Texas Administrative Code
Title 22 - EXAMINING BOARDS
Part 9 - TEXAS MEDICAL BOARD
Chapter 169 - AUTHORITY OF PHYSICIANS TO SUPPLY DRUGS
Section 169.7 - Record Keeping
Universal Citation: 22 TX Admin Code ยง 169.7
Current through Reg. 49, No. 38; September 20, 2024
(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.
Disclaimer: These regulations may not be the most recent version. Texas may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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