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. %%EOF
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. w TNcc 0000014097 00000 n
The division may not consider anonymous comments. 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. window.status = msgStr; } Only the following state agencies are required to submit proposed rules to the division. Applicants. Austin Texas 78711 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. 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. OVERVIEW. Texas State Board of Pharmacy Yes Yes. // function that displays status bar message NABP does not issue a certificate of inspection or make any determination of passed or compliant with regard to any specific state regulations. hXmo6+bh$Ydiri]&jb3kHK\_
bZHJzD2/ ## cxdDhG$YR,eHI4GRYfM dpO 4+`U'`)PpKsYJOh"`C%kF|vWP%R>k "-^k"}C)Q(P!PR@QCKK$?Dzjp"3#I1MAAx~A0nsPcAd*C3 L0EEicsy4(\1c1=gL(;>Ov<8NSq]&yR&nj1r*y^pLn#zV$=0fp:kxTknwNjC'W,g0t7)YOh@1j1FF
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@0-4_'(Yvi7=P|bsa2Lz,V8!Ay$sH|{sa_Z,H*?~RW%YVfua \l8ioB. TIP: The inspector is allowed to take samples of products (e.g. } State-wide Laws, Regulations, and Guidance Related to Opioids The Texas Controlled Substances Act is found in the State's Health and Safety Code, Title 6, Subtitle C, Chapter 481 and defines the State Board of Pharmacy's role in identifying harmful prescribing behaviors by requiring: o Healthcare providers to access the Texas We will provide training at no cost to boards. 0000024672 00000 n
#Ab)*{!QT_ory kv1p Q0*n"{6;J?AJc6kY 8A6+=vmrRl6P'j;Oy^\DqLN;v* q|Kc$^9$_s4jC\$QI'gHS&~ iuhPuSO'$T(Aqshb{6A{B]S(`b$3HK]%E7XAN&fswYsMu. RC50}fI~U1Ng 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. Program(s) of Interest (select all that apply). Create your free business e-Profile account today. General Inspection Form (Non FDA facility), General Inspection Form (With Controlled Substances) - May 2021,
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of such drug product must be documented prior to compounding.
Affected state agencies are required to submit all proposed rules affecting market competition, including new rules, rule amendments, rule repeals, and rules that the agencies propose to readopt or repeal after a review under Section 2001.039, Texas Government Code. w*5/_k`UZWl6 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. IAdminfootr01a_01_02o = new Image(137, 28);IAdminfootr01a_01_02o.src = '/images/txreg_nav_over.gif'; Look here for information about the Board's mission, Compact with Texans, policies and guidelines, members, staff, public . J
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Pharmacy inspection (COMAR 10.34.19.17): Pharmacies will be inspected by the Board at least annually. 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. 0000042574 00000 n
Consumer Services Section MQA.ConsumerServices@flhealth.gov Fax. Pharmacies Compounding Sterile Preparations, Texas Administrative Code (Last Updated: December 8,2022), SUBCHAPTER G. SERVICES PROVIDED BY PHARMACIES. The Verified Pharmacy Program (VPP) provides boards of pharmacy with inspection and license verification services and ensures that you have complete and accurate information to make pharmacy licensure decisions.
