Source: https://www.federalregister.gov/articles/2012/02/28/2012-4597/using-innovative-technologies-and-other-conditions-of-safe-use-to-expand-which-drug-products-can-be
Timestamp: 2016-05-03 22:07:11
Document Index: 26293420

Matched Legal Cases: ['§ 15', 'art 15', 'art 10', 'art 10', '§ 10', '§ 10', '§ 15', 'art 15', '§ 15']

Federal Register | Using Innovative Technologies and Other Conditions of Safe Use To Expand Which Drug Products Can Be Considered Nonprescription; Public Hearing
Dates: Public Hearing: The public hearing will be held on March 22 and 23, 2012, from 9 a.m. to 4 p.m. The meeting may be extended or may end early depending on the level of public participation.
-12062 (4 pages)
Document Number: 2012-4597
Shorter URL: https://federalregister.gov/a/2012-4597 Action
Under the Federal Food, Drug, and Cosmetic Act (FD Act), FDA approves new drugs under section 505 (21 U.S.C. 355) either as prescription or nonprescription. Under section 503(b)(1)(A) of the FD Act (21 U.S.C. 353(b)(1)(A)), a drug must be dispensed by prescription if, “because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, [it] is not safe for use except under the supervision of a practitioner licensed by law to administer such drug.” Under sections 505(d)(1) and (d)(4), FDA has considerable latitude in determining whether the information submitted as part of a new drug application (NDA) is sufficient to ensure that a drug is safe for use under its proposed labeling. FDA also makes a determination under 503(b) as to whether the product meets the criteria for prescription-only dispensing.
II. New Paradigm Back to Top
III. Scope of the Public Hearing Back to Top
10. What are the public health and regulatory implications of the use of in vitro diagnostic tests as conditions of safe use for nonprescription drug products in a pharmacy setting (e.g., as a laboratory under the Clinical Laboratory Improvement Act of 1988 (CLIA) (100))?
IV. Attendance and/or Participation in the Public Hearing Back to Top
Under § 15.30(f), the hearing is informal and the rules of evidence do not apply. No participant may interrupt the presentation of another participant. Only the presiding officer and panel members may question any person during or at the conclusion of each presentation (21 CFR 15.30(e)). Public hearings under part 15 are subject to FDA's policy and procedures for electronic media coverage of FDA's public administrative proceedings (part 10 (21 CFR part 10), subpart C) (§ 10.203(a)). Under § 10.205, representatives of the electronic media may be permitted, subject to certain limitations, to videotape, film, or otherwise record FDA's public administrative proceedings, including presentations by participants. The hearing will be transcribed as stipulated in § 15.30(b). (See section VII of this document for more details.) To the extent that the conditions for the hearing as described in this document conflict with any provisions set out in part 15, this document acts as a waiver of those provisions as specified in § 15.30(h)).