Federal Register / Vol. 76, No. 202 / Wednesday, October 19, 2011 / Rules and Regulations 64813 

IX. References 

The following references have been 

placed on display in the Division of 

Dockets Management, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday. (FDA has verified the 

Web site addresses, but FDA is not 

responsible for any subsequent changes 

to the Web sites after this document 

publishes in the Federal Register.) 

1. Memorandum of telephone conversation to 

John Rost, Crown Packaging Technology, 

from Lauren Robin, FDA, January 5, 

2010. 

2. European Commission, 2007, Commission 

Directive 2007/19/EC of 30 March 2007 

amending Directive 2002/72/EC relating 

to plastic materials and articles intended 

to come into contact with food and 

Council Directive 85/572/EEC laying 

down the list of simulants to be used for 

testing migration of constituents of 

plastic materials and articles intended to 

come into contact with foodstuffs, 

Official Journal of the European Union, 

31.3.2007, L 91/17–36. 

3. IBWA, 2007, IBWA Model Code, Version 

October 2007, accessed online at http:// 

www.bottledwater.org/public/pdf/2008- 

code-of-practice.pdf. 

4. E-mail from Bob Hirst, IBWA, to Lauren 

Robin, FDA, January 5, 2010. 

5. U.S. EPA, Technical factsheet on di (2- 

ethylhexyl) phthalate (DEHP), accessed 

online at http://www.epa.gov/safewater/ 

pdfs/factsheets/soc/tech/dehp.pdf. 

6. Joseph K. Doss, IBWA, Testimony before 

the Subcommittee on Oversight and 

Investigations of the Energy and 

Commerce Committee, United States 

House of Representatives, Hearing on 

Bottled Water Regulation, July 8, 2009, 

accessed online at http:// 

democrats.energycommerce.house.gov/ 

Press_111/20090708/testimony_doss.pdf. 

7. U.S. EPA, EPA Method 506, Rev. 1.1— 

‘‘Determination of phthalate and adipate 

esters in drinking water by liquid/liquid 

extraction or liquid/solid extraction and 

gas chromatography with 

photoionization detection,’’ in ‘‘Methods 

for the Determination of Organic 

Compounds in Drinking Water, 

Supplement III,’’ EPA National Exposure 

Research Laboratory, EPA/600/R–95/131, 

August 1995, accessed online at http:// 

www.epa.gov/nscep/index.html. 

8. U.S. EPA, EPA Method 525.2, Rev. 2.0— 

‘‘Determination of organic compounds in 

drinking water by liquid-solid extraction 

and capillary column gas 

chromatography/mass spectrometry,’’ In 

‘‘Methods for the Determination of 

Organic Compounds in Drinking Water, 

Supplement III,’’ EPA National Exposure 

Research Laboratory, EPA/600/R–95/131, 

August 1995, accessed online at http:// 

www.epa.gov/nscep/index.html. 

9. International Bottled Water Association, 

comment to FDA Docket Number 

1993N–0085, October 4, 1993. 

List of Subjects in 21 CFR Part 165 

Beverages, Bottled water, Food grades 

and standards, Incorporation by 

reference. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 165 is 

amended as follows: 

PART 165—BEVERAGES 

■ 1. The authority citation for 21 CFR 

part 165 continues to read as follows: 

Authority: 21 U.S.C. 321, 341, 343, 343– 

1, 348, 349, 371, 379e. 

■ 2. In § 165.110, in the table in 

paragraph (b)(4)(iii)(C), alphabetically 

add an entry for ‘‘Di(2- 

ethylhexyl)phthalate (117–81–7)’’; 

revise paragraph (b)(4)(iii)(F) 

introductory text; and add new 

paragraphs (b)(4)(iii)(F)(21) and 

(b)(4)(iii)(F)(22) to read as follows: 

§ 165.110 Bottled water. 

* * * * * 

(b) * * * 

(4) * * * 

(iii) * * * 

(C) The allowable levels for pesticides 

and other synthetic organic chemicals 

(SOCs) are as follows: 

Contaminant 

(CAS Reg. No.) 

