37684 Federal Register / Vol. 79, No. 127 / Wednesday, July 2, 2014 / Proposed Rules 

(b) Affected ADs 

None. 

(c) Applicability 

This AD applies to The Boeing Company 

Model 767–200, –300, –300F, and –400ER 

series airplanes; certificated in any category; 

as identified in Boeing Service Bulletin 767– 

28–0105, Revision 1, dated February 6, 2013. 

(d) Subject 

Air Transport Association (ATA) of 

America Code 28, Fuel. 

(e) Unsafe Condition 

This AD was prompted by reports 

indicating that a standard access door was 

located where an impact-resistant access 

door was required, and stencils were missing 

from some impact-resistant access doors. We 

are issuing this AD to prevent foreign object 

penetration of the fuel tank from uncontained 

engine failure or tire debris, which could 

cause a fuel leak near an ignition source (e.g., 

hot brakes or engine nozzle), consequently 

leading to a fuel-fed fire. 

(f) Compliance 

Comply with this AD within the 

compliance times specified, unless already 

done. 

(g) Inspections 

Within 72 months after the effective date 

of this AD, do the actions specified in 

paragraphs (g)(1) and (g)(2) of this AD, in 

accordance with the Accomplishment 

Instructions of Boeing Service Bulletin 767– 

28–0105, Revision 1, dated February 6, 2013. 

(1) Do either a general visual inspection or 

ultrasonic non-destructive test of the left- and 

right-hand wing fuel tank access doors to 

determine whether impact-resistant access 

doors are installed in the correct locations. If 

any standard access door is found, before 

further flight, replace with an impactresistant access door. 

(2) Do a general visual inspection of the 

left- and right-hand wing fuel tank impactresistant access doors to verify stencils and 

index markers are applied. If a stencil or 

index marker is missing, before further flight, 

apply a stencil or index marker, as 

applicable. 

(h) Maintenance or Inspection Program 

Revision 

Within 60 days after the effective date of 

this AD, revise the maintenance or inspection 

program, as applicable, to incorporate critical 

design configuration control limitation 

(CDCCL) Task 57–AWL–01, ‘‘ImpactResistant Fuel Tank Access Door,’’ of Section 

9, Airworthiness Limitations (AWLs) and 

Certification Maintenance Requirements 

(CMRs) of Boeing 767 Maintenance Planning 

Data Document D622T001–9, Revision 

January 2013. 

(i) No Alternative Actions, Intervals, and/or 

CDCCLs 

After accomplishing the revision required 

by paragraph (h) of this AD, no alternative 

actions (e.g., inspections), intervals, and/or 

CDCCLs may be used unless the actions, 

intervals, and/or CDCCLs are approved as an 

alternative method of compliance (AMOC) in 

accordance with the procedures specified in 

paragraph (k) of this AD. 

(j) Credit for Previous Actions 

This paragraph provides credit for the 

actions required by paragraph (g) of this AD, 

if those actions were performed before the 

effective date of this AD using Boeing Service 

Bulletin 767–28–0105, dated January 12, 

2012, which is not incorporated by reference 

in this AD. 

(k) Alternative Methods of Compliance 

(AMOCs) 

(1) The Manager, Seattle Aircraft 

Certification Office (ACO), FAA, has the 

authority to approve AMOCs for this AD, if 

requested using the procedures found in 14 

CFR 39.19. In accordance with 14 CFR 39.19, 

send your request to your principal inspector 

or local Flight Standards District Office, as 

appropriate. If sending information directly 

to the manager of the ACO, send it to the 

attention of the person identified in 

paragraph (l)(1) of this AD. Information may 

be emailed to: 9-ANM-Seattle-ACO-AMOCRequests@faa.gov. 

(2) Before using any approved AMOC, 

notify your appropriate principal inspector, 

or lacking a principal inspector, the manager 

of the local flight standards district office/

certificate holding district office. 

(3) An AMOC that provides an acceptable 

level of safety may be used for any repair 

required by this AD if it is approved by the 

Boeing Commercial Airplanes Organization 

Designation Authorization (ODA) that has 

been authorized by the Manager, Seattle 

ACO, to make those findings. For a repair 

method to be approved, the repair must meet 

the certification basis of the airplane, and the 

approval must specifically refer to this AD. 

