TSBP Determines Current High Risk Compounded Sterile Preparations Rules are Adequate

The Texas State Board of Pharmacy considered the Task Force on Implementation of Rules Related to USP General Chapter 800 regarding requirements of pharmacists compounding "Hazardous Drugs" at their August 1, 2017 quarterly meeting.

There was considerable discussion around the intent and content, in addition to specific scientific data justifying USP Chapter 800 requirements. The Board considered the Task Force Recommendations  and discussed the need to apply necessary requirements to all "List 1, 2 and 3" hazardous chemicals.
              
The Alliance submitted comments to the TSBP outlining the lack of science and data required to prove Chapter 800 requirements for any products other than antineoplastics and asked TSBP consider a phase in over several years to ensure proper compliance and focus on the science.

After considerable discussion, the TSBP recognized the current requirements as being adequate in regards to "hazardous drugs." Current requirements can be found at TSBP Rules, §291.133, Pharmacies Compounding Sterile Preparations, High Risk Compounded Sterile Preparations - Hazardous Drugs.

The Alliance appreciates TSBP thoroughly reviewing USP 800 and determining that current Texas sterile rules are sufficient rather than arbitrarily implementing the chapter.

IACP on Office Use Compounding

An international group of compounders is working with lawmakers to draft a new letter asking FDA to rescind guidance requiring a patient-specific prescription for each drug compounded under 503A, and to return to states control over office-use compounding, saying the agency's prohibition on such compounding runs against congressional intent. The call to rescind the guidance comes as President Donald Trump orders agency heads to improve efficiency by shifting functions to state or local governments. Read more

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Texas Compounding Legislation and Rules

2015 Summer Compounding Update