic form of a blood
derivative).
------------------------------------------------------------------------
Exclusion did not apply to Exclusion applies to the sale, purchase, or
hemophilia treatment trade of, or the offer to sell, purchase,
centers. or trade, by a comprehensive hemophilia
diagnostic treatment center that is
receiving a grant under section 501(a)(2)
of the Social Security Act and that
qualifies as a health care entity, any
drug indicated for a bleeding or clotting
disorder, or anemia, or any drug that is a
blood derivative (or a recombinant or
synthetic form of a blood derivative).
------------------------------------------------------------------------
We describe and respond to the comments on the February 2006
proposal in section II of this document. We grouped into comment
categories those comments with similar types of issues. To make it
easier to identify the comment category and our response, the word
``Comment,'' in parentheses, will appear before the comment category's
description, and the word ``Response,'' in parentheses, will appear
before our response. We have also numbered each comment category to
help distinguish between different comment types. The number assigned
to each comment category is purely for organizational purposes and does
not signify the comment category's value or importance or the order in
which a particular comment was received.
II. Comments on the February 2006 Proposal
We received several types of comments on the proposed rule.
(Comment 1) Some comments requested that the exclusion be expanded
to allow registered blood establishments to distribute other drugs, in
addition to blood derivatives, that are used to treat bleeding
disorders. According to the comments, a number of blood centers in
effect act as regional centers of transfusion medicine and as part of
their core blood-related mission also supply their hospital customers
with certain blood-related products that are not blood derivatives.
Further, the
[[Page 59498]]
comments maintained that the current system is cost-effective whereby
blood centers offer community hospitals the full range of blood-related
products and trained personnel and expertise in handling those
products. The comments contended that patients also benefit from blood
centers' commitment to maintaining an adequate supply of blood-related
products.
(Response) We agree that the exclusion should be expanded to allow
registered blood establishments to distribute certain drugs in addition
to blood derivatives and therefore have modified the final rule to
include within the scope of the exclusion any:
Drug indicated for a bleeding disorder,
Drug indicated for a clotting disorder,
Drug indicated for anemia,
Blood collection container approved under section 505 of
the act (21 U.S.C. 355), and
Drug that is a blood derivative (or a recombinant or
synthetic form of a blood derivative).
(Comment 2) One comment stated that some blood centers, as part of
their core blood-related mission, also supply their hospital customers
with certain blood-related products not derived from human blood. For
example, blood centers distribute recombinant erythropoietin, which is
used to stimulate the production of red blood cells.
(Response) Under the final rule as revised, drugs indicated for
anemia, such as erythropoiesis-stimulating agents, are subject to the
exclusion in Sec. 203.22(h).
(Comment 3) One comment, through a survey of blood centers,
described drugs other than blood derivatives distributed by some blood
centers. These drugs included TRASYLOL (aprotinin injection), STIMATE
nasal spray (desmopressin acetate nasal spray), tetanus and diphtheria
(Td) vaccine, and the rabies vaccines RABAVERT and IMOVAX.
(Response) The manufacturer of TRASYLOL (aprotinin) is removing the
drug from the U.S. market due to safety concerns and therefore at this
time access to TRASYLOL is limited to investigational use of the drug
according to the procedures described in a special treatment protocol.
Desmopressin acetate injection is indicated for treatment of certain
types of blood disorders such as Hemophilia A and von Willebrand's
disease (Type I). It is therefore included in the Sec. 203.22(h)
exclusion for any drug indicated for a bleeding or clotting disorder,
or anemia. Desmopressin acetate nasal spray, however, is not indicated
for a bleeding or clotting disorder, or anemia, and it is not a blood
derivative (or a recombinant or synthetic form of a blood derivative),
and therefore is not included within the exclusion in Sec. 203.22(h).
Tetanus and diphtheria (Td) vaccine and rabies vaccines are not
included within the exclusion in Sec. 203.22(h) because they are not
indicated for a bleeding or clotting disorder, or anemia, and they are
not blood derivatives (or recombinant or synthetic forms of blood
derivatives). Therefore, the further distribution by a registered blood
establishment of Td vaccine and rabies vaccines is prohibited by Sec.