(4) AMOCs for ADs 2008–11–01 R1, 

Amendment 39–16145 (74 FR 68515, 

December 28, 2009); 2010–06–10, 

Amendment 39–16234 (75 FR 15322, March 

29, 2010); or 2011–25–05, Amendment 39– 

16881 (77 FR 2442, January 18, 2012); that 

meet the conditions specified in paragraphs 

(k)(4)(i) and (k)(4)(ii) of this AD are approved 

as AMOCs for the corresponding provisions 

of paragraph (h) of this AD. 

(i) AMOCs that are approved after 

November 2, 2012. 

(ii) AMOCS that include incorporation of 

CDCCL Task 57–AWL–01, ‘‘Impact-Resistant 

Fuel Tank Access Door.’’ 

(l) Related Information 

(1) For more information about this AD, 

contact Suzanne Lucier, Aerospace Engineer, 

Propulsion Branch, ANM–140S, FAA, Seattle 

Aircraft Certification Office, 1601 Lind 

Avenue SW., Renton, WA 98057–3356; 

phone: 425–917–6438; fax: 425–917–6590; 

email: suzanne.lucier@faa.gov. 

(2) For service information identified in 

this AD, contact Boeing Commercial 

Airplanes, Attention: Data & Services 

Management, P.O. Box 3707, MC 2H–65, 

Seattle, WA 98124–2207; telephone 206– 

544–5000, extension 1; fax 206–766–5680; 

Internet https://www.myboeingfleet.com. You 

may view this referenced service information 

at the FAA, Transport Airplane Directorate, 

1601 Lind Avenue SW., Renton, WA. For 

information on the availability of this 

material at the FAA, call 425–227–1221. 

Issued in Renton, Washington, on June 25, 

2014. 

Jeffrey E. Duven, 

Manager, Transport Airplane Directorate, 

Aircraft Certification Service. 

[FR Doc. 2014–15530 Filed 7–1–14; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2014–0428; Directorate 

Identifier 2014–NM–067–AD] 

RIN 2120–AA64 

Airworthiness Directives; the Boeing 

Company Airplanes 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Notice of proposed rulemaking 

(NPRM). 

SUMMARY: We propose to adopt a new 

airworthiness directive (AD) for certain 

The Boeing Company Model 787–8 

airplanes. This proposed AD was 

prompted by reports of deficiencies in 

the flight control module (FCM) 

software. This proposed AD would 

require installing certain FCM software. 

We are proposing this AD to correct 

deficiencies in the FCM software, 

which, if not corrected, could prevent 

continued safe flight and landing. 

DATES: We must receive comments on 

this proposed AD by August 18, 2014. 

ADDRESSES: You may send comments, 

using the procedures found in 14 CFR 

11.43 and 11.45, by any of the following 

methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov. Follow the 

instructions for submitting comments. 

• Fax: 202–493–2251. 

• Mail: U.S. Department of 

Transportation, Docket Operations, M– 

30, West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue SE., 

Washington, DC 20590. 

• Hand Delivery: Deliver to Mail 

address above between 9 a.m. and 5 

p.m., Monday through Friday, except 

Federal holidays. 

For service information identified in 

this proposed AD, contact Boeing 

Commercial Airplanes, Attention: Data 

& Services Management, P.O. Box 3707, 

MC 2H–65, Seattle, WA 98124–2207; 

telephone 206–544–5000, extension 1; 

fax 206–766–5680; Internet https://

www.myboeingfleet.com. You may view 

this referenced service information at 


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the FAA, Transport Airplane 

Directorate, 1601 Lind Avenue SW., 

Renton, WA. For information on the 

availability of this material at the FAA, 

call 425–227–1221. 

Examining the AD Docket 

You may examine the AD docket on 

the Internet at http://

www.regulations.gov by searching for 

and locating Docket No. FAA–2014– 

0428; or in person at the Docket 

Management Facility between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. The AD docket 

contains this proposed AD, the 

regulatory evaluation, any comments 

received, and other information. The 

street address for the Docket Office 

(phone: 800–647–5527) is in the 

ADDRESSES section. Comments will be 

available in the AD docket shortly after 

receipt. 

