37402 Federal Register / Vol. 68, No. 121 / Tuesday, June 24, 2003 / Rules and Regulations 

The request should include an assessment of 

the effect of the modification, alteration, or 

repair on the unsafe condition addressed by 

this AD; and, if the unsafe condition has not 

been eliminated, the request should include 

specific proposed actions to address it.

Compliance: Required as indicated, unless 

accomplished previously. 

To prevent interference with venting 

during a rapid decompression in the bulk 

cargo compartment, which could cause 

damage to the floor structure as well as 

damage to certain control cables leading to 

the empennage, and could result in reduced 

controllability of the airplane, accomplish 

the following: 

Modification 

(a) Within 7 years after the effective date 

of this AD: Modify the installation of the aft 

pressure bulkhead-to-floor insulation 

blankets, in accordance with the 

Accomplishment Instructions of Boeing 

Service Bulletin 767–25A0300, Revision 1, 

dated May 2, 2002. 

Alternative Methods of Compliance 

(b) An alternative method of compliance or 

adjustment of the compliance time that 

provides an acceptable level of safety may be 

used if approved by the Manager, Seattle 

Aircraft Certification Office (ACO), FAA. 

Operators shall submit their requests through 

an appropriate FAA Principal Maintenance 

Inspector, who may add comments and then 

send it to the Manager, Seattle ACO.

Note 2: Information concerning the 

existence of approved alternative methods of 

compliance with this AD, if any, may be 

obtained from the Seattle ACO.

Special Flight Permits 

(c) Special flight permits may be issued in 

accordance with §§ 21.197 and 21.199 of the 

Federal Aviation Regulations (14 CFR 21.197 

and 21.199) to operate the airplane to a 

location where the requirements of this AD 

can be accomplished. 

Incorporation by Reference 

(d) The actions shall be done in accordance 

with Boeing Service Bulletin 767–25A0300, 

Revision 1, dated May 2, 2002. This 

incorporation by reference was approved by 

the Director of the Federal Register in 

accordance with 5 U.S.C. 552(a) and 1 CFR 

part 51. Copies may be obtained from Boeing 

Commercial Airplane Group, P.O. Box 3707, 

Seattle, Washington 98124–2207. Copies may 

be inspected at the FAA, Transport Airplane 

Directorate, 1601 Lind Avenue, SW., Renton, 

Washington; or at the Office of the Federal 

Register, 800 North Capitol Street, NW., suite 

700, Washington, DC. 

Effective Date 

(e) This amendment becomes effective on 

July 29, 2003.

Issued in Renton, Washington, on June 16, 

2003. 

Kalene C. Yanamura, 

Acting Manager, Transport Airplane 

Directorate, Aircraft Certification Service.

[FR Doc. 03–15596 Filed 6–23–03; 8:45 am] 

BILLING CODE 4910–13–P

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. 2002–NM–143–AD; Amendment 

39–13201; AD 2003–13–01] 

RIN 2120–AA64 

Airworthiness Directives; Boeing 

Model 767 Series Airplanes

AGENCY: Federal Aviation 

Administration, DOT.

ACTION: Final rule.

SUMMARY: This amendment adopts a 

new airworthiness directive (AD), 

applicable to certain Boeing Model 767 

series airplanes, that requires an 

inspection to detect cracks and fractures 

of the outboard hinge fitting assemblies 

on the trailing edge of the inboard main 

flap, and follow-on and corrective 

actions if necessary. For certain 

airplanes, this amendment also requires 

a one-time inspection to determine if a 

tool runout procedure has been 

performed in the area. The actions 

specified by this AD are intended to 

prevent the inboard aft flap from 

separating from the wing and 

potentially striking the airplane, which 

could result in damage to the 

surrounding structure and potential 

personal injury. This action is intended 

to address the identified unsafe 

condition.

DATES: Effective July 29, 2003. 

The incorporation by reference of 

certain publications listed in the 

regulations is approved by the Director 

of the Federal Register as of July 29, 

2003.

