I 

109TH CONGRESS 

2D SESSION H. R. 5280 

To amend the Federal Food, Drug, and Cosmetic Act with respect to the 

distribution of the drug dextromethorphan, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MAY 3, 2006 

Mr. UPTON (for himself and Mr. LARSEN of Washington) introduced the 

following bill; which was referred to the Committee on Energy and Commerce 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act with 

respect to the distribution of the drug dextromethorphan, 

and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Dextromethorphan 

5 Distribution Act of 2006’’. 

6 SEC. 2. FINDINGS. 

7 The Congress finds as follows: 

8 (1) Dextromethorphan is a safe and effective 

9 active ingredient found in cough suppressant prod10 ucts sold over-the-counter in a variety of finished 


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1 dosage forms, including tablets, gel capsules, pow2 ders, and liquids. 

3 (2) The bulk powdered form of 

4 dextromethorphan is readily available for purchase 

5 through various commercial channels. 

6 (3) Individuals, including teenagers in par7 ticular, are attempting to get high by taking much 

8 larger than recommended doses of 

9 dextromethorphan. 

10 (4) The Federal Food, Drug, and Cosmetic Act 

11 (21 U.S.C. 301 et seq.) and the regulations of the 

12 Food and Drug Administration govern the sale of 

13 products containing dextromethorphan, the distribu14 tion of certain noncontrolled drugs of abuse, and the 

15 sale, purchase, trade, and distribution of drug prod16 ucts in general. 

17 (5) One critical step that should be taken to 

18 help combat the abuse of dextromethorphan is to 

19 strengthen the Federal controls over the distribution 

20 of dextromethorphan in bulk. 

21 SEC. 3. FOOD AND DRUG ADMINISTRATION; RESTRICTIONS 

22 ON DISTRIBUTION OF UNFINISHED ACTIVE 

23 INGREDIENTS. 

24 (a) IN GENERAL.—Subchapter A of chapter V of the 

25 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 


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1 et seq.) is amended by inserting after section 503A the 

2 following: 

3 ‘‘SEC. 503B. RESTRICTIONS ON DISTRIBUTION OF UNFIN4 ISHED ACTIVE INGREDIENTS. 

5 ‘‘(a) IN GENERAL.—If the Secretary determines that 

6 the distribution of an unfinished active ingredient should 

7 be restricted for the protection of the public health, the 

8 Secretary may by regulation prohibit the distribution of 

9 the ingredient to any person other than a person reg10 istered under section 510, subject to subsections (b) and 

11 (c). 

12 ‘‘(b) FURTHER RESTRICTIONS.—Subsection (a) does 

13 not restrict the authority of the Secretary under section 

14 201.122 of title 21, Code of Federal Regulations. 

15 ‘‘(c) DEXTROMETHORPHAN.—Not later than 180 

16 days after the date of the enactment of the 

17 Dextromethorphan Distribution Act of 2006, the Sec18 retary shall issue a final rule under subsection (a) estab19 lishing restrictions on the distribution of 

20 dextromethorphan. 

21 ‘‘(d) UNFINISHED ACTIVE INGREDIENT.—For pur22 poses of this section, the term ‘unfinished’, with respect 

23 to an active ingredient, means an active ingredient that— 

24 ‘‘(1) is one of the ingredients in a drug that is 

25 not in finished dosage form; or 


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1 ‘‘(2) is the sole ingredient of a drug that is not 

2 in finished dosage form.’’. 

3 (b) ENFORCEMENT.—Section 301 of the Federal 

4 Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend5 ed by adding at the end the following: 

6 ‘‘(hh) The distribution of an unfinished active ingre7 dient in violation of regulations under section 503B.’’. 

Æ 


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