Labelling information

Labeling compliance with these regulations is complex, and further labeling information is available (67,68). 

Additional eonsiderations, e.g. relating to labelling, information supply and emergeney proeedures, arise when marketing and transporting ehemieals. While - as with Chapter 13 and with eontrol measures generally - what is required will vary with speeifie legislation and basie requirements are summarized in Chapters 14 and 15. 

Supplier notification is not required for a pure toxic chemical unless a trade name is used. The identity of the toxic chemical will be known based on label information. 

Adequate labeling information to protect customers workers advice when mode of use involves new form or degree of hazard Adequate labeling and use information either to conform to statute or to fulfill common law obligations special requirements of federal and state insecticide or pure food laws... 

In our meta-analysis, more than half of the clinical trials submitted to the FDA showed no difference between drug and placebo. Most reviewers of the clinical-trials literature have not had access to unpublished studies and may not even know of their existence. But the FDA and other regulatory agencies around the world knew of these data. Nevertheless, their existence is not even mentioned in the product labels, information leaflets and official Summaries of Product Characteristics (SPC) of most antidepressants. 

Bemues A, Olaizola A and Corcoran K (2003), Labelling information demanded by European consumers and relationships with purchasing motives, quality and safety of meat , Meat Sci, 65, 1095-1106. 

FDA labeling information [online]. Available at http //www.fda.gov/ cder/toi/Iabe1/2004/ 1251041bl.pdf, 2004. 

All Monsanto PMN s submitted to date have voluntarily included information beyond that mandated by the act. This has, in some cases, included Material Safety Data Sheets, Label information, details regarding the industrial hygiene programs in the proposed manufacturing site(s), risk assessment information and other related information. While this information is not mandated, we believe in most situations it is to our benefit to assist the agency in this way. 

Electronic labeling information will improve the drug-labeling review process and speed up the approval and public disseminahon of labeling changes, getting important, up-to-date informahon on medicahons to doctors and pahents more quickly. 

Label (manufacturer s) design—Physical label design, e.g., contrast of label information and background, letter font, symbol(s), or logo, causes information to be overlooked or difficult to read. 

Case 051133 Poor Label Design Confusing or Incomplete Label Information Packaging... 

USP received eight reports Ifom pharmacists expressed concern about the labeling on the Bentyl (dieyclomine hydrochloride antispasmodic) 2-mL ampule. Practitioners reported that the label indicates only the drug concentration, 10 mg/mL, not the total volume, and some regarded the label information as incomplete. In one report, a 20-mg dose was ordered, but two ampules were administered (a total of 4 mL instead of 2 mL), leading to an overdose. This happened because the practitioner mistook 10 mg as the total eontents of one vial. 

Labeling experiments with l-deoxy-l-(dibenzylamino)-D-[l- C]-aruI>-mo-2-hexulosuronic acid [l- C] 112 indicated that the C label corresponded to the 5-methyl group of 111 (see Ref. 234). This is also consistent with a l-deoxy-2,3-dicarbonyl intermediate (115), and indicates that 111 is a decarboxylation product (see Scheme 22). The precise step entailing decarboxylation has not yet been determined. The carboxyl group could be carried through to ring closure (furanone formation). Such a step would provide a 2-carboxylate which is a /3-keto acid subject to ready decarboxylation. The labeling information and the initial steps of the mechanism in Scheme 22 are also consistent with the formation of 111 from D-[l- C]ribose and a secondary amine. ... 

A total of 1118 drugs with ADR information were included in the analysis. Incidence data ( common, frequent, infrequent, rare, not known ) associated with each COSTART term for each compound were transformed to binary data. Each ADR for a specific drug was scored as 1 if the COSTART term was listed in its label at any clinical frequency including not known, and as 0 if the term was not listed. Thus, each occurrence of the ADR in the label information is counted as a positive response. 

FDA Electronic Orange Book http //www.fda.gov/cder/ob/default.htm Up-to-date information on all drug approvals and withdrawals in the US. Includes applicant, dosage form, proprietary name, date approved, patent information. Does not include drug label information or safety information. 

Shall accompany the specimen need not be strictly interpreted in the case of archive material. For example, a specimen labeled with an accession number can be stored in the specimen archives while the document that translates the accession number into the additional label information is stored in a separate document archive. As long as both the specimen and the associated document are readily retrievable, the intent of the regulations is met. 

Information in the PI is typically based on the studies submitted by a drug s manufacturer. The FDA has also utilized spontaneous adverse event case reports as a tool in the evaluation of drug-grapefruit juice interaction labeling. Other sources of data that contribute to labeled information include studies or case reports from the medical literature. 

The FDA reviews information that goes on a drug s professional labeling (information on how to use the drug). 

Drug labeling Consumers tend to overlook important label information on OTC drugs, according to a Harris Interactive Market Research Poll conducted for the National Council on Patient Information and Education and released in January 2002. In May 2002, an FDA regulation went into effect that aims to help consumers use OTC drugs more wisely. 

---