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

50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by

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new books are listed in the first FEDERAL

REGISTER issue of each week.

Rules and Regulations Federal Register

10165 

Vol. 75, No. 43 

Friday, March 5, 2010 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 520, 522, 524, and 526 

[Docket No. FDA–2009–N–0665] 

New Animal Drugs; Change of Sponsor 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect a 

change of sponsor for 18 new animal 

drug applications (NADAs) and 1 

abbreviated new animal drug 

application (ANADA) from Fort Dodge 

Animal Health, Division of Wyeth, a 

wholly owned subsidiary of Pfizer, Inc., 

to Boehringer Ingelheim Vetmedica, Inc. 

(Boehringer). In addition, FDA is 

amending the animal drug regulations to 

reflect a change of sponsor for 15 

NADAs from Fort Dodge Animal Health, 

Division of Wyeth Holdings Corp., a 

wholly owned subsidiary of Pfizer, Inc., 

to Boehringer. 

DATES: This rule is effective March 5, 

2010. 

FOR FURTHER INFORMATION CONTACT: 

David R. Newkirk, Center for Veterinary 

Medicine (HFV–100), Food and Drug 

Administration, 7520 Standish Pl., 

Rockville, MD 20855, 240–276–8307, email: david.newkirk@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Fort 

Dodge Animal Health, Division of 

Wyeth, a wholly owned subsidiary of 

Pfizer, Inc., 235 East 42d St., New York, 

NY 10017 (Pfizer) has informed FDA 

that it has transferred ownership of, and 

all rights and interest in, the following 

18 approved NADAs and 1 approved 

ANADA to Boehringer Ingelheim 

Vetmedica, Inc., 2621 North Belt 

Highway, St. Joseph, MO 64506–2002 

(Boehringer): NADA 15–030, 32–702, 

34–879, 45–290, 55–021, 55–022, 55– 

030, 55–048, 55–054, 55 058, 97–222, 

108–114, 119–688, 140–684, 140–806, 

140–854, 141–096, and 141–274; and 

ANADA 200–088. In addition, Fort 

Dodge Animal Health, Division of 

Wyeth Holdings Corp., a wholly owned 

subsidiary of Pfizer, has informed FDA 

that it has transferred ownership of, and 

all rights and interest in, the following 

15 approved NADAs to Boehringer: 

NADA 6–084, 8–774, 12–198, 13–624, 

33–127, 33–318, 33–319, 33–373, 40– 

181, 46–146, 65–269, 99–388, 122–271, 

122–272, and 141–108. Accordingly, the 

agency is amending the regulations in 

21 CFR parts 520, 522, 524, and 526 to 

reflect the transfer of ownership. In 

addition, several sections are being 

revised to reflect the current format. 

This rule does not meet the definition 

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because 

it is a rule of ‘‘particular applicability.’’ 

Therefore, it is not subject to the 

congressional review requirements in 5 

U.S.C. 801–808. 

List of Subjects in 21 CFR Parts 520, 

522, 524, and 526 

Animal drugs. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs and redelegated to 

the Center for Veterinary Medicine, 21 

CFR parts 520, 522, 524, and 526 are 

amended as follows: 

PART 520—ORAL DOSAGE FORM 

NEW ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 520 continues to read as follows: 

Authority: 21 U.S.C. 360b. 

■ 2. Revise § 520.23 to read as follows: 

§ 520.23 Acepromazine. 

(a) Specifications. Each tablet 

contains 5, 10, or 25 milligrams (mg) 

acepromazine maleate. 

(b) Sponsors. See No. 000010 in 

§ 510.600(c) of this chapter. 

(c) Conditions of use—(1) Dogs—(i) 

Amount. 0.25 to 1.0 mg per pound (/lb) 

body weight orally. 

(ii) Indications for use. As an aid in 

tranquilization and as a preanesthetic 

agent. 

(iii) Limitations. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian. 

(2) Cats—(i) Amount. 0.5 to 1.0 mg/lb 

body weight orally. 

(ii) Indications for use. As a 

tranquilizer. 

(iii) Limitations. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian. 

■ 3. Revise § 520.314 to read as follows: 

§ 520.314 Cefadroxil. 