203.20.
(Comment 4) One comment stated that as biotechnology advances,
additional, partial substitutes for human blood are expected to become
available. For example, the comment noted that hemoglobin-based oxygen
carriers derived from bovine blood are in development. Blood centers
would logically be involved in the supply chain of such drug products.
(Response) We agree that flexibility is needed to provide for the
potential future development of drugs, such as blood substitutes, that
would be used to treat bleeding disorders. For purposes of this
discussion, the use of the term ``blood substitute'' refers to products
such as hemoglobin-based oxygen carriers, which may partially or
transitionally replace the function of blood elements. Our intent is
that the exclusions in Sec. 203.22(h) and (i) could apply to a blood
substitute product that might be licensed or approved in the future.
(Comment 5) One comment suggested that hemophilia treatment centers
should be included within the scope of the exclusion. According to the
comment, hemophilia treatment centers currently play a critical role in
the distribution of clotting factor to ensure the appropriate care of
persons with hemophilia and related bleeding disorders. Thus,
prohibiting hemophilia treatment centers from distributing clotting
factor would have a tremendous detrimental effect on access to care for
patients with hemophilia and related bleeding disorders.
(Response) We agree. We recognize the role of hemophilia treatment
centers in ensuring the appropriate care of persons with hemophilia and
related bleeding disorders. We have revised Sec. 203.22(i) to exclude
from the sales restrictions in Sec. 203.20 the sale, purchase, or
trade of, or the offer to sell, purchase, or trade, by a comprehensive
hemophilia diagnostic treatment center that is receiving a grant under
section 501(a)(2) of the Social Security Act\1\ and that qualifies as a
health care entity, any drug indicated for a bleeding or clotting
disorder, or anemia; or any drug that is a blood derivative (or a
recombinant or synthetic form of a blood derivative).
---------------------------------------------------------------------------
\1\ Comprehensive hemophilia diagnostic treatment centers
receive funding, as part of the National Hemophilia Program, through
grants administered by the Department of Health and Human Services
Health Resources and Services Administration under the authority
provided in section 501(a)(2) of the Social Security Act (42 U.S.C.
701(a)(2)).
---------------------------------------------------------------------------
(Comment 6) One comment stated that certain registered blood
establishments can also be hemophilia treatment centers. According to
the comment, at least two federally funded hemophilia treatment centers
are also registered blood establishments. The comment expressed concern
that, if these entities provide health care services unrelated to their
activities as a registered blood establishment, they would not be
eligible for the exclusion. The comment suggested the final rule should
clarify that the health care services provided by a registered blood
establishment that is also a hemophilia treatment center should be
considered related to its activities as a registered blood
establishment. The routine distribution of clotting factor by such an
establishment would be prohibited if it were determined that the
services it provides to persons with hemophilia are not considered
related to its activities as a registered blood establishment.
(Response) We agree with the issue presented in this comment and
have modified the final rule to add an exclusion (Sec. 203.22(i)) for
comprehensive hemophilia diagnostic treatment centers receiving a grant
under section 501(a)(2) of the Social Security Act. This exclusion does
not require that the services provided by a comprehensive hemophilia
diagnostic treatment center be related to its activities as a
registered blood establishment. Thus, a comprehensive hemophilia
diagnostic treatment center that is also a registered blood
establishment may utilize the exclusion in Sec. 203.22(i).
(Comment 7) One comment expressed concern that because blood
centers also distribute blood bags containing anticoagulant, the
presence of anticoagulants in the blood bags makes these products drugs
and therefore subjects the blood bags to the provisions of the PDMA.
(Response) We agree with the concern expressed in this comment. A
blood bag that contains an anticoagulant is regulated under the drug
authorities. We do not want to interfere with current practices and
potentially create
[[Page 59499]]
shortages of products collected in blood bags. Therefore, any blood
collection container approved under section 505 of the act (i.e., a
blood bag containing an anticoagulant) is included in the exclusion in
Sec. 203.22(h).
(Comment 8) Some comments suggested the reference to ``blood
derivatives'' should be modified to clarify that the exclusions cover
all antihemophilic factor, both recombinant and plasma-derived.
