Labeling compliance

A Special agency now called the Bureau of Alcohol, Tobacco, and Firearms (BATF) within the U.S. Treasury Department was empowered to regulate the alcohoHc beverage industries. Although less adversarial, but strictly enforced even today (ca 1997), the regulations and their appHcation remain voluminous and detailed. They specify not only label compliance and matters relating to taxation that are of direct interest to consumers, but contain all the details of permitted processes for and additions to wines. 

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

Producers using purchased complete feed do not have to pay as much attention to quality control. Feed manufacturers are required by feeds legislation in most countries to supply feed of a high standard, which requires them to test ingredients and finished products routinely. In addition, regulatory officials check commercial feeds at random for label compliance. However, it is still advisable for the organic producer to carry out routine checks on any purchased feeds and to communicate regularly with suppliers to ensure that the purchased products meet the standards expected. 

Study Design Factors Affecting Exposure Variability 33 Specific Requirements for Guideline Studies 34 Label Compliance 34 Sample Size 34 Observational Bias 35 Motivational Bias 35... 

SPECIFIC REQUIREMENTS FOR GUIDEUNE STUDIES Label Compliance... 

All pesticides are evaluated, and if additional care over and above simple label compliance is required for their safe use, they receive a restricted use classification. Pesticides classified for restricted use will bear the following statement on the label ... 

In summary, MRLs are derived following an assessment of incurred residues resulting from approved conditions of use and represent the maximum residue concentrations that are consistent with those label uses (e.g., dose and routes of administration). Residues in excess of the MRL are indicative of uses outside the approved conditions of use. Thus, the MRL approach is extremely effective in monitoring label compliance, focusing regulatory resources on those residue cases that represent deviations from the labeled conditions of use. However, because not all extralabel uses result in unsafe residues, the MRL approach may result in compliance cases that cannot claim to protect the public health. ... 

Flame-retardant (unfilled) grades. These use a nonbrominated, nonchlori-nated flame retardant, allowing for ECO-label compliance. They offer a range of thermal and mechanical properties and cost economy for apph-cations including computers and business equipment, electrical, electronic, construction, telecommunications, and appliances. Representative properties of flame-retardant PPE/PS grades appear in Table 9.3. Flame-retardant grades and key features include... 

High-modulus reinforced flame-retardant grades. These offer a broad range of fillers, which provide increased levels of strength, stiffness modulus, dimensional stabdity, and electrical conductivity. These reinforced resin grades use a nonbrominated, nonchlorinated flame retardant, allowing for ECO-label compliance. 

The following items represent minimum marking and labeling compliance requirements ... 

Begin inspection of labeling compliance with the shipping papers in hand, using the shipping papers to determine the HM/TDG being transported. 

Table 3.5 Rouse Theory Expressions for the Modulus (entries labeled 1) and Compliances (entries labeled 2) for Tension and Shear Under Different Conditions ...

In 1966 the PDA utilized the services of the National Academy of Sciences—National Research Council (NAS—NRC) to estabhsh the relative therapeutic efficacies of prescription dmgs marketed between 1938 and 1962. Those products that were found to meet safety and efficacy requirements were allowed to stay on the market. Suitable changes were required for other products for compliance, ie, formulation or label changes, additional data... 

Wind Resistance. Asphalt shingles are certified to wind performance test standards on a continuous basis through independent third-party testing laboratories. Shingles that have passed the standard wind performance requirements, such as ASTM D3161, Standard Test Method for Wind Resistance for Asphalt Shingles, are identified by labels from the testing laboratory with whom they are in compliance. 

Maintain and use 2. Develop 2. Adequately label 2. Use zone 2. Ensure compliance 2. l-.-.lahli sh buildmg 2 Ctsudinjk. ulions... 

Facility Chemical or Waste Recordkeeping, Reporting, and Compliance Assistance (e.g., manifests, labels, report generation) ... 

Data concerning use patterns of food additives and color additives are difficult to obtain. Although additives must be included on product labels in descending order of inclusion, major effort is required to evaluate even a simple presence on this basis, which would provide at best only limited information on the amounts used. In most cases, quantitative analytical controls are limited to efforts by control authorities to determine compliance with legal limits. Levels below these limits are of limited interest and are usually not published. ... 

The reasons that the drug product s compliance with the tamper-evident packaging or labeling requirements of this section is unnecessary or cannot be achieved. 

Thereafter, the primary functions of the study QA specialist fell into two main headings. First, GLP compliance during the collection and documentation of commodity samples had to be assured. This was done via observation of several collections for different shops (collection incidents) at various geographic locations. In these audits, the study QA specialist examined specific items, such as (1) did the shopper follow the written instructions, (2) were the correct types and numbers of samples collected, (3) was the documentation maintained as required, (4) were the samples labeled and packaged correctly, and (5) were the samples delivered to the shipper as required Findings were communicated to study management and used as appropriate in subsequent shops. 

An open-label study of paroxetine and fluoxetine (Alonso et al, 1997) in depressed Hispanic (Mexican descent, n = 13) and non-Hispanic females (n = 13) showed no differences in response rates. At variance with the tricyclic data, Hispanic subjects complained of fewer side effects (2.2 2.0 vs. 5.1 2.5 p < 0.005), but twice as many terminated participation prior to study completion due to non-compliance, intolerable side effects or pregnancy. 

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