The Texas State Board of Pharmacy (TSBP) licenses and regulates pharmacists, pharmacy technicians, and pharmacies throughout Texas. New and existing pharmacies must take particular care to comply with the myriad of state and federal regulations that govern their operations. All complaints against these professionals and pharmacies go to TSBP for investigation. TSBP also files formal disciplinary charges when warranted, handles contested proceedings, and works to resolve these disciplinary proceedings. As a result, you should not hesitate to contact an experienced pharmacist license defense lawyer for assistance if you are facing this situation.
Opening a New Community Pharmacy
Anyone who can pass a criminal background check can own a Class A (community) licensed pharmacy in Texas, whether they are a licensed pharmacist or not. However, a non-pharmacist owner may not perform the tasks required to be performed by a licensed pharmacist. The prospective owner must simply:
- Submit a Class A pharmacy application and fee;
- Pass a criminal background check;
- Complete the Class A pre-inspection checklist; and
- Schedule and pass the pharmacy pre-inspection.
The application, processing, and inspection process will take at least 90 days. However, if the owner has a criminal background or past disciplinary action, a review by the Enforcement Division of TSBP can take several months to complete.
Once Enforcement resolves any concerns, the application goes to the Compliance Division to ensure that the pharmacy meets all legal requirements of the Texas Pharmacy Act and TSBP Rules. Most pharmacies require that a Field Inspector complete a pre-inspection. Any deficiencies must be resolved before the pharmacy may open. If the pharmacy cannot resolve the deficiencies or prepare for a pre-inspection within one year, the application for a new pharmacy will expire. However, if the pharmacy passes the pre-inspection, TSBP will issue a license number and the pharmacy may open.
Compliance Requirements for Class A Pharmacies
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Each class of pharmacy, including Class A or community pharmacies, is subject to a whole host of laws and rules that govern their operations. Not only must new pharmacies meet these requirements as part of their pre-inspection before opening, but they also must maintain these requirements as they continue to operate. Failure to comply with applicable rules and laws can result in disciplinary action by the TSBP, possibly leading to the loss of a pharmacy’s license.
Personnel
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22 Tex. Admin. Code §291.32 outlines the requirements for personnel in Class A pharmacies. Generally, each Class A pharmacy must have a pharmacist-in-charge who is employed full-time and who is responsible for certain functions of the pharmacy, including educating and training pharmacy technicians and trainees, storing all materials, including drugs, chemicals, and biologics, and following all recordkeeping policies, among other functions. The pharmacy owner also has distinct responsibilities under Texas law and must consult with the pharmacist-in-charge on certain issues if they are not licensed. The owner must establish various policies and procedures for the pharmacy, including security, the procurement of drugs and other devices and products dispensed from the pharmacy, and the maintenance, storage, and retrieval of records.
The pharmacy must employ an adequate number of additional licensed pharmacists to operate the pharmacy competently, safely, and adequately to meet patients’ needs. These pharmacists are responsible for assisting the pharmacist-in-charge and supervising pharmacy technicians and trainees. They are also responsible for the legal operation of the pharmacy and compliance with all laws and rules while on duty, as well as those tasks that pharmacists may only perform.
Pharmacy technicians and trainees must undergo specific training to complete their duties, including nonjudgmental technical duties associated with preparing and distributing prescription drugs. These duties may include initiating and authorizing refill requests, entering prescription data into a data processing system, and preparing and packaging prescription drug orders. Pharmacy technicians and trainees also must wear identification tags or badges with their names and job titles.
Operational Standards
Under 22 Tex. Admin. Code §291.33, Class A pharmacies must meet certain operational standards. These standards include meeting specific licensing requirements, such as undergoing annual or biennial registration with the TSBP and timely notifying the TSBP if it changes ownership or locations.
This code section also provides specifications concerning the pharmacy’s environment in terms of cleanliness, orderliness, and proper operation of all equipment. Class A pharmacies must also have confidential patient counseling areas that meet certain requirements.
Operational standards include security requirements, such as effective precautions against the theft or diversion of prescription drugs. When the remainder of the facility is open, the prescription department must be secured physically or electronically. At a minimum, the pharmacy must have a basic alarm system with off-site monitoring.
This code section also addresses security when the pharmacist is temporarily absent, extensive measures for dispensing prescriptions, returning undelivered medications to stock, and the general handling of drugs.
Records
22 Tex. Admin. Code §291.34 addresses recordkeeping requirements for Class A pharmacies, including the general maintenance of records and separate records that must be kept for controlled substances. This section also outlines the responsibilities and rules concerning the handling of prescription drug orders, whether oral, written, or electronic, from a local medical provider, a provider from another state, or a provider from Mexico or Canada. Also addressed in this section are refills, including how to handle refills in the event of natural or man-made disaster situations, records related to dispensing errors, transfer of prescription drug orders, and recordkeeping systems generally.
Pharmacies Compounding Sterile Preparations
22 Tex. Admin. Code §291.36 designates Class A pharmacies that engage in the compounding of sterile preparations as Class A-S pharmacies. These pharmacies must follow special licensing and notification requirements if they change ownership, managing officers, location, or close. They also must maintain a separate license for each principal place of business at a specific location.
Contact Bertolino LLP Today for Legal Assistance
Do not hesitate to get legal assistance if facing potential disciplinary action against your pharmacy license or operations. Retaining the services of legal counsel from the beginning of any disciplinary proceedings before TSBP can be crucial to a more favorable resolution of your case. Contact a Texas pharmacist license defense attorney immediately for help with your disciplinary proceedings today.
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