(a) Specifications.—(1) Each tablet 

contains 50, 100, or 200 milligrams (mg) 

or 1 gram of cefadroxil. 

(2) Each milliliter of suspension 

constituted from powder contains 50 mg 

of cefadroxil. 

(b) Sponsor. See No. 000010 in 

§ 510.600(c) of this chapter. 

(c) Conditions of use in dogs and 

cats—(1) Amount—(i) Dogs. Administer 

10 mg per pound (/lb) body weight 

twice daily orally. 

(ii) Cats. Administer 10 mg/lb body 

weight once daily orally. 

(2) Indications for use—(i) Dogs. For 

the treatment of skin and soft tissue 

infections including cellulitis, 

pyoderma, dermatitis, wound 

infections, and abscesses due to 

susceptible strains of Staphylococcus 

aureus. For the treatment of 

genitourinary tract infections (cystitis) 

due to susceptible strains of Escherichia 

coli, Proteus mirabilis, and S. aureus. 

(ii) Cats. For the treatment of skin and 

soft tissue infections including 

abscesses, wound infections, cellulitis, 

and dermatitis caused by susceptible 

strains of Pasteurella multocida, S. 

aureus, Staphylococcus epidermidis, 

and Streptococcus spp. 

(3) Limitations. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian. 

§ 520.315 [Removed] 

■ 4. Remove § 520.315. 

■ 5. In § 520.645, in paragraph (b), 

remove ‘‘000856’’ and in its place add 

‘‘000010’’; and revise paragraphs 

(d)(1)(i)and (d)(1)(iii) to read as follows: 

§ 520.645 Difloxacin. 

* * * * * 

(d) * * * 

(1) * * * 

(i) Amount. Administer 5 to 10 mg per 

kilogram (2.3 to 4.6 mg per pound) of 

body weight orally once a day for 2 to 

3 days beyond cessation of clinical signs 

of disease up to a maximum of 30 days. 

* * * * * 


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10166 Federal Register / Vol. 75, No. 43 / Friday, March 5, 2010 / Rules and Regulations 

(iii) Limitations. Federal law prohibits 

the extra-label use of this drug in foodproducing animals. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian. 

* * * * * 

■ 6. In § 520.870, in paragraph (b), 

remove ‘‘053501’’ and in its place add 

‘‘No. 000010’’; revise paragraphs 

(d)(1)(i)and (d)(1)(iii to read as follows: 

§ 520.870 Etodolac. 

* * * * * 

(d) * * * 

(1) * * * 

(i) Amount. Administer 10 to 15 mg 

per kilogram (4.5 to 6.8 mg per pound) 

of body weight per day orally. 

* * * * * 

(iii) Limitations. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian. 

* * * * * 

■ 7. Revise § 520.1130 to read as 

follows: 

§ 520.1130 Hetacillin. 

(a) Specifications.—(1) Each capsule 

or tablet contains hetacillin potassium 

equivalent to 50, 100, or 200 milligrams 

(mg) of ampicillin. 

(2) Each milliliter of suspension 

contains hetacillin potassium equivalent 

to 50 mg of ampicillin. 

(b) Sponsor. See No. 000010 in 

§ 510.600(c) of this chapter. 

(c) Conditions of use in dogs and 

cats—(1) Amount—(i) Dogs. Administer 

5 mg per pound (/lb) of body weight 

orally, twice daily. In severe infections, 

administer 5 mg/lb three times daily, or 

up to 10 mg/lb twice daily. For stubborn 

urinary tract infections, administer up 

to 20 mg/lb twice daily. 

(ii) Cats. Administer 50 mg twice 

daily. 

(2) Indications for use. For the 

treatment of respiratory tract infections, 

urinary tract infections, gastrointestinal 

infections, skin infections, soft tissue 

infections, and postsurgical infections 

associated with strains of organisms 

susceptible to hetacillin potassium. 

(3) Limitations. Federal law restricts 

this drug to use only by or on the order 

of a licensed veterinarian. 

§ 520.1130a [Removed] 

■ 8. Remove § 520.1130a. 

§ 520.1130b [Removed] 

■ 9. Remove § 520.1130b. 

§ 520.1130c [Removed] 

■ 10. Remove § 520.1130c. 