(Response) We agree with these comments and have modified the
exclusions in Sec. 203.22(h) and (i) to clarify that the exclusions
extend to recombinant or synthetic forms of blood derivatives.
(Comment 9) Some comments suggested the exclusion in Sec. 203.22
should be broadened to include registered blood establishments that
qualify as health care entities, as long as any health care services
they provide are predominantly related to their activities as a
registered blood establishment.
(Response) We believe that the substitution of the word
``predominantly'' for ``all'' in the phrase referring to the health
care services that a registered blood establishment provides would make
the provision too broad and would not provide the protections intended
in the PDMA. However, we recognize that certain blood establishments,
due to their specialized medical expertise, routinely collect, store
and administer human hematopoietic stem/progenitor cells and conduct
diagnostic testing of specimens concurrently with specimens undergoing
routine donor testing. Our intent is to not interfere with the current
practice of blood establishments to provide these specialized health
care services. Therefore, instead of replacing ``all'' with
``predominantly,'' we extended the exclusion in Sec. 203.22(h) to
those registered blood establishments that collect, process, store, or
administer human hematopoietic stem/progenitor cells or perform
diagnostic testing of specimens provided that these specimens are
tested together with specimens undergoing routine donor testing. Thus,
a registered blood establishment that provides any health care services
unrelated to its activities as a registered blood establishment is not
eligible for the exclusion provided in the rule unless the unrelated
health care services consist of collecting, processing, storing, or
administering human hematopoietic stem/progenitor cells or performing
diagnostic testing of specimens provided these specimens are tested
together with specimens undergoing routine donor testing.
Examples of health care services that we view as related to
registered blood establishments' activities and that would therefore
allow these establishments to utilize the exclusion in Sec. 203.22(h)
include: Therapeutic hemapheresis, therapeutic phlebotomies, plasma
exchange, transfusion services, and ordinary donor screening activities
for donor suitability (e.g., measuring a donor's temperature, blood
pressure, and hematocrit or hemoglobin). We also consider preventive
health care services intended to maintain a healthy donor population,
such as administering influenza virus vaccines and testing the levels
of prostate specific antigen and cholesterol in potential donors, to be
related activities.
An example of a health care service that would prevent a registered
blood establishment from utilizing the exclusion in Sec. 203.22(h) is
administering to a patient antibiotics intended to treat a respiratory
infection unrelated to transfusion medicine. If a registered blood
establishment engages in this activity, the establishment would not be
permitted to distribute any drug indicated for a bleeding or clotting
disorder, or anemia, any blood collection container approved under
section 505 of the act, or any drug that is a blood derivative (or a
recombinant or synthetic form of a blood derivative). Without this
limit on the types of health care services that may be provided, we are
concerned the rule would encourage hospitals and other health care
entities to register as blood establishments strictly to take advantage
of this exclusion.
(Comment 10) One comment suggested the exclusion should extend to
any distribution of drug products used in cellular and related
biological therapies.
(Response) The reference to cellular and related biological therapy
products goes beyond the scope of the proposed rule. Therefore, we
decline to incorporate these products into the exclusions as part of
this final rule.
III. Description of the Final Rule
This document modifies part 203 (21 CFR part 203) to allow a
registered blood establishment\2\ that provides certain health care
services\3\ and that also distributes certain drugs, to continue in
both capacities. The distribution of these drug products, however, is
permitted under this rule only if ``all of the health care services
that the [registered blood] establishment provides are related to its
activities as a registered blood establishment or the health care
services consist of collecting, processing, storing, or administering
human hematopoietic stem/progenitor cells or performing diagnostic
testing of specimens provided that these specimens are tested together
with specimens undergoing routine donor testing.'' This document also
modifies part 203 to allow certain hemophilia treatment centers\4\ that
provide health care services and that also distribute certain drugs to
continue in both capacities.
---------------------------------------------------------------------------
\2\ Establishment is defined as ``a place of business under one
management at one general physical location. The term includes,
among others, human blood and plasma donor centers, blood banks,
transfusion services, other blood product manufacturers and
independent laboratories that engage in quality control and testing
for registered blood product establishments'' (21 CFR 607.3(c)).
