Revenuelaw.state.fl.us

The term "chemical compound" is not defined for purposes of the exemption from tax for this item under section 212.08(2)(a), F.S., so the plain and ordinary meaning of the words must be considered. The term "chemical" is defined as "a substance.obtained by a chemical process, prepared for use in chemical manufacturing or used for producing a chemical effect." Webster's Third New International Dictionary of the English Language, Unabridged (hereafter referred to as "Webster's"), page 384. The term "compound" is defined as "composed of or produced by the union of several elements, ingredients, parts or things." Webster's at page 466. A chemical compound would be a mixture or product, comprised of various components and prepared via a chemical process, having as a purpose the production of a chemical effect. A "reagent" is "a substance used for various purposes (as in detecting, examining or measuring other substances.) because it takes part in one or more chemical reactions or biological processes." Webster's at page 1890. As such, a reagent would be encompassed by the term "chemical compound." Since Federal regulations and Florida regulations both require that a batch of patient test results must be validated by the use of calibration material or a control sample before the test results can be reported to the prescribing physician, calibrators and controls are a necessary part of the procedure which is used in the diagnosis or treatment of human disease, illness, or injury. As such the sale of reagents, calibrators, and controls to medical practitioners and testing laboratories in this state for use in testing patient specimens are exempt from tax as chemical compounds used for the diagnosis of human disease pursuant to section *********************************************************** This is in response to your letter of December 13, 1996, in which you requested the issuance of a technical assistance advisement on behalf of your client XXX (hereinafter "Taxpayer"), regarding the taxable or exempt status of its sales of reagents, calibrators, and controls, to medical practitioners and testing laboratories in the state of Florida. Your client believes it has been erroneously collecting and remitting sales tax on its sales in this state, and wishes to file for a refund You provided our office with an Analyte Application Manual, which describes each Automated Immunoassay System sold by your client together with the materials provided and needed to perform the various tests. A review of the manual clarifies that each System (test kit) is sold separately from the sale of calibrator sets and other materials which are used to perform Your letter provides in pertinent part: [Taxpayer] manufacturers and sells in Florida a variety of Automated Immunoassay Systems (AIA Systems) used for diagnosing and treating human disease, illness and injury. These AIA Systems are of several types and include several types of tests: (1) Thyroid Hormones: TSH, T4, T-Uptake, T3, and Free T4; (2) Tumor Markers: AFP, PSA, and CEA,.; (3) Anemia Markers: Ferritin; (4) Reproductive Hormones: HCG(intact), FSH, Prolactin, Progestrone, Total Beta HCG, LH, and Estradiol; and (5) Additional Analysis: CKMB, Cortisol, C-Peptide, Beta-2 Microglobulin, Insulin, [Taxpayer] sells reagents, calibrators and controls to accredited and non-accredited hospitals as well as independent and physician office laboratories. [Taxpayer's] customers are governed by regulations implemented by the Clinical Laboratory Improvement Amendments of 1988 (CLIA) which became effective January 1, 1992. The relevant portions of the regulations relating to the implementation of the regulations of CLIA are attached These reagents, calibrators and controls are chemical compounds and test kits that [Taxpayer's] customers use for diagnosing and treating human disease, illness and injury. More specifically, reagents, calibrators and controls sold by [Taxpayer] are used by the customers to test human blood, urine or tissue samples from the patient to determine if the person Section 212.08(2)(a), F.S., provides in part: (a) There shall be exempt from the tax imposed by this chapter any product, supply, or medicine dispensed in a retail establishment by a pharmacist licensed by the state, according to an individual prescription or prescriptions written by a prescriber authorized by law to prescribe medicinal drugs; hypodermic needles; hypodermic syringes; chemical compounds and test kits used for the diagnosis or treatment of human disease, illness, or injury; and common household remedies recommended and generally sold for internal or external use in the cure, mitigation, treatment, or prevention of illness or disease in human beings, but not including cosmetics or toilet articles, notwithstanding the presence of medicinal ingredients therein, according to a list prescribed and approved by the Department of Health and Rehabilitative Services, which list shall be certified to the Department of Revenue from time to time and included in the rules promulgated by the Department of Revenue. There shall also be exempt from the tax imposed by this chapter artificial eyes and limbs; orthopedic shoes; prescription eyeglasses and items incidental thereto or which become a part thereof; dentures; hearing aids; crutches; prosthetic and orthopedic appliances; and funerals. (Emphasis Supplied) Rule 12A-1.020(7)(a) and (b), F.A.C., provides: (7)(a) The chemical compounds and test kits specified in this paragraph which are used for the diagnosis or treatment of disease, illness or injury are specifically exempt. Examples of chemical compounds and test kits include, but are