ADDRESSES: The service information 

referenced in this AD may be obtained 

from Boeing Commercial Airplane 

Group, P.O. Box 3707, Seattle, 

Washington 98124–2207. This 

information may be examined at the 

Federal Aviation Administration (FAA), 

Transport Airplane Directorate, Rules 

Docket, 1601 Lind Avenue, SW., 

Renton, Washington; or at the Office of 

the Federal Register, 800 North Capitol 

Street, NW., suite 700, Washington, DC.

FOR FURTHER INFORMATION CONTACT:

Suzanne Masterson, Aerospace 

Engineer, Airframe Branch, ANM–120S, 

FAA, Seattle Aircraft Certification 

Office, 1601 Lind Avenue, SW., Renton, 

Washington 98055–4056; telephone 

(425) 917–6441; fax (425) 917–6590.

SUPPLEMENTARY INFORMATION: A 

proposal to amend part 39 of the Federal 

Aviation Regulations (14 CFR part 39) to 

include an airworthiness directive (AD) 

that is applicable to certain Boeing 

Model 767 series airplanes was 

published in the Federal Register on 

January 6, 2003 (68 FR 518). That action 

proposed to require an inspection to 

detect cracks and fractures of the 

outboard hinge fitting assemblies on the 

trailing edge of the inboard main flap, 

and follow-on and corrective actions if 

necessary. For certain airplanes, that 

action also proposed to require a onetime inspection to determine if a tool 

runout procedure has been performed in 

the area. 

Comments 

Interested persons have been afforded 

an opportunity to participate in the 

making of this amendment. Due 

consideration has been given to the 

comments received. One commenter 

concurs with the contents of the 

proposed AD. 

Request To Change Applicability 

One commenter, the manufacturer, 

asks that the applicability specified in 

the proposed AD be changed. The 

commenter states that line number 870 

is for a Model 767–300 airplane, and is 

outside the line number effectivity 

listed in Boeing Service Bulletin 767–

57A0076, Revision 1, dated March 29, 

2001 (which was referenced in the 

proposed AD and specified line 

numbers 1 through 825 inclusive). 

The FAA agrees with the commenter. 

Line number 870 is for a Model 767–

300ER airplane, and was inadvertently 

added to the applicability specified in 

the proposed AD. The applicability in 

this final rule has been changed 

accordingly. 

Request To Extend Compliance Time 

One commenter states that a 

compliance time grace period of 90 days 

for the inspections specified in 

paragraph (a)(1) of the proposed AD 

would be extremely difficult. The 

commenter asks that the grace period be 

extended to 270 days. The commenter 

adds that this will allow sufficient time 

for affected operators to schedule and 

accomplish the inspections, and will 

provide time for Boeing to produce 

adequate spares. 

We do not agree with the commenter, 

as insufficient supporting data were 

provided to us to substantiate the 

request. Boeing Service Bulletin 767–

57A0076, Revision 1, was issued on 

March 29, 2001, and recommended a 

grace period of 90 days after release of 

the service bulletin. In addition, Boeing 

parts are not necessary unless 

discrepant parts are found during the 

inspections. The terminating action 

provided by paragraph (f) of this final

Federal Register / Vol. 68, No. 121 / Tuesday, June 24, 2003 / Rules and Regulations 37403

rule would require installing the new 

parts, but is not mandatory. Therefore, 

no extension is necessary in order to 

obtain parts. 

In developing an appropriate 

compliance time for this action, we 

considered not only the degree of 

urgency associated with addressing the 

subject unsafe condition, but the 

manufacturer’s recommendation as to 

an appropriate compliance time, and the 

practical aspect of accomplishing the 

required inspections within an interval 

of time that parallels normal scheduled 

maintenance for the majority of affected 

operators. However, under the 

provisions of paragraph (i) of the final 

rule, we may approve requests for 

adjustments to the compliance time if 

data are submitted to substantiate that 

such an adjustment would provide an 

acceptable level of safety. 

Parts Availability 

One commenter states a concern for 

the availability of improved fittings for 

replacement. The commenter notes that, 

due to warranty, it anticipates replacing 

any fittings that do not exhibit the tool 

runout option, regardless of the 

inspection results. 

