Controlled substances storage

Worker safety studies are not likely to normally include a control substance (i.e., a material used in the study to serve as basis of comparison with the test substance). However, if a control substance is included as a treatment group, then it must (1) be fully characterized as to its identity, purity (or strength), and stability (and solubility, if appropriate) (2) be appropriately tested in mixtures with any carrier used and (3) meet all the other GLP recordkeeping, labeling, and storage requirements, as specified for the test substance. There is some regulatory relief here, however, in that water, by definition, is excluded from being considered a control substance, and vehicles (those substances added to enhance solubilization or dispersion of the test substance) are addressed separately in the FIFRA GLP Standards. 

The use of toxics carries with it a responsibility to maintain an effective system to ensure that dangerous chemicals are not released to unauthorized persons. The entire building should be within a secure perimeter and/or individual laboratories or suites of laboratories should be securable. Within laboratories and stockrooms there should be secure storage for any toxics and other controlled substances that are used. 

Controlled Substances. In Domestic Mail Manual United States Postal Service, 2002 79. Issue 57, Section 11. Pharmaceutical stability (1150), USP 29-NF 24 United States Pharmacopeia Rockville, MD, 2006 2994-2995. Good storage and shipping practices (1079), USP 29-NF 24United States Pharmacopeia Rockville, MD, 2006 2915-2920. 

Computers have made record storage much more manageable. An alternative to the three options listed above is to store records in a computer system. This is valid only for Schedules III-V controlled substances. Schedule II controlled substances must be stored separately. 

Valid practitioner registration for the administration, dispensing, or storage of controlled substances for treatment of conditions other than narcotic addiction at the treatment program location. 

Many controlled substances are used in preparation areas and it is the responsibility of the preparing pharmacist to comply with the relevant record keeping and storage requirements. Particular attention should be paid to the reconciliation of the powders in this category. 

In some Countries, e.g. the UK, Controlled substances are required to be stored in a secure room or vault, protected by alarms that can be monitored 24 h a day. However in some Countries the pharmacist is responsible for deciding on the most appropriate storage conditions to ensure that controlled substances are stored in such a way that the risk of abuse is low... 

The Act makes provision for protecting others against risks to health and safety from the way in which work activities are carried out. It also seeks to control certain emissions into the atmosphere, as did the Control of Pollution Act 1974, and to control the storage and use of dangerous substances. In addition, the Act ensures the continuation of the Emplo5unent Medical Advisory Service. 

Preconditions for the adoption of a storage system are its stable long-term durability, a reasonable voltage range, cheap raw materials, as well as controllable substances regarding production techniques, and also a regard for possible environmental damage. 

GLPs require that there are separate areas for test, reference, and control substance receipt and storage, mixing with carrier, and storage of the mixtures. Test, reference and control substances are typically supplied by the sponsor and shipped directly to the field sites to be stored under label conditions. A computerized temperature and relative humidity monitoring device can be packaged with the test chemical prior to shipment, then down-loaded upon arrival to assure that the chemical was not subjected to conditions outside its stability range. 

For studies of more than four weeks in experimental duration, a reserve sample of each batch of the test, reference (analytical reference standard) and control substance must be retained. As this archive sample may be retained by either the sponsor or the contract facility, the responsibility should be addressed in the protocol. Additionally, a sample of the chemical should be collected prior to each application and immediately frozen for possible analysis for "storage stability of the test, reference and control substance at the test site". If the sponsor s storage stability data are inclusive of the storage conditions recorded at the test site, the GLP requirement will have been met and the above storage stability samples will not have to be analyzed (10). It should be noted that all test substance containers must be retained for the duration of the study i.e., until the study director signs the final report. A conditional exception for disposing of the containers may be obtained by writing to the OCM (11). OCM will set forth certain documentation requirements that will be required to account for the test substance containers. 

Prevention of arson Control access at all times Screen employees and casual labour Lock away flammable substances and keep combustibles away from doors, windows, fences Provide regular fire safety patrols, even where automatic systems are provided Secure particularly storage and unmanned areas... 

Extends the scope of Health and Safety at Work etc. Act 1974 to include environmentally-hazardous substances including transportation of such dangerous goods and the control of volatile organic carbon emissions from storage and distribution of petrol. 

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