Texas Board of Pharmacy Winter 2014 Newsletter and Winter 2014 Disciplinary Actions

Winter 2014

Winter 2014 Disciplinary Actions

1099 compounding sales jobs in Colorado, Georgia, Iowa, Indiana, Kansas, New Mexico, New Jersey, Minnesota, Missouri, Nevada, New York, Oklahoma, Texas, Washington

1099 Pharmaceutical Representative

Dallas, TX

 

---

NVYDiA Medical - Pharmaceutical Compound SalesIf you are currently in Pharmaceutical or Medical Sales and have established relationships with physicians (Primary Care, Internal Medicine, Neuro's, Ortho's, Plastic's, Podiatrists, Chronic Pain, Spine, Radiation Oncology, Hospice, Urology, Hand Surgeons, Lower/upper Extremity, Sports Medicine, Rheumatology, Rehabilitation, etc.) this is a great opportunity for you.This is not a position you have to leave your current job for. This is an opportunity for you to supplement your income with an additional revenue stream added to your existing salary.  This opportunity can increase your yearly income without you going outside of your call pattern, if you have existing relationships.  If you have solid contacts in medical, pharmaceutical or other healthcare industries, send your resume and we will contact you.Below is a general description of what you will be offering your physicians:First, we offer everyday used injectable drugs that are administered with in the clinic, for example, B-12, steroid injections, Testosterone injections, antibiotic injections, etc.  Our business model has cut out the middle man to offer these products at a discounted price.  What makes this sale so easy, is that we are offering products that the doctors or clinics are purchasing, we are just helping them save money.Second, pharmaceutical compounding, (done in compounding pharmacies) is the creation of a particular pharmaceutical product to fit the unique needs of a patient. To do this, compounding pharmacists combine or process appropriate ingredients using various tools. This may be done for medically necessary reasons, such as to change the form of the medication from a solid pill to a liquid, to avoid a non-essential ingredient that the patient is allergic to, or to obtain the exact dose needed. More recently it has been suggested that some doctors and clinics have turned away from major drug manufacturers and turned to compounding pharmacies because they often provide a much higher quality of product and charge much lower prices than the major manufacturers.Positions available in:  Colorado, Georgia, Iowa, Indiana, Kansas, New Mexico, New Jersey, Minnesota, Missouri, Nevada, New York, Oklahoma, Texas, WashingtonFor those who meet the qualifications and are interested, send your resume to: resumes@nvydiamedical.com

Iowa Board of Pharmacy Dismisses Charges Against PharMedium Services, Sugar Land, Texas

PharMedium Services, Sugar Land, Texas, nonresident pharmacy license #3763

The Board issued in December 2012 a Statement of Charges for failure to engage in the practice of pharmacy, failure to comply with pharmacy compounding requirements, and engaging in the unlawful manufacture of unapproved drug products.  The charges were brought following an inspection that found the company to be mass producing compounded products that were commercially available and not approved by the FDA and selling to Iowa hospitals without specific patient prescription information.  In June 2013, the Board approved an order to dismiss the current statement of charges without prejudice.  [2013]

PharMEDium Services, Sugar Land, Texas, wholesale license #5759

This wholesale license was issued a Statement of Charges in January 2013 for engaging in the unlawful manufacture of unapproved drug products after a NABP-conducted inspection revealed large amounts of non-FDA approved compounded solutions were being shipped into Iowa. In June 2013, the Board approved an order to dismiss the current statement of charges without prejudice.     [2013]

California Board of Pharmacy Takes Action Against 4 Compounding Pharmacies During Last Couple of Months

Site Licenses

Advanced Compounding Pharmacy, PHY 48591 and LSC 99426, Administrative Case AC 3251
North Hollywood, CA
Through a disciplinary action of the board, the license is revoked, the revocation is stayed and the license is placed on probation for five years.  The terms and conditions of probation include posted notice of probation, development and approval of all master formulas, validation process and restrictions on compounding the first year of probation.  Decision effective 7/8/2013.
View the decision

Grandpa's Compounding Pharmacy, LSC 99109, Administrative Case AC 4929
Placerville, CA
Cease and desist immediately from compounding sterile injectable drug products. Effective 9/10/2013.
View the decision