FOR FURTHER INFORMATION CONTACT: 

Marie Hogestad, Aerospace Engineer, 

Systems and Equipment Branch, ANM– 

130S, Seattle Aircraft Certification 

Office (ACO), FAA, 1601 Lind Avenue 

SW., Renton, WA 98057–3356; phone: 

425–917–6418; fax: 425–917–6590; 

email: marie.hogestad@faa.gov. 

SUPPLEMENTARY INFORMATION: 

Comments Invited 

We invite you to send any written 

relevant data, views, or arguments about 

this proposal. Send your comments to 

an address listed under the ADDRESSES

section. Include ‘‘Docket No. FAA– 

2014–0428; Directorate Identifier 2014– 

NM–067–AD’’ at the beginning of your 

comments. We specifically invite 

comments on the overall regulatory, 

economic, environmental, and energy 

aspects of this proposed AD. We will 

consider all comments received by the 

closing date and may amend this 

proposed AD because of those 

comments. 

We will post all comments we 

receive, without change, to http://

www.regulations.gov, including any 

personal information you provide. We 

will also post a report summarizing each 

substantive verbal contact we receive 

about this proposed AD. 

Discussion 

We have received reports of in-service 

incidents and identified an indicating 

system shortcoming due to deficiencies 

in the FCM software, which have been 

determined to be safety issues in Model 

787–8 airplanes. 

We have received several reports of 

FCM airborne resets that occurred 

during trailing edge variable camber 

operation which, due to a software 

deficiency, incorrectly resulted in the 

flaps being shut down and the ‘‘FLAPS 

DRIVE’’ (caution) message, which 

directs the flightcrew to execute a flaps 

up landing. The flaps up landing 

procedure requires a high speed landing 

and, in combination with abnormal 

landing conditions such as a short 

runway or adverse weather conditions, 

could result in a runway excursion. 

Additionally, we received a report of 

a single flap position sensor failure 

which, due to a software deficiency, 

incorrectly resulted in flap position data 

being declared invalid. Invalid flap data 

causes the primary flight controls to 

transition to secondary mode, the 

spoiler droop commands to default to 

flaps up (i.e., no-droop) position, the 

autopilot to disengage, the flaps to 

remain in the last commanded position, 

and loss of flap position on the displays. 

This failure could prevent continued 

safe flight and landing if it occurs 

during final approach below 

approximately 100 feet due to the 

combination of high workload, the flight 

control mode change, and the wing lift 

loss, which may result in a high 

airplane sink rate landing or a ground 

impact short of the runway. 

We have also determined that a single 

spoiler failure requires an engine 

indication and crew alerting system 

(EICAS) alert because a single spoiler 

failure with flaps down can result in 

significant levels of buffet, which, 

without annunciation, the flightcrew 

might interpret either as a stall, landing 

gear damage, structural damage, or other 

external damage. 

These conditions, if not corrected, 

could prevent continued safe flight and 

landing. 

Relevant Service Information 

We reviewed Boeing Alert Service 

Bulletin B787–81205–SB270020–00, 

Issue 001, dated February 6, 2014. For 

information on the procedures and 

compliance times, see this service 

information at http://

www.regulations.gov by searching for 

Docket No. FAA–2014–0428. 

Concurrent Service Information 

For certain airplanes, Boeing Alert 

Service Bulletin B787–81205– 

SB270020–00, Issue 001, dated February 

6, 2014, specifies concurrent 

accomplishment of the FCM software 

installation specified in Boeing Alert 

Service Bulletin B787–81205– 

SB270017–00, Issue 001, dated 

September 18, 2013. For information on 

the procedures, see Boeing Alert Service 

Bulletin B787–81205–SB270017–00, 

Issue 001, dated September 18, 2013, at 

http://www.regulations.gov by searching 

for Docket No. FAA–2014–0428. 

FAA’s Determination 

We are proposing this AD because we 

evaluated all the relevant information 

and determined the unsafe condition 

described previously is likely to exist or 

develop in other products of the same 

type design. 

Proposed AD Requirements 

This proposed AD would require 

installing certain FCM software as 

specified in the service information 

described previously. 

Explanation of ‘‘RC’’ Steps in Service 

Information 

The FAA worked in conjunction with 

industry, under the Airworthiness 

Directives Implementation Aviation 

Rulemaking Committee, to enhance the 

AD system. One enhancement was a 

new process for annotating which steps 

in the service information are required 

for compliance with an AD. 

