IAdminfootr01a_01_03 = new Image(226, 28);IAdminfootr01a_01_03.src = '/images/tac_nav.gif'; Veterinarians are strongly encouraged to keep their CE records in the facility where they are practicing. Pharmacies Compounding Sterile Preparations, Texas Administrative Code (Last Updated: December 8,2022), SUBCHAPTER G. SERVICES PROVIDED BY PHARMACIES. OVERVIEW. State Securities Board Response to Coronavirus (COVID-19), Reporting Suspected Financial Exploitation of Vulnerable Adults. H\@=OQEn&dy ! .|1=@qRn}};]3kvpM[OTCu}wtt:wic|oc;_a/t/D^M:N?Ct|$x:UwYH+?g=Oj//eY__W+-yC~g~G`Ns,d^"2
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[B#. Texas Sterile Compounding Regulations. The
methodology for documenting unavailability includes maintaining a
copy of the wholesaler's notification showing back-ordered, discontinued,
or out-of-stock items. Texas State Board of Plumbing Examiners, Title 22 Texas Administrative Code 361.1, 361.4, 361.6, 361.10, 361.12, and 361.15. The on-site inspections are generally scheduled in advance and are focused on registered investment advisers and those registered dealers who are located in Texas but are not members of the Financial Industry Regulatory Authority (FINRA). In order for comments to be considered, the identity of the commenter must be clearly indicated. 0000034619 00000 n
Use either the Universal Inspection Form Sterile Compounding Module (Universal Inspection Form) or the states sterile compounding inspection form, which has been reviewed by our staff to ensure that it meets the Inspection Blueprint standards. The state determines a facilitys compliance based on the findings of the inspection, and completion of the inspection does not imply our endorsement or approval. The Regulatory Compliance Division was authorized by Senate Bill 1995 during the 86th Regular Legislative Session and is established in accordance with Subchapter C, Chapter 57, Texas Occupations Code. This documentation must be available in hard-copy
or electronic format for inspection by the board. 0000010680 00000 n
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a8 d=.1y]:XT)R"0Iz MK;\, document.getElementById( "ak_js_1" ).setAttribute( "value", ( new Date() ).getTime() ); To apply for an NABP inspection, businesses must meet basic eligibility requirements. Please be aware that all information you submit to the division is subject to public disclosure under the Texas Public Information Act. Section 291.17 - Inventory Requirements (a) General requirements. The Multistate Inspection Blueprint Program supports states that have the resources to perform resident inspections by providing the Inspection Blueprint, a living document that includes a minimum set of criteria for pharmacy inspections. This documentation must be available in hard-copy or electronic format for inspection by the board. Admin. Copyright 2020 National Association of Boards of Pharmacy (NABP). CE Checklist; Dispensing Tech in Training Certification of 500 Hours; Hotline Form; Managing Pharmacists Certification of Trainee Hours; . Attest that the inspectors/compliance officers who conduct these inspections receive qualified NABP-approved training. Under rule 573.64, CE records must be maintained for the last 3 renewal cycles and be provided to the Board investigators for inspection upon request. Member Relations and Government Affairs staff, Contact our Member Relations and Government Affairs staff. 0000099488 00000 n
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Our Supply Chain Inspection service is a regulatory inspection for facilities engaged in the distribution of prescription drugs and prescription medical devices. Apply for VPP as a standalone program or maximize your investment by creating a comprehensive compliance package for one streamlined, cost-effective accreditation process. Welcome to the Department of Consumer Protection, Drug Control Division Inspection Form webpage. 1405 0 obj
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suppliers inspection, disciplinary, and licensing data, Inspection sharing across states through NABP. 60 Improper doc - umentation of training 49 Substitution noncompliance 91 RPh visits/contact . 0000000016 00000 n
Member boards seeking to enhance their inspection processes have identified us as their best option for assistance. Want to pursue NABP Compounding Pharmacy Accreditation for which VPP is a prerequisite. 0000006635 00000 n
