|(a) Pharmacist-in-charge. (1) General. (A) Each Class D pharmacy shall have one pharmacist-in-charge who is employed or under written agreement, at least on a part-time basis, but may be employed on a full-time basis if desired, and who may be pharmacist-in-charge of more than one clinic pharmacy. (B) A written agreement shall exist between the clinic and the pharmacist-in-charge, and a copy of the written agreement shall be made available to the board upon request. (2) Responsibilities. The pharmacist-in-charge shall have at a minimum, the responsibility for the following: (A) continuous supervision of registered nurses, licensed vocational nurses, physician assistants, pharmacy technicians, pharmacy technician trainees, and assistants carrying out the pharmacy related aspects of provision; (B) documented periodic on-site visits as specified in §291.93(h) and §291.94(b) of this title (relating to Operational Standards and Records), either personally or by the consultant pharmacist or staff pharmacist, to insure that the clinic is following set policies and procedures; documentation shall be as specified in §291.94(b) of this title; (C) development of a formulary for the clinic, in conjunction with the clinic's pharmacy and therapeutics committee, consisting of drugs and/or devices needed to meet the objectives of the clinic; (D) procurement and storage of drugs and/or devices, but he or she may receive input from other appropriate staff of the clinic; (E) determining specifications of all drugs and/or devices procured by the clinic; (F) maintenance of records of all transactions of the pharmacy as may be required by applicable law and as may be necessary to maintain accurate control over and accountability for all drugs and/or devices; (G) development and at least annual review of a policy and procedure manual for the pharmacy in conjunction with the clinic's pharmacy and therapeutics committee; (H) meeting inspection and other requirements of the Texas Pharmacy Act and these sections; (I) dispensing of prescription orders; and (J) conducting inservice training at least annually for supportive personnel who provide drugs; such training shall be related to actions, contraindications, adverse reactions, and pharmacology of drugs contained in the formulary. (b) Consultant pharmacist. (1) The consultant pharmacist may be the pharmacist-in-charge. (2) The consultant pharmacist may be retained by more than one clinic. (c) Staff pharmacists. (1) The pharmacist-in-charge may be assisted by a sufficient number of additional pharmacists as may be required to operate the clinic pharmacy competently, safely, and adequately to meet the needs of the patients of the clinic. (2) Staff pharmacists and/or the consultant pharmacist shall assist the pharmacist-in-charge in meeting the responsibilities as outlined in subsection (a)(2) of this section and in ordering, supervising, and accounting for drugs and/or devices. (3) Staff pharmacists and/or the consultant pharmacist shall be responsible for any delegated act performed by supportive personnel under his or her supervision. (d) Supportive personnel. (1) Qualifications. (A) Supportive personnel shall possess education and training necessary to carry out their responsibilities. (B) Supportive personnel shall be qualified to perform the pharmacy tasks assigned to them. (2) Duties. Duties may include: (A) prepackaging and labeling unit of use packages, under the direct supervision of a pharmacist with the pharmacist conducting in-process and final checks and affixing his or her signature to the appropriate quality control records; (B) maintaining inventories of drugs and/or devices; and (C) maintaining pharmacy records. (3) Absence of the pharmacist. The pharmacist-in-charge shall designate from among the supportive personnel a person to supervise the day-to-day pharmacy-related operations of the clinic. (e) Owner. The owner of a Class D pharmacy shall have responsibility for all administrative and operational functions of the pharmacy. The pharmacist-in-charge may advise the owner on administrative and operational concerns. The owner shall have responsibility for, at a minimum, the following, and if the owner is not a Texas licensed pharmacist, the owner shall consult with the pharmacist-in-charge or another Texas licensed pharmacist: (1) establishment of policies for procurement of prescription drugs and devices and other products provided or dispensed from the Class D pharmacy; (2) establishment and maintenance of effective controls against the theft or diversion of prescription drugs; (3) providing the pharmacy with the necessary equipment and resources commensurate with its level and type of practice; and (4) establishment of policies and procedures regarding maintenance, storage, and retrieval of records in a data processing system such that the system is in compliance with state and federal requirements.
|Source Note: The provisions of this §291.92 adopted to be effective January 7, 1987, 11 TexReg 5128; amended to be effective September 18, 2007, 32 TexReg 6348; amended to be effective September 7, 2008, 33 TexReg 7242