Differentiating these steps from other 

tasks in the service information is 

expected to improve an owner’s/

operator’s understanding of crucial AD 

requirements and help provide 

consistent judgment in AD compliance. 

The actions specified in the service 

information described previously 

include steps that are labeled as RC 

(required for compliance) because these 

steps have a direct effect on detecting, 

preventing, resolving, or eliminating an 

identified unsafe condition. 

As noted in the specified service 

information, steps labeled as RC must be 

done to comply with the proposed AD. 

However, steps that are not labeled as 

RC are recommended. Those steps that 

are not labeled as RC may be deviated 

from, done as part of other actions, or 

done using accepted methods different 

from those identified in the service 

information without obtaining approval 

of an alternative method of compliance 

(AMOC), provided the steps labeled as 

RC can be done and the airplane can be 

put back in a serviceable condition. Any 

substitutions or changes to steps labeled 

as RC will require approval of an 

AMOC. 

Costs of Compliance 

We estimate that this proposed AD 

affects 11 airplanes of U.S. registry. 

We estimate the following costs to 

comply with this proposed AD: 


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37686 Federal Register / Vol. 79, No. 127 / Wednesday, July 2, 2014 / Proposed Rules 

ESTIMATED COSTS

Action Labor cost Parts cost Cost per 

product 

Cost on U.S. 

operators 

FCM BP3 software installation 2 work-hours × $85 per hour = $170 ..................................... $0 $170 $1,870 

Concurrent FCM BP2 software 

installation (Group 1 airplanes).

2 work-hours × $85 per hour = $170 ..................................... $630 $800 $8,800 

According to the manufacturer, all of 

the costs of this proposed AD may be 

covered under warranty, thereby 

reducing the cost impact on affected 

individuals. We do not control warranty 

coverage for affected individuals. As a 

result, we have included all costs in our 

cost estimate. 

The parts cost for the FCM BP3 

software installation is not included in 

our cost estimate. It is considered 

Boeing-provided loadable software, 

which is referenced in Boeing Alert 

Service Bulletin B787–81205– 

SB270020–00, Issue 001, dated February 

6, 2014, under ‘‘Parts & Materials 

Supplied by the Operator.’’ 

Authority for This Rulemaking 

Title 49 of the United States Code 

specifies the FAA’s authority to issue 

rules on aviation safety. Subtitle I, 

section 106, describes the authority of 

the FAA Administrator. Subtitle VII: 

Aviation Programs, describes in more 

detail the scope of the Agency’s 

authority. 

We are issuing this rulemaking under 

the authority described in Subtitle VII, 

Part A, Subpart III, Section 44701: 

‘‘General requirements.’’ Under that 

section, Congress charges the FAA with 

promoting safe flight of civil aircraft in 

air commerce by prescribing regulations 

for practices, methods, and procedures 

the Administrator finds necessary for 

safety in air commerce. This regulation 

is within the scope of that authority 

because it addresses an unsafe condition 

that is likely to exist or develop on 

products identified in this rulemaking 

action. 

Regulatory Findings 

We determined that this proposed AD 

would not have federalism implications 

under Executive Order 13132. This 

proposed AD would 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. 

For the reasons discussed above, I 

certify this proposed regulation: 

(1) Is not a ‘‘significant regulatory 

action’’ under Executive Order 12866, 

(2) Is not a ‘‘significant rule’’ under 

the DOT Regulatory Policies and 

Procedures (44 FR 11034, February 26, 

1979), 

(3) Will not affect intrastate aviation 

in Alaska, and 

(4) 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. 

List of Subjects in 14 CFR Part 39 

Air transportation, Aircraft, Aviation 

safety, Incorporation by reference, 

Safety. 

The Proposed Amendment 

Accordingly, under the authority 

delegated to me by the Administrator, 

the FAA proposes to amend 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. The FAA amends § 39.13 by adding 

the following new airworthiness 

directive (AD): 

The Boeing Company: Docket No. FAA– 

2014–0428; Directorate Identifier 2014–NM– 

067–AD. 

(a) Comments Due Date 

We must receive comments by August 18, 

2014. 

(b) Affected ADs 

None. 