Concentration 

in milligrams 

per liter 

* * * * * 

Di(2-ethylhexyl)phthalate 

(117–81–7) ...................... 0.006 

* * * * * 

* * * * * 

(F) Analyses to determine compliance 

with the requirements of paragraphs 

(b)(4)(iii)(B) and (b)(4)(iii)(C) of this 

section shall be conducted in 

accordance with an applicable method 

or applicable revisions to the methods 

listed in paragraphs (b)(4)(iii)(F)(1) 

through (b)(4)(iii)(F)(22) of this section 

and described, unless otherwise noted, 

in ‘‘Methods for the Determination of 

Organic Compounds in Drinking 

Water,’’ Office of Research and 

Development, EMSL, EPA/600/4–88/ 

039, December 1988, or in ‘‘Methods for 

the Determination of Organic 

Compounds in Drinking Water, 

Supplement 1,’’ Office of Research and 

Development, EMSL, EPA/600/4–90/ 

020, July 1990, or in ‘‘Methods for the 

Determination of Organic Compounds 

in Drinking Water, Supplement III,’’ 

EPA National Exposure Research 

Laboratory, Office of Research and 

Development, EPA/600/R–95/131, 

August 1995, including Errata, 

November 27, 1995. The Director of the 

Federal Register approves this 

incorporation by reference in 

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

1 CFR part 51. Copies of these 

publications are available from National 

Technical Information Service, U.S. 

Department of Commerce, 5285 Port 

Royal Rd., Springfield, VA 22161. You 

may inspect a copy at the Division of 

Dockets Management, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852, 

301–827–6860 or at the National 

Archives and Records Administration 

(NARA). Hearing-impaired or speechimpaired individuals may access this 

number through TTY by calling the tollfree Federal Relay Service at 800–877– 

8339. For information on the availability 

of this material at NARA, call 202–741– 

6030, or go to: http://www.archives.gov/ 

federal-register/cfr/ibr-locations.html. 

* * * * * 

(21) Method 506, Rev. 1.1— 

‘‘Determination of phthalate and adipate 

esters in drinking water by liquid/liquid 

extraction or liquid/solid extraction and 

gas chromatography with 

photoionization detection,’’ EPA/600/R– 

95/131, 1995, (applicable to di(2- 

ethylhexyl)phthalate), which is 

incorporated by reference in accordance 

with 5 U.S.C. 552(a) and 1 CFR part 51, 

or 

(22) Method 525.2, Rev. 2.0— 

‘‘Determination of organic compounds 

in drinking water by liquid-solid 

extraction and capillary column gas 

chromatography/mass spectrometry,’’ 

EPA/600/R–95/131, 1995, (applicable to 

di(2-ethylhexyl)phthalate), which is 

incorporated by reference in accordance 

with 5 U.S.C. 552(a) and 1 CFR part 51. 

* * * * * 

Dated: October 11, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–26707 Filed 10–18–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Parts 1300, 1304, 1306 and 

1311 

[Docket No. DEA–360] 

Electronic Prescriptions for Controlled 

Substances Clarification 

AGENCY: Drug Enforcement 

Administration (DEA), Department of 

Justice. 


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64814 Federal Register / Vol. 76, No. 202 / Wednesday, October 19, 2011 / Rules and Regulations 

1The Attorney General’s delegation of authority 

to DEA may be found at 28 CFR 0.100. 

2 ‘‘Epidemic: Responding to America’s 

Prescription Drug Abuse Crisis,’’ Office of National 

Drug Control Policy, Executive Office of the 

President of the United States, 2011. http:// 

www.whitehousedrugpolicy.gov/publications/pdf/

rx_abuse_plan.pdf. 

3National Vital Statistics Reports, Vol. 59, No. 4, 

March 16, 2011, http://www.cdc.gov/nchs/data/ 

nvsr59/nvsr59_04.pdf. 

ACTION: Clarification and notification. 