Owners or operators of establishments that engage in the
manufacturing of blood products are required to register as
described in 21 CFR 607.7(a).
\3\ Health care services are provided by a health care entity
defined in relevant part in Sec. 203.3(q) as ``any person that
provides diagnostic, medical, surgical, or dental treatment, or
chronic or rehabilitative care, but does not include any retail
pharmacy or any wholesale distributor.''
\4\ The exclusion in the final rule extends to comprehensive
hemophilia diagnostic treatment centers receiving grants under
section 501(a)(2) of the Social Security Act.
---------------------------------------------------------------------------
The final rule amends Sec. 203.22, which contains exclusions from
the sales restrictions in Sec. 203.20. New paragraph (h) provides a
limited exclusion for certain registered blood establishments that also
qualify as health care entities. Under the exclusion, the sales
restrictions in Sec. 203.20 would not apply to the sale, purchase, or
trade of (or the offer to sell, purchase, or trade) any: (1) Drug
indicated for a bleeding or clotting disorder, or anemia; or (2) blood
collection container approved under section 505 of the act; or (3) drug
that is a blood derivative (or a recombinant or synthetic form of a
blood derivative), by a registered blood establishment that qualifies
as a health care entity as long as all of the health care services that
the establishment provides are related to its activities as a
registered blood establishment or the health care services consist of
collecting, processing, storing, or administering human hematopoietic
stem/progenitor cells or performing diagnostic testing of specimens
provided that these specimens are tested together with specimens
undergoing routine donor testing.
For a registered blood establishment located within a hospital,
such as a blood bank or transfusion service, we consider the registered
blood establishment to be that part of the hospital that functions as a
registered blood establishment and, for the purposes of this final
rule, to be
[[Page 59500]]
included in the Sec. 203.22(h) exclusion. If, however, on a case-by-
case basis, the facts show that a registered blood establishment
located in a hospital is taking advantage of the exclusion but is
providing health care services beyond those specified in Sec.
203.22(h), then that registered blood establishment is in violation of
this final rule and the PDMA and may be subject to administrative or
regulatory action, or criminal prosecution, for any such violation.
New Sec. 203.22(i) provides a limited exclusion for certain
hemophilia treatment centers that qualify as health care entities.
Under the exclusion, the sales restrictions in Sec. 203.20 would not
apply to the sale, purchase, or trade of (or the offer to sell,
purchase, or trade) any drug indicated for a bleeding or clotting
disorder, or anemia, or any drug that is a blood derivative (or a
recombinant or synthetic form or a blood derivative), by a
comprehensive hemophilia diagnostic treatment center that is receiving
a grant under section 501(a)(2) of the Social Security Act and that
qualifies as a health care entity.
The exclusions in Sec. 203.22(h) and (i) are intended to allow for
the sale, purchase, trade of (or offer to sell, purchase, or trade)
drugs related to the hematological needs of a patient related to
bleeding, anemia, or hematological replacement therapies. These drugs
include clotting factors such as Factor VIII, Factor IX, and von
Willebrand Factor used to treat hemophilic disorders; pharmaceuticals
such as tranexamic acid used to prevent bleeding from clot lysis; and,
erythropoiesis stimulating agents used to treat anemia. Examples of
drugs that are blood derivatives, which are included in the exclusions,
are immune globulins, coagulation proteins, and human serum albumin.
Recombinant and synthetic forms of blood derivatives, such as
coagulation proteins and antihemophilic clotting factor, are also
included in the exclusions. In addition, blood bags containing
anticoagulant are covered by the exclusion's provision for blood
collection containers approved under section 505 of the act.
The exclusions in Sec. 203.22(h) and (i) apply only to a
registered blood establishment (Sec. 203.22(h)) or a comprehensive
hemophilia diagnostic treatment center (Sec. 203.22(i)), and not to
other entities. These exclusions are narrow and apply only to certain
registered blood establishments and comprehensive hemophilia diagnostic
treatment centers that qualify as health care entities and that meet
other specific criteria. These exclusions do not exempt any person or
entity from the other requirements in part 203 Prescription Drug
Marketing .
