Governing Entities - Regulatory

Texas State Board of Pharmacy - Drug Diversion Cases

One area of utmost concern to pharmacies and pharmacists-in-charge is diversion of controlled substances.  Approximately nine out of ten instances of diversion in the pharmacy are caused by registered pharmacy technicians.  The likelihood that diversion could occur increases when the technicians are given key duties that the pharmacist should be performing instead.  Some of these duties include: (1) permitting technicians to order controlled substances directly from the wholesalers; (2) permitting technicians to check in to inventory controlled substances; and (3) permitting technicians unsupervised access to controlled substances that should be locked up.  The disciplinary action that could be imposed by the TSBP against the pharmacy and pharmacist-in-charge can be severe depending on the overall percentage of audit shortages or quantity of pills diverted.  Representation by an attorney is critical in diversion cases.

Texas Department of Public Safety

A new area of regulatory enforcement for pharmacies and pharmacists to be concerned about is coming, courtesy of the Texas Department of Public Safety.  The DPS investigators will come to your pharmacy unannounced and in plain clothes and walk right into any area of your pharmacy, just to see if they can access your most sensitive areas.  Their primary concern is safety of controlled substances.  Any unlocked doors will result in a violation. Secondarily, they are concerned about diversion.  Hence, the DPS investigators will conduct an audit of select controlled substances, usually confined to C-II’s.  Even the smallest audit shortage will result in a violation.   The DPS will send a letter offering to settle any violations found and offer the opportunity to appear at an informal conference.  Be sure to accept the opportunity and appear at the informal conference so that you can argue for dismissal or reduction in the monetary administrative penalty being sought.  Representation by an attorney is important in dealing with the new regulatory scheme. 

Texas Department of State Health Services

While most pharmacies and pharmacists will never get a visit from the Texas Department of State Health Services (DSHS), when they do arrive, it is usually going to be in connection with doing salvage operations.  DSHS licenses drug salvage brokers, whose job it is to handle prescription drugs that have expired or are about to expire. This becomes a pharmacy issue if your pharmacy uses a drug salvage broker to handle removal and disposal of your pharmacy’s expired/soon to expire drugs.  DSHS’s drug and medical device division has the power to investigate and detain products not properly stored and when they have not been disposed of properly.  DSHS will also conduct investigations in conjunction with the U.S. Food and Drug Administration.  The key point here is to make sure that you use a reputable licensed drug salvage broker to properly remove and dispose of your expired/soon to expire drugs in conformity with state and federal regulations. 

The Office of Inspector General (OIG)

The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452 (as amended), is to protect the integrity of Department of Health and Human Services (HHS) (now CMS) programs, as well as the health and welfare of the beneficiaries of those programs. The OIG has a responsibility to report both to the Secretary and to the Congress, program and management problems and recommendations to correct them.  The OIG's duties are carried out through a nationwide network of audits, investigations, inspections and other mission-related functions performed by OIG components. Pharmacies are increasingly coming under the scrutiny of the OIG in conjunction with CMS and the Attorney General of Texas.

The Centers for Medicare and Medicaid Services (CMS)

The Centers for Medicare and Medicaid services administers numerous Federal Health and Welfare programs promulgated by federal legislation, including but not limited to the following:

The Affordable Care Act includes significant changes to the Medicaid prescription drug program. These changes include revising the definition of average manufacturer price (AMP), establishing a new formula for calculating Federal Upper Limit (FUL), increasing the rebate percentages for covered outpatient drugs dispensed to Medicaid patients, including the rebate offset associated with the increase in the rebate percentages, and extending the prescription drug rebates to covered outpatient drugs dispensed to enrollees of Medicaid managed care organizations (MCOs).