(a) 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.
(b) Invoices or records of receipt.
- (1) Each Class D pharmacy shall maintain invoices and/or records of procurement in accordance with the requirements of the Texas Dangerous Drug Law and the Texas Pharmacy Act and rules.
- (2) 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 available for inspection, upon request, within two business days.
(c) Prepackaging. Records of prepackaging shall include the following:
- (1) name and strength of drug;
- (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 packaged;
- (7) name(s) of the supportive personnel who prepackages the drug under direct supervision of a pharmacist; and
- (8) 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 and/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 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.