New rules for physicians implement sample drug bill.

Abstract

Record keeping requirements for dangerous drugs, including samples, has been a source of confusion for physicians and often has lead to misinterpretation of the law. To clarify this issue and to assist in implementing Senate Bill 788 (the sample drug bill), the Texas State Board of Medical Examiners recently has adopted rules for record keeping for dangerous drugs and controlled substances. A dangerous drug is any drug or device that is not listed in the Controlled Substances Act and thus is not safe for self-medication, or bears the legend, "Caution: Federal law prohibits dispensing without a prescription." The Dangerous Drugs Act requires a physician to maintain records for 2 years after the date of the acquisition or disposal of the dangerous drug. The new TSBME rules provide a presumption of compliance by a physician for record keeping for dangerous drug samples if he or she (1) retains a copy of the signed request form required by the Prescription Drug Marketing Act of 1987 for 2 years and (2) makes appropriate entries in a patient's medical records when a dangerous drug sample is supplied to the patient. Generally, a drug company representative provides a copy of the request as a receipt at the time the physician receives the samples. For dangerous drugs that the physician acquires other than as samples, the physician needs to retain a copy of the invoice or receiving order or other form of documentation of receipt or acquisition for 2 years. Once again, the physician should make appropriate entries in patients' records.(ABSTRACT TRUNCATED AT 250 WORDS)