This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

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REGISTER issue of each week.

Rules and Regulations Federal Register

38915 

Vol. 75, No. 129 

Wednesday, July 7, 2010 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1310 

[Docket No. DEA–296F] 

RIN 1117–AB10 

Removal of Thresholds for the List I 

Chemicals Pseudoephedrine and 

Phenylpropanolamine 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Final rule. 

SUMMARY: The Drug Enforcement 

Administration (DEA) is removing the 

thresholds for importation, exportation, 

and domestic distributions of the List I 

chemicals pseudoephedrine and 

phenylpropanolamine. This rulemaking 

is being conducted as part of DEA’s 

implementation of the Combat 

Methamphetamine Epidemic Act of 

2005 and is needed to implement the 

Act’s requirements for import and 

production quotas and to address the 

potential diversion of these chemicals. 

DEA is also clarifying that all 

transactions of drug products containing 

ephedrine, pseudoephedrine, and 

phenylpropanolamine, except retail 

transactions, are considered to be 

regulated transactions. 

DATES: Effective Date: This rule is 

effective August 6, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Mark W. Caverly, Chief, Liaison and 

Policy Section, Office of Diversion 

Control, Drug Enforcement 

Administration, 8701 Morrissette Drive, 

Springfield, VA 22152, (202) 307–7297. 

SUPPLEMENTARY INFORMATION: 

DEA’s Legal Authority 

DEA implements 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. DEA publishes the 

implementing regulations for these 

statutes in Title 21 of the Code of 

Federal Regulations (CFR), parts 1300 to 

end. These regulations are designed to 

ensure that there is a sufficient supply 

of controlled substances for legitimate 

medical, scientific, research, and 

industrial purposes and deter the 

diversion of controlled substances to 

illegal purposes. The CSA mandates that 

DEA establish a closed system of control 

for manufacturing, distributing, and 

dispensing controlled substances. Any 

person who manufactures, distributes, 

dispenses, imports, exports, or conducts 

research or chemical analysis with 

controlled substances must register with 

DEA (unless exempt) and comply with 

the applicable requirements for the 

activity. The CSA, as amended, also 

requires DEA to regulate the 

manufacture, distribution, retail sale, 

import, and export of chemicals that 

may be used to manufacture controlled 

substances illegally. Listed chemicals 

that are classified as List I chemicals are 

important to the manufacture of 

controlled substances. Those classified 

as List II chemicals may be used to 

manufacture controlled substances. 

Combat Methamphetamine Epidemic 

Act of 2005 

On March 9, 2006, the President 

signed the Combat Methamphetamine 

Epidemic Act of 2005 (CMEA), which is 

Title VII of the USA PATRIOT 

Improvement and Reauthorization Act 

of 2005 (Pub. L. 109–177). Among other 

actions, CMEA imposed new 

requirements regarding the retail sale of 

scheduled listed chemical products 

(drugs containing ephedrine, 

pseudoephedrine, or 

phenylpropanolamine, that may be 

marketed or distributed lawfully in the 

United States under the Federal Food, 

Drug and Cosmetic Act as 

nonprescription products) (21 U.S.C. 

802(45)(A)). In a separate rulemaking, 

‘‘Retail Sales of Scheduled Listed 

Chemical Products; Self-Certification of 

Regulated Sellers of Scheduled Listed 

Chemical Products’’ [Docket No. DEA– 

291, RIN 1117–AB05] (71 FR 56008, 

September 26, 2006; corrected at 71 FR 

60609, October 13, 2006), DEA 

promulgated regulations implementing 

these provisions (21 U.S.C. 830(d), (e); 

21 CFR part 1314). 

The CMEA also subjects material 

containing ephedrine, pseudoephedrine, 

and phenylpropanolamine to 

manufacturing and import restrictions. 

Specifically, CMEA amended section 

1002 of the CSA (21 U.S.C. 952(a)(1)) by 

adding the List I chemicals ephedrine, 

pseudoephedrine, and 

phenylpropanolamine to those narcotic 

raw materials whose importation into 

the United States is prohibited except 

for such amounts as the Attorney 

General finds to be necessary to provide 

for medical, scientific, or other 

legitimate purposes. CMEA also 

amended section 306 of the Act (21 

U.S.C. 826) to establish the total annual 

needs of ephedrine, pseudoephedrine, 

and phenylpropanolamine to provide 

for the estimated medical, scientific, 

research, and industrial needs of the 

United States, for lawful export 

requirements, and for the establishment 

and maintenance of reserve stocks. 

Individual manufacturing and 

procurement quotas for ephedrine, 

pseudoephedrine, and 

phenylpropanolamine were also 

required to be established for persons 

conducting manufacturing activities 

with those chemicals. In a separate 

rulemaking, ‘‘Import and Production 

Quotas for Certain List I Chemicals’’ 

[Docket No. DEA–293, RIN 1117–AB08] 

(72 FR 37439, July 10, 2007; Final Rule 

73 FR 73549, December 3, 2008), DEA 

promulgated regulations to implement 

these provisions (21 CFR part 1315). 

Further, the CMEA requires that 

importers, exporters, and persons 

involved in international transactions of 

all listed chemicals, including 

ephedrine, pseudoephedrine, and 

phenylpropanolamine, provide DEA 

with information regarding the 

transferee (i.e., the downstream 

customer), of the chemical, as well as 

information regarding the quantity of 

the chemical to be transferred. 

Importers, exporters, and persons 

involved in international transactions 

are further required to provide DEA 

with a return declaration regarding each 

import, export, or international 

transaction after the transaction is 

completed (CMEA § 716, 21 U.S.C. 

971(d) and (g), as amended). In a 

separate rulemaking, ‘‘Implementation 

of the Combat Methamphetamine 

Epidemic Act of 2005; Notice of 


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Transfers Following Importation or 

Exportation’’ [Docket No. DEA–292, RIN 

1117–AB06] (72 FR 17401, April 9, 

2007; Temporary Stay of Certain 

Provisions 72 FR 28601, May 22, 2007), 

DEA promulgated regulations 

implementing these provisions (21 CFR 

1313.16, 1313.17, 1313.26, 1313.27, 

1313.32, 1313.35). 

Finally, the CMEA requires that the 

notice of importation (DEA Form 486) 

for ephedrine, pseudoephedrine, and 

phenylpropanolamine ‘‘shall include all 

information known to the importer on 

the chain of distribution of such 

chemical from the manufacturer to the 

importer.’’ (CMEA § 721, 21 U.S.C. 