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Source Note: The provisions of this 291.133 adopted to be effective December 10, 2013, 38 TexReg 8869; amended to be effective September 11, 2014, 39 TexReg 7128; amended to be effective June 11, 2015, 40 TexReg 3647; amended to be effective September 14, 2015, 40 TexReg 6111; amended to be effective June 12, 2016, 41 TexReg 4257; amended to be effective September 11, 2016, 41 TexReg 6718; amended to be effective January 4, 2018, 42 TexReg 7700; amended to be effective September 16, 2018, 43 TexReg 5784. P.O. } 0000092702 00000 n
The division, after review of a proposed rule, issues a determination letter approving or rejecting the rule. Submit the application for one or multiple locations. 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. A VPP inspection is conducted by our inspectors and, when applicable, verifies compliance with United States Pharmacopeia Chapters <795> and <797>. D pharmacy 79 Nametags 50 Out of state verbal Rx for C/S 64 Violation of limited formulary . Inspect the sterile compounding pharmacies no less than once every 18 months. [64B16-28.108 F.A.C.] 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. 0000002062 00000 n
Attn: Regulatory Compliance Division and scope of a State Board of Pharmacy's inspection authority. Once received and reviewed, a member from the Box 12428 0000034658 00000 n
The board is in the process of updating some Self-Assessment forms through a formal rulemaking. 0000003561 00000 n
Pharmacy inspections will not change, but the report pharmacies receive will. Code 110.113 (a). Pharmacy Inspection Form - Compliance Reducing regulators workloads for inspection compliance. SECTION 291.133. The division reviews proposed rules that affect market competition to assess their consistency with state policy as clearly articulated by the Legislature in state statute. Pharmacies that operate in multiple states have found VPP to be a practical and cost-effective solution because just one inspection often satisfies the requirements in most states. Home. This subchapter was added to the Texas Occupations Code by Senate Bill 1995 during the 86th Regular Legislative Session. Pharmacy has policy and procedures manual available for inspection. IAdminfootr01a_01_01 = new Image(52, 28);IAdminfootr01a_01_01.src = '/images/home_nav.gif'; %%EOF
The division must complete each review not later than the 90th day after the date the proposed rule was submitted to the division. 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. OS[Obz>O6oy9I@#;:+G:*eEEo, =2.'"F?zOb&u)'3f}Mu]};NF0;. Prescription Drug Abuse Prevention. When states lack the resources to conduct timely and robust inspections, VPP can bridge the gaps. 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#. A VPP inspection is conducted by our inspectors and, when applicable, verifies compliance with United States Pharmacopeia Chapters <795> and <797>. 0000003114 00000 n
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The NABP Preoperational Inspection allows for a facility to obtain an onsite inspection prior to operation. We will be updating the forms on this page regularly and all forms are subject to change without being posted on the website. %PDF-1.2
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Working closely with board members, inspectors and compliance staff, and board executive officers, we have created tools and services that enable the exchange of valuable knowledge and the building of robust inspection programs in any state. } document.returnValue = false; 0000019186 00000 n
IAdminfootr01a_01_03o = new Image(226, 28);IAdminfootr01a_01_03o.src = '/images/tac_nav_over.gif'; document.getElementById( "ak_js_1" ).setAttribute( "value", ( new Date() ).getTime() ); To apply for an NABP inspection, businesses must meet basic eligibility requirements. b 42P+1@$Dvbtp(,o/s#cMu30a2|N_t|k"#! . Review the policy information prior to starting the VPP application. 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. The division has provided guidance to affected state agencies on the divisions policies and procedures. If you want to use your own sterile compounding inspection form, we will first crosswalk or compare it to the Universal Inspection Form. //-->, Pharmacies Compounding Non-Sterile Preparations. 1405 0 obj
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compounds). 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). 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. function dmim(msgStr) { 0000002900 00000 n
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View Rule Submission Memorandum for Rules 361.1, 361.4, 361.6, 361.10, 361.12, and 361.15. TEXAS PHARMACY LICENSE APPLICATION Pre-Inspection Checklist . Data is securely stored and easily accessible for board staff through NABP. 0000034619 00000 n
Determine whether vulnerabilities exist for internal diversion. Share inspection reports with other states (if not prohibited by state law). 0000006088 00000 n
