Removal of Exemption for Certain Pseudoephedrine Products Marketed Under the Food, Drug, and Cosmetic Act (FD&C Act)

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Parts 1309, 1310, 1313

[DEA NUMBER 138P]

RIN 1117-AA32

Removal of Exemption for Certain Pseudoephedrine Products

Marketed Under the Food, Drug, and Cosmetic Act (FD&C Act)

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Final rule; withdrawal.

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SUMMARY: DEA is withdrawing its rulemaking regarding Removal of

Exemption for Certain Pseudoephedrine Products Marketed Under the Food,

Drug, and Cosmetic Act (FD&C Act) which was published in the Federal

Register on August 7, 1996 (61 FR 40981). The final rule has been

superseded by the Comprehensive Methamphetamine Control Act of 1996,

which declares the final rule null and void and of no effect.

FOR FURTHER INFORMATION CONTACT: Frank Sapienza, Chief, Drug and

Chemical Evaluation Section, Office of Diversion Control, Drug

Enforcement Administration, Washington, DC. 20537, Telephone (202) 307-

7183.

SUPPLEMENTARY INFORMATION: DEA published a notice of proposed

rulemaking (NPRM) regarding Removal of Exemption for Certain

Pseudoephedrine Products Marketed Under the Food, Drug, and Cosmetic

Act (FD&C Act) in the Federal Register on October 31, 1995 (60 FR

55348). The NPRM proposed certain amendments to Title 21, Code of

Federal Regulations (CFR), Parts 1309, 1310, and 1313, and was open for

public comment until January 2, 1996. Following the comment period, DEA

published a final rulemaking on August 7, 1996 (61 FR 40981), which was

to become effective on October 7, 1996. However, on September 29, 1996,

Congress passed the Comprehensive Methamphetamine Control Act of 1996,

which provides that ``The final rule concerning removal of exemption

for certain pseudoephedrine products marketed under the Federal Food,

Drug, and Cosmetic Act published in the Federal Register of August 7,

1996 (61 FR 40981-40933) is null and void and of no force or effect.''

As a result, the amendments contained in the final rule are canceled

and the regulatory text of 21 CFR Parts 1309, 1310, and 1313 remains

unchanged.

Accordingly, DEA's rulemaking entitled Removal of Exemption for

Certain Pseudoephedrine Products Marketed Under the Food, Drug, and

Cosmetic Act (FD&C Act), published in the Federal Register as a

proposed rule on October 31, 1995 (60 FR 55348) and as a final rule on

August 7, 1996 (61 FR 40981), is withdrawn.

Dated: October 2, 1996.

Gene R. Haislip,

Deputy Assistant Administrator, Office of Diversion Control.

[FR Doc. 96-25665 Filed 10-4-96; 8:45 am]

BILLING CODE 4410-09-M