SECTION 291.94. Records

(a) Maintenance of records.

(1) Every inventory or other record required to be kept under the provisions of §291.91 of this title (relating to Definitions), §291.92 of this title (relating to Personnel), §291.93 of this title (relating to Operational Standards), and §291.94 of this title (relating to Records), contained in Clinic Pharmacy (Class D) shall be:

(A) kept by the pharmacy and be available, for at least two years from the date of such inventory or record, for inspecting and copying by the board or its representative and to other authorized local, state, or federal law enforcement agencies; and

(B) supplied by the pharmacy within 72 hours, if requested by an authorized agent of the Texas State Board of Pharmacy. If the pharmacy maintains the records in an electronic format, the requested records must be provided in a mutually agreeable electronic format if specifically requested by the board or its representative. Failure to provide the records set out in this section, either on site or within 72 hours, constitutes prima facie evidence of failure to keep and maintain records in violation of the Act.

(2) Records, except when specifically required to be maintained in original or hard-copy form, may be maintained in an alternative data retention system, such as a data processing system or direct imaging system provided:

(A) the records maintained in the alternative system contain all of the information required on the manual record; and

(B) the data processing system is capable of producing a hard copy of the record upon the request of the board, its representative, or other authorized local, state, or federal law enforcement or regulatory agencies.

(3) Invoices and records of receipt may be kept at a location other than the pharmacy. Any such records not kept at the pharmacy shall be supplied by the pharmacy within 72 hours, if requested by an authorized agent of the Texas State Board of Pharmacy.

(b) On-site visits. A record of on-site visits by the pharmacist-in-charge, consultant pharmacist, or staff pharmacist shall be maintained and include the following information:

(1) date of the visit;

(2) pharmacist's evaluation of findings; and

(3) signature of the visiting pharmacist.

(c) Prepackaging. Records of prepackaging shall include the following:

(1) name, strength, and dosage form of drug;

(2) name of the manufacturer;

(3) manufacturer's lot number;

(4) expiration date;

(5) facility's lot number;

(6) quantity per package and number of packages;

(7) date packaged;

(8) name(s), signatures, or electronic signatures of the supportive personnel who prepackages the drug under direct supervision of a pharmacist; and

(9) name, signature, or electronic signature of the pharmacist who prepackages the drug or supervises the prepackaging and checks and releases the drug.

(d) Labeling. Records of labeling of drugs or devices in original manufacturer's containers shall include the following:

(1) name and strength of the drug or device labeled;

(2) name of the manufacturer;

(3) manufacturer's lot number;

(4) manufacturer's expiration date;

(5) quantity per package and number of packages;

(6) date labeled;

(7) name of the supportive personnel affixing the label; and

(8) the signature of the pharmacist who checks and releases the drug.

(e) Provision. Records of drugs and/or devices provided shall include logs, patient records, or other acceptable methods for documentation. Documentation shall include:

(1) patient name;

(2) name, signature, or electronic signature of the person who provides the drug or device;

(3) date provided; and

(4) the name of the drug or device and quantity provided.

(f) Dispensing. Record-keeping requirements for dangerous drugs dispensed by a pharmacist are the same as for a Class A pharmacy as set out in §291.34 of this title (relating to Records).

Source Note: The provisions of this §291.94 adopted to be effective January 7, 1987, 11 TexReg 5128; amended to be effective September 7, 2008, 33 TexReg 7242