)Av0Yq"K % ) C%rY+\3ODh|X3AHzq hPdFr0j. xref Pharmacy Services Committee meets at least annually. Once received and reviewed, a member from the Attn: Regulatory Compliance Division // 0000007246 00000 n H< *xLJH3Bi= Vf``dde f9L}f9R390Y This documentation must be available in hard-copy or electronic format for inspection by the board. . Office of the Governor 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. 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. To view the divisions determination letters, please visit the Determination Letters page. w*5/_k`UZWl6 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. and scope of a State Board of Pharmacy's inspection authority. 0000002587 00000 n 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. (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). DownloadGuidance For Affected State Agencies as PDF, Download Rule Submission Memorandum Template as PDF. 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. TEXAS STATE BOARD OF PHARMACY 1801 Congress Avenue Suite 13.100 Austin, TX 78701 (512) 305-8000 www.pharmacy.texas.gov LIC-000A (07/2022) Page 1 . 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. All registrants, however, are subject to inspection. Box 12428 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. The third-party pharmacy inspection program most widely recognized by state boards of pharmacy across the nation. RJH Form F0904 (07/17/2014 - Rev. (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. 1405 0 obj <> endobj Share inspection reports with other states (if not prohibited by state law). 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. 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 TNcc Z/*Fg"^Z"b!"E}}CCccSSssKK"Ftkw$s|x: >NH6` qw~ In order for comments to be considered, the identity of the commenter must be clearly indicated. 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. 0000005586 00000 n Agree that the inspectors/compliance officers will participate in annual training. 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. 0000001910 00000 n 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. 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. immediate reporting of significant violations of state and federal law. endstream endobj 126 0 obj <>>> endobj 127 0 obj <> endobj 128 0 obj <>/ExtGState<>/Font<>/ProcSet[/PDF/Text/ImageB]/Properties<>/XObject<>>>/Rotate 0/TrimBox[0.0 0.0 603.0 783.0]/Type/Page>> endobj 129 0 obj [130 0 R 131 0 R] endobj 130 0 obj <>/Border[0 0 0]/H/N/Rect[184.427 232.173 211.238 221.355]/Subtype/Link/Type/Annot>> endobj 131 0 obj <>/Border[0 0 0]/H/N/Rect[99.6259 221.173 177.511 210.355]/Subtype/Link/Type/Annot>> endobj 132 0 obj <> endobj 133 0 obj <> endobj 134 0 obj <> endobj 135 0 obj [/Separation/PANTONE#20302#20U/DeviceCMYK<>] endobj 136 0 obj <> endobj 137 0 obj <> endobj 138 0 obj <> endobj 139 0 obj <>stream } Austin, Texas 78711-2428, Office of the Governor Texas Sterile Compounding Regulations. 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). 0000010119 00000 n var showMsg = navigator.userAgent != "Mozilla/4.0 (compatible; MSIE 4.0; Mac_PowerPC)"; P.O. H\j }X4!B.zi IVhs*0?#dzmyZDpe9(-=[8u8XY Pharmacy inspections will not change, but the report pharmacies receive will. 6 0 obj << /Length 7 0 R /Filter /FlateDecode >> stream 0000037594 00000 n endstream endobj 142 0 obj <> endobj 143 0 obj <>stream Want to pursue NABP Compounding Pharmacy Accreditation for which VPP is a prerequisite. It seems that JavaScript is not working in your browser. OVERVIEW. endstream endobj 1406 0 obj <>/Metadata 66 0 R/Names 1446 0 R/OpenAction 1407 0 R/Outlines 175 0 R/PageLayout/SinglePage/Pages 1399 0 R/StructTreeRoot 186 0 R/Type/Catalog/ViewerPreferences<>>> endobj 1407 0 obj <> endobj 1408 0 obj <>/Font<>/ProcSet[/PDF/Text/ImageC]/Shading<>/XObject<>>>/Rotate 0/StructParents 0/Tabs/S/TrimBox[0.0 0.0 612.0 792.0]/Type/Page>> endobj 1409 0 obj <>stream In the future, participation may expand to include general pharmacy and nonsterile compounding. 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. To speak with a member of our federal defense team about your DEA pharmacy inspection, please call 888-680-1745 or contact us online. 0 Texas State Board of Plumbing Examiners, Title 22 Texas Administrative Code 361.1, 361.4, 361.6, 361.10, 361.12, and 361.15. 0000030593 00000 n 0000037169 00000 n 0000014097 00000 n Attn: Regulatory Compliance Division if (showMsg) { This inspection program is part of the Compounding Pharmacy Information-Sharing Project developed in partnership with FDA, NABP, and the boards of pharmacy. } and other areas that are in close proximity to the ISO Class 5 environment during the certification of the primary engineering control. H\j0l/Wi\pIjhd8y)]Xh&v?mr>v.5vc\lXyLvP+nn /r;[Vco9+]{U}Iv26&Z-_bl;&u"/Og3xC- 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. 0000030857 00000 n } Inspect the sterile compounding pharmacies no less than once every 18 months.