Wow Wonder What the Texas State Board of Pharmacy Did to the three Compounding Pharmacies Who Failed to Yield the Acceptable Potency and I wonder which Pharmacies They Where? Wonder Who Texas Used to Test these Samples?

Division staff collected 28 samples of compounded preparations during FY2012, which represented 9 fewer samples (24% decrease) than were collected in FY2011.   Although all of the sterile preparations collected in FY2012 sterile and free of endotoxins (100%  sterility), test results show that 3 of the 28 collected samples (11%) failed to yield the acceptable potency results.  See Ongoing Objective #2 for additional information.

quoted from 2012 Texas Board of Pharmacy Annual Report found  here

Refresher: Texas Law on Pharmacies Compounding Sterile Preparations

PART 15 TEXAS STATE BOARD OF PHARMACY CHAPTER 291 PHARMACIES SUBCHAPTER G SERVICES PROVIDED BY PHARMACIES RULE §291.133 Pharmacies Compounding Sterile Preparations (A) Sterile preparations may be compounded in licensed pharmacies:       (i) upon presentation of a practitioner's prescription drug or medication order based on a valid pharmacist/patient/prescriber relationship;      (ii) in anticipation of future prescription drug or medication orders based on routine, regularly observed prescribing patterns; or      (iii) in reasonable quantities for office use by a practitioner and for use by a veterinarian.    (B) Sterile compounding in anticipation of future prescription drug or medication orders must be based upon a history of receiving valid prescriptions issued within an established pharmacist/patient/prescriber relationship, provided that in the pharmacist's professional judgment the quantity prepared is stable for the anticipated shelf time.       (i) The pharmacist's professional judgment shall be based on the criteria used to determine a beyond-use date outlined in paragraph (5)(G) of this subsection.      (ii) Documentation of the criteria used to determine the stability for the anticipated shelf time must be maintained and be available for inspection.      (iii) Any preparation compounded in anticipation of future prescription drug or medication orders shall be labeled. Such label shall contain:         (I) name and strength of the compounded preparation or list of the active ingredients and strengths;        (II) facility's lot number;        (III) beyond-use date as determined by the pharmacist using appropriate documented criteria as outlined in paragraph (5)(G) of this subsection;        (IV) quantity or amount in the container;        (V) appropriate ancillary instructions, such as storage instructions or cautionary statements, including hazardous drug warning labels where appropriate; and        (VI) device-specific instructions, where appropriate.    (C) Commercially available products may be compounded for dispensing to individual patients provided the following conditions are met:       (i) the commercial product is not reasonably available from normal distribution channels in a timely manner to meet patient's needs;      (ii) the pharmacy maintains documentation that the product is not reasonably available due to a drug shortage or unavailability from the manufacturer; and      (iii) the prescribing practitioner has requested that the drug be compounded as described in subparagraph (D) of this paragraph.    (D) A pharmacy may not compound preparations that are essentially copies of commercially available products (e.g., the preparation is dispensed in a strength that is only slightly different from a commercially available product) unless the prescribing practitioner specifically orders the strength or dosage form and specifies why the patient needs the particular strength or dosage form of the preparation. The prescribing practitioner shall provide documentation of a patient specific medical need and the preparation produces a clinically significant therapeutic response (e.g. the physician requests an alternate product due to hypersensitivity to excipients or preservative in the FDA-approved product, or the physician requests an effective alternate dosage form) or if the drug product is not commercially available. The unavailability of such drug product must be documented prior to compounding. The methodology for documenting unavailability includes maintaining a copy of the wholesaler's notification showing back-ordered, discontinued, or out-of-stock items. This documentation must be available in hard-copy or electronic format for inspection by the board.    (E) A pharmacy may enter into an agreement to compound and dispense prescription/medication orders for another pharmacy provided the pharmacy complies with the provisions of §291.125 of this title (relating to Centralized Prescription Dispensing).    (F) Compounding pharmacies/pharmacists may advertise and promote the fact that they provide sterile prescription compounding services, which may include specific drug preparations and classes of drugs.    (G) A pharmacy may not compound veterinary preparations for use in food producing animals except in accordance with federal guidelines.  (2) Microbial Contamination Risk Levels. Risk Levels for sterile compounded preparations shall be as outlined in Chapter 797, Pharmacy Compounding--Sterile Preparations of the USP/NF and as listed below.     (A) Low-risk level compounded sterile preparations.       (i) Low-Risk conditions. Low-risk level compounded sterile preparations are those compounded under all of the following conditions.         (I) The compounded sterile preparations are compounded with aseptic manipulations entirely within ISO Class 5 or better air quality using only sterile ingredients, products, components, and devices.        (II) The compounding involves only transfer, measuring, and mixing manipulations with closed or sealed packaging systems that are preformed promptly and attentively.        (III) Manipulations are limited to aseptically opening ampuls, penetrating sterile stoppers on vials with sterile needles and syringes, and transferring sterile liquids in sterile syringes to sterile administration devices and packages of other sterile products.        (IV) For a low-risk preparation, in the absence of direct sterility testing results or appropriate information sources that justify different limits, the storage periods may not exceed the following periods: before administration, 48 hours at controlled room temperature, for not more than 14 days if stored at a cold temperature, and for 45 days if stored in a frozen state at minus 20 degrees Celsius or colder). For delayed activation device systems, the storage period begins when the device is activated.      (ii) Examples of Low-Risk Compounding. Examples of low-risk compounding include the following.         (I) Single volume transfers of sterile dosage forms from ampuls, bottles, bags, and vials using sterile syringes with sterile needles, other administration devices, and other sterile containers. The solution content of ampules shall be passed through a sterile filter to remove any glass particles.        (II) Manually measuring and mixing no more than three manufactured products to compound drug admixtures.    (B) Low-Risk Level compounded sterile preparations with 12-hour or less beyond-use date. Low-risk level compounded sterile preparations are those compounded pursuant to a physician's order for a specific patient under all of the following conditions.       (i) The compounded sterile preparations are compounded in compounding aseptic isolator or compounding aseptic containment isolator that does not meet the requirements described in paragraph (5)(A)(ii)(II) of this subsection relating to Low and Medium Risk Preparations or the compounded sterile preparations are compounded in laminar airflow workbench or a biological safety cabinet that cannot be located within an ISO Class 7 buffer area.      (ii) The primary engineering control device is located in a segregated compounding area restricted to sterile compounding activities that minimizes the risk of contamination of the compounded sterile preparation.      (iii) The segregated compounding area shall not be in a location that has unsealed windows or doors that connect to the outdoors, or that is adjacent to construction sites, warehouses, or food preparation.      (iv) For a low-risk preparation compounded as described in clauses (i) - (iii) of this subparagraph, administration of such compounded sterile preparations must commence within 12 hours of preparation or as recommended in the manufacturers' package insert, whichever is less.    (C) Medium-risk level compounded sterile preparations.       (i) Medium-Risk Conditions. Medium-risk level compounded sterile preparations, are those compounded aseptically under low-risk conditions and one or more of the following conditions exists.         (I) Multiple individual or small doses of sterile products are combined or pooled to prepare a compounded sterile preparation that will be administered either to multiple patients or to one patient on multiple occasions.        (II) The compounding process includes complex aseptic manipulations other than the single-volume transfer.        (III) The compounding process requires unusually long duration, such as that required to complete the dissolution or homogenous mixing (e.g., reconstitution of intravenous immunoglobulin or other intravenous protein products).        (IV) The compounded sterile preparations do not contain broad spectrum bacteriostatic substances and they are administered over several days (e.g., an externally worn infusion device).        (V) For a medium-risk preparation, in the absence of direct sterility testing results or appropriate information sources that justify different limits the beyond use dates may not exceed the following time periods: before administration, the compounded sterile preparations are properly stored and are exposed for not more than 30 hours at controlled room temperature, for not more than 9 days at a cold temperature, and for 45 days in solid frozen state at minus 20 degrees Celsius or colder.      (ii) Examples of medium-risk compounding. Examples of medium-risk compounding include the following.         (I) Compounding of total parenteral nutrition fluids using a manual or automated device during which there are multiple injections, detachments, and attachments of nutrient source products to the device or machine to deliver all nutritional components to a final sterile container.        (II) Filling of reservoirs of injection and infusion devices with multiple sterile drug products and evacuations of air from those reservoirs before the filled device is dispensed.        (III) Filling of reservoirs of injection and infusion devices with volumes of sterile drug solutions that will be administered over several days at ambient temperatures between 25 and 40 degrees Celsius (77 and 104 degrees Fahrenheit).        (IV) Transfer of volumes from multiple ampuls or vials into a single, final sterile container or product.    (D) High-risk level compounded sterile preparations.       (i) High-risk Conditions. High-risk level compounded sterile preparations are those compounded under any of the following conditions.         (I) Non-sterile ingredients, including manufactured products are incorporated or a non-sterile device is employed before terminal sterilization.        (II) Sterile ingredients, components, devices, and mixtures are exposed to air quality inferior to ISO Class 5. This includes storage in environments inferior to ISO Class 5 of opened or partially used packages of manufactured sterile products that lack antimicrobial preservatives.        (III) Non-sterile preparations are exposed no more than 6 hours before being sterilized.        (IV) It is assumed, and not verified by examination of labeling and documentation from suppliers or by direct determination, that the chemical purity and content strength of ingredients meet their original or compendial specifications in unopened or in opened packages of bulk ingredients.        (V) For a high-risk preparation, in the absence of direct sterility testing results or appropriate information sources that justify different limits, the storage periods cannot exceed the following time periods: before administration, the compounded sterile preparations are properly stored and are exposed for not more than 24 hours at controlled room temperature, for not more than 3 days at a cold temperature, and for 45 days in solid frozen state at minus 20 degrees or colder.Cont'd...