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compounds). Inspections and Compliance staff also investigate complaints and review disclosure information concerning persons and firms registered with the Texas Securities Commissioner. A rule affects market competition if it would create a barrier to market participation in the state or would result in higher prices or reduced competition for a product or service provided by or to a license holder in the state. 0000036815 00000 n
This inspections focus is adopted from our Drug Distributor Accreditation and provides a snapshot of a suppliers operations at a point in time. Utilizing VPP inspection reports, along with license verification and disciplinary information provided through the NABP Clearinghouse, you can efficiently make informed decisions on licensure or the licensure renewal for nonresident pharmacies. Box 12428 If you wish to join the Blueprint Program, your board must agree to the following processes for inspecting in-state sterile compounding pharmacies that ship to other states: Contact our Member Relations and Government Affairs staff for your program agreement form today. Dont have an account? } function dm(msgStr) { This is also an important educational opportunity for inspectors to provide guidance and answer your questions about pharmacy laws and regulations. )/9xpXyN|3O,D\ 74TPxj%A`e+9F%M"IFA{P @UXs&]MYxL4_2cde`V4n %yw23097Mebs,Y6iS0r##b&q m,2a`cy2m (.BU1CSC[V b 0000014097 00000 n
Only the following state agencies are required to submit proposed rules to the division. Over the years, we have proven our ability to balance the needs of the boards and make the protection of public health a primary concern. if (document.images) { 0000042574 00000 n
The self-inspections are completed on forms the commission provides. Motorist's safety is a top priority in Texas; as a result, vehicles registered in Texas are required to pass an annual inspection to ensure compliance with safety standards. 0000022736 00000 n
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For basic instructions on submitting your application, read theApplication Basics document. and other areas that
are in close proximity to the ISO Class 5 environment during the certification
of the primary engineering control. View Rule Submission Memorandum for Rules 361.1, 361.4, 361.6, 361.10, 361.12, and 361.15. Submit the application for one or multiple locations. The goal of an inspection is to safeguard the health and safety of consumers. #Ab)*{!QT_ory kv1p Q0*n"{6;J?AJc6kY 8A6+=vmrRl6P'j;Oy^\DqLN;v* q|Kc$^9$_s4jC\$QI'gHS&~ iuhPuSO'$T(Aqshb{6A{B]S(`b$3HK]%E7XAN&fswYsMu. RC50}fI~U1Ng That guidance and the rule submission memorandum template that agencies must use when submitting a proposed rule to the division are below. %PDF-1.2
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To speak with a member of our federal defense team about your DEA pharmacy inspection, please call 888-680-1745 or contact us online. Essential Elements of Compounded Sterile Preparations (LP3 Network) - ACPE number 0864-9999-18-047-H07-P/T [64B16-28.108 F.A.C.] //help_ftr_01_05o = new Image(38, 28);help_ftr_01_05o.src = '/images/help_nav_over.gif'; If you choose the Universal Inspection Form, you will use this form when inspecting pharmacies that ship sterile compounded products to other states. 0
You can track the status of your request in e-Profile. After conducting its review of a proposed rule, the division issues a determination letter approving or rejecting the rule. The state determines a facilitys compliance based on the findings of the inspection, and completion of the inspection does not imply our endorsement or approval. Get started on your path to an inspection by following the steps below: Use the Apply link to log in to NABP e-Profile and start the application process. If your pharmacy is seeking nonresident licensure, VPP allows state boards of pharmacy to access your verified pharmacy licensure details, VPP inspection report, inspection responses, and other important data through the . 0000092702 00000 n
Referral Letter to the Texas State Board of Pharmacy Issued 03/24/2021 (PDF - 249KB) Untitled Letter Issued 09/29/2020 (PDF - 182KB) 483 Issued 11/08/2018 (PDF - 468KB) The information collected about a supplier when it goes through an inspection equips your board with the detailed information needed to make accurate, fully informed licensing and license renewal decisions. Subchapter C, Chapter 57, Texas Occupations Code, establishes and governs the Regulatory Compliance Division. IAdminfootr01a_01_01 = new Image(52, 28);IAdminfootr01a_01_01.src = '/images/home_nav.gif'; 0000042535 00000 n
