Labels legal requirements

Legal requirements for pharmaceutical product assessment and registration specify how pharmaceutical production should be carried out, and lay down requirements concerning packaging, information to be provided by labels and inserts, methods of analysis, etc. 

Legal Controls. These include a labeling law requiring all economic poisons to be clearly labeled according to content and amount of each ingredient, with appropriate statements on first aid measures and precautions and an adequate system of inspection for the presence of poisonous residues on the surface of, or within, the foods placed on the market. It is recommended also that the states adopt legislation consistent with the federal laws. 

Chemicals and consumables normally arrive from the supplier in a suitable container, appropriately labelled. The information given on the packaging is the responsibility of the supplier and is legally required to conform to minimum requirements under packaging and labelling regulations. Typically, the label on a container for a commercially sold chemical will indicate the following ... 

It is a legal requirement to affix a prescription label on the immediate container of prescription medications. The pharmacist is responsible for the accuracy of the label. It should bear the name, address, and the telephone number of the pharmacy, the date of dispensing, the prescription number, the prescriber s name, the name and address of the patient, and the directions for use of the medication. Some states require additional information. The name and strength of the medication, and the refill directions are also written frequently. The label for a sample prescription is in Figure 3.2. 

If the intermediate or API is intended to be transferred outside the control of the manufacturer s material management system, the name and address of the manufacturer, quantity of contents and special transport conditions, and any special legal requirements should also be included on the label. For intermediates or APIs with an expiry date, the expiry date should be indicated on the label and certificate of analysis. For intermediates or APIs with a retest date, the retest date should be indicated on the label and/or certificate of analysis. 

Products labeled as "organic" meet strict legal requirements, including certification by a third party. 

The following section contains a description of the legal requirements for composition and labeling of margarine and table spreads. Such information is essential for formulating products to meet speciflc claims however, because it contains... 

All labels for dispensed medicines must have the name of the patient, preferably the full name, not just initials and if possible the title of the patient (Mr, Mrs, Miss, Master, Ms, etc.) as this helps to distinguish between family members. The date and the name and address of the pharmacy are also legally required. This will normally automatically appear on most computer labelling systems with the date being reset automatically. The words Keep out of the reach of children are also legally required, but most labels used for dispensing purposes are already pre-printed with these... 

Volume 1 background and legal requirements, employer responsibilities, SARA Title III, sample forms, compliance checklists, label suppliers, and training program index. Volume 2 model hazard communication program. 

Any special legal requirements, e.g. product category, poison schedule, weights and measures, labelling. 

Ethical products should either have a print free area or a printed area which does not contain vital or legally required information which would be covered or obliterated when the pharmacist s label giving information for the patient is applied. The standard size for this label is 70 mmx40 mm, or 70 mmx35 mm. 

Japanese labelling requirements are not as comprehensive as in the EC and the USA, and there is currently no legal requirement for MSDSs. Specified and designated chemical substances under the MITI/MHW scheme have to be labelled appropriately, as do dangerous substances under the MOL law and other legislation. 

Do not expect a label to deliver more than it can. Extensive information, hazard warnings, safety information, imagery, use instructions, etc. cannot effectively be squeezed into a small label. If a small label is all that s possible, then perceptual elements must predominate— size and variety of print, color and color contrast, isolation and emphasis of hazard and warning areas, layout factors. At the very least, the label must communicate the product name, what it does, legally required warnings, and necessary use information rapidly and with minimal difficulty. 

Packaging operations must follow dearly defined written procedures in order to produce finished products of the requisite quality and must comply with their authorised packaging documents as well as all legal requirements. Special attention must be paid to labels and labelling throughout the entire packaging cycle. 

Many consumers place excessive importance on alcohol content as an essential qnality factor. Most countries legally require the alcohol content to be displayed on barrels in retail shops and wine labels. In some cases, wines are priced on the basis of alcohol content. It is nevertheless true that there is a relationship between vinous character and alcohol content, on the one hand, and soft, fnll-bodied flavor, on the other hand. 

Although no legal requirement exists, the customer should usually be able to trust the information about substances provided by the producer or distributor. Therefore, the classification, labeling, and submitted safety data sheets are from the best available data source. Of course, in the case of an obviously wrong declaration, a correction has to be made, preferable after feedback to the supplier. In the case of different classifications by different suppliers, an own assessment has to be done. 

Samples, reagents, solvents, and mobile phases on laboratory benches and shelves are labeled clearly and in accordance with (legal) requirements. Samples and specimens in refrigerators and freezers, are checked, for example, for expiration date, clear labeling. 

Although there is a legal requirement that chemical manufacturers produce MSDSs for chemicals that they sell, there is no specific required format. However, the American National Standards Institute designed a 16-part format that was recommended by OSHA" and a similar format has been adopted by the United Nations for its Safety Data Sheets in its Globally Harmonized System of Classification and Labelling of Chemicals (GHS). ... 

This chapter deals not oifly with the legal requirements on labelling and patient information leaflet, but also with reconstitution and other manipulation needed prior to use or administration as well as instructing the patient about it, with the focus on the needs of the patient. 

First of all this means product information related to a particular medicine. Directions for use, storage and expiration date are normally part of the label and the package leaflet, as a legal requirement. This chapter describes how to deal with these requirements. 

Label and Patient Information Leaflet 37.3.1 Legal Requirements... 

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