What Texas Board of Pharmacy Budget Request for 2014-15 Says About Inspectors and Compounding, and Testing of Compounding Products

10  Enforcement Services & On-Going
Category:   Programs - Service Reductions (FTEs-Layoffs)
Item Comment:  If the agency’s budget were reduced by an additional 5%, the Enforcement Division would be forced to eliminate 2 Compliance Officer positions,
which would reduce the number of field inspectors from 7 to 5.  This reduction would result in 33% fewer pharmacies being inspected each year.  The number of
annual inspections would fall from 1,800 to 1,200.  TSBP licenses 6,476 pharmacies located in Texas.  The field staff’s geographical regions are extremely large.  If
2 field staff were eliminated, the geographical regions would be required to be further enlarged, which in turn, would mean more travel, fewer inspections, & higher
costs per inspection.  TSBP needs more inspectors, not less.
Inspections are a key component to the agency’s preventative enforcement activities.  The Board is convinced that a strong & active inspection program is
cost-effective because it increases compliance, which in turn, decreases the need to conduct more expensive enforcement activities (e.g., field investigations &
disciplinary action).



Testing of Compounding Products:  Testing of pharmacy compounded products was authorized by SB 492 passed by the 79th session. The agency was funded in
FY08-09 & provided additional funding in FY10-11 to carry out the testing of compounded products.  However, because of the cuts in FY2012-13 the agency was forced
to reduce the funds for this important function by 72%.  The term “compounding” means the preparation, mixing, assembling, packaging, or labeling of a drug or device.
Pharmacies compound prescription drugs based upon the order of a physician for use by or for administration to patients. Products compounded by pharmacies include
sterile products that are administered by injection. It is crucial that all of these compounded products are randomly tested to assure they contain the correct amount of
drug and that the sterile compounded products are sterile and that they do not contain any contaminates that will harm patients. Any problem with these products,
especially sterile compounded products could have a dramatic & potentially life threatening effects on the patient.

Inspections ensure that the public is protected because a myriad of areas are checked, such as drug stock, security, practice standards, operational standards, &
competency.  If the pharmacy is compounding prescription drugs, including sterile pharmaceuticals (e.g., injectable drugs), Inspectors conduct numerous other
checks.  Inspections of pharmacies that compound high-risk sterile drugs are especially critical, in that improper training or procedures could result in contaminated
products being dispensed to Texas patients, which, in turn, could be fatal to the patients receiving these drugs.
If the agency’s budget were reduced by a total of 10%, TSBP would be forced to cut 5 enforcement-related positions, which would have a huge negative impact on
the agency’s ability to resolve complaints, enter disciplinary orders, & conduct inspections. TSBP estimates that the average complaint resolution time would
potentially increase from 200 to 350 days.

Quoted from Budget Request, which can be viewed in its entirety here