§ 520.1630 [Amended] 

■ 11. In paragraph (b) of § 520.1630, 

remove ‘‘000856’’ and in its place add 

‘‘No. 000010’’. 

■ 12. Revise § 520.2200 to read as 

follows: 

§ 520.2200 Sulfachlorpyridazine. 

(a) Specifications.—(1) Sodium 

sulfachlorpyridazine powder. 

(2) Each bolus contains 2 grams 

sulfachlorpyridazine. 

(3) Each tablet contains 250 

milligrams (mg) sulfachlorpyridazine. 

(b) Sponsor. See No. 000010 in 

§ 510.600(c) of this chapter. 

(c) Related tolerances. See § 556.630 

of this chapter. 

(d) Conditions of use. It is used as 

follows: 

(1) Calves—(i) Amount. Administer 

30 to 45 mg sulfachlorpyridazine 

powder per pound (/lb) of body weight 

per day in milk or milk replacer, or in 

a bolus, in divided doses twice daily for 

1 to 5 days. 

(ii) Indications for use. For the 

treatment of diarrhea caused or 

complicated by Escherichia coli 

(colibacillosis). 

(iii) Limitations. Treated ruminating 

calves must not be slaughtered for food 

during treatment or for 7 days after the 

last treatment. A withdrawal period has 

not been established for this product in 

preruminating calves. Do not use in 

calves to be processed for veal. 

(2) Swine—(i) Amount. Administer 20 

to 35 mg/lb body weight per day, in 

divided doses twice daily for 1 to 5 

days: 

(A) In drinking water or 

(B) For individual treatment, in an 

oral suspension containing 50 mg per 

milliliter. 

(ii) Indications for use. For the 

treatment of diarrhea caused or 

complicated by E. coli (colibacillosis). 

(iii) Limitations. Treated swine must 

not be slaughtered for food during 

treatment or for 4 days after the last 

treatment. 

(3) Dogs—(i) Amount. Administer 

tablets orally at 500 mg per 10 to 15 lb 

of body weight daily, in two or three 

divided doses. 

(ii) Indications for use. As an aid in 

the treatment of infectious 

tracheobronchitis and infections caused 

by E. coli, and in the treatment of 

infections caused by other Grampositive and Gram-negative organisms 

that are susceptible to sulfonamide 

therapy. 

(iii) Limitations. Federal law restricts 

this drug to use only by or on the order 

of a licensed veterinarian. 

§ 520.2200a [Removed] 

■ 13. Remove § 520.2200a. 

§ 520.2200b [Removed] 

■ 14. Remove § 520.2200b. 

§ 520.2200c [Removed] 

■ 15. Remove § 520.2200c. 

§ 520.2260a [Amended] 

■ 16. In paragraph (a)(1) of § 520.2260a, 

remove ‘‘053501’’ and in its place add 

‘‘000010’’. 

§ 520.2261a [Amended] 

■ 17. In § 520.2261a, in the first 

sentence of paragraph (a), remove 

‘‘053501’’ and in its place add ‘‘000010’’; 

and remove paragraph (d). 

§ 520.2261b [Amended] 

■ 18. In paragraph (b) of § 520.2261b, 

remove ‘‘053501’’ and in its place add 

‘‘000010’’. 

§ 520.2345d [Amended] 

■ 19. In paragraphs (b)(3), (d)(1)(iii), and 

(d)(2)(iii) of § 520.2345d, remove 

‘‘053501’’ and in its place add ‘‘000010’’. 

§ 520.2481 [Removed] 

■ 20. Remove § 520.2481. 

§ 520.2482 [Removed] 

■ 21. Remove § 520.2482. 

■ 22. Add § 520.2483 to read as follows: 

§ 520.2483 Triamcinolone. 

(a) Specifications.—(1) Each tablet 

contains 0.5 milligram (mg) or 1.5 mg 

triamcinolone acetonide. 

(2) Each 15 grams of powder contains 

10 mg triamcinolone acetonide. 

(b) Sponsor. See No. 000010 in 

§ 510.600(c) of this chapter. 

(c) Special considerations. See 

§ 510.410 of this chapter. 