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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. Create your free business e-Profile account today. The third-party pharmacy inspection program most widely recognized by state boards of pharmacy across the nation. For questions and reporting USP related issues please emailDCP.DrugUSPcompounding@ct.gov. Pharmacy Services Committee meets at least annually. IAdminfootr01a_01_01o = new Image(52, 28);IAdminfootr01a_01_01o.src = '/images/home_nav_over.gif'; TEXAS STATE BOARD OF PHARMACY: CHAPTER 291: PHARMACIES: SUBCHAPTER G: SERVICES PROVIDED BY PHARMACIES: RULE 291.133: Pharmacies Compounding Sterile Preparations . Attest that the inspectors/compliance officers who conduct these inspections receive qualified NABP-approved training. Admin. Protecting the public health against ongoing threats to our nations drug supply chain. All registrants, however, are subject to inspection. endstream
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H< *xLJH3Bi= Vf``dde f9L}f9R390Y This inspections focus is adopted from our Drug Distributor Accreditation and provides a snapshot of a suppliers operations at a point in time. on-site inspections by a PA Pharmacy Board Inspector. Conduct a criminal background check after consulting with your State police agency or pharmacy association; Consult your State pharmacy board to determine whether any prior disciplinary action has been taken against the potential employee; and Conduct a financial background check. Dr. Nick Oberheiden . 0000000016 00000 n
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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. 125 0 obj
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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. Helping get the inspector in and out of your pharmacy fast, while leaving a good impression. Records reflect on-site consultations by consultant pharmacist at least monthly unless otherwise directed by Board. The goal of an inspection is to safeguard the health and safety of consumers. document.returnValue = true; 1444 0 obj
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IAdminfootr01a_01_04o = new Image(123, 28);IAdminfootr01a_01_04o.src = '/images/om_nav_over.gif'; Retail Pharmacy Pre-Inspection Form (New Pharmacies Only) [64B16-28.702(2)(b)(c)(d), FAC.] xref
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Austin, Texas 78701. 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. Policies established by the pharmacy should consider provisions of USP 797. /uploadedFiles/bopnvgov/content/Forms/Inspection/AmbulatorySurgeryCenterInspectionForm.pdf, /uploadedFiles/bopnvgov/content/Forms/Inspection/DispensingPractitionerInspForm.pdf, /uploadedFiles/bopnvgov/content/Forms/Inspection/InstitutionalPharmacyInspectionForm.pdf, /uploadedFiles/bopnvgov/content/Forms/MDEG Inspection Form 10.19.2022.pdf, /uploadedFiles/bopnvgov/content/Forms/Non-Sterile Compounding Inspection Form updated 3.23.20.pdf, /uploadedFiles/bopnvgov/content/Forms/RetailPharmacyInspectionForm7.20.2022.pdf, /uploadedFiles/bopnvgov/content/Forms/Retail Pharmacy Pre-inspection form updated 3.26.2020.pdf, /uploadedFiles/bopnvgov/content/Forms/Sterile Compounding Inspection Form updated 3.25.20.pdf, /uploadedFiles/bopnvgov/content/Forms/VDS-Inspection-Form(1).pdf, /uploadedFiles/bopnvgov/content/Forms/WH-WA-MA_Inspection Form 10.19.2022.pdf, /uploadedFiles/bopnvgov/content/Forms/01-November 2021.pdf, /uploadedFiles/bopnvgov/content/Forms/01-December 2021.pdf, /uploadedFiles/bopnvgov/content/Forms/JANUARY 2022.pdf, /uploadedFiles/bopnvgov/content/Forms/February 2022.pdf, /uploadedFiles/bopnvgov/content/Forms/March 2022.pdf, /uploadedFiles/bopnvgov/content/Forms/April 2022.pdf, /uploadedFiles/bopnvgov/content/Forms/May 2022.pdf, /uploadedFiles/bopnvgov/content/Forms/June 2022.pdf, /uploadedFiles/bopnvgov/content/Forms/July 2022.pdf, The Official State of Nevada Website | Copyright 2021 State of Nevada - All Rights Reserved, Dispensing Tech in Training Certification of 500 Hours, Managing Pharmacists Certification of Trainee Hours, Biennial Report - July 1, 2008 - June 30, 2010, Biennial Report - July 1, 2006 - October 31, 2008, Ambulatory Surgery Center Inspection Form, Retail Pharmacy Pre-Inspection Form (New Pharmacies Only), Wholesaler, Warehouse and Manufacturer Inspection Form. 0000030593 00000 n
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. 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 . // The java used for navigation in the Public OM page 0000004117 00000 n
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TEXAS STATE BOARD OF PHARMACY INSPECTION REPORT CLASS: A B C (BEDS____) D Name of Pharmacy TSBP License # . Pharmacy. The division welcomes public comments on the proposed rules currently under review. Nick Oberheiden. hb```b``^[ ,@QF ?AU`6cPl]Jgk^zSo-K Complete the form belowfor more information about how we can help enhance your inspection processes. Nevada State Board of Pharmacy. 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. 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. 0000036815 00000 n
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Submit this page only after all items on this checklist are completed. Texas State Board of Plumbing Examiners, Title 22 Texas Administrative Code 361.1, 361.4, 361.6, 361.10, 361.12, and 361.15. Inspections and Compliance staff periodically inspect the business premises of registered dealers and investment advisers to ensure compliance with all applicable securities laws and regulations. Dont have an account? Complete responsibility for compliance falls on the pharmacy owners. Log in to your business e-Profile account and visit the Instructions and FAQs section to access pricing. For more information, please send us a messageor call512-463-8500. To avoid unnecessary delays, review the Verified Pharmacy Program eligibility requirements below to determine if you are qualified to apply. Participants of the program will receive an inspection report that may satisfy an inspection requirement from an entity or agency. 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. 1600 Feehanville Dr Mount Prospect, IL 60056. ~#?rdd 5g`>>>>>>>>,,zA^P/QEEEE/9YxsVRRRRz*GjatwW s