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Texas State Board of Pharmacy Winter 2013 Newsletter Containing Disciplinary Action

To read the newsletter click here

Texas Board of Pharmacy Offering A Lot of Training--including training on changes to pharmacy rules and most common deficiencies found during inspections

TSBP Continuing Education Program

Texas Pharmacy Laws and Rules Update
The programs will review recent changes to pharmacy rules and review the most common deficiencies found during inspections of pharmacies. One hour of continuing education (CE) credit approved by TSBP is available for individuals attending the webcast. Registration space is limited.
February 28, 2013 10:00 a.m. https://student.gototraining.com/r/6951458104106044672
May 21, 2013 10:00 a.m. https://student.gototraining.com/r/4952438214244520960
August 22, 2013 10:00 a.m. https://student.gototraining.com/r/4523862875388968704
November 14, 2013 10:00 a.m. https://student.gototraining.com/r/344999609235624704

Pharmacist-in-Charge Training
Are you a new pharmacist-in-charge (PIC) or just need a refresher on the requirements and responsibilities as PIC? The Texas State Board of Pharmacy (TSBP) is hosting free one-hour webcasts for individuals interested in learning about the responsibilities of the PIC, primarily in community (Class A) pharmacy settings. These programs will cover the same information; please only register for one session. One-hour of TSBP approved CE is available for individuals attending the webcast. Registration space is limited.
April 11, 2013 10:00 a.m. https://student.gototraining.com/r/5488950409298696960
July 16, 2013 10:00 a.m. https://student.gototraining.com/r/2252934856637711872
October 10, 2013 10:00 a.m. https://student.gototraining.com/r/3895992256628062464

Regulating Pharmacy Technicians
This program is intended for individuals interested in finding our more about the regulation of pharmacy technicians and the registration process in Texas.
June 4, 2013 10:00 a.m. https://student.gototraining.com/r/6269272712019912192
September 10, 2013 10:00 a.m https://student.gototraining.com/r/8122624906239380736