SUMMARY: DEA wishes to emphasize that 

third-party audits of software 

applications for Electronic Prescriptions 

for Controlled Substances (EPCS) must 

encompass all applicable requirements 

in our regulations, including security, 

and must address ‘‘processing integrity’’ 

as set forth in our regulations. Likewise, 

where questions or gaps may arise in 

reviewing a particular application, DEA 

recommends consulting federal 

guidelines set forth in NIST Special 

Publication 800–53A. DEA is also 

announcing the first DEA approved 

certification process for EPCS. 

Certifying organizations with a 

certification process approved by DEA 

pursuant to the regulations are posted 

on DEA’s Web site once approved. 

FOR FURTHER INFORMATION, CONTACT: 

Imelda L. Paredes, Office of Diversion 

Control, Drug Enforcement 

Administration, 8701 Morrissette Drive, 

Springfield, Virginia 22152; Telephone 

(202) 307–7165. 

SUPPLEMENTARY INFORMATION: 

Background 

The Drug Enforcement 

Administration (DEA) is a component of 

the Department of Justice and is the 

primary agency responsible for 

coordinating the drug law enforcement 

activities of the United States. DEA also 

assists in the implementation of the 

President’s National Drug Control 

Strategy. The diversion control program 

(DCP) is a strategic component of the 

DEA’s law enforcement mission. It is 

primarily the DCP within DEA that 

implements and enforces Titles II and III 

of the Comprehensive Drug Abuse 

Prevention and Control Act of 1970, 

often referred to as the Controlled 

Substances Act (CSA) and the 

Controlled Substances Import and 

Export Act (CSIEA) (21 U.S.C. 801–971), 

as amended (hereinafter, ‘‘CSA’’).1 DEA 

drafts and publishes the implementing 

regulations for these statutes in Title 21 

of the Code of Federal Regulations 

(CFR), parts 1300 to 1321. The CSA 

together with these regulations are 

designed to establish a closed system for 

controlled substances and to prevent, 

detect, and eliminate the diversion of 

controlled substances and listed 

chemicals into the illicit market while 

ensuring a sufficient supply of 

controlled substances and listed 

chemicals for legitimate medical, 

scientific, research, and industrial 

purposes. 

The CSA and DEA’s implementing 

regulations establish the legal 

requirements for possession and 

dispensing of controlled substances, 

most notably pursuant to a prescription 

issued for a legitimate medical purpose 

by a practitioner acting in the usual 

course of professional practice. ‘‘The 

responsibility for the proper prescribing 

and dispensing of controlled substances 

is upon the prescribing practitioner, but 

a corresponding responsibility rests 

with the pharmacist who fills the 

prescription.’’ 21 CFR 1306.04(a). A 

prescription serves both as a record of 

the practitioner’s determination of the 

legitimate medical need for the drug to 

be dispensed, and as a record of the 

dispensing, providing the pharmacy 

with the legal justification and authority 

to dispense the medication prescribed 

by the practitioner. The prescription 

also provides a record of the actual 

dispensing of the controlled substance 

to the ultimate user (the patient) and, 

therefore, is critical to documenting that 

controlled substances held by a 

pharmacy have been dispensed legally. 

The maintenance by pharmacies of 

complete and accurate prescription 

records is an essential part of the overall 

CSA regulatory scheme established by 

Congress. 

Electronic Prescriptions for Controlled 

Substances (EPCS) 

Historically, where federal law 

required that a prescription for a 

controlled substance be issued in 

writing, that requirement could only be 

satisfied through the issuance of a paper 

prescription. Given advancements in 

technology and security capabilities for 

electronic applications, DEA recently 

amended its regulations to provide 

practitioners with the option of issuing 

electronic prescriptions for controlled 

substances (EPCS) in lieu of paper 

prescriptions. Efforts to develop EPCS 

have been underway for a number of 

years. DEA’s Interim Final Rule for 

Electronic Prescriptions for Controlled 

Substances was published on March 31, 

2010 at 75 FR 16236–16319 and became 

effective on June 1, 2010. While these 

regulations have paved the way for 

controlled substance prescriptions to be 

issued electronically, not all States have 

authorized electronic prescriptions for 

controlled substances, particularly 

Schedule II controlled substances which 

have a significant potential for abuse. 