971(h) as amended). In a separate 

rulemaking, ‘‘Information on Foreign 

Chain of Distribution for Ephedrine, 

Pseudoephedrine, and 

Phenylpropanolamine’’ [Docket No. 

DEA–295, RIN 1117–AB07] (73 FR 

16793, March 31, 2008), DEA proposed 

regulations to implement this provision. 

The List I chemicals ephedrine, 

pseudoephedrine, and 

phenylpropanolamine as single entity or 

combination products all serve as 

precursor chemicals for the illicit 

manufacture of controlled substances. 

Ephedrine and pseudoephedrine are the 

primary precursors used in the illicit 

synthesis of methamphetamine, a 

schedule II controlled substance, and 

methcathinone, a schedule I controlled 

substance. Phenylpropanolamine is the 

primary precursor used in the illicit 

synthesis of amphetamine, a schedule II 

controlled substance. 

Licit Use 

Ephedrine, pseudoephedrine, and 

phenylpropanolamine all have 

therapeutic uses in both over-thecounter and prescription drug products. 

Ephedrine is lawfully marketed under 

the Federal Food, Drug, and Cosmetic 

Act as an ingredient in nonprescription 

(‘‘over-the-counter’’ (OTC)) drugs as a 

bronchodilator for the treatment of 

asthma. Ephedrine is also available as a 

nonprescription product in combination 

with the active ingredient guaifenesin, 

which is an expectorant. 

As a prescription drug, ephedrine is 

used in parenteral (injectable) form in 

hospitals as part of anesthesiology kits. 

Ephedrine has the beneficial effect of 

increasing blood pressure very rapidly 

in the event of hypotensive crisis (i.e., 

sudden loss of blood pressure 

sometimes experienced during surgery). 

Parenteral ephedrine is also sometimes 

used to relieve acute bronchospasm. 

Oral dosage forms of ephedrine are also 

available as prescription drugs for the 

treatment of asthma. These prescription 

drug products primarily consist of 

ephedrine in combination with other 

active ingredients such as potassium 

iodide (an expectorant) and/or 

theophylline (a bronchospamolytic). 

Pseudoephedrine is lawfully 

marketed under the Federal Food, Drug, 

and Cosmetic Act for over-the-counter 

use as a decongestant. 

Phenylpropanolamine has historically 

been marketed in the United States for 

OTC use as a decongestant and diet aid 

and there have been many legend 

(prescription) drug products that 

contain pseudoephedrine or 

phenylpropanolamine. In the vast 

majority of these preparations, 

pseudoephedrine or 

phenylpropanolamine were in 

combination with other active 

ingredients, such as antihistamines, 

expectorants, and/or antitussives. 

In November 2000, the U.S. Food and 

Drug Administration (FDA) issued a 

public health advisory concerning 

phenylpropanolamine and requested 

that all drug companies discontinue 

marketing products containing 

phenylpropanolamine due to risk of 

hemorrhagic stroke. In response, many 

companies have voluntarily 

reformulated their products to exclude 

phenylpropanolamine. Subsequently, 

on December 22, 2005, the FDA 

published a Notice of Proposed 

Rulemaking (70 FR 75988) proposing to 

categorize all over-the-counter nasal 

decongestants and weight control drug 

products containing 

phenylpropanolamine preparations as 

Category II, nonmonograph, i.e., not 

generally recognized as being safe for 

human consumption. Most products 

containing phenylpropanolamine 

intended for humans have been 

withdrawn from the market, but 

phenylpropanolamine is still sold by 

prescription for veterinary uses. 

While ephedrine and 

pseudoephedrine are pharmacologically 

different (and have quite different 

therapeutic uses), they are directly 

substitutable in the production of 

methamphetamine. This is because of 

the similarity of the chemical structures 

of the two drugs. 

Discussion of the NPRM 

On November 20, 2007, DEA 

published a Notice of Proposed 

Rulemaking (NPRM) (72 FR 65248) 

addressing two issues related to CMEA 

implementation. First, DEA proposed to 

eliminate the thresholds for 

distribution, importation, and 

exportation of pseudoephedrine and 

phenylpropanolamine; the threshold for 

distribution, importation, and 

exportation of ephedrine was eliminated 

previously. Limits on retail transactions 

are set in the CMEA and were addressed 

in DEA’s Interim Rule regarding the 

retail provisions of the CMEA (71 FR 

56008, September 26, 2006; corrected at 

71 FR 60609, October 13, 2006). Second, 

DEA proposed to clarify that all 

distribution, importation, and 

exportation transactions involving drug 

products containing ephedrine, 

pseudoephedrine, or 

phenylpropanolamine are regulated 

transactions. 

The comment period for the NPRM 

closed on January 22, 2008. DEA 

received one comment on the NPRM. 

Thresholds 

Under the existing regulations (21 

CFR 1310.04), the threshold for nonretail distribution, import, export, and 

international transactions of 

pseudoephedrine is 1 kilogram and for 

phenylpropanolamine, 2.5 kilograms. A 

single transaction or multiple 

transactions in a month with a single 

customer that equal or exceed the 

threshold are considered regulated 

transactions and trigger the reporting 

and recordkeeping requirements of 21 

CFR part 1310. If DEA has not 

established a monthly threshold for a 

List I chemical, then all transactions 

must be reported. DEA has not 

established a threshold for ephedrine; 

thus all non-retail distribution, import, 

and export transactions involving 

ephedrine are already subject to 

recordkeeping and reporting 

requirements. 

CMEA mandates that DEA establish 

the total annual need for ephedrine, 

pseudoephedrine, and 

phenylpropanolamine to be 

manufactured or imported each 

calendar year to provide for the 

estimated medical, scientific, research, 

and industrial needs of the United 

States, for lawful export requirements, 

and for the establishment and 

maintenance of reserve stocks (21 U.S.C. 

826). These requirements apply equally 

to products containing these three List 

I chemicals as they do to the List I 

chemicals themselves. To limit the 

supply of the chemicals to the amount 

needed to meet the national need, 

CMEA requires DEA to establish import 

and production quotas for all three 

chemicals. DEA published regulations 

implementing procedures for import 

and production quotas for the List I 

chemicals ephedrine, pseudoephedrine, 

and phenylpropanolamine on July 10, 

2007 (72 FR 37439; Final Rule 73 FR 

73549, December 3, 2008). DEA 

established the 2008 assessment of 

annual national needs for the List I 

chemicals ephedrine, pseudoephedrine, 

and phenylpropanolamine on December 


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Federal Register / Vol. 75, No. 129 / Wednesday, July 7, 2010 / Rules and Regulations 38917 

26, 2007 (72 FR 73361) and has 

established the assessment of annual 

national needs every year thereafter. 