Texas State Board of Pharmacy Feb. 5, 2013 Meeting Agenda

TEXAS STATE BOARD OF PHARMACY
333 Guadalupe Street Suite 3-600 Austin, Texas 78701-3943 512-305-8000(voice) 512-305-8082(fax)
Texas State Board of Pharmacy
333 Guadalupe Street, Suite 2-225
Austin, Texas
Board Business Meeting
Tuesday, February 5, 2013
9:00 a.m. – Conclusion
A G E N D A
A. JW Announcements
● Meeting Procedures
● Board Members
● Staff
● Continuing Education
B. JW Discussion and Approval of Minutes (Tab 01)
● TSBP Board Business Meeting, Held November 6, 2012
● Temporary Suspension Hearings
○ Held November 26, 2012, Concerning Richard Demond Broussard, R.Ph.
○ Held December 12, 2012, Concerning The Medicine Shoppe Pharmacy; Esther Cohen, R.Ph.; and Rachel Cohen, Pharmacy Technician.
AGENDA, Board Business Meeting
February 5, 2013
Page 2
C. AB Discussion of and Possible Action Regarding Rules
C.1 Final Adoption of Rules
C.1.1 Amendments to §291.31 Concerning Definitions
(Tab 02)
C.1.2 Amendments to §291.32 Concerning Personnel (Tab 03)
C.1.3 Amendments to §295.8 Concerning Continuing Education Requirements (Tab 04)
C.2 Proposal of Rules
C.2.1 Amendments to §281.61 Concerning Definitions of Discipline Authorized (Tab 05)
C.2.2 Amendments to §291.33 Concerning Operational Standards (Tab 06)
C.2.3 Amendments to §291.34 Concerning Records (Tab 07)
C.2.4 Amendments to §297.8 Concerning Continuing Education Requirements for Pharmacy Technicians
(Tab 08)
C.3 Rule Reviews in Accordance with Government Code,
Section §2001.039 (Tab 09)
C.3.1 For Adoption
C.3.1.1 Chapter 297 Concerning Pharmacy Technicians (§§297.1-297.9) (Tab 10)
C.3.1.2 Chapter 291 Concerning Pharmacies (Services Provided by Pharmacies)
(§§291.120-291.121, 291.123, 291.125, 291.127, 291.129, 291.131, 291.133) (Tab 11)
D. AB Discussion of and Possible Action Concerning Reports of Committees/Task Forces
D.1 Task Force on Pharmacy Compounding (Tab 12)
● Recommendation to Prohibit Out-of-State Pharmacies From
Shipping Compounded

Continue reading here

Repost: Proposed Rules in Texas: Readers Comments

FRIDAY, FEBRUARY 8, 2013

Texas State Board of Pharmacy Feb. 5, 2013 Meeting Agenda

TEXAS STATE BOARD OF PHARMACY
333 Guadalupe Street Suite 3-600 Austin, Texas 78701-3943 512-305-8000(voice) 512-305-8082(fax)
Texas State Board of Pharmacy
333 Guadalupe Street, Suite 2-225
Austin, Texas
Board Business Meeting
Tuesday, February 5, 2013
9:00 a.m. – Conclusion
A G E N D A
A. JW Announcements
● Meeting Procedures
● Board Members
● Staff
● Continuing Education
B. JW Discussion and Approval of Minutes (Tab 01)
● TSBP Board Business Meeting, Held November 6, 2012
● Temporary Suspension Hearings
○ Held November 26, 2012, Concerning Richard Demond Broussard, R.Ph.
○ Held December 12, 2012, Concerning The Medicine Shoppe Pharmacy; Esther Cohen, R.Ph.; and Rachel Cohen, Pharmacy Technician.
AGENDA, Board Business Meeting
February 5, 2013
Page 2
C. AB Discussion of and Possible Action Regarding Rules
C.1 Final Adoption of Rules
C.1.1 Amendments to §291.31 Concerning Definitions
(Tab 02)
C.1.2 Amendments to §291.32 Concerning Personnel (Tab 03)
C.1.3 Amendments to §295.8 Concerning Continuing Education Requirements (Tab 04)
C.2 Proposal of Rules
C.2.1 Amendments to §281.61 Concerning Definitions of Discipline Authorized (Tab 05)
C.2.2 Amendments to §291.33 Concerning Operational Standards (Tab 06)
C.2.3 Amendments to §291.34 Concerning Records (Tab 07)
C.2.4 Amendments to §297.8 Concerning Continuing Education Requirements for Pharmacy Technicians
(Tab 08)
C.3 Rule Reviews in Accordance with Government Code,
Section §2001.039 (Tab 09)
C.3.1 For Adoption
C.3.1.1 Chapter 297 Concerning Pharmacy Technicians (§§297.1-297.9) (Tab 10)
C.3.1.2 Chapter 291 Concerning Pharmacies (Services Provided by Pharmacies)
(§§291.120-291.121, 291.123, 291.125, 291.127, 291.129, 291.131, 291.133) (Tab 11)
D. AB Discussion of and Possible Action Concerning Reports of Committees/Task Forces
D.1 Task Force on Pharmacy Compounding (Tab 12)
● Recommendation to Prohibit Out-of-State Pharmacies From
Shipping Compounded