The information technology industry 

is currently in the process of developing 

and testing applications to implement 

the requirements set forth in the Interim 

Final Rule. As this process continues, 

DEA believes it prudent to issue the 

following clarifications, 

recommendation, and update to help 

ensure that the requirements of the 

Interim Final Rule are properly 

implemented. Specifically, DEA is 

clarifying that third-party audits must 

be conducted by qualified persons and 

must determine that an application 

meets all of the applicable requirements 

in 21 CFR part 1311 as well as other 

requirements referenced in Part 1311. 

‘‘Processing integrity’’ must be 

addressed in audits of EPCS 

applications. DEA recommends that 

federal guidelines as set forth by the 

National Institute of Standards and 

Technology (NIST), including NIST 

Special Publication 800–53A, be 

consulted where questions arise. DEA 

has also announced an approved 

certification process for EPCS 

applications and has posted this 

information on its Web site. DEA notes 

its concern that proposed EPCS 

applications receive careful review prior 

to being used to create, sign, transmit or 

process controlled substance 

prescriptions so as to ensure the closed 

system for controlled substances 

established by the CSA. Secure and safe 

dispensing of controlled substances is 

necessary to protect the public interest 

and prevent diversion of controlled 

substances to illicit purposes. As with 

any violations of the CSA or DEA’s 

implementing regulations, if diversion 

occurs in the EPCS environment, or if 

controlled substances are otherwise 

dispensed in violation of the EPCS 

regulations, those responsible may be 

subject to administrative and/or judicial 

action, to include civil injunction. 

Current Issues 

National Prescription Drug Abuse 

Epidemic 

Implementation of electronic 

prescriptions for controlled substances 

is occurring at the same time the 

President has declared current 

prescription drug misuse and abuse as 

an epidemic constituting a major public 

health and public safety crisis.2 The 

non-medical use of prescription drugs is 

on the rise in the United States. Drug 

induced deaths now exceed motor 

vehicle accident deaths in the United 

States.3 According to the ‘‘Drug Abuse 

Warning Network (DAWN), 2009: 

National Estimates of Drug-Related 

Emergency Department Visits,’’ the 


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Federal Register / Vol. 76, No. 202 / Wednesday, October 19, 2011 / Rules and Regulations 64815 

4Behavioral Health Statistics and Quality, 

‘‘Highlights of the 2009 Drug Abuse Warning 

Network (DAWN) Findings on Drug-Related 

Emergency Department Visits,’’ The DAWN Report, 

December 28, 2010. 

5 Id. at 4. 

6 Id. at 3. 

7Substance Abuse and Mental Health Services 

Administration, ‘‘Results from the 2009 National 

Survey on Drug Use and Health: Volume I, 

Summary of National Findings,’’ Office of Applied 

Studies, 2010 (NSDUH Series H–38A, HHS 

Publication No. SMA 10–4856), http:// 

www.oas.samhsa.gov/nsduh/2k9NSDUH/ 

2k9Results.pdf. 

8Partnership for a Drug-Free America and 

MetLife Foundation, ‘‘2009 Parents and Teens 

Attitude Tracking Study Report’’ March 2, 2010. 

9http://www.marketwire.com/ 

printer_friendly?id=1529987; http:// 

business.financialpost.com/2011/06/23/surveyfinds-90-of-u-s-companies-hacked-in-past-year/. 

10For example, among others, see Wall Street 

Journal articles May 19 (U.N. International Atomic 

Energy Agency), May 27 (Lockheed Martin), June 2 

(Google), June 10 (Citigroup), June 11 (Sony), 2011; 

Workers’ Compensation California Medical Record 

Privacy Breach, August 23, 2011, http://workerscompensation.blogspot.com/2011/08/majorcalifornia-medical-record-privacy.html; New York 

Times article September 8, 2011 (electronic medical 

record breaches). 