NABP's Verified Pharmacy Program (VPP ) is the most widely recognized multistate, uniform inspection program accepted by state boards of pharmacy across the nation.. Prescription Drug Abuse Prevention. SECTION 291.133. IAdminfootr01a_01_02o = new Image(137, 28);IAdminfootr01a_01_02o.src = '/images/txreg_nav_over.gif'; Agree that the inspectors/compliance officers will participate in annual training. document.returnValue = true; 850-488-0796 Mailing Address. gD.DO\p`jF>nY\DjwDa7qJz@ K+/%!N'\Q GF>!\@Cm"5c.z~kmW-aMXI)T Apply for a Facility License. 0000001276 00000 n
We will work with you on any changes that must be made to ensure uniformity across participating states. Via NABP e-Profile Connect, you may view: The supply chain inspection is not an accreditation program, and we do not make any determination of passed or compliant with regard to any specific state regulations. The unavailability
of such drug product must be documented prior to compounding. } These agencies are only required to submit rules that the agency has determined affect market competition or that the division has identified as possibly affecting market competition. The following information can be accessed at any time via the secure NABP e-Profile Connect: Complete the members inspection inquiry formfor more information about how we can help enhance your inspection processes. Note: This guideis simply a guideline and should not be considered a guarantee of state inspection passage and neither R.J. Hedg es nor PPA makes any warranties of such. } 1100 San Jacinto P.O. IAdminfootr01a_01_02 = new Image(137, 28);IAdminfootr01a_01_02.src = '/images/txreg_nav.gif'; w*5/_k`UZWl6 endstream
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Through this program, our surveyors perform the pharmacy inspection at no cost to you. NABP conducts an unannounced on-site inspection of your pharmacys activities, All business e-Profile information is accessible to the state boards of pharmacy to view, The board staff receives alerts when new documents are available on the business e-Profile for pharmacies that are licensed and or seeking licensure, Must be a licensed pharmacy operating in the United States, with current and active licenses in good standing, in all jurisdictions in which it is conducting business, Business location must be operational in all its activities for at least 30 days, If sterile compounding, the pharmacy must have certification reports dated within six months of application payment date, The pharmacy is not currently the subject of one or more serious health care-related disciplinary or criminal proceedings or regulatory or law enforcement investigations including, without limitation, product or document seizures. It could be because it is not supported, or that JavaScript is intentionally disabled. H\j }X4!B.zi IVhs*0?#dzmyZDpe9(-=[8u8XY 110-49 Credentials for Nonresident Pharmacy Dispensing only for Animals, effective August 6, 2020 Guidance Concerning Disciplinary Processes and Standard Sanctions for Violations and Inspection Deficiencies 110-9 Pharmacy Inspection Deficiency Monetary Penalty Guide effective November 25, 2021 (pdf) hbbd```b``Q AD2H`\Vvgx40[6 `l(,H2@"I?v9do>6DW `sl1F+Xyf20 ?7 D
States requiring pharmacies and distributors to undergo a preoperational inspection will find our Preoperational Inspection can supplement their own inspections, reducing board staff workload and assisting with inspection requests from facilities. Once received and reviewed, a member from the D pharmacy 79 Nametags 50 Out of state verbal Rx for C/S 64 Violation of limited formulary . The divisions review process ensures that there is sufficient legal authority for proposed rules that may be anticompetitive, thus providing important protections for Texas consumers, licensed professionals, and state boards and their volunteer members. Note your area(s) of interest in the message box. Learn more. Once your application, required documentation, and specified fees have been received and you have agreed to the terms and conditions: Complete the form to request more information. The division, after review of a proposed rule, issues a determination letter approving or rejecting the rule. 0
This page will be updated with inspection forms used by the Drug Control Division during inspections inside the State of Connecticut. and scope of a State Board of Pharmacy's inspection authority. It is recommended that individuals that intend to utilize these forms obtain a copy from the website each time to ensure that the most current form is utilized. The following proposed rules are currently under review by the division. We will be updating the forms on this page regularly and all forms are subject to change without being posted on the website. 0000092111 00000 n