We have been assured by the parts 

manufacturer that a sufficient number of 

replacement parts is available. However, 

this may not cover all parts without the 

tool runout option, regardless of the 

condition of the parts. If the commenter 

expects to replace a large number of 

parts, ordering the parts in advance so 

the manufacturer has time to produce 

adequate replacement parts is 

recommended. 

Request To Provide a Method To 

Identify Certain Fittings 

One commenter states that the 

proposed AD specifies that certain part 

numbers may not be installed on any 

aircraft unless the requirements of the 

proposed AD have been accomplished. 

The commenter notes that neither the 

proposed AD nor the referenced service 

bulletins provide instructions on how to 

identify fittings that have met the 

requirements of the proposed AD. 

Although the commenter does not 

make a specific request, we infer that 

the commenter wants the FAA to 

provide instructions in the final rule for 

identification of the fittings that meet 

the AD requirements. We do not agree 

that such additional instructions are 

necessary because it is the operator’s 

responsibility to show documented 

compliance to the requirements of the 

AD. If a spare part is installed on an 

airplane, and the previous inspection 

history of the part is not documented, 

the applicable inspection must be done 

and must be repeated at the intervals 

required by this AD. Paragraph (h) of the 

proposed AD identifies the part 

numbers for fittings that cannot be 

installed unless the applicable 

requirements of the AD have been 

accomplished for that fitting. Those 

requirements are specified in 

paragraphs (a) through (f) of the AD. No 

change is made to the final rule in this 

regard.

Request To Change Cost Impact Section 

One commenter estimates that the 

detailed visual and eddy current 

inspections specified in the proposed 

AD take 15 work hours per airplane to 

do, at a cost of $117,000 for the 

operator’s fleet. 

Although the commenter does not 

make a specific request, we infer that 

the commenter wants the work hours 

and cost for the detailed visual and 

eddy current inspections specified in 

the Cost Impact section to be changed. 

We do not agree to change the number 

of estimated work hours for the 

inspections. The number of work hours 

necessary to accomplish the 

inspections, specified as 5 in the cost 

impact information, is consistent with 

the service bulletin. This number 

represents the time necessary to perform 

only the inspections actually required 

by this AD. Therefore, no change is 

made to the final rule in this regard. 

Request To Clarify Applicability 

One commenter would like to obtain 

clarification of the applicability 

specified in the proposed AD relative to 

airplanes in the Model 767–400 fleet 

having fuselage numbers 875 (variable 

number VQ085) and 877 (variable 

number VQ086), which are not listed in 

the applicability section. The 

commenter states that, according to the 

effectivity in the original issue of Boeing 

Alert Service Bulletin 767–57A0079, 

dated June 20, 2002, only an airplane 

having fuselage number 877 is not 

affected by the proposed AD. 

The terminology ‘‘fuselage numbers’’

actually refers to airplane line numbers, 

rather than the terminology used by the 

commenter for tracking its airplanes. 

Boeing Airplane Information Report 

dated October 2, 2002, shows Model 767 

line number 875 as having variable 

number VS701, line number 876 having 

variable number VQ085, line number 

877 having variable number VS721, and 

line number 878 having variable 

number VQ086; these figures do not 

match the variable numbers provided by 

the commenter. Regardless, the line 

numbers specified in the proposed AD 

and the referenced service bulletin are 

correct. No change is made to the final 

rule in this regard. 

Request To Clarify Certain Wording in 

Paragraph (c) 

One commenter asks that the last 

sentence in paragraph (c) of the 

proposed AD be changed for 

clarification from ‘‘This AD requires 

that the terminating action, if required, 

be accomplished before further flight’’

to ‘‘This AD requires that the 

terminating action, if required because 

cracks have been found, be 

accomplished before further flight.’’ The 

commenter states that it is not explicit 

in paragraph (c) that the terminating 

action is required only if cracks are 

found. The commenter adds that 

specifying the need to accomplish 

terminating action before further flight, 

without explicitly referencing cracks, 

may confuse the operator. 

We do not agree with the commenter. 