Substance Abuse and Mental Health 

Services Administration (SAMHSA),4

emergency department visits involving 

non-medical use of pharmaceuticals 

(misuse or abuse) almost doubled 

between 2004 and 2009 from 627,291 in 

2004 to 1,244,679 visits in 2009 (a 98.4 

percent increase).5 About half of the 

2009 emergency department visits 

related to abuse or misuse of 

pharmaceuticals involved painkillers 

and more than one-third involved drugs 

to treat insomnia and anxiety.6

The 2009 National Survey on Drug 

Use and Health (NSDUH) 7 estimated 

that 7.0 million persons used 

prescription-type psychotherapeutic 

drugs—pain relievers, anti-anxiety 

medications, stimulants, and 

sedatives—non-medically. This 

represents 2.8 percent of the population 

aged twelve or older. These estimates 

were 13 percent higher than those from 

the 2008 Survey. In 2009, 2.2 million 

persons aged twelve or older used pain 

relievers non-medically for the first 

time; that averages to over 6,000 new 

users per day. Teenagers (grades 9–12) 

believe that prescription drugs are easier 

to obtain than illegal drugs. There is a 

concern that young people may perceive 

prescription and/or over-the-counter 

drugs as ‘‘safer’’ than illegal drugs 

because of their intended, legitimate 

medical use.8

Increased Security Breaches 

Cyber attacks are growing in 

frequency, size and complexity and are 

of concern as EPCS goes online. 

Responses by 583 U.S. businesses of all 

sizes to a recent independent survey 

conducted by the Ponemon Institute 

released June 22, 2011 found that 90 

percent had at least one cyber security 

breach in the past 12 months. This 

survey found that the top two endpoints 

from which these security breaches 

occurred are employees’ laptop 

computers and employee’s mobile 

devices.9 Numerous recent news articles 

describe incidents of major security 

breaches or hacking incidents into major 

U.S. private and government computer 

systems, including incidents involving 

electronic health records.10 These 

incidents occur for many reasons, but 

access to controlled substances has not 

been cited as an objective because such 

substances have not been 

communicated via an electronic system. 

With the impending implementation of 

electronic prescriptions for controlled 

substances, DEA wishes to reiterate that 

adequate security of EPCS has been and 

continues to be a primary consideration 

in any electronic system used to 

communicate a legitimate controlled 

substance prescription for the purpose 

of dispensing to an ultimate user. 

Clarifications 

DEA wishes to provide the following 

clarifications. 

Third-Party Audits of EPCS 

Applications 

EPCS, as with paper prescriptions, 

requires the individual practitioner be 

responsible for ensuring the 

prescription conforms to all legal 

requirements and the pharmacist, acting 

under the authority of the DEAregistered pharmacy, has a 

corresponding responsibility to ensure 

the prescription is valid and meets all 

legal requirements. Review of an EPCS 

application must be thorough in order to 

provide the prescriber and pharmacist 

the level of assurance needed in order 

to use the application. 

Before any application may be used 

for electronic prescriptions for 

controlled substances, it must be 

reviewed, tested and determined by a 

third party to meet all of the 

requirements of 21 CFR part 1311. See 

21 CFR 1311.300(a). There are two 

alternative processes for review of EPCS 

applications: (1) A third-party audit 

conducted by a person qualified to 

conduct a SysTrust, WebTrust or SAS 

70 audit or a Certified Information 

System Auditor as stated in 21 CFR 

1311.300(b), which comports with the 

requirements of paragraphs (c) and (d) 

of 21 CFR 1300.300 or (2) A certification 

by a certifying organization whose 

certification process has been approved 

by DEA as stated in 21 CFR 1311.300(e), 

which certification verifies that the 

application meets all of the 

requirements of 21 CFR part 1311. 

21 CFR 1311.300(c) and 21 CFR 

1311.300(d) state respectively that an 

audit for installed applications and 

application service providers must, 

among other things, determine that the 

application meets all of the applicable 

requirements in Part 1311. This 

includes all of Part 1311 and references 

to Parts 1300, 1304 and 1306. 