(d) Conditions of use—(1) Dogs and 

cats. Use tablets described in paragraph 

(a)(1) of this section as follows: 

(i) Amount. Administer 0.05 mg per 

pound (/lb) of body weight daily by 

mouth; up to 0.1 mg per pound (/lb) of 

body weight daily, if response to the 

smaller dose is inadequate. Therapy 

may be initiated with a single injection 

of triamcinolone acetonide suspension 

as in § 522.2483 of this chapter, in 

which case triamcinolone acetonide 

tablets should be administered 

beginning 5 to 7 days after the injection. 

(ii) Indications for use. As an antiinflammatory agent. 

(iii) Limitations. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian. 

(2) Horses. Use oral powder described 

in paragraph (a)(2) of this section as 

follows: 


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Federal Register / Vol. 75, No. 43 / Friday, March 5, 2010 / Rules and Regulations 10167 

(i) Amount. Administer 0.005 to 0.01 

mg/lb of body weight twice daily, 

sprinkled (top-dressed) on a small 

portion of feed. Therapy may be 

initiated with a single injection of 

triamcinolone acetonide suspension as 

in § 522.2483 of this chapter, in which 

case triamcinolone acetonide oral 

powder should be administered 

beginning 3 or 4 days after the injection. 

(ii) Indications for use. As an antiinflammatory agent. 

(iii) Limitations. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian. Do not use in 

horses intended for human 

consumption. 

PART 522—IMPLANTATION OR 

INJECTABLE DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 23. The authority citation for 21 CFR 

part 522 continues to read as follows: 

Authority: 21 U.S.C. 360b. 

■ 24. Revise § 522.23 to read as follows: 

§ 522.23 Acepromazine. 

(a) Specifications. Each milliliter of 

solution contains 10 milligrams (mg) 

acepromazine maleate. 

(b) Sponsors. See sponsors in 

§ 510.600(c) of this chapter: 

(1) No. 000010 for use as in 

paragraphs (d) and (e) of this section. 

(2) No. 059130 for use as in paragraph 

(d) of this section. 

(c) Special considerations. Federal 

law restricts this drug to use by or on 

the order of a licensed veterinarian. 

(d) Conditions of use. It is used in 

dogs, cats, and horses as follows: 

(1) Amount. Dogs: 0.25 to 0.5 mg per 

pound (/lb) of body weight; Cats: 0.5 to 

1.0 mg/lb of body weight; Horses: 2.0 to 

4.0 mg per 100 lbs of body weight. 

(2) Indications for use. As a 

tranquilizer. 

(e) Conditions of use. It is used in 

dogs as follows: 

(1) Amount. Dogs: 0.25 to 0.5 mg/lb of 

body weight. 

(2) Indications for use. As an aid in 

tranquilization and as a preanesthetic 

agent. 

§ 522.90b [Amended] 

■ 25. In § 522.90b, in the section 

heading, remove ‘‘sterile’’; and in 

paragraph (b)(1), remove ‘‘000856’’ and 

in its place add ‘‘No. 000010’’. 

§ 522.775 [Amended] 

■ 26. In paragraph (b) of § 522.775, 

remove ‘‘000856’’ and in its place add 

‘‘000010’’. 

§ 522.870 [Amended] 

■ 27. In paragraph (b) of § 522.870, 

remove ‘‘000856’’ and in its place add 

‘‘000010’’. 

§ 522.1145 [Amended] 

■ 28. In paragraph (c)(2) of § 522.1145, 

remove ‘‘000856’’ and in its place add 

‘‘No. 000010’’. 

§ 522.1222a [Amended] 

■ 29. In paragraph (b) of § 522.1222a, 

remove ‘‘000856,’’. 

■ 30. Revise § 522.2200 to read as 

follows: 

§ 522.2200 Sulfachlorpyridazine. 

(a) Specifications. Each milliliter of 

solution contains sodium 

sulfachlorpyridazine equivalent to 200 

milligrams (mg) sulfachlorpyridazine. 

(b) Sponsor. See No. 000010 in 

§ 510.600(c) of this chapter. 

(c) Related tolerances. See § 556.630 

of this chapter. 

(d) Conditions of use in calves. It is 

used as follows: 

(1) Amount. Administer 30 to 45 mg 

per pound (/lb) of body weight in 

divided doses by twice daily injection 

for 1 to 5 days. 

