federal_register: 01-31400
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
This data as json
| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 01-31400 | Child-Resistant Packaging for Certain Over-the-Counter Drug Products; Correction | Rule | The Consumer Product Safety Commission (CPSC or Commission) corrects the rule published in the Federal Register of August 2, 2001 that requires child-resistant (CR) packaging of certain previously prescription-only oral drug products approved by the Food and Drug Administration (FDA) for over-the-counter (OTC) sale. Drug products that are the subject of the August 2 rule are members of the category known as "OTC switched drug products." The Commission intended that the August 2 rule apply to an oral drug product that is granted OTC status as the result of an application to switch the product from prescription to OTC status (an OTC switch application) submitted to the FDA on or after the January 29, 2002 effective date of the CPSC rule, except in the following circumstances. The rule was not intended to cover a drug product that contains only active ingredients covered by prior OTC switch applications submitted by the same or any other applicant before the effective date of the CPSC rule. Since publication of the August 2 rule, the Commission has become aware that a correction is necessary to avoid confusion over this point and is thus issuing a clarifying amendment. | 2001-12-21 | 2001 | 12 | https://www.federalregister.gov/documents/2001/12/21/01-31400/child-resistant-packaging-for-certain-over-the-counter-drug-products-correction | https://www.govinfo.gov/content/pkg/FR-2001-12-21/pdf/01-31400.pdf | Consumer Product Safety Commission | 84 | The Consumer Product Safety Commission (CPSC or Commission) corrects the rule published in the Federal Register of August 2, 2001 that requires child-resistant (CR) packaging of certain previously prescription-only oral drug products approved by the... |