Some individuals may be 

misinterpreting 21 CFR 1311.300(c) and 

(d), which state that audits ‘‘for installed 

applications must address processing 

integrity and determine that the 

application meets the requirements of 

this part,’’ and audits ‘‘for application 

service providers must address 

processing integrity and physical 

security and determine that the 

application meets the requirements of 

this part.’’ (emphasis added). To further 

clarify, the Code of Federal Regulations 

is organized by title, chapter, part, 

subpart, section and paragraph. Any 

audit must include all of the applicable 

requirements for electronic 

prescriptions of controlled substances 

found in 21 CFR part 1311 and not just 

section 1311.300 of part 1311. Part 1311 

also cross-references Parts 1300, 1304 

and 1306 which establish specific 

requirements that must be the subject of 

any audit. Thorough review and testing 

of all requirements is both required by 

the regulations and necessary to ensure 

secure and effective electronic 

prescribing and dispensing of controlled 

substances in the interests of public 

health and safety. 

‘‘Processing Integrity’’ must be 

addressed in audits of EPCS prescriber 

and pharmacy applications. 

EPCS applications must address 

security to prevent insider threats and 

outsider attacks on any system. Careful 

review by an independent, qualified 

third-party of the ‘‘processing integrity’’ 

of any application is required to 

determine whether an application or 

application service provider has 

adequate protection against the range of 

potential security threats. 

Person qualified to conduct a thirdparty audit. 

DEA notes that 21 CFR 1311.300(b)(1) 

and (2) require that a third-party audit 

be conducted by a person qualified to 

conduct a SysTrust, WebTrust or SAS 

70 audit or by a Certified Information 

System Auditor. The regulations do not 

require one of these types of audits, but 

rather that the person conducting the 

audit must have specified qualifications. 

As provided in 21 CFR 1311.300(c) and 

(d), any audit must address processing 


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64816 Federal Register / Vol. 76, No. 202 / Wednesday, October 19, 2011 / Rules and Regulations 

11http://csrc.nist.gov/publications/nistpubs/800- 

53A-rev1/sp800-53A-rev1-final.pdf. Note that the 

latest version of SP800–53A should be consulted as 

it is regularly updated to meet technology 

developments. 

integrity and determine that the 

application meets the requirements of 

DEA’s regulations. DEA is reviewing the 

fact that the American Institute of 

Certified Public Accountants has 

replaced SAS 70 audits referenced in 21 

CFR 1311.300(b)(1) and will necessarily 

address this issue in the final rule on 

EPCS. 

Recommendation 

Where questions arise in reviewing a 

particular EPCS prescriber or pharmacy 

application, DEA recommends that 

federal guidelines as set forth by the 

National Institute of Standards and 

Technology (NIST), specifically NIST 

Special Publication 800–53A, be 

consulted. Other NIST standards and 

publications are incorporated by 

reference in the Interim Final Rule and 

must be complied with as stated in the 

Interim Final Rule. 

Some of the questions surrounding 

interpretation of DEA’s EPCS 

regulations as applied to specific 

applications are addressed by federal 

guidelines articulated by the National 

Institute of Standards and Technology 

in NIST Special Publication (SP) 800– 

53A, as revised. Federal computer 

systems must comply with federal 

guidelines as outlined in NIST SP 800– 

53A.11 As NIST SP 800–53A states, the 

publication may be used by 

nongovernmental organizations on a 

voluntary basis. Although the Interim 

Final Rule does not require compliance 

with NIST SP 800–53A, DEA believes 

this publication provides useful 

guidance and that it is advisable for 

private sector entities to consult the 

publication when reviewing security 

requirements for EPCS applications. In 

addition, EPCS will be used on federal 

systems in the military, the Department 

of Veterans Affairs and elsewhere where 

such systems must comply with federal 

guidelines. 

DEA notes that the Notice of Proposed 

Rulemaking (NPRM) in June 27, 2008 

discussed NIST SP 800–53A and 

whether or not it should be the basis for 

security requirements. 73 FR 36746–47 

(June 27, 2008). DEA did not require 

application of NIST SP 800–53A in the 

Interim Final Rule due to the perceived 

need for flexibility and because security 

would be ensured by review of 

‘‘processing integrity.’’ In light of 

developments since that time, DEA will 

be revisiting this issue as it is clear that 

a mechanism must be established in the 

EPCS regulations to keep EPCS 

applications current with technology, 

particularly security requirements. 