Santa Clara Drug “The Compounding Shop”, PHY 51229, Administrative Case AC 4842
San Jose, CA
Through a disciplinary action of the board, the license is revoked, the revocation is stayed and the license is placed on probation for five years. The terms and conditions of probation are set forth in the final order of the board. Decision effective 8/20/2013.
View the decision

Specialty Compounding LLC, NRP 1021
Cedar Park, Texas
Cease and Desist from furnishing sterile injectable compounded products.  Effective 8/9/2013.
View the decision

KUDOS! California Board of Pharmacy Issues Cease and Desist Order Against Specialty Compounding LLC in Cedar Park, Texas

Specialty Compounding LLC, NRP 1021
Cedar Park, Texas
Cease and Desist from furnishing sterile injectable compounded products.  Effective 8/9/2013.
View the decision

Refresher: Don't Forget in Texas that the Texas State Board of Veterinary Medical Examiners Also Have Rules Specifically Dealing With Compounding Drugs

RULE §573.44 COMPOUNDING DRUGS
(a) A veterinarian may only compound drugs for a specific animal or herd with which the veterinarian has established and maintained a valid veterinarian-client-patient relationship.
(b) A veterinarian may only prescribe compounded drugs to treat a specific occurrence of a disease or condition, which threatens the health of the animal or will cause suffering or death if left untreated, that the veterinarian has observed and diagnosed in the particular patient for whom the compounded drugs are prescribed. The amount of a drug that a veterinarian compounds or orders compounded must not exceed the established need for specific compounded drugs for patients with which the veterinarian has established and maintained a valid veterinarian-client-patient relationship.
(c) Labeling Requirements.
(1) All compounded drugs must bear the labeling information required under §573.40 of this title (relating to Labeling of Medications Dispensed), as well as the following information:
(A) date on which the drug was compounded;
(B) name and strength of medically active ingredients;
(C) identity of treated animals;
(D) withdrawal/withholding times if needed; and
(E) condition or disease to be treated.
(2) In addition to the information listed in paragraph (1) of this subsection, compounded drugs dispensed to the client must also state a date dispensed and an expiration date, which should not exceed the length of the prescribed treatment.
(d) Limitations on Compounded Products.
(1) A veterinarian shall not compound or order a drug compounded if there is a FDA-approved,
commercially available animal or human drug that, when used as labeled or in an extra-label fashion in its available dosage form and concentration, will appropriately treat the patient.
(2) A veterinarian shall only compound or order compounded products with FDA-approved commercially available animal or human drugs as the active ingredients.
(3) A veterinarian shall not promote and/or distribute compounded drugs that are essentially similar to FDAapproved products.
(4) A veterinarian must ensure the safety and efficacy of a compounded drug, including but not limited to avoiding known drug incompatibilities and inappropriate combinations, and must use a pharmacist to perform drug compounding when the complexity of the compounding exceeds the veterinarian's knowledge, skill, facilities, or available equipment.
(e) Compounding for Food Producing Animals.
(1) For animals intended for human consumption, a veterinarian must establish an extended withdrawal interval for the compounded product sufficient to ensure food safety and may not compound from any drugs prohibited for use in food producing animals. The withdrawal period must be supported by scientific information, and the veterinarian shall note the method used to determine the withdrawal interval in the patient records.
(2) A veterinarian shall not compound or order a drug compounded if the compounded drug results in
violative food residue, or any residue that may present a risk to public health.
(3) Compounding from a human drug for use in food-producing animals is not permitted if an approved animal drug can be used for compounding.
(4) Veterinarians shall ensure that procedures are in place to maintain the identity of treated animals, and shall note those procedures in the patient records.
(f) Limitations on Promotion and Sale of Compounded Drugs.
(1) A veterinarian shall not prepare for sale any compounded drugs which employ fanciful names or trade names, colorings or other additives, or that in any way imply that the compounds have some unique effectiveness or composition.
(2) A veterinarian shall not advertise, promote, display, resell, or in any other way market prepared
compounded drugs.
(3) A veterinarian shall not offer compounded drugs to other state licensed veterinarians, pharmacists or other commercial entities for resale.
Source Note: The provisions of this §573.44 adopted to be effective June 14, 2012, 37 TexReg 4229