To obtain the information needed to 

assess the national need and set quotas 

to limit imports and production to meet 

that need, DEA identified two 

inadequacies regarding its existing 

regulations. First, persons who 

manufacture or import prescription 

drugs containing the chemicals are not 

registered. In a separate rulemaking, 

‘‘Registration Requirements for 

Importers and Manufacturers of 

Prescription Drug Products Containing 

Ephedrine, Pseudoephedrine, or 

Phenylpropanolamine’’ [Docket No. 

DEA–294, RIN 1117–AB09] (73 FR 3432, 

January 18, 2008), DEA proposed to 

revise its registration requirements to 

cover manufacturers and importers of 

prescription drugs containing these 

chemicals and will issue quotas to them 

although the distribution and export of 

prescription drugs containing the 

chemicals will continue to be exempt 

from DEA regulatory control. 

The second inadequacy involves the 

thresholds that apply to 

pseudoephedrine and 

phenylpropanolamine. To determine the 

annual national need and set quotas, 

DEA must obtain information on all 

imports and production involving the 

chemicals, not just those that exceed the 

existing thresholds. The existing 

thresholds, although relatively low, 

potentially allow a considerable market 

in the chemicals to continue 

unregulated. For example, under the 

current 1 kilogram (2.2 pound) 

threshold for pseudoephedrine, a person 

could import or distribute more than 2 

pounds a month, or approximately 25 

pounds a year, of pseudoephedrine 

without exceeding the threshold and 

triggering DEA’s controls. Assuming a 

conservative 50 percent conversion of 

pseudoephedrine to methamphetamine, 

a person could annually manufacture 

approximately 12.5 pounds of 

methamphetamine with that total sum 

of sub-threshold quantities. DEA trend 

reporting for 2008 indicated that the 

national price for one pound of 

methamphetamine hydrochloride 

(powder) ranged from as low as $5,000 

per pound in the DEA New Orleans and 

Washington DC Field Divisions, to as 

much as $26,000 and $27,000 per pound 

in the DEA New York and Atlanta Field 

Divisions, respectively. To further 

implement the CMEA, this rule seeks to 

curb the availability of pseudoephedrine 

at the wholesale level for illicit 

purposes. 

Additionally, under the current 2.5 

kilogram (5.5 pound) threshold for 

phenylpropanolamine, a person could 

import or distribute more than 5 pounds 

a month, or approximately 66 pounds a 

year of phenylpropanolamine without 

exceeding the threshold and triggering 

DEA’s controls. Assuming a 

conservative 50 percent conversion of 

phenylpropanolamine to amphetamine, 

a person could annually manufacture 

approximately 33 pounds of 

amphetamine with that total sum of subthreshold quantities. To the extent that 

amphetamine is marketed on the street 

as methamphetamine, amphetamine 

often has a street value comparable to 

methamphetamine. To further 

implement the CMEA, this rule seeks to 

curb the availability of 

phenylpropanolamine at the wholesale 

level for illicit purposes. 

Currently, DEA is notified of all 

imports, exports, and international 

transactions of these chemicals which 

exceed the established thresholds or for 

which no threshold is established. DEA 

does not, however, receive import, 

export, and international transaction 

notifications for imports, exports, and 

international transactions of listed 

chemicals less than established 

thresholds. If DEA does not eliminate 

the threshold for imports, exports, and 

international transactions of 

pseudoephedrine and 

phenylpropanolamine, DEA will not 

have complete and accurate information 

regarding the quantities of these 

chemicals imported into, and exported 

from, the United States. Further, 

manufacturers and distributors are not 

required to maintain records of 

distributions of listed chemicals at or 

below established thresholds. Without 

the maintenance of these records, DEA 

will not have complete and accurate 

information regarding the quantities of 

these chemicals being distributed 

domestically. 

Comments Regarding Removal of 

Thresholds for Pseudoephedrine and 

Phenylpropanolamine 

DEA did not receive any comments 

regarding the proposed removal of 

thresholds for the List I chemicals 

pseudoephedrine and 

phenylpropanolamine and therefore, is 

finalizing those provisions as proposed. 

Thus, to establish the controls that 

Congress mandated and limit imports 

and production to that needed for 

legitimate uses, DEA is eliminating the 

thresholds for all transactions involving 

the List I chemicals pseudoephedrine 

and phenylpropanolamine. As 

discussed previously, no threshold 

currently exists for transactions 

involving the List I chemical ephedrine; 

thus, all transactions are regulated. Any 

registrant manufacturing, distributing, 

importing, or exporting 

pseudoephedrine or 

phenylpropanolamine, in any quantity, 

either as bulk chemicals or in over-thecounter drug products, will be subject to 

the reporting and recordkeeping 

requirements. Any manufacturer or 

importer of prescription drug products 

containing one of the chemicals will 

also be subject to reporting and 

recordkeeping requirements. 

Importation of the chemicals is allowed 

only if it is within an import quota that 

the importer has applied for and been 

granted by DEA. The one exception to 

the import limits provided in the CMEA 

is that an individual may import not 

more than 7.5 grams in any 30-day 

period of a scheduled listed chemical 

product (i.e., a product containing 

ephedrine, pseudoephedrine, or 

phenylpropanolamine which may be 

marketed or distributed lawfully in the 

United States under the Federal Food, 

Drug, and Cosmetic Act as a 

nonprescription drug) by means of the 

U.S. Postal Service or a private or 

commercial carrier (21 U.S.C. 844(a)). 

The distribution and export of 

prescription drug products containing 

the chemicals are not covered because 

DEA will be able to obtain the 

information it needs for the assessment 

of annual national needs from importers 

and manufacturers of these products. 

DEA has not determined that 

prescription drug products are being 

diverted. 

Regulated Transactions 

The definition of ‘‘regulated 

transaction’’ as amended by CMEA (21 

U.S.C. 802(39)(A)(iv)) excludes: 

(iv) Any transaction in a listed 

chemical that is contained in a drug that 

may be marketed or distributed lawfully 

in the United States under the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

301 et seq.), subject to clause (v), 

unless— 

(I) The Attorney General has 

determined under section 204 of the Act 

(21 U.S.C. 814) that the drug or group 

of drugs is being diverted to obtain the 

listed chemical for use in the illicit 

production of a controlled substance; 

and 

(II) The quantity of the listed chemical 

contained in the drug included in the 

transaction or multiple transactions 

equals or exceeds the threshold 

established for that chemical by the 

Attorney General. 