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NABP does not issue a certificate of inspection or make any determination of passed or compliant with regard to any specific state regulations. 125 49
OVERVIEW. If you have a course that you would like to submit for approval please send the course to. '5ue)t6[bh*PC}kGeZQ^uG"19)m+f@V Office of the Governor Pharmacy licenses (resident and nonresident) and pharmacist-in-charge licenses are verified to ensure they are active and in good standing in all jurisdictions in which they are doing business. 0000030857 00000 n
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(A) All pharmacists engaged in compounding shall: (i) possess the education, training, and proficiency necessary to properly and safely perform compounding duties undertaken or supervised; and (ii) obtain continuing education appropriate for the type of compounding done by the pharmacist. After completion of the Preoperational Inspection, the boards and other state regulators will have comprehensive information on the facilitys physical structure, security features, anticipated onsite activities/scope of services, and accountability processes in order to make licensing decisions. records at any time with secure access 24/7. Department of Health 4052 Bald Cypress Way, Bin C75 Tallahassee, Florida 32399-3260 Austin, Texas 78711-2428, Office of the Governor TEXAS STATE BOARD OF PHARMACY: CHAPTER 291: PHARMACIES: SUBCHAPTER G: SERVICES PROVIDED BY PHARMACIES: RULE 291.133: Pharmacies Compounding Sterile Preparations . xref
The division welcomes public comments on the proposed rules currently under review. hb```b``[ @1v
490000m!M]%P %fR#5 L,3"LV=5s6*LSTp#Y rgsrVNb3f[Xnw|pti:'N v],_=Y8E|",0- b 42P+1@$Dvbtp(,o/s#cMu30a2|N_t|k"#! Need a nonresident pharmacy inspection required by an out-of-state board of pharmacy for renewing or obtaining nonresident licensure. State Insurance Building Utilizing the current United States Pharmacopeia standards, along with field operations best practices developed in partnership with participating boards of pharmacy, the Inspection Blueprint provides the various tools needed to ensure that you can inspect resident sterile compounding pharmacies that ship across state lines. Copyright 2023 by eLaws. The compliance binder serves several purposes: Helping the pharmacy manager ensure that all documentation is up to date and complete. Pharmacy Inspection Form - Nuclear Pharmacy, Pharmacy Inspection Form - Ownership Change, Pharmacy Inspection Form - Balance Certification, Pharmacy Inspection Form - Safe Inspection, Certification Submission Form - September 2022. xpMy9m0Gj'IhKJJ.P1 Approved program(s) for Designated Pharmacists must at minimum include a total 30 hours (can be obtained from different programs) of education in the following areas: Sanitation of pharmacy controlled environments, Engineering controls for sterile compounding, Below are courses that have been approved already. [/\Z. i$;ldS*u3FZ1?*ZtqBx`SZbxYlQ( 9nGs \,a;^pkJ
ssfW; 4bH~)t `=gK`RL)E]b8u"*<7XV:\6N&K vHf js %=OezW Program(s) of Interest (select all that apply). For questions and reporting USP related issues please emailDCP.DrugUSPcompounding@ct.gov. trailer
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If your pharmacy is seekingnonresident licensure, VPPallows stateboards of pharmacyto access yourverified pharmacy licensure details, VPP inspection report, inspection responses, and other important datathrough the use of a secure information sharing network. Records reflect on-site consultations by consultant pharmacist at least monthly unless otherwise directed by Board. PA Pharmacy Board Inspector Checklist Item . The new inspection rules require all pharmacies to conduct an annual self-inspection in March and within 30 days of naming a new pharmacist in charge. P.O. Participants of the program will receive an inspection report that may satisfy an inspection requirement from an entity or agency. } All registrants, however, are subject to inspection. IAdminfootr01a_01_04 = new Image(123, 28);IAdminfootr01a_01_04.src = '/images/om_nav.gif'; 0000007246 00000 n
Contact our. %%EOF
(1) The pharmacist-in-charge shall be responsible for taking all required inventories, but may delegate the performance of the inventory to another person (s). 0000038067 00000 n
