Drug Products, Labeling, and Packaging

Ensuring Effectiveness, Safety, and Access to Orphan Drug Products (1413)

Source: Council on Therapeutics

To encourage continued research on and development of orphan drug products; further,

To advocate for the use of innovative strategies and incentives to expand the breadth of rare diseases addressed by this program; further,

To encourage postmarketing research to support the safe and effective use of these drug products for approved and off-label indications; further,

To urge health policymakers, payers, and pharmaceutical manufacturers to develop innovative ways to ensure patient access to orphan drug products.

This policy supersedes ASHP policy 0715.

Standardized Clinical Drug Nomenclature (0920)

Source: Council on Pharmacy Management

To encourage federal agencies, the pharmaceutical industry, pharmacy and medical software providers, and purveyors of clinical data repositories and drug databases to explore the potential benefits of supplementing or modifying the National Drug Code with a coding system that can be used effectively to support patient care, research, and financial management; further,

To encourage that such a coding system encompass prescription drug products, nonprescription medications, and dietary supplements and include both active and inactive ingredients.

This policy was reviewed in 2013 by the Council on Pharmacy Management and by the Board of Directors and was found to still be appropriate.

Disclosure of Excipients in Drug Products (0808)

Source: Council on Pharmacy Practice

To advocate that manufacturers declare the name and derivative source of all excipients in drug products on the official label.

(Note: Derivative source means the botanical, animal, or other source from which the excipient is originally derived.)

This policy was reviewed in 2012 by the Council on Pharmacy Practice and by the Board of Directors and was found to still be appropriate.

Standardizing Prefixes and Suffixes in Drug Product Names (0720)

Source: Council on Public Policy

To collaborate with others, including the United States Pharmacopeia and the Food and Drug Administration, in standardizing and defining the meaning of prefixes and suffixes for prescription and nonprescription drugs to prevent medication errors and ensure patient safety.

This policy was reviewed in 2011 by the Council on Public Policy and by the Board of Directors and was found to still be appropriate.

Elimination of Surface Contamination on Vials of Hazardous Drugs (0618)

Source: Council on Professional Affairs

To advocate that pharmaceutical manufacturers eliminate surface contamination on vials of hazardous drugs; further,

To inform pharmacists and other personnel of the potential presence of surface contamination on the vials of hazardous drugs; further,

To encourage health care organizations to adhere to published standards and regulations to protect workers from undue exposure to hazardous drugs.

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