Section 814 (b) states that: 

In removing a drug or group of drugs 

from exemption * * * the Attorney 

General shall consider, with respect to 

a drug or group of drugs that is 


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38918 Federal Register / Vol. 75, No. 129 / Wednesday, July 7, 2010 / Rules and Regulations 

proposed to be removed from 

exemption— 

(1) The scope, duration, and 

significance of the diversion; 

(2) Whether the drug or group of 

drugs is formulated in such a way that 

it cannot be easily used in the illicit 

production of a controlled substance; 

and 

(3) Whether the listed chemical can be 

readily recovered from the drug or 

group of drugs. 

DEA in this rule is clarifying that 

nonprescription (OTC) drug products 

containing ephedrine, pseudoephedrine, 

and phenylpropanolamine do not 

qualify for the exemption from the 

definition of ‘‘regulated transaction’’ 

based on the three factors listed in 21 

U.S.C. 814(b) for the reasons discussed 

below. 

Evaluation of Statutory Factors for 

Removal of Exemption From the 

Definition of ‘‘Regulated Transaction’’ 

Note: For a more detailed discussion of 

DEA’s analysis regarding each factor, see the 

NPRM preamble (72 FR 65248, November 20, 

2007). 

Factor 1: Scope, Duration, and 

Significance of Diversion 

Throughout the late 1970s, 

methamphetamine was illicitly 

produced primarily through the use of 

the precursor phenylacetone (phenyl-2- 

propanone (P2P)) by outlaw motorcycle 

gangs in the United States. In response 

to the use of P2P, DEA controlled P2P 

as a schedule II controlled substance in 

1980, under the immediate precursor 

provisions of the CSA, specifically 21 

U.S.C. 811(e). Clandestine laboratory 

operators responded by developing a 

variety of synthetic methods for 

producing P2P and also migrated to the 

use of ephedrine as precursor material. 

In 1989, DEA control of chemicals 

was initiated with passage of the 

Chemical Diversion and Trafficking Act 

of 1988 (CDTA) (Subtitle A of Title VI 

of Pub. L. 100–690). This law placed 

recordkeeping and reporting 

requirements on a wide variety of 

precursors and essential chemicals used 

in every aspect of clandestine drug 

manufacture, including bulk powder 

ephedrine, pseudoephedrine, and 

phenylpropanolamine. In response to 

the regulations, traffickers moved to the 

illicit use of single-entity ephedrine 

OTC tablets as an unregulated source of 

precursor material for the production of 

methamphetamine. 

In the early 1990s, a number of wellpublicized seizures of rogue businesses 

(and prosecutions of their owners) 

began to impact the tablet 

manufacturing industry, and a loophole 

allowing the sale of single-entity 

ephedrine products was closed in late 

1993 with the passage of the Domestic 

Chemical Diversion Control Act of 1993 

(DCDCA) (Pub. L. 103–200). 

In 1996, the existing controls on 

precursor and essential chemicals 

imposed by the CDTA and DCDCA were 

further tightened with the passage of the 

Comprehensive Methamphetamine 

Control Act of 1996 (MCA) (Pub. L. 104– 

237). What followed was a series of 

legislative actions on both the Federal 

and State levels to tighten controls on 

pharmaceutical products that serve as 

precursor material for clandestine 

methamphetamine laboratories. At the 

Federal level, this effort included 

passage of the Methamphetamine AntiProliferation Act of 2000 (MAPA) (Title 

XXXVI of Pub. L. 106–310). Today, 

however, ephedrine and 

pseudoephedrine OTC products 

continue to serve as the primary 

precursor source for the illicit 

production of methamphetamine, which 

has spread across the entire United 

States in epidemic proportions. 

Current Seizures 

As DEA discussed in the NPRM, 

methamphetamine remains the primary 

drug produced in illicit laboratories 

within the United States. Data from the 

El Paso Intelligence Center’s (EPIC) 

Clandestine Laboratory Database 

indicates that 10,022 methamphetamine 

laboratories were seized in calendar 

year 2004, 6,021 laboratories in calendar 

year 2005, 3,977 laboratories in calendar 

year 2006, 3,097 laboratories in calendar 

year 2007, and 3,924 laboratories in 

calendar year 2008 (as reported to EPIC 

through November 27, 2009). According 

to EPIC, from January 1, 2000, through 

December 31, 2008, there were at least 

7,385 laboratories reportedly using 

ephedrine and 51,102 reportedly using 

pseudoephedrine as precursor material 

for methamphetamine production. 

Additionally EPIC reports the seizure of 

48 amphetamine laboratories (using 

phenylpropanolamine) during the same 

period. The vast majority of these 

laboratories used pharmaceutical 

products containing pseudoephedrine, 

ephedrine, and phenylpropanolamine as 

the source of precursor material. 

Illicit Uses 

Factor 2: Whether the Drug or Group of 

Drugs Is Formulated in Such a Way 

That It Cannot Be Easily Used in the 

Illicit Production of a Controlled 

Substance 

Factor 3: Whether the Listed Chemical 

Can Be Readily Recovered From the 

Drug or Group of Drugs 

As DEA discussed in the NPRM, the 

production of methamphetamine from 

ephedrine or pseudoephedrine can be 

accomplished via a series of reactions 

using widely available ‘‘recipes’’ and can 

be accomplished with little or no 

chemistry expertise. A variety of 

different methods exist to convert the 

precursor material to 

methamphetamine. If very small batches 

are made, there is not even a 

requirement to heat the reactants. For 

example, quantities of ephedrine or 

pseudoephedrine, iodine, and red 

phosphorous can be reacted with the 

addition of water and small quantities of 

methamphetamine can be produced. For 

larger batches the reactants are 

combined and heated for several hours. 

A variety of different reagents can be 

used to make the conversion to 

methamphetamine if the precursors 

ephedrine and pseudoephedrine are 

obtained. These reactants can also be 

used to convert phenylpropanolamine 

to amphetamine. Manufacturing 

procedures are readily available on the 

Internet and even unskilled persons can 

obtain a 50–70 percent yield of 

methamphetamine or amphetamine. 

Pseudoephedrine and ephedrine can 

also serve as precursor material for the 

manufacture of the schedule I controlled 

substance methcathinone. From January 

1, 2000, through December 31, 2008, 

there were 202 methcathinone 

laboratory seizures reported to EPIC. 

As DEA discussed in the NPRM, there 

is a common misconception in industry 

and among some in the public that OTC 

drug products, particularly 

pseudoephedrine or ephedrine products 

in combination with other medically 

active ingredients (‘‘combo products’’), 

are somehow less likely to be diverted 

or are less desirable among clandestine 

laboratory operators for the manufacture 

of methamphetamine. This is not the 

case. 