Update 

All certifying organizations with a 

certification process approved by DEA 

pursuant to 21 CFR 1311.300(e) are 

posted on DEA’s Web site once 

approved. 

As noted above, the Interim Final 

Rule provides that, as an alternative to 

the audit requirements of 21 CFR 

1311(b) through (d), an electronic 

prescription or pharmacy application 

may be verified and certified as meeting 

the requirements of 21 CFR Part 1311 by 

a certifying organization whose 

certification process has been approved 

by DEA. The preamble to the Interim 

Final Rule further indicated that, once 

a qualified certifying organization’s 

certification process has been approved 

by DEA in accordance with 21 CFR 

1311.300(e), such information will be 

posted on DEA’s Web site. 75 FR 16243, 

March 31, 2010. On September 22, 2011, 

DEA approved the certification process 

developed by InfoGard Laboratories, 

Inc. and relevant information has been 

posted on DEA’s Web site at http:// 

www.DEAdiversion.usdoj.gov under 

electronic prescriptions. 

Dated: October 7, 2011. 

Joseph T. Rannazzisi, 

Deputy Assistant Administrator, Office of 

Diversion Control. 

[FR Doc. 2011–26738 Filed 10–18–11; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

[TD 9552] 

RIN 1545–BJ24 

Deduction for Qualified Film and 

Television Production Costs 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Final and temporary 

regulations. 

SUMMARY: This document contains final 

and temporary regulations relating to 

deductions for the cost of producing 

film and television productions. These 

temporary regulations reflect changes to 

the law made by the Tax Extenders and 

Alternative Minimum Tax Relief Act of 

2008, and affect taxpayers that produce 

films and television productions within 

the United States. The text of these 

temporary regulations also serves as the 

text of the proposed regulations set forth 

in the notice of proposed rulemaking on 

this subject in the Proposed Rules 

section in this issue of the Federal 

Register. 

DATES: Effective Date: These regulations 

are effective on October 18, 2011. 

Applicability Dates: For dates of 

applicability, see § 1.181–6T. 

FOR FURTHER INFORMATION CONTACT: 

Bernard P. Harvey, (202) 622–4930 (not 

a toll-free number). 

SUPPLEMENTARY INFORMATION: 

Background 

This document contains amendments 

to 26 CFR part 1 to provide regulations 

under section 181 of the Internal 

Revenue Code of 1986 (Code). Section 

181 permits the deduction of certain 

production costs by the producer of a 

qualified film or television production. 

Section 181 was added to the Code by 

section 244 of the American Jobs 

Creation Act of 2004, Public Law 108– 

357 (118 Stat. 1418) (October 22, 2004), 

and was modified by section 403(e) of 

the Gulf Opportunity Zone Act of 2005, 

Public Law 109–135 (119 Stat. 2577) 

(December 21, 2005). Section 502 of the 

Tax Extenders and Alternative 

Minimum Tax Relief Act of 2008, Public 

Law 110–343 (122 Stat. 3765) (October 

3, 2008) further modified section 181 for 

film and television productions 

commencing after December 31, 2007, 

and extended section 181 to film and 

television productions commencing 

before January 1, 2010. Section 181 was 

extended again to film and television 

productions commencing before January 

1, 2012, by section 744 of the Tax Relief, 

Unemployment Insurance 

Reauthorization, and Job Creation Act of 

2010, Public Law 111–312 (December 

17, 2010). 

On September 30, 2011, the IRS and 

the Treasury Department published in 

the Federal Register (TD 9551, 76 FR 

60721) final regulations relating to 

deductions for the cost of producing 

film and television productions under 

section 181 as enacted by the American 

Jobs Creation Act of 2004 and modified 

by the Gulf Opportunity Zone Act of 

2005. 

Explanation of Provisions 

Section 181 permits an owner of a 

qualified film or television production 

to elect to deduct production costs paid 

or incurred by that owner for the year 

the costs are paid or incurred, in lieu of 

capitalizing the costs and recovering 

them through depreciation allowances. 

For a qualified film or television 

production that commenced before 

January 1, 2008 (a ‘‘pre-amendment 

production’’), this deduction is available 


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