Here are the boards comments, which can be found here,  on that new rules:

22 TAC §573.44 

The Board adopts new §573.44, regarding Compounding Drugs, which sets out the limited circumstances in which a veterinarian can compound a drug.  The adopted new rule parallels current state and federal regulations on the compounding of drugs by veterinarians while emphasizing issues that are of particular significance for veterinarians, such as the importance of the veterinary-client-patient relationship and the limitations on drugs compounded for foodproducing animals. The adopted rule is structured by subject-area, to clarify the limitations that apply to all compounded products, the limitations on compounding for food producing animals, and the limitations on promotion and sale  of compounded drugs. The new adopted rule strengthens the requirement that a veterinarian must establish and maintain a veterinarian-client
-patient relationship with any animal for which the veterinarian compounds drugs. The Board intends the adopted rule to limit drug compounding by veterinarians only  to treat a specific occurrence of a disease or condition that the veterinarian has diagnosed in a specific patient, and to prohibit veterinarians from compounding on any other basis or in quantities greater than those needed for the treatment of the particular disease occurrence in the specific diagnosed patient.   The Board's concern is that some  veterinarians compound significant quantities of drugs in advance of diagnosis for business profit reasons without first diagnosing the condition or disease the compounded drug is designed to treat in a particular patient with whom the veterinarian has established and maintained a  veterinarian-client-patient relationship. Compounding drugs for
office use is allowed under the rule, but only in amounts that do not exceed the established historical need for specific compounded drugs  for patients with which the veterinarian has established and maintained a valid veterinarian-client-patient relationship. The adopted rule includes more detailed provisions requiring that a veterinarian only compound products made with FDA-approved drugs as active ingredients, and not promote or distribute compounds that are essentially the same as other FDA-approved drugs. The subsection of the adopted rule regarding compounding for food-producing animals parallels existing federal and state law on the subject by requiring that the veterinarian set withdrawal times that are based on scientific
information and note the method used to determine the withdrawal period in the patient records, and ensure that procedures are in place to maintain the identity of any food-producing animal that receives a compounded drug. With regard to labeling requirements for compounded drugs, the new adopted rule eliminates redundancies in the labeling information required for all drugs under §573.44, and requires that the label for  compounded drugs include both name and strength of medically active ingredients. 

RULE §573.45 EXTRA-LABEL OR OFF-LABEL USE OF DRUGS provides:

(a) Extra-label or off-label use is the actual or intended use of a drug in an animal that is not in accordance with the approved labeling, and includes, but is not limited to:
(1) compounded drugs;
(2) use in species not listed in the labeling;
(3) use for diseases or other conditions not listed in the labeling;
(4) use at dosage levels, frequencies, or routes of administration other than those stated in the labeling; and
(5) deviation from the labeled withdrawal time based on these different uses.
(b) A veterinarian must use his or her discretion in the off-label use of drugs for animals. In exercising such discretion, a veterinarian shall consider, to the extent possible:
(1) whether the off-label use of a drug meets the community standard of humane care and treatment set out in §573.22 of this title (relating to Professional Standard of Care);
(2) the established safety of the off-label usage;
(3) the inclusion of a drug in a standard veterinary formulary;
(4) analyses of off-label usage in the veterinary medical literature and in articles and commentaries written by the veterinarian's peers in the veterinary medical profession;
(5) information provided by the drug's manufacturer, vendor or the FDA as to whether off-label usage of a drug may present a risk to public health; and
(6) any other sources of pertinent information

(c) If anticipated off-label use of a drug is not commonly accepted or used by average veterinarians in the community in which the veterinarian practices or if the off-label usage does not have an established safety record, the veterinarian shall orally or in writing inform the client that the off-label usage is not commonly accepted or used in the veterinary community and that such usage could pose a risk to the e health of the animal.

Any oral notification shall be recorded in the patient records.

(d) Extra-Label Drug Use in Food Producing Animals.
(1) For animals intended for human consumption, a veterinarian must establish an extended withdrawal interval sufficient to ensure food safety. The withdrawal period must be supported by scientific information, and the veterinarian shall note the method used to determine the withdrawal interval in the patient records.
(2) A veterinarian shall not prescribe an extra-label drug in a manner that will result in violative food residue, or any residue that may present a risk to public health.
(3) Veterinarians shall ensure that procedures are in place to maintain the identity of treated animals, and shall note those procedures in the patient records.
Source Note: The provisions of this §573.45 adopted to be effective June 14, 2012,

The board's comments about rule 573.45 are as follows.

