SECTION 169.7. Record Keeping

(a) The following provisions relate to dangerous drugs.

(1) A licensee shall be presumed to have complied with record keeping requirements for dangerous drugs (the Texas Health and Safety Code, Chapter 483) received as pharmaceutical samples if:

(A) the licensee maintains a copy of each signed request form for samples required by the Prescription Drug Marketing Act of 1987, Public Law Number 100-293, 102 Statute 95 (21 United States Code 503(D) for a period of two years from the date of acquisition; and

(B) the licensee makes appropriate entries in patients' medical records when a pharmaceutical sample is supplied to a patient.

(2) A licensee shall be presumed to have complied with record keeping requirements for dangerous drugs (the Texas Health and Safety Code, Chapter 483) received or acquired other than as a pharmaceutical sample if:

(A) the licensee maintains all invoices for purchases, receiving orders, or other documentation of receipt or acquisition for a period of two years from the date of receipt or acquisition; and

(B) the licensee makes appropriate entries in patients' medical records when a dangerous drug is provided, administered, or supplied to a patient.

(b) The following provisions relate to controlled substances.

(1) A licensee shall be presumed to have complied with record keeping requirements for controlled substances (the Texas Health and Safety Code, Chapter 481) received as pharmaceutical samples if:

(A) the licensee maintains a copy of each signed request form for samples required by the Prescription Drug Marketing Act of 1987, Public Law Number 100-293, 102 Statute 95 (21 United States Code 503(D) for a period of two years from the date of acquisition; and

(B) the licensee maintains records of pharmaceutical samples as required by the Texas Department of Public Safety under 37 TAC §§13.201 - 13.209 (Controlled Substances - Record Keeping).

(2) A licensee shall be presumed to have complied with the record keeping requirements for controlled substances (the Texas Health and Safety Code, Chapter 481) received or acquired other than as a pharmaceutical sample if the licensee maintains records of such controlled substances as required by 37 TAC §§13.201 - 13.209, controlled substance regulations.

Source Note: The provisions of this §169.7 adopted to be effective April 27, 1990, 15 TexReg 2167; amended to be effective April 27, 2003, 28 TexReg 3325; amended to be effective January 20, 2009, 34 TexReg 338