Record Keeping Requirements

Two kinds of records are required by OSHA. Section 8(c) of the OSH Act requires employers to maintain records necessary or appropriate for enforcing the Act. They are  

Affidavits, certificates, medical forms, measurements, and other such documentation that help the agency gauge the employer s compliance with specific safety and health standards. 

Logs and supporting documents showing the number, nature, and circumstances of injuries and illnesses that occur in the workplace. 

Qualified inspectors will prepare a report that  

Every motor carrier should ensure that each motor vehicle subject to its control is properly lubricated and free of oil and grease leaks.  

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Increasing and overlapping regulatory demands —Documentary and record-keeping requirements —Formal and demonstrable programs... 

The Firearms Owners Protection Act of 1986 liberalized some of these requirements. Long guns (rifles and shotguns), but not handguns, could be sold across state lines. Guns and ammunition could be purchased through the mail subject to various restrictions. Gun dealers could sell firearms in a place other than a store (such as a flea market or a gun show). Record-keeping requirements were reduced. 

All predicate rule requirements will be enforced. This includes record and record-keeping requirements. 

The records-keeping requirements to demonstrate the safety and efficacy of products are also applicable for persons exporting human drags, biological products, devices, animal drags, food, and cosmetics that may not be marketed or sold in the United States.1... 

There are many other reasons why pharmaceutical and healthcare organizations are required to hold records, not just for regulatory purposes. The record-keeping requirements of local environmental, safety, or financial regulations should also be considered when determining the length of time a record is required to be held. Whatever requirement stipulates the longest retention time is the one that should be adhered to and recorded to determine the disposal criteria. 

Record keeping requirements for pseudoephedrine products and PPA products do not become effective until October 3, 1997. At that time, the record keeping threshold will be 24 grams for these distributors. 

The range of careers is very diverse. Pharmacists may choose to remain clinically focused, providing hands-on care to the patient. Opportunities exist to do research on the delivery and use of drugs in the home environment. Extended stability studies are one area where the pharmacist can become involved. If the pharmacist gets involved in clinical research, they should ensure that all appropriate policies and procedures are followed, that the patient and health care providers have appropriate information concerning the drug(s), and that all required record-keeping requirements are met. 

MBOCA is designated as a hazardous substance (EPA 1985, 1989) and is subject to reporting and record-keeping requirements (EPA 1986, 1988f). 

Information rule reporting and record keeping requirement... 

EPA. 1986. 4,4 -Methylenebis (2-chloroaniline) Final reporting and record keeping requirements. U.S. Environmental Protection Agency. Federal Register 51 (75) 13220-13224. 

This act established a record keeping requirement for the receipt and dispensing of opium or coca leaf products. A tax was assessed, also, for the dispensing of these products. Physicians were allowed to prescribe these products in the course of legitimate treatment to patients other than drug addicts. The possession of narcotics without a prescription became illegal. 

A central fill pharmacy is not open for walk in pharmacy business. A patient cannot walk into the central fill pharmacy and request that a prescription be filled. The central fill pharmacy cannot accept phone prescriptions from a practitioner and it cannot deliver a filled prescription to a practitioner or a patient. The central fill pharmacy must receive the prescription from the retail pharmacy. There are two ways that the prescription can be transmitted to the central fill pharmacy. (1) Facsimile transmission the retail pharmacy can send a facsimile of the prescription. The retail pharmacy maintains the original prescription and the central fill pharmacy maintains the facsimile of the prescription. (2) Electronic transmission the DBA allows electronic transmission by the retail pharmacy to the central fill pharmacy. Both pharmacies must maintain the prescription information in a readily retrievable manner and must comply with all applicable federal and state record keeping requirements. 

OSHA s mandatory record keeping requirements has simplified the process of collecting safety and health statistics for the purpose of monitoring problems and taking appropriate actions. Both exempt and nonexempt employers must report the following types of accidents within 48 hours (1) those that result in deaths, and (2) those that result in the hospitalization of five or more employees. 

Under Section 30.51, records of all transfers, receipts, and disposal of radioactive materials normally must be kept for at least 2 years after transfer or disposal of a radioactive material, or in some cases until the NRC authorizes the termination of the need to keep the records. There are other record keeping requirements in other parts of Title 10. 

In order to support the teaching of laboratory courses in small colleges and high schools, the committee recommends a careful review of current record-keeping requirements to avoid excessive burdens on teachers at small institutions. 

G.2 Record-keeping Requirements for Significant Adverse Reaction Allegations—TSCA 8(c) 211... 

There is an exemption from the PMN requirement for chemicals used for R D, or in a use regulated by another agency (such as solely for medical use regulated by FDA), but EPA still considers R D use to be a commercial activity. There are significant personnel notification and record-keeping requirements under this exemption (R D Exerr5>tion 40 CFR 720.3, 720.36, and 720.78). 

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