(2) Indications for use. For the 

treatment of diarrhea caused or 

complicated by Escherichia coli 

(colibacillosis). 

(3) Limitations. Treated calves must 

not be slaughtered for food during 

treatment or for 5 days after the last 

treatment. A withdrawal period has not 

been established for this product in 

preruminating calves. Do not use in 

calves to be processed for veal. 

■ 31. Amend § 522.2260 as follows: 

■ a. Revise the section heading; 

■ b. Revise paragraphs (a) and (b); 

■ c. Remove paragraph (d); 

■ d. Redesignate paragraph (e) as (d); 

and 

■ e. Revise newly redesignated 

paragraph (d) introductory text and 

paragraph (d)(1). 

■ The revisions read as follows: 

§ 522.2260 Sulfamethazine. 

(a) Specifications. Each milliliter of 

solution contains 250 milligrams 

sulfamethazine sodium. 

(b) Sponsor. See No. 000010 in 

§ 510.600(c) of this chapter. 

* * * * * 

(d) Conditions of use in cattle—(1) 

Amount. 20 milliliters for each 50 

pounds of body weight (100 milligrams 

per pound) initially; 20 milliliters per 

100 pounds of body weight (50 

milligrams per pound) daily, thereafter. 

* * * * * 

■ 32. Revise § 522.2483 to read as 

follows: 

§ 522.2483 Triamcinolone. 

(a) Specifications. Each milliliter of 

suspension contains 2 or 6 milligrams 

(mg) triamcinolone acetonide. 

(b) Sponsor. See No. 000010 in 

§ 510.600(c) of this chapter. 

(c) Conditions of use—(1) Dogs and 

cats—(i) Amount—(A) Intramuscular or 

subcutaneous. For inflammatory, 

arthritic, or allergic disorders, 

administer 0.05 to 0.1 mg per pound (/ 

lb) of body weight as a single injection. 

For dermatologic disorders, administer 

0.1 mg per pound (/lb) of body weight 

as a single injection. If symptoms recur, 

the dose may be repeated, or oral 

corticosteroid therapy may be instituted. 

(B) Intralesional. Administer 1.2 to 

1.8 mg, divided in several injections 

around the lesion, spaced 0.5 to 2.5 

centimeters apart, depending on lesion 

size. At any one site, the dose injected 

should not exceed 0.6 mg. and should 

be well into the cutis to prevent rupture 

of the epidermis. When treating animals 

with multiple lesions, do not exceed a 

total dose of 6 mg. 

(C) Intra-articular and intrasynovial. 

Administer 1 to 3 mg as a single 

injection, depending on the size of the 

joint and severity of symptoms. After 3 

or 4 days, repeat dosage if indicated. If 

initial results are inadequate or too 

transient, dosage may be increased, not 

to exceed 3 mg. 

(ii) Indications for use. For the 

treatment of inflammation and related 

disorders, and the management and 

treatment of acute arthritis and allergic 

and dermatologic disorders. 

(iii) Limitations. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian. 

(2) Horses—(i) Amount—(A) 

Intramuscular or subcutaneous. 

Administer 0.01 to 0.02 mg/lb of body 

weight as a single injection. Usual dose 

is 12 to 20 mg. 

(B) Intra-articular and intrasynovial. 

Administer 6 to 18 mg as a single 

injection, depending on the size of the 

joint and severity of symptoms. After 3 

or 4 days, repeat dosage if indicated. If 

initial results are inadequate or too 

transient, dosage may be increased, not 

to exceed 18 mg. 

(ii) Indications for use. For the 

treatment of inflammation and related 

disorders. 

(iii) Limitations. Do not use in horses 

intended for human consumption. 

Federal law restricts this drug to use by 

or on the order of a licensed 

veterinarian. 

§ 522.2662 [Amended] 

■ 33. In paragraph (b)(2) of § 522.2662, 

remove ‘‘000856’’ and in its place add 

‘‘000010’’. 


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PART 524—OPHTHALMIC AND 

TOPICAL DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 34. The authority citation for 21 CFR 

part 524 continues to read as follows: 

Authority: 21 U.S.C. 360b. 

§ 524.2481 [Redesignated as § 524.2483] 

■ 35. Redesignate § 524.2481 as 

§ 524.2483. 