Paragraph (c) of the proposed AD 

merely clarifies that, if the referenced 

service bulletins specify corrective 

action (i.e., if cracked or fractured 

fittings are found, do Part 3—

Terminating Action), such action is 

required before further flight. No change 

is made to the final rule in this regard. 

Conclusion 

After careful review of the available 

data, including the comments noted 

above, the FAA has determined that air 

safety and the public interest require the 

adoption of the rule with the change 

previously described. The FAA has 

determined that this change will neither 

increase the economic burden on any 

operator nor increase the scope of the 

AD. 

Cost Impact 

There are approximately 783 

airplanes of the affected design in the 

worldwide fleet. The FAA estimates that 

354 airplanes of U.S. registry will be 

affected by this AD. 

It will take approximately 2 work 

hours per airplane to accomplish the 

detailed inspection, at an average labor 

rate of $60 per work hour. Based on 

these figures, the cost impact of this 

action is estimated to be $42,480, or 

$120 per airplane, per inspection cycle. 

It will take approximately 5 work 

hours per airplane to accomplish the 

detailed visual and eddy current 

inspections, at an average labor rate of 

$60 per work hour. Based on these 

figures, the cost impact of these actions 

is estimated to be $106,200, or $300 per 

airplane, per inspection cycle. 

The cost impact figures discussed 

above are based on assumptions that no 

operator has yet accomplished any of 

37404 Federal Register / Vol. 68, No. 121 / Tuesday, June 24, 2003 / Rules and Regulations 

the requirements of this AD action, and 

that no operator would accomplish 

those actions in the future if this AD 

were not adopted. The cost impact 

figures discussed in AD rulemaking 

actions represent only the time 

necessary to perform the specific actions 

actually required by the AD. These 

figures typically do not include 

incidental costs, such as the time 

required to gain access and close up, 

planning time, or time necessitated by 

other administrative actions. 

The terminating action, if 

accomplished, will take approximately 

24 work hours per airplane, at an 

average labor rate of $60 per work hour. 

Based on these figures, the cost impact 

of this action is estimated to be $1,440 

per airplane. 

Regulatory Impact 

The regulations adopted herein will 

not have a substantial direct effect 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. Therefore, it is 

determined that this final rule does not 

have federalism implications under 

Executive Order 13132. 

For the reasons discussed above, I 

certify that this action (1) is not a 

‘‘significant regulatory action’’ under 

Executive Order 12866; (2) is not a 

‘‘significant rule’’ under DOT 

Regulatory Policies and Procedures (44 

FR 11034, February 26, 1979); and (3) 

will not have a significant economic 

impact, positive or negative, on a 

substantial number of small entities 

under the criteria of the Regulatory 

Flexibility Act. A final evaluation has 

been prepared for this action and it is 

contained in the Rules Docket. A copy 

of it may be obtained from the Rules 

Docket at the location provided under 

the caption ADDRESSES.

List of Subjects in 14 CFR Part 39 

Air transportation, Aircraft, Aviation 

safety, Incorporation by reference, 

Safety.

Adoption of the Amendment

■ Accordingly, pursuant to the authority 

delegated to me by the Administrator, 

the Federal Aviation Administration 

amends part 39 of the Federal Aviation 

Regulations (14 CFR part 39) as follows:

PART 39—AIRWORTHINESS 

DIRECTIVES

■ 1. The authority citation for part 39 

continues to read as follows:

Authority: 49 U.S.C. 106(g), 40113, 44701.

§ 39.13 [Amended]

■ 2. Section 39.13 is amended by adding 

the following new airworthiness 

directive:

2003–13–01 Boeing: Amendment 39–13201. 

Docket 2002–NM–143–AD.

Applicability: Model 767 series airplanes, 

certificated in any category; line numbers 1 

through 826 inclusive, 830, 842, 855, 856, 

859, 862, 864 through 866 inclusive, 868, 

869, 871 through 874 inclusive, and 876.