Most of the clandestine laboratories 

found in the United States are using 

tablets, either single-entity or 

combination. In many of the 

methamphetamine exhibits analyzed by 

DEA analytical laboratories, the 

presence of antihistamines is detected, 

indicating that combination products 

were used in the reactions. 

While the vast majority of clandestine 

laboratories seized have used tableted 

pseudoephedrine and ephedrine 

products, gel caps and liquid dosage 

form products can easily serve as the 

source of precursor material for the 

production of methamphetamine. DEA 


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Federal Register / Vol. 75, No. 129 / Wednesday, July 7, 2010 / Rules and Regulations 38919 

scientific studies show that liquid, gel 

cap, and combination products are 

easily used as the source of precursor 

material and the pseudoephedrine/ 

ephedrine from these products can be 

easily extracted with appropriate 

reagents/solvents. These reagents/ 

solvents are all readily available at 

hardware and auto parts stores in the 

United States. 

The controlled substances produced 

from these chemicals, 

methamphetamine and amphetamine, 

have a high abuse potential. The public 

health consequences of the 

manufacture, trafficking, and abuse of 

these two substances are well known 

and documented. 

Comments Regarding Clarification of 

Regulated Transactions 

In response to the November 20, 2007, 

NPRM (72 FR 65248), DEA received one 

comment. The commenter expressed 

concerns regarding the findings made by 

DEA that concluded that OTC products 

containing either pseudoephedrine or 

ephedrine (in combination with other 

active ingredients) are (1) Easily used in 

the illicit production of a controlled 

substance (e.g. methamphetamine) and 

(2) the listed chemical can be readily 

recovered. The commenter further 

expressed concerns regarding the 

applicability of these findings to 

combination products in the form of 

liquids, gel caps and solid dosage forms. 

The commenter expressed concerns that 

the NPRM did not provide sufficient 

data to substantiate DEA’s findings, 

including OTC combination product 

seizures and evidence of diversion of 

such materials. Additionally, the 

commenter asserted that ephedrine/ 

guaifenesin combination products 

warrant special treatment and should 

not be subject to the proposed 

rulemaking. 

DEA disagrees with the commenter’s 

basic premise that ephedrine and 

pseudoephedrine combination products 

(in liquid, soft-gel capsule, and solid 

dosage form) have less utility in 

clandestine laboratory processing of 

methamphetamine. DEA laboratory 

extraction studies have scientifically 

demonstrated that such materials are 

easily used as precursor material in the 

production of methamphetamine. 

Additionally, such materials have been 

identified at seized clandestine 

methamphetamine laboratories, and 

contaminants identified in seized 

methamphetamine exhibits document 

the use of such products as precursor 

material. These data demonstrate that 

these materials are (1) easily used in the 

illicit production of methamphetamine 

and (2) the listed chemical can be 

readily recovered. This has been 

documented in both DEA laboratory 

studies and in actual seizures. 

Use of OTC Combination Products as 

Precursor Material 

DEA’s Office of Forensic Sciences has 

performed extraction studies 

demonstrating that combination OTC 

pseudoephedrine/ephedrine products 

(in soft-gel capsules, liquids, and solid 

forms, and containing combination 

ingredients) can be readily extracted 

and utilized as the source of precursor 

material for production of 

methamphetamine. These studies 

illustrated that such extractions were 

readily achievable and precursor 

materials were readily extractible. 

Furthermore, the DEA Special Testing 

and Research Laboratory conducts indepth analyses of seized 

methamphetamine samples. The 

information obtained from these 

analyses is derived from samples 

obtained and analyzed from a selective 

sampling of domestic and foreign 

seizures, and is not necessarily 

representative of all methamphetamine 

samples submitted to the DEA 

laboratory system. Among other things, 

the in-depth analytical procedures 

enable analysts to determine when 

combination OTC ephedrine and/or 

pseudoephedrine products are used as 

the source of precursor chemicals, due 

to impurities present in seized 

methamphetamine. The crude isolation 

procedures used in clandestine 

methamphetamine laboratories to 

extract l–ephedrine or dpseudoephedrine from OTC products 

usually co-extract some of the other 

active ingredients commonly found in 

combination products. As a result, 

methamphetamine samples often 

contain one or more of the following coingredients: brompheniramine, 

chlorpheniramine, triprolidine, 

loratadine, carbinoxamine, and other 

common co-ingredients or their 

respective reaction by-products. 

Between Calendar Year 2005 and 

Calendar Year 2007, combination 

ephedrine and pseudoephedrine 

products were utilized as precursor 

material in 760 out of 1343 samples 

analyzed. For the reporting period 

ending July 2009, 78 out of 145 

additional methamphetamine samples 

analyzed contained these coingredients, therefore illustrating that 54 

percent of these samples were made 

using combination ephedrine or 

pseudoephedrine products. 

Additionally, DEA’s System to 

Retrieve Information on Drug Evidence 

(STRIDE) indicates that such products 

have been utilized as precursor material 

in the manufacture of 

methamphetamine. For the period 

January 2004 through November 2009, 

approximately 725 methamphetamine 

exhibits analyzed by DEA laboratories 

contained the common OTC 

combination product ingredients 

chlorpheniramine, diphenhydramine, 

guaifenesin or triprolidine. The number 

of guaifenesin exhibits accounted for 

approximately 5 percent of these 

samples. For the period January 2004 

through November 2009, approximately 

299 additional exhibits were identified 

as containing ephedrine and/or 

pseudoephedrine in combination with 

guaifenesin. 

Based upon DEA scientific extraction 

studies, actual seizures of OTC 

ephedrine and/or pseudoephedrine 

combination products (including gel 

capsules, liquids and tablets) and the 

analysis of seized methamphetamine 

containing co-ingredients commonly 

found in OTC products, DEA finds that 

such materials are (1) Easily used in the 

illicit production of a controlled 

substance (e.g., methamphetamine) and 

(2) the listed chemical can be readily 

recovered. DEA therefore finds that 

these sources of precursor material 

should be subject to regulatory controls 

under the CSA. 

Findings 

Therefore, based on the above 

discussion, the Administrator of the 

Drug Enforcement Administration, 

under the authority delegated by the 

Attorney General, finds, after 

considering the factors specified in 21 

U.S.C. 814(b), that drug products 

containing the List I chemicals 

ephedrine, pseudoephedrine, and 

phenylpropanolamine are being 

diverted for the illicit production of 

controlled substances, namely 

methamphetamine and amphetamine. 

