59496 Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Rules and Regulations 

FDC date State City Airport FDC 

No. Subject 

07/10/08 ...... MI ......... MANISTEE ...................... MANISTEE CO.–BLACKER ................ 8/6401 VOR RWY 27, ORIG 

09/04/08 ...... GQ ....... AGANA ............................ GUAM INTL ......................................... 8/6576 ILS OR LOC/DME RWY 6L, 

AMDT 3B 

09/05/08 ...... CO ........ DENVER ......................... ROCKY MOUNTAIN METROPOLITAN 8/6770 GPS RWY 29L, ORIG–A 

09/05/08 ...... CO ........ DENVER ......................... ROCKY MOUNTAIN METROPOLITAN 8/6771 GPS RWY 29R, ORIG–A 

09/05/08 ...... MT ........ BUTTE ............................. BERT MOONEY .................................. 8/6864 ILS Y RWY 15, AMDT 6 

09/05/08 ...... MT ........ ANACONDA .................... BOWMAN FIELD ................................. 8/6866 VOR/DME OR GPS A, AMDT 1 

09/05/08 ...... OR ........ EUGENE ......................... MAHLON SWEET FIELD .................... 8/6867 ILS OR LOC/DME RWY 16L, 

ORIG 

09/05/08 ...... AK ........ PERRYVILLE .................. PERRYVILLE ....................................... 8/6868 RNAV (GPS) RWY 2, ORIG 

09/08/08 ...... KY ........ DANVILLE ....................... STUART POWELL FIELD ................... 8/7015 LOC/DME RWY 30, AMDT 1A 

09/08/08 ...... AR ........ FORT SMITH .................. FORT SMITH RGNL ............................ 8/7062 RNAV (GPS) RWY 7, ORIG–B 

09/08/08 ...... AR ........ FORT SMITH .................. FORT SMITH RGNL ............................ 8/7064 VOR/DME OR TACAN RWY 7, 

AMDT 11B 

09/08/08 ...... AR ........ FORT SMITH .................. FORT SMITH RGNL ............................ 8/7065 RNAV (GPS) RWY 25, ORIG–B

09/08/08 ...... AR ........ FORT SMITH .................. FORT SMITH RGNL ............................ 8/7067 ILS OR LOC RWY 25, AMDT 

21D 

09/08/08 ...... AR ........ FORT SMITH .................. FORT SMITH RGNL ............................ 8/7068 ILS OR LOC RWY 7, ORIG–B 

09/08/08 ...... AR ........ FORT SMITH .................. FORT SMITH RGNL ............................ 8/7069 VOR OR TACAN RWY 25, 

AMDT 20G 

09/10/08 ...... OK ........ TULSA ............................. TULSA INTL ......................................... 8/7352 ILS OR LOC RWY 18R, AMDT 7 

09/10/08 ...... CA ........ VAN NUYS ...................... VAN NUYS ........................................... 8/7460 ILS RWY 16R, AMDT 5A 

09/11/08 ...... VA ........ DUBLIN ........................... NEW RIVER VALLEY .......................... 8/7673 ILS OR LOC RWY 6, AMDT 4A 

09/12/08 ...... LA ........ LAFAYETTE .................... LAFAYETTE REGIONAL ..................... 8/7965 TAKEOFF MINIMUMS AND (OBSTACLE) DEPARTURE PROCEDURES (ODP), AMDT 1 

[FR Doc. E8–23916 Filed 10–8–08; 8:45 am] 

BILLING CODE 4910–13–P 

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 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)) 


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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 

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 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 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. 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 

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 


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59498 Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Rules and Regulations 

1Comprehensive 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)). 

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, 

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 

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 


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Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Rules and Regulations 59499 

2Establishment 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). 

3Health 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.’’ 

4The exclusion in the final rule extends to 

comprehensive hemophilia diagnostic treatment 

centers receiving grants under section 501(a)(2) of 

the Social Security Act. 

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. 

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 

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 


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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 

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. 

■ 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 Exclusions. 

* * * * * 


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Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Rules and Regulations 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 

■ 4. The authority citation for 21 CFR 

part 205 continues to read as follows: 

Authority: 21 U.S.C. 351, 352, 353, 371, 

374. 

■ 5. Section 205.3 is amended by 

revising paragraph (h) to read as 

follows: 

§ 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 § 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 

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 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Correcting amendment. 

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: 

Background 

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. 

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. 

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 * * * 

■ 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 

AGENCY: Department of Defense. 

ACTION: Final rule. 

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 


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