Legal Status
Prescription drugs
Showing 1-20 of 88 results since 1994. View 68 more results.
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Schedules of Controlled Substances: Placement of Acetyl Fentanyl Into Schedule I
With the issuance of this final order, the Administrator of the Drug Enforcement Administration will maintain the placement of the substance acetyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N- phenylacetamide), including its isomers, esters, ethers, salts, and salts of isomers, esters and ethers, in schedule I of the Controlled Substances Act....
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List of Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act
The Food and Drug Administration (FDA or Agency) is proposing a regulation to identify an initial list of bulk drug substances that can be used to compound drug products in accordance with certain compounding provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), although they are neither the subject of an applicable United...
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Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements
The Food and Drug Administration (FDA or the Agency) is amending its current good manufacturing practice (CGMP) and labeling regulations regarding medical gases. FDA is requiring that portable cryogenic medical gas containers not manufactured with permanent gas use outlet connections have gas-specific use outlet connections that cannot be...
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Amendments to the Regulation Regarding the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or the Agency) is proposing to amend its regulations to revise the list of drug products that have been withdrawn or removed from the market because the drug products or components of such drug products have been found to be unsafe or not effective. Drugs appearing on this list may not be compounded under...
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Additions and Modifications to the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or the Agency) is amending its regulations to revise the list of drug products that have been withdrawn or removed from the market because the drug products or components of such drug products have been found to be unsafe or not effective. Drugs appearing on this list may not be compounded under the...
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Schedules of Controlled Substances: Placement of AH-7921 Into Schedule I
With the issuance of this final order, the Administrator of the Drug Enforcement Administration places the substance AH-7921 (Systematic IUPAC Name: 3,4-dichloro-N- [(1dimethylamino)cyclohexylmethyl]benzamide), including its isomers, esters, ethers, salts, and salts of isomers, esters and ethers, into schedule I of the Controlled Substances Act....
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Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph
The Food and Drug Administration (FDA or the Agency) is proposing to revise its regulations on prescription fixed-combination drugs to apply the regulations to both prescription and nonprescription fixed-combination and co-packaged drugs and combinations of active ingredients under consideration for inclusion in an over-the-counter (OTC)...
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Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
The Food and Drug Administration (FDA or we) is amending our regulation for Current Good Manufacturing Practice In Manufacturing, Packing, or Holding Human Food in two fundamental ways. First, we are modernizing the long-standing current good manufacturing practice requirements. Second, we are adding requirements for domestic and foreign...
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Food and Drug Administration Regulations; Change of Addresses; Technical Amendment
The Food and Drug Administration (FDA) is amending its regulations to update address information for the Center for Biologics Evaluation and Research (CBER) as a result of the recent relocation of CBER offices and laboratories to the FDA White Oak campus in Silver Spring, MD, as well as make other related technical revisions. These changes are...
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Additions and Modifications to the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or the Agency) is proposing to amend its regulations to revise the list of drug products that may not be compounded under the exemptions provided by the Federal Food, Drug, and Cosmetic Act (the FD&C Act) because the drug products have been withdrawn or removed from the market after the drug products or...
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Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act
The Food and Drug Administration (FDA or Agency) is issuing a regulation to establish a list of ``qualifying pathogens'' that have the potential to pose a serious threat to public health. This final rule implements a provision of the Generating Antibiotic Incentives Now (GAIN) title of the Food and Drug Administration Safety and Innovation Act...
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Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act
The Food and Drug Administration (FDA or Agency) is proposing a regulation to establish a list of ``qualifying pathogens'' that have the potential to pose a serious threat to public health. The proposed rule would implement a provision of the Generating Antibiotic Incentives Now (GAIN) title of the Food and Drug Administration Safety and...
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Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food
The Food and Drug Administration (FDA) is proposing to amend its regulation for Current Good Manufacturing Practice In Manufacturing, Packing, or Holding Human Food (CGMPs) to modernize it and to add requirements for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to...
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Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; Revision of Certain Labeling Controls
The Food and Drug Administration (FDA) is amending the packaging and labeling control provisions of the current good manufacturing practice (CGMP) regulations for human and veterinary drug products by limiting the application of special control procedures for the use of cut labeling to immediate container labels, individual unit cartons, or...
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Technical Amendments and Corrections to DEA Regulations
This final rule updates the Code of Federal Regulations pertaining to DEA by alphabetizing definitions and eliminating the numeric listings in those definitions in order to simplify future rulemakings where additional definitions are added or deleted. This rule also corrects typographic errors, reflects organizational changes, and updates...
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Schedules of Controlled Substances: Placement of Carisoprodol Into Schedule IV
With the issuance of this final rule, the Administrator of the Drug Enforcement Administration (DEA) places the substance carisoprodol, including its salts, isomers, and salts of isomers, whenever the existence of such salts, isomers, and salts of isomers is possible, into Schedule IV of the Controlled Substances Act (CSA). This action is...
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Schedules of Controlled Substances: Placement of 5-Methoxy-N,N-Dimethyltryptamine into Schedule I of the Controlled Substances Act
With the issuance of this final rule, the Deputy Administrator of the Drug Enforcement Administration (DEA) places the substance 5- methoxy-N,N-dimethyltryptamine (5-MeO-DMT), including its salts, isomers and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, into schedule I of the Controlled...
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Listing of Approved Drug Products Containing Dronabinol in Schedule III
This proposed rule is issued by the Deputy Administrator of the Drug Enforcement Administration (DEA) to modify the listing of the Marinol[supreg] formulation in schedule III so that certain generic drug products are also included in that listing. Several products are currently the subject of Abbreviated New Drug Applications (ANDAs) under...
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Schedules of Controlled Substances: Placement of Propofol Into Schedule IV
This proposed rule is issued by the Deputy Administrator of the Drug Enforcement Administration (DEA) to place the substance propofol, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, into schedule IV of the Controlled Substances Act (CSA). This proposed action is...
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Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System Changes and FY2011 Rates; Provider Agreements and Supplier Approvals; and Hospital Conditions of Participation for Rehabilitation and Respiratory Care Services; Medicaid Program: Accreditation for Providers of Inpatient Psychiatric Services
We are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems and to implement certain provisions of the Affordable Care Act and other legislation. In addition, we describe the...
Showing 1-20 of 88 results since 1994. View 68 more results.