§ 524.2483 [Amended] 

■ 36. In paragraph (b) of newly 

redesignated § 524.2483, remove 

‘‘015914, 053501, and 054925’’ and in its 

place add ‘‘000010, 015914, and 

054925’’. 

PART 526—INTRAMAMMARY DOSAGE 

FORMS 

■ 37. The authority citation for 21 CFR 

part 526 continues to read as follows: 

Authority: 21 U.S.C. 360b. 

§ 526.363 [Amended] 

■ 38. In paragraph (b) of § 526.363, 

remove ‘‘000856’’ and in its place add 

‘‘000010’’. 

§ 526.365 [Amended] 

■ 39. In paragraph (b) of § 526.365, 

remove ‘‘000856’’ and in its place add 

‘‘000010’’. 

■ 40. In § 526.464a, revise the section 

heading and paragraph (c) to read as 

follows: 

§ 526.464a Cloxacillin benzathine. 

* * * * * 

(c) Sponsor. See No. 000010 in 

§ 510.600(c) of this chapter for use in 

dairy cows. 

* * * * * 

§ 526.1130 [Amended] 

■ 41. In § 526.1130, in paragraph (b), 

remove ‘‘000856’’ and in its place add 

‘‘000010’’; and in paragraph (c)(3), 

remove the first sentence. 

Dated: February 26, 2010. 

Steven D. Vaughn, 

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. 2010–4560 Filed 3–4–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1313 

[Docket No. DEA–295F] 

RIN 1117–AB07 

Information on Foreign Chain of 

Distribution for Ephedrine, 

Pseudoephedrine, and 

Phenylpropanolamine 

AGENCY: Drug Enforcement 

Administration (DEA), Justice. 

ACTION: Final rule. 

SUMMARY: The Drug Enforcement 

Administration (DEA) is finalizing, 

without change, the Notice of Proposed 

Rulemaking published in the Federal 

Register on March 31, 2008 (73 FR 

16793). The Combat Methamphetamine 

Epidemic Act of 2005 (CMEA) requires 

DEA to collect from importers of 

ephedrine, pseudoephedrine, and 

phenylpropanolamine all information 

known to the importer on the foreign 

chain of distribution of the chemical 

from the manufacturer to the importer. 

This rule amends DEA regulations to 

incorporate the requirement for this 

information. 

DATES: Effective Dates: This Final Rule 

is effective May 4, 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, Telephone (202) 

307–7297. 

SUPPLEMENTARY INFORMATION: 

Background and 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 

1399. These regulations are designed to 

ensure that there is a sufficient supply 

of controlled substances for legitimate 

medical, scientific, research, and 

industrial purposes and to 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, 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. 

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). The changes 

made by this rule are needed to 

implement the statutory provisions. 

This Final Rule amends the language of 

the regulations to be consistent with 

that of the statute. 

Import/Export Declaration 

Requirements 

Under existing DEA regulations (21 

CFR part 1313), importers of listed 

chemicals are required to provide DEA 

with advance notification of imports 

unless the importer has met the 

requirements as a regular importer of 

the listed chemical; for regular 

importers, the notification must be filed 

by the date of importation. In the 

importation declaration (DEA Form 

486), the importer must provide 

information on the chemical (name, size 

and weight of the container, number of 

containers, total weight of chemical), 

importation (date, foreign port of 

shipment, United States port of entry) 

and the foreign supplier (name, address, 

contact information). 

CMEA imposes several new 

requirements on imports of listed 

chemicals. CMEA amended 21 U.S.C. 

971, ‘‘Notification, suspension of 

shipment, and penalties with respect to 

importation and exportation of listed 

chemicals,’’ to require DEA to collect 

information regarding persons to whom 

the U.S. importer, exporter, broker, or 

trader transfers the listed chemical, 

actual quantities shipped, and the date 

the shipment occurred. If the person to 

whom the listed chemical is to be 

transferred is not a regular customer of 

the U.S. importer or exporter, then the 

importer or exporter must notify DEA 

no later than 15 days before the 

transaction is to take place. Further, if 

the person to whom the chemical is to 

be transferred changes subsequent to 

initial notification of DEA, or if the 

amount of the chemical to be transferred 

increases, the importer or exporter shall 


erowe on DSK5CLS3C1PROD with RULES