not limited to the following: Albustix reagent strips and tablets; blood pressure units; cholesterol tests; clinistix reagent strips; clinitest tablets; combistix reagent strips; dextrostix, reagent strips; dextrotest kit and refills; diabetic test kits; galatest; ictotest reagent tablets; sugar test tablets for diabetics; thermometers for human use; tuberculin patch test; urine testing kits; urograph test. (b) Likewise exempt is any chemical compound and test kit used for the diagnosis or treatment of disease, illness, or injury, ordered and dispensed in a retail establishment by a pharmacist licensed by the State of Florida, according to an individual prescription or prescriptions written by a duly licensed practitioner authorized by the laws of the Section 212.08(2)(a), F.S., exempts from tax, chemical compounds and test kits which are used for the diagnosis or treatment of human disease, illness, or injury. The term "chemical compound" is not defined for purposes of this statutory exemption, so the plain and ordinary meaning of the words must be considered. The term "chemical" is defined as "a substance. obtained by a chemical process, prepared for use in chemical manufacturing or used for producing a chemical effect." Webster's Third New International Dictionary of the English Language, Unabridged (hereafter referred to as "Webster's"), page 384. The term "compound" is defined as "composed of or produced by the union of several elements, ingredients, parts or things." Webster's at page 466. A chemical compound would be a mixture or product, comprised of various components and prepared via a chemical process, having as a purpose the production of a chemical effect. A "reagent" is "a substance used for various purposes (as in detecting, examining or measuring other substances.) because it takes part in one or more chemical reactions or biological processes." Webster's at page 1890. As such, a reagent would be encompassed by the term "chemical compound." Controls are reagents which are used for quality control of the particular test being done. Calibrators contain reagents which are used to calibrate the particular test. Therefore, the controls and calibrators in question fit the description of "chemical compounds " under s. 212.08(2)(a), F.S. It must be determined whether these reagents or chemical compounds, are used for the diagnosis or treatment of human disease, illness, or injury. Federal Regulation section 493.1218, requires that, for quantative testing, testing laboratories that report patient specific results must include at least two samples of either calibration materials or control materials not less frequently than once each run of patient samples in order to assess the accuracy and precision of patient Rule 59A-7.029(7), F.A.C., states that control samples must be included at least once with each run of patient specimens; must be tested in the same manner as patient specimens; must be processed through each step of patient testing; and must meet the laboratory's criteria for acceptability prior to reporting Since the Federal regulations and the Florida regulations both require that a batch of patient test results must be validated by the use of calibration material or a control sample, such as the ones in question, before the test results can be reported to the prescribing physician, these calibrators and controls are a necessary part of the procedure which is used in the diagnosis or treatment of human disease, illness, or injury. As such, your client's sales of reagents, calibrators, and controls to medical practitioners and testing laboratories in this state for use in testing patient specimens are exempt from tax as chemical compounds used for the diagnosis of human disease pursuant to section 212.08(2)(a), F.S. Concerning applications for refunds of sales tax, section 215.26(2), F.S., provides that they must be filed with the Comptroller within 3 years after the right to the refund shall have accrued, except applications for refunds of sales tax which was paid after September 30, 1994, must be filed with the Comptroller within 5 years after the date the tax is paid. If your client has sold chemical compounds and test kits which are exempt from tax, and collected tax thereon, it must first refund the tax to its customers before filing an application for refund with the Department on form DR-26. Your client must provide documentation with its refund application to show that the items are exempt from tax and that the tax was refunded to its This response constitutes a Technical Assistance Advisement under s. 213.22, F.S., which is binding on the department only under the facts and circumstances described in the request for this advice as specified in s. 213.22, F.S. Our response is predicated on those facts and the specific situation summarized above. You are advised that subsequent statutory or administrative rule changes or judicial interpretations of the statutes or rules upon which this advice is based may subject similar future transactions to a different treatment than You are further advised that this response and your request are public records under Chapter 119, F.S., which are subject to disclosure to the public under the conditions of s. 213.22, F.S. Your name, address, and any other details which might lead to identification of the taxpayer must be deleted by the Department before disclosure. In an effort to protect the confidentiality of such information, we request you notify the undersigned in writing within 15 days of any deletions you wish made to the

Source: https://revenuelaw.state.fl.us/LawLibraryDocuments/1997/01/TAA-102510_7431f562-69a2-4359-9693-410e93ef69b7.pdf