Note 1: This AD applies to each airplane 

identified in the preceding applicability 

provision, regardless of whether it has been 

modified, altered, or repaired in the area 

subject to the requirements of this AD. For 

airplanes that have been modified, altered, or 

repaired so that the performance of the 

requirements of this AD is affected, the 

owner/operator must request approval for an 

alternative method of compliance in 

accordance with paragraph (i) of this AD. The 

request should include an assessment of the 

effect of the modification, alteration, or repair 

on the unsafe condition addressed by this 

AD; and, if the unsafe condition has not been 

eliminated, the request should include 

specific proposed actions to address it.

Compliance: Required as indicated, unless 

accomplished previously. 

To prevent the inboard aft flap from 

separating from the wing and potentially 

striking the airplane, which could result in 

damage to the surrounding structure and 

potential personal injury, accomplish the 

following: 

Inspection 

(a) Perform either a detailed inspection, or 

a detailed inspection plus an eddy current 

inspection, of the outboard hinge fitting 

assemblies on the trailing edge of the inboard 

main flap to detect cracks and fractures and 

evidence of a tool runout procedure, as 

applicable. 

(1) For Model 767–200, –300, and –300F 

series airplanes: Inspect before the airplane 

accumulates 2,700 total flight cycles, or 

within 90 days after the effective date of this 

AD, whichever occurs later, in accordance 

with Boeing Service Bulletin 767–57A0076, 

Revision 1, dated March 29, 2001. 

(2) For Model 767–400ER series airplanes: 

Inspect before the airplane accumulates 

12,000 total flight cycles, in accordance with 

Boeing Alert Service Bulletin 767–57A0079, 

dated June 20, 2002.

Note 2: For the purposes of this AD, a 

detailed inspection is defined as: ‘‘An 

intensive visual examination of a specific 

structural area, system, installation, or 

assembly to detect damage, failure, or 

irregularity. Available lighting is normally 

supplemented with a direct source of good 

lighting at intensity deemed appropriate by 

the inspector. Inspection aids such as mirror, 

magnifying lenses, etc., may be used. Surface 

cleaning and elaborate access procedures 

may be required.’’

Follow-On/Corrective Actions 

(b) Following the initial inspection(s) 

required by paragraph (a) of this AD: Perform 

applicable follow-on and corrective actions at 

the time(s) specified in Figure 1 of Boeing 

Service Bulletin 767–57A0076, Revision 1, 

dated March 29, 2001 (for Model 767–200, 

–300, and –300F series airplanes); or Boeing 

Alert Service Bulletin 767–57A0079, dated 

June 20, 2002 (for Model 767–400ER series 

airplanes). Do the follow-on and corrective 

actions (including repetitive inspections and 

replacement of the fittings with new fittings) 

in accordance with Part 1 or Part 2 of the 

service bulletin, as applicable, except as 

required by paragraph (d) of this AD. For 

Model 767–200, –300, and –300F series 

airplanes: If the fitting has the tool runout, 

and no cracking or fracture is found during 

the inspection, this AD requires no further 

action for that hinge fitting. 

Exceptions to Service Bulletin Procedures 

(c) Where the terminating action in Part 3 

of the service bulletin is specified as 

corrective action in Boeing Service Bulletin 

767–57A0076, Revision 1, dated March 29, 

2001; and Boeing Alert Service Bulletin 767–

57A0079, dated June 20, 2002: This AD 

requires that the terminating action, if 

required, be accomplished before further 

flight. 

(d) Boeing Service Bulletin 767–57A0076, 

Revision 1, dated March 29, 2001, specifies 

to contact Boeing before the terminating 

action is done as corrective action for any 

cracking or fracture found on a Model 767–

200, –300, or –300F series airplane with the 

tool runout. This AD requires that any such 

crack or fracture on those airplanes be 

reported to the FAA in accordance with 

paragraph (e) of this AD and repaired in 

accordance with Part 3 of the service 

bulletin. 

Reporting Requirement 

(e) For any Model 767–200, –300, or –300F 

series airplane with the tool runout, on 

which any cracking or fracture is found 

during the inspection(s) required by 

paragraph (a) of this AD: Submit a report of 

the inspection findings to the Manager, 

Seattle Aircraft Certification Office (ACO), 

FAA, at the applicable time specified in 

paragraph (e)(1) or (e)(2) of this AD. The 

report must include the inspection results, a 

description of any discrepancies found, the 

airplane serial number, and the number of 

landings and flight hours on the airplane. 