As DEA has discussed, these products 

have a demonstrated history over the 

past 20 years of diversion for illicit 

purposes. These List I chemicals are 

diverted regardless of formulation— 

liquid, nonliquid, gel capsule—and 

regardless of dosage strength. 

Accordingly, the Administrator of the 

Drug Enforcement Administration 

removes drug products containing the 

List I chemicals ephedrine, 

pseudoephedrine, and 

phenylpropanolamine from exemption 

from the definition of ‘‘regulated 

transaction’’ under 21 U.S.C. 

802(39)(a)(iv). As such, unless otherwise 

exempted, such materials are subject to 

the chemical regulatory control 

provisions of the CSA. DEA is adding a 

new section 1310.14 that removes these 

drugs from the exemption. 


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38920 Federal Register / Vol. 75, No. 129 / Wednesday, July 7, 2010 / Rules and Regulations 

The CSA has specifically exempted 

retail transactions involving scheduled 

listed chemical products from the 

definition of regulated transaction (21 

U.S.C. 802(39)(a)(v)) and established a 

separate set of regulations, 21 CFR part 

1314, that control those retail 

transactions (71 FR 56008, September 

26, 2006; corrected at 71 FR 60609, 

October 13, 2006). 

Technical Correction 

While drafting this rulemaking, DEA 

became aware of an inaccurate citation 

in 21 CFR 1310.10, the section 

paralleling the criteria to be considered 

in evaluating the statutory factors for 

removal of exemption from the 

definition of ‘‘regulated transaction’’ at 

21 U.S.C. 814 and discussed above. 

Specifically, the definition of ‘‘regulated 

transaction’’ cited in 21 CFR 1310.10 is 

inaccurate. Therefore, to alleviate any 

confusion, DEA is correcting this 

citation. 

Regulatory Certifications 

Regulatory Flexibility Act 

The Deputy Administrator hereby 

certifies that this rulemaking has been 

drafted in accordance with the 

provisions of the Regulatory Flexibility 

Act (RFA) (5 U.S.C. 601–612). Without 

this rule, DEA would not be able to 

effectively implement the quota and 

import provisions of CMEA. 

As DEA has demonstrated throughout 

this document, traffickers and others in 

search of the chemicals necessary for 

clandestine manufacture of 

methamphetamine and amphetamine, 

are actively looking to exploit any 

loophole in chemical controls. 

DEA notes that the effect of 

eliminating the thresholds for 

pseudoephedrine and 

phenylpropanolamine could impose a 

minimal burden on regulated entities. 

Although it is likely that many of the 

registrants who handle the two 

chemicals are small businesses under 

the Small Business Administration 

definition of small entities, the changes 

impose virtually no burden on these 

entities for three reasons. First, most, if 

not all, legitimate transactions at the 

import, export, manufacturing, and 

distribution level are in excess of the 

previous thresholds. Second, although it 

is possible that some registrants may 

have some transactions that will be 

newly regulated, the recordkeeping for 

these can be met with standard business 

records. The only information required 

in records for regulated transactions is 

the name and address of the seller and 

purchaser (plus their DEA registration 

numbers, if applicable); the date of the 

transaction; the name, quantity, and 

form of packaging of the listed chemical; 

the method of transfer; and the method 

of identification used by the customer 

and any unique identification number 

associated with the identification. This 

information is normally included on 

purchase orders or invoices and the 

shipping papers and is needed to 

complete and track the transaction. As 

long as the purchaser can extract the 

records for examination, if necessary, no 

additional effort is needed. Because 

almost all business records for 

manufacturers, importers, and 

distributors are now generated and 

transmitted electronically, DEA does not 

expect that any registrant will need 

additional recordkeeping. 

Third, if any person is importing or 

exporting in very small quantities, there 

may be some additional import/export 

declarations required, but these forms 

require less than half an hour to 

complete and file. The only other 

requirement is to report suspicious 

transactions. These reports also require 

less than a half hour to complete and 

file. 

As noted above, DEA does not believe 

that legitimate importers or exporters 

are handling such small quantities. The 

purpose of this rule is to close a 

loophole that could be exploited by 

those seeking the chemicals for illicit 

purposes and to ensure that DEA can 

accurately assess the legitimate need. 

The Deputy Administrator, therefore, 

certifies that the rule will not have a 

significant economic impact on a 

substantial number of small entities. 

Executive Order 12866 

The Deputy Administrator further 

certifies that this rulemaking has been 

drafted in accordance with the 

principles in Executive Order 12866 

section 1(b). It has been determined that 

this is ‘‘a significant regulatory action.’’ 

Therefore, this action has been reviewed 

by the Office of Management and 

Budget. This rule supports 

implementation of provisions of the 

CMEA. The CMEA is expansive in its 

breadth, essentially reclassifying 

ephedrine, pseudoephedrine, and 

phenylpropanolamine as schedule II 

controlled substances for purposes of 

importation and production, imposes 

new retail restrictions on these 

products, and mandates new domestic 

and import quotas. Without this rule, 

traffickers could exploit belowthreshold transactions, which are not 

reported to DEA and for which records 

are not required to be maintained, to 

divert valuable quantities of 

pseudoephedrine and 

phenylpropanolamine for the 

clandestine manufacture of 

methamphetamine and/or 

amphetamine. Further, without this 

rule, DEA will not have complete 

information on which to base its 

assessment of the annual national needs 

for the List I chemicals ephedrine, 

pseudoephedrine, and 

phenylpropanolamine as DEA does not 

receive information regarding belowthreshold transactions. This lack of 

information would create a loophole in 

the quota system, and would prevent 

DEA from fulfilling its legislative 

mandate that imports of 

pseudoephedrine and 

phenylpropanolamine be prohibited 

except for medical, scientific, or other 

legitimate purposes. Without this rule, 

DEA will not be able to effectively and 

fully implement the quota and import 

provisions of the CMEA. 

As discussed above, DEA does not 

anticipate that this change will impose 

more than the minimal costs that would 

be associated with reporting 

transactions that the registrant thought 

suspicious and possibly filing forms for 

import and export notifications. The 

benefits of the rule are those associated 

with controlling access to chemicals 

used to manufacture methamphetamine, 

and other controlled substances, 

illicitly. As has been discussed 

extensively throughout this document, 

traffickers and others are actively 

looking to exploit any loophole in 

chemical controls to continue their 

operations. As noted previously, the 

current thresholds could permit a 

person to divert approximately 25 

pounds of pseudoephedrine and 66 

pounds of phenylpropanolamine 

annually, without exceeding existing 

thresholds. This rule closes a loophole 

that could result in the undocumented 

diversion of these chemicals for illicit 

production of significant quantities of 

methamphetamine and/or 

amphetamine. As noted previously in 

this rule, below-threshold transactions 

are not documented to DEA; the 

diversion of below-threshold quantities 

of these precursor chemicals could 

result in the illicit production of 

significant quantities of 

methamphetamine and/or 

amphetamine. 

