New Drugs Exempted From Prescription-Dispensing Requirements; Technical Amendment

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; technical amendment.

SUMMARY:

Amendments to the Federal Food, Drug, and Cosmetic Act (the act) necessitate several changes to the citations used in Food and Drug Administration (FDA) regulations regarding the prescription-exemption procedure and the list of new drugs that are exempted from the prescription-dispensing requirements. These changes are editorial, pertaining only to citations, and do not constitute a change in FDA regulation.

DATES:

This rule is effective March 30, 2007.

FOR FURTHER INFORMATION CONTACT:

Gerald M. Rachanow, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 5496, Silver Spring, MD 20993, 301-796-2090.

SUPPLEMENTARY INFORMATION:

Section 126 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115) amended section 503(b)(1) of the act (21 U.S.C. 353(b)(1)). Specifically, the previous paragraph (b)(1)(A) of the act was stricken from the act and paragraphs (b)(1)(B) and (b)(1)(C) were redesignated as paragraphs (b)(1)(A) and (b)(1)(B), respectively. This amendment to the act necessitates that FDA revise the corresponding citations in its regulations. FDA is making this change in 21 CFR part 310 (§§ 310.200 and 310.201). These changes are editorial, pertaining only to citations, and do not constitute a change in FDA regulation.

Publication of this document constitutes final action on this change under the Administrative Procedure Act (5 U.S.C. 553). Notice and public procedures are unnecessary because FDA is merely implementing a change in citation to a section of the act as a result of amendment of the act.

List of Subjects in 21 CFR Part 310

• Administrative practice and procedure
• Drugs
• Labeling
• Medical devices
• Reporting and recordkeeping requirements

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 310 is amended as follows:

PART 310—NEW DRUGS

1. The authority citation for 21 CFR part 310 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360b-360f, 360j, 361(a), 371, 374, 375, 379e; 42 U.S.C. 216, 241, 242(a), 262, 263b-263n.

2. In § 310.200(a), (b), and (e) remove “503(b)(1)(C)” wherever it appears and add in its place “503(b)(1)(B)”.

3. In § 310.201(a) remove “503(b)(1)(C)” and add in its place “503(b)(1)(B)”.