Information collection requirements 

contained in this AD have been approved by 

the Office of Management and Budget (OMB) 

under the provisions of the Paperwork 

Reduction Act of 1980 (44 U.S.C. 3501 et 

seq.) and have been assigned OMB Control 

Number 2120–0056. 

(1) For airplanes on which the initial 

inspection is done after the effective date of 

this AD: Submit the report within 30 days 

after performing the inspection required by 

paragraph (a) of this AD. 

(2) For airplanes on which the initial 

inspection was done before the effective date 

of this AD: Submit the report within 30 days 

after the effective date of this AD. 

Terminating Action 

(f) Unless required to do so by paragraph 

(b) of this AD: Operators may choose to 

accomplish the terminating action (including 

replacement of the fittings with new fittings, 

Federal Register / Vol. 68, No. 121 / Tuesday, June 24, 2003 / Rules and Regulations 37405

and reinstallation of existing upper skin 

access panels and fairing midsections on the 

trailing edge of the main flap) in accordance 

with Part 3 of the Work Instructions of 

Boeing Service Bulletin 767–57A0076, 

Revision 1, dated March 29, 2001; or Boeing 

Alert Service Bulletin 767–57A0079, dated 

June 20, 2002; as applicable. 

Accomplishment of the terminating action 

terminates the repetitive inspection 

requirements of paragraph (b) of this AD. 

Credit for Prior Accomplishment Per Earlier 

Service Information 

(g) Accomplishment before the effective 

date of this AD of an inspection, associated 

follow-on and corrective actions, and 

terminating action in accordance with Boeing 

Alert Service Bulletin 767–57A0076, dated 

October 26, 2000, is acceptable for 

compliance with the corresponding 

requirements of this AD for applicable 

airplanes. 

Part Installation 

(h) As of the effective date of this AD, no 

person may install on any airplane a hinge 

fitting assembly that has any part number 

listed in Table 1 of this AD, unless the 

applicable requirements of this AD have been 

accomplished for that fitting. Table 1 follows:

TABLE 1.—HINGE FITTING ASSEMBLY

PART NUMBERS

113T2271–13 ..................... 113T2271–14 

113T2271–23 ..................... 113T2271–24 

113T2271–29 ..................... 113T2271–30 

113T2271–33 ..................... 113T2271–34 

113T2271–401 ................... 113T2271–402 

Alternative Methods of Compliance 

(i) An alternative method of compliance or 

adjustment of the compliance time that 

provides an acceptable level of safety may be 

used if approved by the Manager, Seattle 

ACO. Operators shall submit their requests 

through an appropriate FAA Principal 

Maintenance Inspector, who may add 

comments and then send it to the Manager, 

Seattle ACO.

Note 3: Information concerning the 

existence of approved alternative methods of 

compliance with this AD, if any, may be 

obtained from the Seattle ACO.

Special Flight Permits 

(j) Special flight permits may be issued in 

accordance with §§ 21.197 and 21.199 of the 

Federal Aviation Regulations (14 CFR 21.197 

and 21.199) to operate the airplane to a 

location where the requirements of this AD 

can be accomplished. 

Incorporation by Reference 

(k) Unless otherwise specified in this AD, 

the actions shall be done in accordance with 

Boeing Service Bulletin 767–57A0076, 

Revision 1, dated March 29, 2001; and 

Boeing Alert Service Bulletin 767–57A0079, 

dated June 20, 2002; as applicable. This 

incorporation by reference was approved by 

the Director of the Federal Register in 

accordance with 5 U.S.C. 552(a) and 1 CFR 

part 51. Copies may be obtained from Boeing 

Commercial Airplane Group, P.O. Box 3707, 

Seattle, Washington 98124–2207. Copies may 

be inspected at the FAA, Transport Airplane 

Directorate, 1601 Lind Avenue, SW., Renton, 

Washington; or at the Office of the Federal 

Register, 800 North Capitol Street, NW., suite 

700, Washington, DC. 

Effective Date 

(l) This amendment becomes effective on 

July 29, 2003.