Executive Order 12988 

This regulation meets the applicable 

standards set forth in sections 3(a) and 

3(b)(2) of Executive Order, 12988 Civil 

Justice Reform. 

Executive Order 13132 

This rulemaking does not impose 

enforcement responsibilities on any 

State; nor does it diminish the power of 


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Federal Register / Vol. 75, No. 129 / Wednesday, July 7, 2010 / Rules and Regulations 38921 

any State to enforce its own laws. 

Accordingly, this rulemaking does not 

have federalism implications warranting 

the application of Executive Order 

13132. 

Unfunded Mandates Reform Act of 1995 

This rule will not result in the 

expenditure by State, local, and Tribal 

governments, in the aggregate, or by the 

private sector, of $120,000,000 or more 

(adjusted for inflation) in any one year, 

and will not significantly or uniquely 

affect small governments. Therefore, no 

actions were deemed necessary under 

the provisions of the Unfunded 

Mandates Reform Act of 1995. 

Congressional Review Act 

This rule is not a major rule as 

defined by section 804 of the Small 

Business Regulatory Enforcement 

Fairness Act of 1996 (Congressional 

Review Act). This rule will not result in 

an annual effect on the economy of 

$100,000,000 or more; a major increase 

in costs or prices; or significant adverse 

effects on competition, employment, 

investment, productivity, innovation, or 

on the ability of United States-based 

companies to compete with foreignbased companies in domestic and 

export markets. 

Paperwork Reduction Act 

This rule requires that records be 

maintained regarding distributions of 

the List I chemicals pseudoephedrine 

and phenylpropanolamine. These 

records are maintained as a normal 

course of business. 

The rule also reduces the thresholds 

for the List I chemicals 

pseudoephedrine and 

phenylpropanolamine from 1 kilogram 

and 2.5 kilograms, respectively, to zero, 

thereby requiring that DEA receive 

advance notification of all importations 

and exportations of these List I 

chemicals. DEA notes that it already 

receives some Import/Export 

Declarations if the cumulative amount 

of the transactions exceeds the 

thresholds on a monthly basis. 

Therefore, DEA does not believe that 

this change will significantly increase 

the burden associated with this 

information collection. Specifically, 

DEA estimates that 53 additional export 

notifications and 53 additional export 

return declarations will be received 

annually. Further, DEA estimates that 

50 additional import declarations and 

55 additional import return declarations 

will be received annually. DEA assumes 

10 percent of all imports will not be 

transferred in the first thirty days and 

will necessitate submission of a 

subsequent return declaration. The 

receipt of these additional forms 

increases the hour burden by 55 hours 

annually. DEA did not receive any 

comments regarding the Paperwork 

Reduction Act aspects of the Notice of 

Proposed Rulemaking. Therefore, DEA 

is revising its existing information 

collection [OMB approval number 

1117–0023 ‘‘Import/Export Declaration 

for List I and List II Chemicals’’, DEA 

Form 486] to reflect the increased 

burden associated with receipt of these 

import/export declarations. 

The Department of Justice, Drug 

Enforcement Administration, submitted 

the following information collection 

request to the Office of Management and 

Budget for review and clearance in 

accordance with review procedures of 

the Paperwork Reduction Act of 1995. 

The proposed information collections 

were published in the NPRM to obtain 

comments from the public and affected 

agencies 

Overview of Information Collection 

1117–0023 

(1) Type of Information Collection: 

Revision of a Currently Approved 

Collection. 

(2) Title of the Form/Collection: 

Import/Export Declaration for List I and 

List II Chemicals. 

(3) Agency form number, if any, and 

the applicable component of the 

Department sponsoring the collection: 

Form number: DEA Form 486 and 

DEA Form 486A. 

Component: Office of Diversion 

Control, Drug Enforcement 

Administration, U.S. Department of 

Justice 

(4) Affected public who will be asked 

or required to respond, as well as a brief 

abstract: 

Primary: Business or other for-profit. 

Other: None. 

Abstract: Persons importing, 

exporting, and conducting international 

transactions with List I and List II 

chemicals must notify DEA of those 

transactions in advance of their 

occurrence, including information 

regarding the person(s) to whom the 

chemical will be transferred and the 

quantity to be transferred. Persons must 

also provide return declarations, 

confirming the date of the importation, 

exportation, or international transaction 

and transfer, and the amounts of the 

chemical transferred. For the List I 

chemicals ephedrine, pseudoephedrine, 

and phenylpropanolamine, importers 

must report all information known to 

them on the chain of distribution of the 

chemical from the foreign manufacturer 

to the United States importer. This 

information is used to prevent 

shipments not intended for legitimate 

purposes. 

(5) An estimate of the total number of 

respondents and the amount of time 

estimated for an average respondent to 

respond: A respondent may submit 

multiple responses. The table below 

presents information regarding the 

number of respondents, responses, and 

associated burden hours. 

Number of 

respondents 

Number of 

responses Average time per response Total 

Form 486 (export) ..................................................................... 193 10,380 0.283 hour (17 minutes) ......... 2,941 hours. 

Form 486 (export Return Declaration) ...................................... 193 10,380 0.166 hour (10 minutes) ......... 1,730 hours. 

Form 486 (import) ..................................................................... 120 1,268 0.333 hour (20 minutes) ......... 422.6 hours. 

Form 486 (import return declaration) * ...................................... 120 1,395 0.2 hour (12 minutes) ............. 279 hours. 

Form 486A (import) * ................................................................. 30 400 0.4 hour (24 minutes) ............. 160 hours. 

Form 486A (import return declaration)* .................................... 30 440 0.2 hour (12 minutes) ............. 88 hours. 

Form 486 (international transaction) ......................................... 14 14 0.2 hour (12 minutes) ............. 2.8 hours.

Form 486 (international transaction return declaration) ............ 14 14 0.08 hour (5 minutes) ............. 1.2 hours. 

Quarterly reports for imports of acetone, 2-butanone, and toluene.110 440 0.5 hour (30 minutes) ............. 220 hours. 

