Controlled Substance Staff

Consulting the Controlled Substance Staff on INDs and Protocols That Use Schedule I Controlled Substances and Drugs (Issued May 8, 2003)... 

Abuse liability Central nervous system Conditioned place preference Controlled Substance Staff Discriminative stimulus Drug dependence Drug development Intracranial self-stimulation Self-administration... 

Development of Controlled Substances Staff (CSS) at FDA and proactive discussion about drug abuse liability data I... 

Regardless of which method is used, most pharmacies also conduct a physical inventory at least annually. This encompasses counting or scanning every item in the pharmacy. Pharmacy staff then can compare the product on-hand quantities in the computer or the value of inventory on the financial statements with what is actually on the shelves. It is important to conduct a physical inventory to verify periodically the accuracy of the pharmacy s financial records. Additionally, pharmacy managers should follow state board of pharmacy regulations with respect to inventory counts and control with respect to controlled substances, especially narcotics. 

Prescriptions for controlled substances should be dated and signed on the day of their issuance and must bear the full name and address of the patient and the printed name, address, and DEA number of the practitioner they should be signed as one would sign a legal document. Preprinted orders are not allowed in most states, and presigned blanks are prohibited by federal law. When oral orders are not permitted (schedule 11), the prescription must be written with ink or typewritten. The order may be prepared by a member of the physician s staff, but the prescriber is responsible for the signature and any errors that the order may contain. 

Prescription blanks often are stolen and used to sustain abuse of controlled substances and to divert legitimate drug products to the illicit market. To prevent such diversion, prescription pads should be protected in the same manner as one would protect a personal checkbook. A prescription blank should never be pre-signed for a staff member to fill in at a later time. Also, a minimum number of pads should be stocked, and they should be kept in a locked, secure location except when in use. If a pad or prescription is missing, it should be reported immediately to local authorities and pharmacies some areas have systems in place to allow the rapid dissemination of such information. 

The practitioner should write the prescription using indelible pencil, ink, or a typewriter with the signature in the practitioner s own hand. The practitioner may delegate a staff member to prepare the prescription. The practitioner is ultimately responsible for the contents of the prescription. The practitioner must insure that the prescription is correct and that the prescription meets the laws, rules, and regulations for a controlled substance prescription, regardless of whether he or she delegated the preparation of the prescription to a staff member or not. 

A hospital s DEA number may be used by authorized practitioners who cannot obtain their own DEA number. An intern, resident, staff physician, or midlevel practitioner who is an employee of a hospital or other institution may use the hospital s DEA number to prescribe controlled substances provided the following circumstances are met ... 

Communicate the carrier s Controlled Substances and Alcohol percentile to all staff, and explain to them individually what they can do to help the carrier improve the percentile. 

Train all staff who are required to monitor and track controlled substance and alcohol comph-ance on the appropriate company policies, including those related to discipline and incentives. 

Operation includes nonual start-up, normal and emergency shutdown, and most activities performed by die production team. Whilst inlierently safe plant design limits inventories of hazardous substances, inherently safe operation ensures die number of individuals at risk are minimized. Access to die plant for non-essendal operational people such as maintenance engineers, post staff, administrators, quality control samplers, warehouse staff delivering raw material or plant items or collecting finished product, members of security, visitors etc., must be controlled. 

CRAC is the basic client organization within CMA. It consists of 15 company representatives, one-third of which are replaced each year by new representatives. This standing technical committee is served by CMA staff, outside consultants and outside counsel, as appropriate. While the various sections of the Toxic Substances Control Act are interrelated and interdependent this se c t i o n - b y - s e c t i o n task group structure has so far proved extremely effective in dealing with the various proposals which EPA has issued. Our key organizational theme, therefore, has been to utilize a multidisciplinary team concept to... 

Many of the chemicals and much of the equipment used in laboratories are potentially hazardous. It is essential that these hazards are clearly identified and appropriate working procedures defined together with adequate training of staff and readily available facilities to deal with the effects of any possible accident. These aspects of laboratory work are covered in the UK by COSHH (Control of Substances Hazardous to Health) Regulations and by OSHA (Occupational Safety and Health Administration) in the USA. 

Commission des Substances Explosive s(Fr) explosives developed oi approved by the CSE(eg 55-CSE-1948)(see the text) Combat Service Group Council for Scientific and Industrial Research Commonwealth Scientific and Industrial Research Organ zation(Australia) cast steel plate cast semi-steel central standard time Chief of Staff, US Army Chief of Staff, US Air Force Controlled target cyanuric triazide carbon tetrachloride Commander Task-Force cartridge... 

Intraexperiment Variability (Figure 5) The intraexperiment variability is evaluated by examining the variation in the replicate measures obtained within a given repeat experiment. This value is most useful for workers within a laboratory, since it is an indicator of the performance of a particular assay on a specific day. While useful for internal monitoring, this value does not provide a particularly good indication of how an assay performs over time. This is because replicate measures are obtained under conditions where sources of variability such as different technical staff, preparation of the test substances, preparation of cell cultures, and preparation of media are tightly controlled. Because of this control, results obtained from a group of replicate measures best represent a precise estimate of test variability at the particular time under the particular conditions when the test was run. It is not necessarily an accurate reflection of a test s performance over multiple runs. Thus, the performance of an assay over time within one laboratory is best measured at the level of the repeat experiment. 

The health status of animals from which starting materials are derived and of those used for quality control and safety testing should be monitored and recorded. Staff employed in animal quarters must be provided with special clothing, changing facilities and showers. Where monkeys are used for the production or quality control of biological products, special consideration is required, as laid down in the revised Requirements for Biological Substances No. 7 (Requirements for Polio-myelitis Vaccine (Oral))(5). 

Furthermore, the substance or the preparation in which it is incorporated has to be handled only by customers staff in controlled conditions, and it must not be made available to the general public at any time either on its own or in a preparation. 

Not only federal decision makers are concerned with exposure estimation. In private industry, assessments of employee exposure to various toxic substances used in the workplace, aside from those required by OSHA, are performed by industrial hygienists. Where exposures are felt to have the potential to result in employee health effects, systems engineers may be called in to alter the process or to add additional control technology, or special hazard warnings may be given to the affected employees. Similarly, if unusual clusters of health effects are observed by an industry s medical staff, they may seek exposure data to confirm a correlation between exposure to a certain chemical and the observation of a specific type of effect. In a similar fashion, public interest groups may seek exposure data to confirm a suspected dose-effect relationship. 

President s Council on Environmental Quality. 1971. Council on Environmental Quality, Toxic Substances, reprinted in Staff House Committee on Interstate and Foreign Commerce, 94th Congress, 2nd Session, Legislative History of the Toxic Substances Control Act (TSCA Legislative History) at 760 (Comm. Print 1976), pp. 759-760. 

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