[Federal Register Volume 73, Number 197 (Thursday, October 9, 2008)]
[Rules and Regulations]
[Pages 59496-59501]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-24050]


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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.

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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
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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.
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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).
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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:
    <bullet> Drug indicated for a bleeding disorder,
    <bullet> Drug indicated for a clotting disorder,
    <bullet> Drug indicated for anemia,
    <bullet> Blood collection container approved under section 505 of 
the act (21 U.S.C. 355), and
    <bullet> 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).
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    \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)).
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    (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.
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    \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.
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    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