//help_ftr_01_05 = new Image(38, 28);help_ftr_01_05.src = '/images/help_nav.gif'; During the inspection, the pharmacy should provide access to: All stock of dangerous drugs and devices; All records of manufacture, sale, acquisition, receipt, shipment and disposition. View Rule Submission Memorandum for Rules 361.1, 361.4, 361.6, 361.10, 361.12, and 361.15. The NABP Preoperational Inspection allows for a facility to obtain an onsite inspection prior to operation. hb```b``^[ ,@QF ?AU`6cPl]Jgk^zSo-K function di(id,name){ The division has provided guidance to affected state agencies on the divisions policies and procedures. The division must complete each review not later than the 90th day after the date the proposed rule was submitted to the division. After the . Retail Pharmacy Pre-Inspection Form (New Pharmacies Only) Senate Bill 1995 was passed in response to the United States Supreme Courts decision in North Carolina State Board of Dental Examiners v. Federal Trade Commission and guidance later issued by the Federal Trade Commission. Texas Public Information Act Request Form, instructions for making a public information request, Subchapter C, Chapter 57, Texas Occupations Code, Texas Appraiser Licensing and Certification Board, Texas Behavioral Health Executive Council, Texas Board of Professional Engineers and Land Surveyors, Texas Board of Professional Geoscientists, Texas State Board of Acupuncture Examiners, Texas Board of Medical Radiologic Technology, Texas Board of Occupational Therapy Examiners, Texas Board of Physical Therapy Examiners, State Board of Veterinary Medical Examiners. TEXAS PHARMACY LICENSE APPLICATION Pre-Inspection Checklist . Attn: Regulatory Compliance Division 1600 Feehanville Dr Mount Prospect, IL 60056.
Address/Name Change. 0000012491 00000 n
The official version of the form is the one used by the inspecting agent. The Regulatory Compliance Division conducts an independent review of certain state licensing agencies proposed rules that affect market competition. Pharmacy inspection (COMAR 10.34.19.17): Pharmacies will be inspected by the Board at least annually. Box 12428 window.status = msgStr;
Ensuring that any pharmacist, even floater pharmacists, can quickly find records for an inspector. Texas State Board of Pharmacy Yes Yes. We will arrange for you to speak with one of our senior federal defense lawyers as soon as possible. [64B16-28.702(2)(b)(c)(d), FAC.] IAdminfootr01a_01_03o = new Image(226, 28);IAdminfootr01a_01_03o.src = '/images/tac_nav_over.gif'; HW%
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Code 110.113 (a). Pharmacy. Pharmacy licenses (resident and nonresident) and pharmacist-in-charge licenses are verified to ensure they are active and in good standing in all jurisdictions in which they are doing business. WHAT THE BOARD EXPECTS FROM YOU The Board of Pharmacy appreciates your cooperation during this inspection. Whether NABP programs are new to your business, or you are already NABP accredited and are looking to expand your portfolio, our processes simplify your journey toward VPP Inspection. Determine whether vulnerabilities exist for internal diversion. Such balance shall be properly maintained and subject to periodic inspection by the Texas State Board of Pharmacy; (E) equipment and utensils necessary for the proper compounding . H\j0l/Wi\pIjhd8y)]Xh&v?mr>v.5vc\lXyLvP+nn
/r;[Vco9+]{U}Iv26&Z-_bl;&u"/Og3xC- Create your free business e-Profile account today. 2016 CT.gov | Connecticut's Official State Website. The uniform Drug Supply Chain Security Act (DSCSA) compliance assessment of wholesale drug distributors provides personalized state inspection projects for the boards. 12/2020) Pennsylvania Pharmacy Board Inspection Guide font size, Please use this document to prepare for your, For questions and reporting USP related issues please email, Pharmacy Inspection Form - Nuclear Pharmacy, Sterile Compounding Inspection Requirements, Essential Elements of Compounded Sterile Preparations, Sterile Compounding eLearning Course Curriculum 29 lessons with 34 hours of CE, Inspection Form Version 1 September 2015. RJH Form F0904 (07/17/2014 - Rev. The divisions rules at 1 TAC 5.201-5.213 contain additional guidance for agencies submitting proposed rules to the division and detail the divisions practices for reviewing proposed rules. Learn more about how our accreditation programs ensure public safety. Log in to your business e-Profile account and visit the Instructions and FAQs section to access pricing. Create and complete a business e-Profile account: Once your request has been submitted, it may take up to 3 business days for processing. State Agencies State Jobs ADA Assistance. The boards and other state regulators can use the Preoperational Inspection to obtain inspection documentation to ensure they have complete and accurate information when making licensure decisions. Some of the features on CT.gov will not function properly with out javascript enabled. endstream
