Enforcement Policies

Department of Justice and some of the larger federal and state agencies, but, typically, in name only. We don t have enforceable policies yet to protect us. We don t have fallbacks of unions or pension funds. We don t have real protection. That s humbling and it makes me angry. 

On March 15, 1912, Wiley himself resigned, following Hesse out of government service. He had been worn down by years of fighting with Wilson and McCabe, and was weary of his frequent inability to establish enforcement policies, such as the mandatory... 

Extensive Website devoted to education about many drugs, current trends, and law enforcement policies. 

Rivers, P.A., A. Dobalian, and F.A. Germinario. 2005. A review and analysis of the clinical laboratory improvement amendment of 1988 Compliance plans and enforcement policies. Health Care Manage Rev. 30(2) 93-102. 

FDA, CPG 7153.17, Enforcement Policy 21 CFR Part 11 Electronic Records Electronic Signatures, May 1999. 

EPA (1991c). U.S. Environmental Protection Agency. Enforcement policy on mixed waste storage, 56 FR 42730 (U.S. Government Printing Office, Washington). 

FDA issues CPG Enforcement Policy for 21 CFR Part 11 FDA publishes Computerized Systems Used in Clinical Trials FDA issues CPG Year 2000 Computer Compliance... 

Compliance Policy Guide (1999), Enforcement Policy, 7153.17 21 CFR Part 11 Electronic Records, Electronic Signatures, Food and Drug Administration, Rockville, MD. 

I32a.I5) Input/Output Checking (CPG 7I32a.07) Identification of Persons on Batch Production and Control Records (CPG 7I32a.08) Enforcement Policy 21 CFR Part II Electronic Records Electronic Signatures (CPG 7153.17). 

Table 55.2 Formulary enforcement policies used by managed care organizations...

Drug sampling is a controversial marketing technique used to promote pharmaceuticals. Pharmacists should be encouraged to get involved in efforts to promote safe and appropriate use of samples and ensure control and security. Clinics and institutions should have and enforce policies and procedures for managing samples. Control-... 

Additional language in the preamble (TJ 15) to the GLP revisions of 1987 (4) as well as enforcement policies of individual the FDA investigators have broadly interpreted the requirement to include the current status of each study on the master schedule. According to this view, the master schedule should include such study events as test article-mixture preparation, test system dosing, and in-life observation. Because such detailed information is usually available in other study documentation (e.g., protocol, study schedules), most laboratories limit a description of current status to broad categories such as in-life phase, study terminated, report preparation, and report issuance. ... 

The best guarantee that outdated reagents and solutions will not be used is a strictly enforced policy for discard of such materials, although that is not a GLP requirement. The GLPs require only that outdated materials not be used. 

Includes general enforcement regulations, product jurisdiction, enforcement policy, hearings, protection of human subjects, financial disclosure by clinical investigators, institutional review boards, and good laboratory practice for nonclinical laboratory studies. 

Enforcement policies and practices. According to the official policy of the Dutch Labour Inspectorate, the obli on for companies and establishments to produce a risk ass sment should eventually lead to a reduced role for the Labour Inspectorate in routine infection. Hiat is, it uld be internal checks and balances in a company that come to play a key role in correcting enqjloyers unwillii ess or bad behaviour with reg d to OHS matters. 

Enforcement Policy Regarding Failures to Report Information Under Section 6(a)(2) of the Federal Insecticide, Fungicide and Rodenticide Act... 

Computerised Systems Used in Clinical Trials. FDA, 1999 http // www.fda.gov/ora/compliance ref/bimo/ffinalcct.htm Enforcement Policy Electronic Records Electronic Signatures— Compliance Policy Guide Guidance for FDA Personnel, FDA, 1999 http //www.fda.gov/ora/compliance ref/partll/FRs/np-dates/cpg-esig-enf-noa.htm... 

ERP, 12. For a discussion of the TSCA enforcement policies, see Chapter 14. Penalties and Enforcement. For a discussion of the penalties applicable to PMN violations, see Chapter 4, Premanufacture Notifications. 

Fed. Reg. 11110, Toxic Substances Control Act Statement of Interpretation and Enforcement Policy Notification of Substantial Risk (Mar. 16, 1978) (the 1978 Statement of Interpretation), now largely superseded ... 

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