IV. Paperwork Reduction Act of 1995
This final rule contains no collections of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3520) (PRA) is not required.
V. Environmental Impact
The agency has determined under 21 CFR 25.30 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.
VI. Federalism
FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies that have substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, the agency has concluded
that the rule does not contain policies that have federalism
implications as defined in the Executive order and, consequently, a
federalism summary impact statement is not required.
VII. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). 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 net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this final rule is not a significant regulatory action under the
Executive order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because this rule proposes a narrow revision that is
intended to maintain the status quo, the agency certifies that the
final rule will not have a significant economic impact on a substantial
number of small entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $130 million, using the most current (2007) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.
List of Subjects
21 CFR Part 203
Labeling, Prescription drugs, Reporting and recordkeeping
requirements, Warehouses.
21 CFR Part 205
Intergovernmental relations, Prescription drugs, Reporting and
recordkeeping requirements, Security measures, Warehouses.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under the
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
203 and 205 are amended as follows:
PART 203--PRESCRIPTION DRUG MARKETING
0
1. The authority citation for 21 CFR part 203 continues to read as
follows:
Authority: 21 U.S.C. 331, 333, 351, 352, 353, 360, 371, 374,
381.
0
2. Section 203.3 is amended by revising paragraph (q) to read as
follows:
Sec. 203.3 Definitions.
* * * * *
(q) Health care entity means any person that provides diagnostic,
medical, surgical, or dental treatment, or chronic or rehabilitative
care, but does not include any retail pharmacy or any wholesale
distributor. Except as provided in Sec. 203.22(h) and (i), a person
cannot simultaneously be a ``health care entity'' and a retail pharmacy
or wholesale distributor.
* * * * *
0
3. Section 203.22 is amended by adding paragraphs (h) and (i) to read
as follows:
Sec. 203.22 Exclusions.
* * * * *
[[Page 59501]]
(h) The sale, purchase, or trade of, or the offer to sell,
purchase, or trade, by a registered blood establishment that qualifies
as a health care entity any:
(1) Drug indicated for a bleeding or clotting disorder, or anemia;
(2) Blood collection container approved under section 505 of the
act; or
(3) Drug that is a blood derivative (or a recombinant or synthetic
form of a blood derivative); as long as all of the health care services
that the establishment provides are related to its activities as a
registered blood establishment or the health care services consist of
collecting, processing, storing, or administering human hematopoietic
stem/progenitor cells or performing diagnostic testing of specimens
provided that these specimens are tested together with specimens
undergoing routine donor testing. Blood establishments relying on the
exclusion in this paragraph must satisfy all other requirements of the
act and this part applicable to a wholesale distributor or retail
pharmacy.
(i) The sale, purchase, or trade of, or the offer to sell,
purchase, or trade, by a comprehensive hemophilia diagnostic treatment
center that is receiving a grant under section 501(a)(2) of the Social
Security Act and that qualifies as a health care entity, any drug
indicated for a bleeding or clotting disorder, or anemia, or any drug
that is a blood derivative (or a recombinant or synthetic form of a
blood derivative). Comprehensive hemophilia diagnostic treatment
centers relying on the exclusion in this paragraph must satisfy all
other requirements of the act and this part applicable to a wholesale
distributor or retail pharmacy.
PART 205--GUIDELINES FOR STATE LICENSING OF WHOLESALE PRESCRIPTION
DRUG DISTRIBUTORS
0
4. The authority citation for 21 CFR part 205 continues to read as
follows:
Authority: 21 U.S.C. 351, 352, 353, 371, 374.
0
5. Section 205.3 is amended by revising paragraph (h) to read as
follows:
Sec. 205.3 Definitions.
* * * * *
(h) Health care entity means any person that provides diagnostic,
medical, surgical, or dental treatment, or chronic or rehabilitative
care, but does not include any retail pharmacy or any wholesale
distributor. Except as provided in Sec. 203.22(h) and (i) of this
chapter, a person cannot simultaneously be a ``health care entity'' and
a retail pharmacy or wholesale distributor.
Dated: October 3, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-24050 Filed 10-8-08; 8:45 am]
BILLING CODE 4160-01-S