(c) Applicability 

This AD applies to The Boeing Company 

Model 787–8 airplanes, certificated in any 

category, as identified in Boeing Alert 

Service Bulletin B787–81205–SB270020–00, 

Issue 001, dated February 6, 2014. 

(d) Subject 

Air Transport Association (ATA) of 

America Code 27, Flight Controls. 

(e) Unsafe Condition 

This AD was prompted by reports of 

deficiencies in the flight control module 

(FCM) software. We are issuing this AD to 

correct deficiencies in the FCM software, 

which, if not corrected, could prevent 

continued safe flight and landing. 

(f) Compliance 

Comply with this AD within the 

compliance times specified, unless already 

done. 

(g) Flight Control Module (FCM) Software 

Installation 

Within 6 months after the effective date of 

this AD: Use the onboard data load function 

(ODLF) to install FCM operational program 

software (OPS), FCM loadable diagnostic 

information (LDI) database (DB) software, 

and FCM air data reference function (ADRF) 

DB software, in accordance with the 

Accomplishment Instructions of Boeing Alert 

Service Bulletin B787–81205–SB270020–00, 

Issue 001, dated February 6, 2014. 

(h) Concurrent Requirements 

For Group 1 airplanes, as identified in 

Boeing Alert Service Bulletin B787–81205– 

SB270020–00, Issue 001, dated February 6, 

2014: Prior to or concurrently with 

accomplishing the actions required by 

paragraph (g) of this AD, use the ODLF to 

install FCM OPS, FCM LDI DB, and central 

maintenance computer function (CMCF) LDI 

DB software, in accordance with the 

Accomplishment Instructions of Boeing Alert 

Service Bulletin B787–81205–SB270017–00, 

Issue 001, dated September 18, 2013. 

(i) Parts Installation Prohibition 

After installation of the new software 

specified in paragraphs (g) and (h) of this AD, 

no person may install any previous versions 

of the FCM OPS, FCM LDI DB, FCM ADRF 

DB, or CMCF LDI DB software, on any 

airplane. 

(j) Alternative Methods of Compliance 

(AMOCs) 

(1) The Manager, Seattle Aircraft 

Certification Office (ACO), FAA, has the 

authority to approve AMOCs for this AD, if 

requested using the procedures found in 14 

CFR 39.19. In accordance with 14 CFR 39.19, 

send your request to your principal inspector 

or local Flight Standards District Office, as 

appropriate. If sending information directly 

to the manager of the ACO, send it to the 

attention of the person identified in 

paragraph (k)(1) of this AD. Information may 

be emailed to: 9–ANM-Seattle-ACO–AMOCRequests@faa.gov. 

(2) Before using any approved AMOC, 

notify your appropriate principal inspector, 

or lacking a principal inspector, the manager 

of the local flight standards district office/

certificate holding district office. 

(3) If the service information contains steps 

that are labeled as RC (Required for 


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Compliance), those steps must be done to 

comply with this AD; any steps that are not 

labeled as RC are recommended. Those steps 

that are not labeled as RC may be deviated 

from, done as part of other actions, or done 

using accepted methods different from those 

identified in the specified service 

information without obtaining approval of an 

AMOC, provided the steps labeled as RC can 

be done and the airplane can be put back in 

a serviceable condition. Any substitutions or 

changes to steps labeled as RC require 

approval of an AMOC. 

(k) Related Information 

(1) For more information about this AD, 

contact Marie Hogestad, Aerospace Engineer, 

Systems and Equipment Branch, ANM–130S, 

Seattle Aircraft Certification Office (ACO), 

FAA, 1601 Lind Avenue SW., Renton, WA 

98057–3356; phone: 425–917–6418; fax: 425– 

917–6590; email: marie.hogestad@faa.gov. 

(2) For service information identified in 

this AD, contact Boeing Commercial 

Airplanes, Attention: Data & Services 

Management, P. O. Box 3707, MC 2H–65, 

Seattle, WA 98124–2207; telephone 206– 

544–5000, extension 1; fax 206–766–5680; 

Internet https://www.myboeingfleet.com. You 

may view this referenced service information 

at the FAA, Transport Airplane Directorate, 

1601 Lind Avenue SW., Renton, WA. For 

information on the availability of this 

material at the FAA, call 425–227–1221. 

Issued in Renton, Washington, on June 24, 

2014. 