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pharmacies inspection, disciplinary, and licensing data, immediate reporting of significant violations of state and federal law, and. Austin, Texas 78701. Pharmacy Inspection Checklists/Forms Usually, each State Board of Pharmacy has a specific checklist or form that is completed by the inspector on the date of the inspec-tion.1 State Board of Pharmacy focus areas for inspections may also be ascertained by review of State Board of . g9~7S {g.cpTz^|wS(C^!E>+Q1~ r? Via NABP e-Profile Connect, you may view: The pharmacy inspection is not an accreditation program, and we do not make any determination of passed or compliant with regard to any specific state regulations. To avoid unnecessary delays, review the Verified Pharmacy Program eligibility requirements below to determine if you are qualified to apply. 0000030166 00000 n
Pharmacy inspections will not change, but the report pharmacies receive will. Applicants. Look here for information about the Board's mission, Compact with Texans, policies and guidelines, members, staff, public . The checklist may be done on paper or electronically and must be completed prior to . [64B16-28.702(5), FAC.] . Report fraud, waste, or abuse of state resources to the State Auditor's Officeor call (800) 892-8348. //-->, Pharmacies Compounding Non-Sterile Preparations. Texas dentists administering nitrous oxide or Level 1, 2, 3, or 4 sedation/anesthesia must create, maintain, and include in the patient's dental records a document titled "preoperative sedation/anesthesia checklist." 22 Tex. 0000010119 00000 n
0000003114 00000 n
Submit this page only after all items on this checklist are completed. Complete responsibility for compliance falls on the pharmacy owners. This inspection program is part of the Compounding Pharmacy Information-Sharing Project developed in partnership with FDA, NABP, and the boards of pharmacy. The information collected about a pharmacy when it goes through a VPP inspection equips you with the detailed information you need to make accurate, fully informed licensing and license renewal decisions. About Us The Texas State Board of Pharmacy is the state agency responsible for the licensing/registration of Texas pharmacists, pharmacy technicians, and pharmacies; for establishing regulations for pharmacy practice; and for disciplining licensees and registrants. Working together to create a state-based program of robust inspection processes. 0000006088 00000 n
0000011218 00000 n
on-site inspections by a PA Pharmacy Board Inspector. . A state agency may not finally adopt or implement a proposed rule under the divisions review until the division has approved the rule or the agency has revised the rule according to the divisions instructions. Create your free business e-Profile account today. %%EOF
Share inspection reports with other states (if not prohibited by state law). During the inspection, the . Designated Pharmacist - means a pharmacist responsible for overseeing the compounding of sterile pharmaceuticals and the application of the USP chapters, as said chapters pertain to sterile compounding. )Av0Yq"K % ) C%rY+\3ODh|X3AHzq hPdFr0j. 0000030593 00000 n
(E) A pharmacy may enter into an agreement to compound and dispense prescription drug or medication orders for another pharmacy provided the pharmacy complies with the provisions of 291.125 of this title (relating to Centralized Prescription . 0000024672 00000 n
The program equips the state boards of pharmacy with quality and timely data that can assist in decreasing the time it takes to make licensing decisions. 0000004842 00000 n
function dmim(msgStr) { TIP: The inspector is allowed to take samples of products (e.g. 0000004408 00000 n
To view the divisions determination letters, please visit the Determination Letters page. Inspect the sterile compounding pharmacies no less than once every 18 months. DownloadGuidance For Affected State Agencies as PDF, Download Rule Submission Memorandum Template as PDF. All rights reserved. 0000004294 00000 n
In the future, participation may expand to include general pharmacy and nonsterile compounding. About Us The Texas State Board of Pharmacy is the state agency responsible for the licensing/registration of Texas pharmacists, pharmacy technicians, and pharmacies; for establishing regulations for pharmacy practice; and for disciplining licensees and registrants.
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