22 TAC §573.45
The Board adopts new §573.45, regarding Extra-Label or Off-Label Use of Drugs, which sets out the conditions under which a veterinarian may prescribe a drug for an off-label use. The adopted new rule includes compounded drugs explicitly among the list of extra-label or offlabel uses for drugs. Although compounding is commonly considered an off-label use, some licensees have expressed confusion over whether the limitations on extra-label use applied to compounded drugs as well as approved drugs. The adopted rule includes limitations on extralabel drug use in food-producing animals, based on federal regulations and is intended to parallel the requirements for compounded drugs set out in adopted new §573.44. 

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...

Next Page       Previous Page

Texas State Board of Pharmacy Winter 2013 Newsletter Containing Disciplinary Action

To read the newsletter click here

Bill Introduced in Texas Allowing Out-of-State Inspections

83R10338 MAW-F
	By: Van de Putte	S.B. No. 1100

	A BILL TO BE ENTITLED
	AN ACT
	relating to the licensing and inspection of certain out-of-state
	pharmacies by the Texas State Board of Pharmacy; authorizing fees.
	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
	SECTION 1.  Subchapter B, Chapter 556, Occupations Code, is
	amended by adding Section 556.0551 to read as follows:
	Sec. 556.0551.  INSPECTION OF LICENSED OUT-OF-STATE
	PHARMACY. (a) The board may conduct a random inspection of a
	pharmacy that holds a Class E pharmacy license and that compounds
	sterile prescription drugs for delivery to patients in this state
	as necessary to ensure compliance with the safety standards and
	other requirements of this subtitle and board rules.
	(b)  The board by rule shall set fees in amounts reasonable
	and necessary to cover the costs incurred by the board in inspecting
	a pharmacy as provided by Subsection (a).
	SECTION 2.  Section 560.052, Occupations Code, is amended by
	amending Subsection (c) and adding Subsection (g) to read as
	follows:
	(c)  To qualify for a Class E pharmacy license, an applicant,
	in addition to satisfying the other requirements of this chapter,
	must provide to the board:
	(1)  evidence that the applicant holds a pharmacy
	license, registration, or permit in good standing issued by the
	state in which the pharmacy is located;
	(2)  the name of the owner and pharmacist-in-charge of
	the pharmacy for service of process;
	(3)  evidence of the applicant's ability to provide to
	the board a record of a prescription drug order dispensed by the
	applicant to a resident of this state not later than 72 hours after
	the time the board requests the record;
	(4)  an affidavit by the pharmacist-in-charge that
	states that the pharmacist has read and understands the laws and
	rules relating to a Class E pharmacy;
	(5)  proof of creditworthiness; and
	(6)  except as provided by Subsection (f) or (g), an
	inspection report issued:
	(A)  not more than two years before the date the
	license application is received; and
	(B)  by the pharmacy licensing board in the state
	of the pharmacy's physical location[, except as provided by
	Subsection (f)].
	(g)  A Class E pharmacy license may not be issued to a
	pharmacy that compounds sterile prescription drugs for delivery to
	patients in this state unless the pharmacy has been inspected by the
	board to ensure the pharmacy meets the safety standards and other
	requirements of this subtitle and board rules. The board by rule
	shall set fees in amounts reasonable and necessary to cover the
	costs incurred by the board in inspecting an applicant as required
	by this subsection.
	SECTION 3.  Not later than November 1, 2013, the Texas State
	Board of Pharmacy shall adopt rules as required by Section
	556.0551, Occupations Code, as added by this Act, and Section
	560.052, Occupations Code, as amended by this Act.
	SECTION 4.  Section 560.052, Occupations Code, as amended by
	this Act, applies only to an application for a pharmacy license
	submitted to the Texas State Board of Pharmacy on or after the
	effective date of this Act. An application submitted before the
	effective date of this Act is governed by the law in effect on the
	date the application was submitted, and the former law is continued
	in effect for that purpose.
	SECTION 5.  This Act takes effect September 1, 2013.

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