Continue reading here

Texas Pharmacy Board Meeting Feb. 5, 2013 Agenda

Board Meeting Agenda Tuesday, February 5, 2013 at 9:00 a.m. Public Hearing The Board will commence in open session to hear testimony concerning * Amendments to §295.8 Concerning Continuing Education Requirements. The proposed amendments were published in the December 14, 2012, issue of the Texas Register. The Board business meeting will begin Tuesday, February 5, 2013, immediately following the public hearing. The public hearing and meeting will be held at the William P. Hobby Building, 333 Guadalupe, Tower 2, Room 225, Austin, Texas. Click here to view the agenda and supporting materials. Rules to be Considered for Adoption Amendments to the following rules were proposed by the Board and published in the  December 14, 2012, issue of the Texas Register and will be consider for adoption at the February 5, 2013, Board business meeting.

Texas Board Surveys Pharmacies About Compounding Practices, Will Seek Legislative Support for Additional Inspectors

January 16, 2013 5:05 pm Topics: Compounding

In the wake of the meningitis outbreak linked to contaminated drugs compounded by the New England Compounding Center (NECC), the Texas State Board of Pharmacy conducted a special survey to determine how many pharmacies in the state are engaging in sterile and nonsterile compounding. The Board surveyed approximately 6,000 pharmacies and the data obtained will help guide future inspection plans. The Board will also ask the Texas Legislature to approve the hiring of at least three new inspectors in 2013. The Texas Board inspects pharmacies engaged in compounding every two years, and the Board’s inspectors receive intensive training in sterile compounding standards along with regular updates. The Board is also considering adopting a separate inspection form for sterile compounding facilities.
The Texas Board has in place compounding regulations that include most of United States Pharmaecopia (USP) Chapter 797 standards and some more detailed requirements not included in USP 797 (such as training for pharmacists and pharmacy technicians and specific recall procedures). In addition, the Board’s inspection process includes sampling compounded products for testing. The Board has the authority to sample both sterile and nonsterile products for testing. In Texas, nonsterile products are tested for potency, and sterile products are tested for potency, sterility, and pyrogenicity. Since the NECC incident, Texas has added testing for fungi to the requirements. Product samples are processed by an outside lab and the Board tracks data from the results. When a failure is detected, the Board will take action to resolve the issue with the pharmacy. Or, if testing were to determine that a product would be an imminent danger to the public, the Board would require the pharmacy to immediately recall the product and cease all compounding of that product. Of note, the Board has never had a product prepared under sterile conditions fail the sterility testing, including samples taken from entities compounding high volumes of drug products.
The Board indicates that there are currently pharmacies in Texas that compound products for distribution to out-of-state entities. The Texas Board has instructed inspectors to place a high priority on the inspection of all pharmacies that compound sterile products, including those that are distributing products to out-of-state entities. The Board has formed a task force to assist it in a thorough review of all of the laws and rules related to compounding and to make recommendations for changes to these rules and/or laws.

Source found here

Next Texas State Board of Pharmacy Meeting Scheduled for FEBRUARY 5-6, 2013--No Agenda Published Yet