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Structured Product Labeling (SPL) is a Health Level Seven International (HL7) standard which defines the content of human prescription drug labeling in an XML format. [1] The "drug labeling" includes all published material accompanying a drug, such as the Prescribing Information which contains a great deal of detailed information about the drug.
The documents published use the HL7 version 3 Structured Product Labeling (SPL) standard, [1] which is an XML format that combines the human readable text of the product label with structured data elements that describe the composition, form, packaging, and other properties of the drug products in detail according to the HL7 Reference ...
Health Level Seven, abbreviated to HL7, is a range of global standards for the transfer of clinical and administrative health data between applications with the aim to improve patient outcomes and health system performance.
The HL7 community is organized in the form of a global organization (Health Level Seven International, Inc.) and country-specific affiliate organizations: Health Level Seven International, Inc. (HL7) is headquartered in Ann Arbor, Michigan. [2]
Besides, it shall contain adequate direction for use, including conditions and purposes, drug dosage, timing and route of administration. [5] In general, the expiry date of the drug is required and shall appear on the mediate container and the outer package. [5] Additional, label statements should be displayed with prominence and conspicuousness.
These codes were used by the U.S. Census Bureau, the Department of Agriculture to form milk-processing plant numbers, some cash registers during check approval, and in the Emergency Alert System (EAS). The FCC assigned additional numeric codes used with the EAS for territorial waters of the U.S., but these were not part of the FIPS standard.
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The Prescribing Information follows one of two formats: "physician labeling rule" format or "old" (non-PLR) format. For "old" format labeling a "product title" may be listed first and may include the proprietary name (if any), the nonproprietary name, dosage form(s), and other information about the product. The other sections are as follows: