Prescriptions; dispensing controlled substances in institutional practitioner emergency rooms--Drug Enforcement Administration, Justice. Withdrawal of proposed rule

A Notice of Proposed Rulemaking published on September 17, 1982, would have amended Part 1306 of Title 21 of the Code of Federal Regulations to permit hospital emergency room personnel to dispense controlled substances to nonpatients when alternate pharmacy services were not available. This proposed action was initiated in response to requests from various state agencies and hospitals. After assessing the comments and objections to the proposal, the Drug Enforcement Administration (DEA) has determined that the need for the proposed rule change has not been established at this time and the proposal is therefore withdrawn for further study.     

Placement of gamma-butyrolactone in List I of the Controlled Substances Act (21 U.S.C. 802(34)). Drug Enforcement Administration, Justice. Final rule

Public Law 106-172, signed into law on February 18, 2000, and known as the "Hillory J. Farias and Samantha Reid Date-Rape Drug Prohibition Act of 1999," amends section 102(34) of the Controlled Substances Act as amended (CSA) by designating gamma-butyrolactone (GBL), the precursor to gamma-hydroxybutyric acid (GHB), as a List I chemical. Reflecting this change in stature, the Drug Enforcement Administration (DEA) is amending its regulation to reflect the status of GBL as a List I chemical subject to the requirements of the CSA and its regulations. Establishment of a threshold for GBL will be the subject of a separate rulemaking. Therefore, unless and until a threshold is established, any distribution of GBL is a regulated transaction as described by 21 CFR 1300.02(b)(28). All handlers of GBL must comply with the CSA regulatory requirements pertaining to List I chemicals as described in the body of this document.     

Over-the-counter drug products containing colloidal silver ingredients or silver salts. Department of Health and Human Services (HHS), Public Health Service (PHS), Food and Drug Administration (FDA). Final rule

The Food and Drug Administration (FDA) is issuing a final rule establishing that all over-the-counter (OTC) drug products containing colloidal silver ingredients or silver salts for internal or external use are not generally recognized as safe and effective and are misbranded. FDA is issuing this final rule because many OTC drug products containing colloidal silver ingredients or silver salts are being marketed for numerous serious disease conditions and FDA is not aware of any substantial scientific evidence that supports the use of OTC colloidal silver ingredients or silver salts for these disease conditions.     

List of drug products that have been withdrawn or removed from the market for reasons of safety or effectiveness. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is amending its regulations to include a list of drug products that may not be used for pharmacy compounding under the exemptions under section 503A of the Federal Food, Drug, and Cosmetic Act (the act) because they have had their approval withdrawn or were removed from the market because the drug product or its components have been found to be unsafe or not effective. The list has been compiled under the new statutory requirements of the Food and Drug Administration Modernization Act of 1997 (Modernization Act).     

Medicare program; recognition of the Community Health Accreditation Program, Inc. (CHAP) for hospices. Health Care Financing Administration (HCFA), HHS. Final notice

This notice recognizes the Community Health Accreditation Program, Inc. (CHAP) as a national accreditation organization for hospices that request participation in the Medicare program. We believe that accreditation of hospices by CHAP demonstrates that all Medicare hospice conditions of participation are met or exceeded. Thus, we grant deemed status to those hospices accredited by CHAP. The proposed notice included the application from the Joint Commission for Accreditation of Healthcare Organizations (JCAHO). We have separated the final notices to appropriately process each application and will issue a separate final notice containing the decision for JCAHO under HCFA-2039-FN.     

Revision of requirements applicable to albumin (human), plasma protein fraction (human), and immune globulin (human). Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is amending the biologics regulations by removing, revising, or updating specific regulations applicable to blood derivative products to be more consistent with current practices and to remove unnecessary or outdated requirements. FDA is taking this action as part of the agency's "Blood Initiative" in which FDA is reviewing and revising, when appropriate, its regulations, policies, guidance, and procedures related to blood products, including blood derivatives.     

International Conference on Harmonisation; guidance on quality of biotechnological/biological products: derivation and characterization of cell substrates used for production of biotechnological/biological products; availability. Notice. Food and Drug Administration,HHS

The Food and Drug Administration (FDA) is publishing a guidance entitled "Q5D Quality of Biotechnological/Biological Products:Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).The document provides broad guidance on appropriate standards for the derivation and characterization of cell substrates used in the production of biotechnological/biological products and recommends information in these areas that should be presented in marketing applications.