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Friday, June 27, 2014
Thursday, June 26, 2014
Texas Board of Pharmacy 2003 Minutes discussing task force on compounding very telling--the task force also recognized that the repeated incidents of improperly prepared and contaminated sterile preparations that have injured and killed patients in other states have pointed to a potential problem that could happen in Texas. PCCA award winning compounder opposed 5 percent rule
Task Force on Compounding
President Anderson introduced Larry Trissel, R.Ph., Chair of the Task Force on Pharmacy Compounding. President Anderson explained that Mr. Trissel would present the task force report, and the Board would vote on whether to accept the report, but no action would be taken until a later date.
Mr. Trissel directed the Board's attention to the final report of the task force, which included a list of the task force members. (See Attachment #33.) Mr. Trissel recognized task force members Ben Fry, R.Ph., and Pat Downing, R.Ph., who were also present. Mr. Trissel reported that the task force held two meetings, on September 5, 2002, and January 17, 2003. The task force was charged with:
reviewing current federal and state requirements for pharmacy compounding;
reviewing current standards of practice for pharmacy compounding; and
making recommendations to the Board regarding standards for pharmacy compounding in Texas that provide necessary compounded medications while protecting the health, safety, and welfare of the public.
Mr. Trissel directed the Board's attention to the written task force report (See Attachment #33). He then made a brief presentation to the Board that included the following comments:
The task force recognized . . . there could be no doubt that the need for compounding of patient-specific preparations is essential to the proper conduct of modern therapies.
. . . the task force also recognized and agreed that the current Texas pharmacy rules regarding pharmacy compounding have already included some important and necessary safeguards that may not be in place in some other states.
. . . the task force also recognized that the repeated incidents of improperly prepared and contaminated sterile preparations that have injured and killed patients in other states have pointed to a potential problem that could happen in Texas.
Although the task force believed additional quality assurance functions are necessary, there also was recognition that the United States Pharmacopeia (USP), the official drug standards setting body for the United States, is in the process of issuing a comprehensive delineation of the necessary requirements for sterile compounding. . . . specifically designated to set appropriate and necessary quality assurance standards for pharmacy compounding that can be enforced by the state boards of pharmacy.
It was the consensus of the task force that the best approach the Texas State Board of Pharmacy could take for the citizens of Texas is to adopt these USP requirements and enforce them for all categories of pharmacies located in Texas and for Class E pharmacies that send compounded preparations into Texas.
The task force also reached consensus on the need to enhance pharmacists' training and education with regard to compounding and pharmaceutical calculations. To this end, additional continuing education requirements specific to compounding have been recommended. In addition, the task force has suggested that the Texas State Board of Pharmacy formally recommend to appropriate educational associations and institutions that education and training in compounding and pharmaceutical calculations receive greater emphasis (or be reintroduced in some cases) in pharmacy school curriculums providing strengthened and more thorough understanding of the complexities involved.
. . . the task force agreed that the principal distinction of compounded preparations compared to manufactured drug products is the patient-pharmacist-physician relationship that exists in compounding that does not exist in manufacturing. . . . The task force agreed unanimously that any preparation compounded by a pharmacist for a specific patient in response to a valid prescription or medication order was clearly compounding and not manufacturing. . . . there was less agreement on what proportion of a compounding pharmacy's business needs to be patient-specific to qualify as a pharmacy and not be a manufacturer. . . . A suggestion was made by Mr. Peacock to equate obtaining and recording the identities of patients who received pharmacy-compounded preparations administered by practitioners in their practices after the actual administration with conventional patient-specific prescriptions and medication orders for purposes of this determination . . . the majority of the task force members (but not all) agreed to recommend to the Board that a maximum of 5% of all prescription medications dispensed in the previous 12 months be permitted to be non-patient-specific compounded dosage units for an establishment to be considered a pharmacy and not a manufacturer, if the patients' identities could be obtained after the fact of drug administration.
(See Attachment #33 for the complete text of Mr. Trissel's comments.)
President Anderson recognized Karen Tannert, R.Ph., a member of the task force, who was also in the audience.
The Board discussed the recommendations of the task force. Mr. Trissel answered questions posed by the Board. Mr. Downing advised the Board that he did not agree with the 5% restriction. The Board felt that Mr. Peacock's suggestion to obtain patient-specific information was innovative. Ms. Dodson pointed out that any rules the Board passes will have to match federal regulations.
Ms. Tannert advised the Board that the 5% recommendation fell within the limits established by the Food, Drug, and Cosmetic Act.
Following additional discussion, the motion was made by Mr. Caldwell to thank the task force for their efforts and accept the report, as presented. The motion was seconded by Mr. Brimberry and passed unanimously.
The Board directed staff to:
draft rules, based on the recommendations of the task force;
submit the draft of the rules to the task force for review and comments; and
present the suggested rules to the Board at the May 2003 Board Meeting.
Mr. Brimberry advised the Board that he had copies of materials from an NABP meeting in Chicago that compare USP guidelines and FDA rules concerning compounding, if anyone would like to have a copy. Ms. Dodson advised the Board that currently TSBP's rules concerning compounding are more stringent than NABP's recommendations.
Third Question of Day June 26, 2014 If traditional Compounders are only compounding patient specific compounds and following all the rules such as no commercially available that works and outsourcing facilities compounded larger quantities then how much money would traditional compounders make? Is this why traditional Compounders fight so hard to be able to compound for office use? Greed and money? The needs will be met by outsources who are regulated by the FDA so Compounders cannot argue consumers will have to do without the drugs.
FDA Warns GSK plant
Flulaval is the company’s older flu drug, which has been to some extent superceded by Relenza – but FDA inspectors noted “deviations from current good manufacturing practice (CGMP) requirements” in its production at GSK’s plant in Quebec.
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