{"data":{"id":"us-ok/okla.-stat.-tit.-63-63-2209.1","jurisdiction":"us-ok","citation":"Okla. Stat. tit. 63, § 63-2209.1","heading":"Permits - Rules","body":"A. On or after November 1, 1999, no person, corporation,\n\npartnership, association or other legal entity shall establish,\n\noperate or maintain a tissue bank that procures bone, skin, or\n\nconnective tissue unless that entity has been issued a permit by the\n\nState Department of Health.\n\nB. The State Board of Health shall promulgate rules necessary\n\nto implement the provisions of this section which shall include, but\n\nnot be limited to:\n\n1. Requirements for the tissue banks to submit an initial\n\npermit application that identifies the proposed service area, the\n\ntissue transplantation patient needs in the service area, the\n\nprobable impact of the establishment and operation of the entity on\n\nother tissue banks currently servicing the area, and whether the\n\ntissue bank is a for profit or not for profit entity;\n\n2. A requirement that tissue banks, within one (1) year after\n\nreceipt of a permit, be accredited by the American Association of\n\nTissue Banks or another nationally recognized accreditation\n\norganization for tissue agencies;\n\n3. Provisions that all tissue banks employ a procurement\n\ntechnician or other technical operations personnel certified as a\n\nCertified Tissue Bank Specialist by the American Association of\n\nTissue Banks or another nationally recognized accreditation or\n\ncertification organization for tissue agencies and personnel;\n\n4. A requirement that each tissue bank maintain compliance with\n\nfederal Food and Drug Administration regulations;\n\n5. A provision that each tissue bank have a medical director\n\nwho is a physician licensed to practice medicine in this state;\n\n6. Requirements for tissue banks to give priority in tissue\n\ndistribution to the Oklahoma medical community and Oklahoma\n\npatients; and\n\n7. A requirement that each tissue bank submit an annual report\n\nto the Department which shall provide the accreditation status of\n\nthe entity, report of regulatory or internal inspections that affect\n\nquality, the certification status of personnel employed by the\n\ntissue agency, identity and qualification of the current medical\n\ndirector, type and geographic origins of donor tissue obtained, and\n\nunits of processed tissue used for patients in the service area of\n\nthe tissue bank.\n\nC. A permit application or renewal thereof, shall be\n\naccompanied by a non-refundable fee established by the Board of\n\nHealth not to exceed One Thousand Dollars ($1,000.00).\n\nD. Upon receipt of a complete initial permit application, the\n\nDepartment shall cause a public notice of the proposed tissue bank\n\nto be published in a newspaper with the greatest circulation. The\n\nDepartment shall also provide written notice of the permit\n\napplication to existing tissue banks in the state. Any person or\n\norganization may submit written comments regarding the proposed\n\ntissue bank to the Department.\n\nE. The Department shall issue or deny an initial permit within\n\nseventy-five (75) days after publication of the notice. All permits\n\nshall be issued for a period not to exceed thirty-six (36) months\n\nand shall automatically expire unless renewed.\n\nF. The Department may deny, revoke, suspend or not renew a\n\npermit for failure of a tissue bank to comply with the provisions of\n\nthis section or rules promulgated pursuant thereto. Any tissue bank\n\nthat has been determined by the Department to have violated any\n\nprovision of this section or rule promulgated pursuant thereto, is\n\nliable for an administrative penalty of no more than One Hundred\n\nDollars ($100.00) for each day on which a violation occurs or\n\ncontinues. The maximum administrative penalty shall not exceed Ten\n\nThousand Dollars ($10,000.00) for any related series of violations.\n\nG. The issuance, denial, suspension, non-renewal or revocation\n\nof a permit may be appealed under the provisions of Article II of\n\nthe Administrative Procedures Act, Section 308a of Title 75 of the\nd\n\nDollars ($100.00) for each day on which a violation occurs or\n\ncontinues. The maximum administrative penalty shall not exceed Ten\n\nThousand Dollars ($10,000.00) for any related series of violations.\n\nG. The issuance, denial, suspension, non-renewal or revocation\n\nof a permit may be appealed under the provisions of Article II of\n\nthe Administrative Procedures Act, Section 308a of Title 75 of the\n\nOklahoma Statutes.\n\nH. The Department may bring an action in a court of competent\n\njurisdiction for equitable relief to redress or restrain any entity\n\nfrom providing tissue bank services without a valid permit. Said\n\ncourt shall have jurisdiction to determine said action, and to grant\n\nthe necessary appropriate relief, including but not limited to,\n\nmandatory or prohibitive injunctive relief or interim equitable\n\nrelief.","path":["OK Code","Title 63"],"source_url":"https://www.oklegislature.gov/OK_Statutes/CompleteTitles/os63.pdf","current_through":"2026-08-14","vintage":"open-us-law v2026.08, retrieved 2026-09-14","retrieved_at":"2026-09-14T18:32:36Z","sha256":"5cff7cfed8ece3222bb761cb18fb1a275ebf60a185156ac09770edbeafff5d42","source_id":"us-ok","stale":false,"prev":"us-ok/okla.-stat.-tit.-63-63-2200.9a","next":"us-ok/okla.-stat.-tit.-63-63-2210"},"notice":"GroundRules: Original legal text. Not legal advice."}