Jeffrey E. Duven, 

Manager, Transport Airplane Directorate, 

Aircraft Certification Service. 

[FR Doc. 2014–15505 Filed 7–1–14; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 216 

[Docket No. FDA–1999–N–0194 (Formerly 

99N–4490)] 

RIN 0910–AH10 

Additions and Modifications to the List 

of Drug Products That Have Been 

Withdrawn or Removed From the 

Market for Reasons of Safety or 

Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule; withdrawal of 

previous proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

proposing to amend its regulations to 

revise the list of drug products that may 

not be compounded under the 

exemptions provided by the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C Act) because the drug products 

have been withdrawn or removed from 

the market after the drug products or 

components of such drug products were 

found to be unsafe or not effective. 

Specifically, the proposed rule would 

add 25 drug products to this list of drug 

products and modify the description of 

one drug product on this list to add an 

exception. These revisions are necessary 

because new information has come to 

the Agency’s attention since March 8, 

1999, when FDA published the original 

list as a final rule. FDA is also 

withdrawing the previous proposed rule 

regarding additions to this list (see the 

Federal Register of January 4, 2000). 

DATES: Submit either electronic or 

written comments on the proposed rule 

by September 2, 2014. The January 4, 

2000, proposed rule (65 FR 256) is 

withdrawn as of July 2, 2014. 

ADDRESSES: You may submit comments, 

identified by Agency name and Docket 

No. FDA–1999–N–0194 and/or 

Regulatory Information Number (RIN) 

number 0910–AH10, by any of the 

following methods: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• Mail/Hand delivery/Courier (for 

paper submissions): Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

Instructions: All submissions received 

must include the Agency name, Docket 

No. FDA–1999–N–0194, and RIN 0910– 

AH10 for this rulemaking. All 

comments received may be posted 

without change to http://

www.regulations.gov, including any 

personal information provided. For 

additional information on submitting 

comments, see the ‘‘Request for 

Comments’’ heading of the 

SUPPLEMENTARY INFORMATION section of 

this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Edisa Gozun, Center for Drug Evaluation 

and Research (HFD–310), Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 5199, 

Silver Spring, MD 20993–0002, 301– 

796–3110. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 503A of the FD&C Act (21 

U.S.C. 353a) describes the conditions 

that must be satisfied for human drug 

products compounded by a licensed 

pharmacist or licensed physician to be 

exempt from the following three 

sections of the FD&C Act: (1) Section 

501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) 

(concerning current good manufacturing 

practice); (2) section 502(f)(1) (21 U.S.C. 

352(f)(1)) (concerning the labeling of 

drugs with adequate directions for use); 

and (3) section 505 (21 U.S.C. 355) 

(concerning the approval of drugs under 

new drug applications (NDAs) or 

abbreviated new drug applications 

(ANDAs)). 

One of the conditions that must be 

satisfied to qualify for the exemptions 

under section 503A of the FD&C Act is 

that the licensed pharmacist or licensed 

physician does not compound a drug 

product that appears on a list published 

by the Secretary in the Federal Register 

of drug products that have been 

withdrawn or removed from the market 

because such drug products or 

components of such drug products have 

been found to be unsafe or not effective 

(see section 503A(b)(1)(C) of the FD&C 

Act). 

A. Court Decisions Regarding the 

Pharmacy Compounding Provisions of 

the FD&C Act 

As originally enacted, section 503A of 

the FD&C Act included prohibitions on 

the advertising and solicitation of 

prescriptions for any particular 

compounded drug, class of drug, or type 

of drug. Seven compounding 

pharmacies challenged the advertising 

and solicitation provisions of section 

503A of the FD&C Act as an 

impermissible regulation of commercial 

speech. In February 2001, the U.S. Court 

of Appeals for the Ninth Circuit held 

that the prohibition on advertising and 

promotion in section 503A(c) and the 

provision of section 503A(a) of the 

FD&C Act that requires that the 

prescription be ‘‘unsolicited,’’ were 

unconstitutional restrictions on 

commercial speech. (See Western States 

Med. Ctr. v. Shalala, 238 F.3d 1090 (9th 

Cir. 2001).) Furthermore, the Ninth 

Circuit held that the advertising and 

solicitation provisions could not be 

severed from the rest of section 503A 

and, as a result, found section 503A of 

the FD&C Act to be invalid in its 


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