} All medication properly labeled. hb```b``[ @1v
490000m!M]%P %fR#5 L,3"LV=5s6*LSTp#Y rgsrVNb3f[Xnw|pti:'N v],_=Y8E|",0- In the future, participation may expand to include general pharmacy and nonsterile compounding. Welcome to the Department of Consumer Protection, Drug Control Division Inspection Form webpage. The following proposed rules are currently under review by the division. Copyright 2020 National Association of Boards of Pharmacy (NABP). 12/2020) Pennsylvania Pharmacy Board Inspection Guide 0
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. Apply for a Personal License. Veterinarians are strongly encouraged to keep their CE records in the facility where they are practicing. CE Checklist; Dispensing Tech in Training Certification of 500 Hours; Hotline Form; Managing Pharmacists Certification of Trainee Hours; . In order for comments to be considered, the identity of the commenter must be clearly indicated. Attn: Regulatory Compliance Division Some of the features on CT.gov will not function properly with out javascript enabled. COPZ]ffp Ny+\oF{{A95cd@lM;V Lb&=9mPEY'uC.RB document.returnValue = false; This documentation must be available in hard-copy or electronic format for inspection by the board. 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. 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). 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. 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 . The uniform Drug Supply Chain Security Act (DSCSA) compliance assessment of wholesale drug distributors provides personalized state inspection projects for the boards. 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. State Insurance Building Create and complete a business e-Profile account: Once your request has been submitted, it may take up to 3 business days for processing. NABP's Verified Pharmacy Program (VPP ) is the most widely recognized multistate, uniform inspection program accepted by state boards of pharmacy across the nation.. Application Processing Timeframes. In order for comments to be considered by the division, they must be submitted to the division in writing not later than the deadline provided by the division on this website. 0000002761 00000 n
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Apply for VPP as a standalone program or maximize your investment by creating a comprehensive compliance package for one streamlined, cost-effective accreditation process. )Av0Yq"K % ) C%rY+\3ODh|X3AHzq hPdFr0j. (ii) A pharmacy operated by the state or a local government that qualifies for a Class D license is not required to pay a fee to obtain a license. 0000004294 00000 n
Speak with a Federal Defense Lawyer about Your DEA Pharmacy Inspection. 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. 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. Note your area(s) of interest in the message box. 1100 San Jacinto 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. It seems that JavaScript is not working in your browser. a Og
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(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). 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. 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. Z/*Fg"^Z"b!"E}}CCccSSssKK"Ftkw$s|x:
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State Agencies State Jobs ADA Assistance. It is the responsibility of the individual designated pharmacist to acquire the appropriate number of hours from the areas outlined above and maintain a records of the courses that have been completed. Consumer Protection and Enforcement. Working together to create a state-based program of robust inspection processes. Public comments will be accepted through April 3, 2023. 0000099488 00000 n
immediate reporting of significant violations of state and federal law. NABPs Verified Pharmacy Program (VPP) is the most widely recognized multistate, uniform inspection program accepted by state boards of pharmacy across the nation. 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. Texas Sterile Compounding Regulations. 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. if (document.images) {document.images[id].src=eval(name+".src"); } WHAT THE BOARD EXPECTS FROM YOU The Board of Pharmacy appreciates your cooperation during this inspection. //help_ftr_01_05 = new Image(38, 28);help_ftr_01_05.src = '/images/help_nav.gif'; 0000010680 00000 n
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This documentation must be available in hard-copy
or electronic format for inspection by the board. // 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) )/9xpXyN|3O,D\ 74TPxj%A`e+9F%M"IFA{P @UXs&]MYxL4_2cde`V4n %yw23097Mebs,Y6iS0r##b&q m,2a`cy2m (.BU1CSC[V b 0000004842 00000 n
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(512) 463-2000, Office of the Texas Governor | Greg Abbott. 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 2020 National Association of Boards of Pharmacy (NABP). Contact our. The self-inspections are completed on forms the commission provides. Disclosure of Disciplinary Action, Arrest, or Conviction. 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.