Issued in Renton, Washington, on June 16, 

2003. 

Kalene C. Yanamura, 

Acting Manager, Transport Airplane 

Directorate, Aircraft Certification Service.

[FR Doc. 03–15594 Filed 6–23–03; 8:45 am] 

BILLING CODE 4910–13–P

DEPARTMENT OF JUSTICE

Drug Enforcement Administration 

21 CFR Parts 1300, 1301, 1304, 1305 

and 1306 

[Docket No. DEA–208F] 

RIN 1117–AA58 

Allowing Central Fill Pharmacies and 

Retail Pharmacies To Fill Prescriptions 

for Controlled Substances on Behalf of 

Retail Pharmacies

AGENCY: Drug Enforcement 

Administration (DEA), Justice.

ACTION: Final rule.

SUMMARY: DEA is finalizing a Notice of 

Proposed Rulemaking (NPRM) defining 

central fill pharmacy activities and 

permitting central fill pharmacies to 

prepare controlled substances 

prescriptions on behalf of retail 

pharmacies with which the central fill 

pharmacies have a contractual 

agreement to provide such services or 

with which the pharmacies share a 

common owner. When one retail 

pharmacy receives a prescription and a 

second pharmacy prepares and 

subsequently delivers the controlled 

substance medication to the first retail 

pharmacy for dispensing to the patient, 

the second pharmacy is engaging in a 

‘‘central fill activity’’. Records must be 

maintained by both the central fill 

pharmacy and the retail pharmacy that 

completely and accurately reflect the 

disposition of all controlled substance 

prescriptions dispensed. With respect to 

security, central fill pharmacies would 

be required to comply with the same 

security requirements applicable to 

retail pharmacies including the general 

requirement to maintain effective 

controls and procedures to guard against 

theft and diversion of controlled 

substances. DEA is creating an 

allowance for retail pharmacies that also 

perform central fill activities to do so 

without separate DEA registration, 

separate inventories, or separate 

records. This rulemaking is sought by 

the regulated industry and will allow for 

more efficient delivery of controlled 

substance prescriptions to patients.

EFFECTIVE DATE: July 24, 2003.

FOR FURTHER INFORMATION CONTACT:

Patricia M. Good, Chief, Liaison and 

Policy Section, Office of Diversion 

Control, Drug Enforcement 

Administration, Washington, DC 20537, 

Telephone (202) 307–7297.

SUPPLEMENTARY INFORMATION: 

Background 

On September 6, 2001, DEA 

published a Notice of Proposed 

Rulemaking (NPRM) in the Federal 

Register (66 FR 46567) proposing to 

allow central fill pharmacies to fill 

prescriptions for controlled substances 

on behalf of retail pharmacies. The 

NPRM was published in response to 

significant changes taking place in the 

pharmacy industry. Increased demands 

are being placed on traditional 

pharmacy systems by the rapid growth 

in the number of prescriptions written 

and dispensed. 

At present, there is no provision in 

DEA’s regulations for central fill 

pharmacy operations. Retail 

pharmacies, including those which 

utilize the mail service and the Internet, 

are registered by DEA to dispense 

prescriptions for controlled substances 

directly to the patient. ‘‘Dispensing’’ is 

defined in the Controlled Substances 

Act as delivering a controlled substance 

‘‘to an ultimate user’’ (21 U.S.C. 

802(10)). DEA regulations do not 

currently provide for central fill 

pharmacy operations which fill 

prescriptions for delivery to a 

traditional retail pharmacy. Current 

DEA regulations do not permit a 

prescription for controlled substances to 

be brought to one pharmacy, filled at a 

second pharmacy, and then returned to 

the first pharmacy for dispensing to the 

patient. Allowing central fill pharmacies 

to fill prescriptions on behalf of retail 

pharmacies for subsequent dispensing 

to the ultimate user is a legitimate 

extension of current practice. 

Therefore, the regulations are being 

amended to allow for central fill 

pharmacies to fill prescriptions on 

behalf of retail pharmacies and to allow 

retail pharmacies to perform central fill 

activities without separate DEA 

registration and separate inventories.