Total ................................................................................... 193 .................... ................................................. 5,844.6 hours. 

* DEA assumes 10 percent of all imports will not be transferred in the first 30 days and will necessitate submission of a subsequent return 

declaration. 


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38922 Federal Register / Vol. 75, No. 129 / Wednesday, July 7, 2010 / Rules and Regulations 

(6) An estimate of the total public 

burden (in hours) associated with the 

collection: 5,845 annual burden hours. 

If additional information is required, 

contact: Lynn Bryant, Department 

Clearance Officer, United States 

Department of Justice, Justice 

Management Division, Policy and 

Planning Staff, Patrick Henry Building, 

Suite 1600, 601 D Street, NW., 

Washington, DC 20530. 

List of Subjects in 21 CFR Part 1310 

Drug traffic control, Exports, Imports, 

Reporting and recordkeeping 

requirements. 

■ For the reasons set forth above, 21 

CFR part 1310 is amended as follows: 

PART 1310—RECORDS AND 

REPORTS OF LISTED CHEMICALS 

AND CERTAIN MACHINES 

■ 1. The authority citation for part 1310 

continues to read as follows: 

Authority: 21 U.S.C. 802, 827(h), 830, 

871(b), 890. 

■ 2. Section 1310.04 is amended by 

revising paragraphs (f)(1)(i) table and 

(ii), (g)(1)(i) through (vii), and adding 

paragraphs (g)(1)(viii) and (ix) to read as 

follows: 

§ 1310.04 Maintenance of records. 

* * * * * 

(f) * * * 

(1) * * * 

(i) * * * 

Code Chemical Threshold by base weight 

8522 ........................ N-Acetylanthranilic acid, its esters, and its salts ................................................... 40 kilograms. 

8530 ........................ Anthranilic acid, its esters, and its salts ................................................................ 30 kilograms. 

8256 ........................ Benzaldehyde ........................................................................................................ 4 kilograms. 

8735 ........................ Benzyl cyanide ....................................................................................................... 1 kilogram. 

8675 ........................ Ergonovine and its salts ........................................................................................ 10 grams. 

8676 ........................ Ergotamine and its salts ........................................................................................ 20 grams. 

8678 ........................ Ethylamine and its salts ......................................................................................... 1 kilogram. 

6695 ........................ Hydriodic acid ........................................................................................................ 1.7 kilograms (or 1 liter by volume). 

8704 ........................ Isosafrole ................................................................................................................ 4 kilograms. 

8520 ........................ Methylamine and its salts ...................................................................................... 1 kilogram. 

8502 ........................ 3,4–Methylenedioxyphenyl-2-propanone ............................................................... 4 kilograms. 

8115 ........................ N–Methylephedrine, its salts, optical isomers, and salts of optical isomers ......... 1 kilogram. 

8119 ........................ N–Methylpseudoephedrine, its salts, optical isomers, and salts of optical isomers.1 kilogram. 

6724 ........................ Nitroethane ............................................................................................................. 2.5 kilograms. 

8317 ........................ Norpseudoephedrine, its salts, optical isomers, and salts of optical isomers ...... 2.5 kilograms. 

8791 ........................ Phenylacetic acid, its esters, and its salts ............................................................. 1 kilogram. 

2704 ........................ Piperidine and its salts ........................................................................................... 500 grams. 

8750 ........................ Piperonal (also called heliotropine) ....................................................................... 4 kilograms. 

8328 ........................ Propionic anhydride ............................................................................................... 1 gram. 

8323 ........................ Safrole .................................................................................................................... 4 kilograms. 

(ii) For List I chemicals that are 

contained in scheduled listed chemical 

products as defined in 

§ 1300.02(b)(34)(i) of this chapter, the 

thresholds established in paragraph (g) 

of this section apply only to non-retail 

distribution, import, and export. Sales 

of these products at retail are subject to 

the requirements of part 1314 of this 

chapter. 

* * * * * 

(g) * * * 

(1) * * * 

(i) Ephedrine, its salts, optical 

isomers, and salts of optical isomers; 

(ii) Gamma-Butyrolactone (Other 

names include: GBL; Dihydro-2(3H)- 

furanone; 1,2-Butanolide; 1,4- 

Butanolide; 4-Hydroxybutanoic acid 

lactone; gamma-hydroxybutyric acid 

lactone) 

(iii) Hypophosphorous acid and its 

salts (including ammonium 

hypophosphite, calcium hypophosphite, 

iron hypophosphite, potassium 

hypophosphite, manganese 

hypophosphite, magnesium 

hypophosphite, and sodium 

hypophosphite) 

(iv) Iodine 

(v) N-phenethyl-4-piperidone (NPP) 

(vi) Pseudoephedrine, its salts, optical 

isomers, and salts of optical isomers 

(vii) Phenylpropanolamine, its salts, 

optical isomers, and salts of optical 

isomers 

(viii) Red phosphorus 

(ix) White phosphorus (Other names: 

Yellow Phosphorus) 

* * * * * 

■ 3. Section 1310.10 is amended by 

revising paragraph (a) introductory text 

to read as follows: 

§ 1310.10 Removal of the exemption of 

drugs distributed under the Food, Drug and 

Cosmetic Act. 

(a) The Administrator may remove 

from exemption under 

§ 1300.02(b)(28)(i)(D) of this chapter any 

drug or group of drugs that the 

Administrator finds is being diverted to 

obtain a listed chemical for use in the 

illicit production of a controlled 

substance. In removing a drug or group 

of drugs from the exemption the 

Administrator shall consider: 

* * * * * 

■ 4. Section 1310.14 is added to read as 

follows: 

§ 1310.14 Removal of exemption from 

definition of regulated transaction. 

The Administrator finds that the 

following drugs or groups of drugs are 

being diverted to obtain a listed 

chemical for use in the illicit production 

of a controlled substance and removes 

the drugs or groups of drugs from 

exemption under § 1300.02(b)(28)(i)(D) 

of this chapter pursuant to the criteria 

listed in § 1310.10 of this part: 

(a) Nonprescription drugs containing 

ephedrine, its salts, optical isomers, and 

salts of optical isomers. 

(b) Nonprescription drugs containing 

phenylpropanolamine, its salts, optical 

isomers, and salts of optical isomers. 

(c) Nonprescription drugs containing 

pseudoephedrine, its salts, optical 

isomers, and salts of optical isomers. 

Dated: June 19, 2010. 

Michele M. Leonhart, 

Deputy Administrator. 

[FR Doc. 2010–16388 Filed 7–6–10; 8:45 am] 

BILLING CODE 4410–09–P 


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