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AGENCY FOR HEALTH CARE ADMINISTRATION vs CREATIVE LIVING CENTERS, INC., D/B/A COVE MANOR RETIREMENT, 02-002511 (2002)
Division of Administrative Hearings, Florida Filed:Panama City, Florida Jun. 20, 2002 Number: 02-002511 Latest Update: Mar. 19, 2003

The Issue The issues are whether Respondent failed to maintain an accurate medication record relating to narcotic medications in violation of Section 400.419(1)(b), Florida Statutes, and Rule 58A-5.0185(3)(b), Florida Administrative Code; and if so, what penalty should be imposed.

Findings Of Fact Petitioner has authority to license assisted living facilities (ALFs) and the duty to enforce all statutes and rules governing such facilities. Respondent is a licensed ALF with a total capacity for 35 residents. Respondent's License No. AL5888 is effective March 20, 2002, through March 19, 2004. On January 31, 2002, Petitioner completed a biennial survey of Respondent's facility. During the survey, Petitioner's staff observed Respondent's staff administering medication to six residents who needed medication assistance. Resident No. 6 received a narcotic medication, in tablet form, that she was supposed to take by mouth three times daily, as needed, for pain. The medication is addictive and may be obtained only by prescription. The prescription bottle at issue here indicated that it was filled on January 21, 2002, with 100 tablets. There is no other evidence regarding the number of tablets in the bottle when it arrived at Respondent's facility. Respondent did not count the tablets in the bottle upon receiving it from the pharmacy. Resident 6's MOR showed that she received the narcotic tablet three times daily, everyday, with no missed doses during the time period at issue here. According to the MOR, Resident 6 received a total of 32 doses of the medication beginning January 21, 2002, at 7:00 a.m. through January 31, 2002, at 12:25 p.m. However, the bottle contained only 54 tablets as of January 31, 2002, at 12.25 p.m. Respondent's staff could not explain or account for the 14 missing narcotic tablets. Under cover of a letter dated February 12, 2002, Petitioner advised Respondent that the biennial survey had identified a Class II deficiency relative to Resident 6's medication administration. The letter requested Respondent to file a plan of correction within ten days. Resident 6's narcotic medication was refilled on February 19, 2002, with 100 tablets. As of March 8, 2002, Resident 6 had 51 pills remaining in the new prescription bottle. On March 8, 2002, Petitioner's staff conducted a follow-up visit to Respondent's facility. The count of tablets in Resident 6's narcotic medication prescription bottle, when compared to the MOR, was correct at that time. Under cover of a letter dated March 15, 2002, Petitioner advised Respondent that the previously cited deficiency had been corrected.

Recommendation Based on the foregoing Findings of Facts and Conclusions of Law, it is RECOMMENDED: That Petitioner enter a final order dismissing the Administrative Complaint. DONE AND ENTERED this 10th day of October, 2002, in Tallahassee, Leon County, Florida. SUZANNE F. HOOD Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 10th day of October, 2002. COPIES FURNISHED: Michael O. Mathis, Esquire Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building Three, Suite 3431 Tallahassee, Florida 32308-5403 Alvin L. Peters, Esquire 25 East Eighth Street Panama City, Florida 32401 Lealand McCharen, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 Valda Clark Christian, General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3431 Tallahassee, Florida 32308

Florida Laws (2) 120.569120.57
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DEPARTMENT OF CHILDREN AND FAMILIES vs KID CITY USA - SANFORD, 12-002856 (2012)
Division of Administrative Hearings, Florida Filed:Orlando, Florida Aug. 24, 2012 Number: 12-002856 Latest Update: Oct. 03, 2024
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BOARD OF DENTISTRY vs. NORMAN G. BECKER, JR., 81-002672 (1981)
Division of Administrative Hearings, Florida Number: 81-002672 Latest Update: Feb. 22, 1982

Findings Of Fact Respondent, Norman G. Becker, Jr., is a licensed dentist having been issued license number DN 0002281 by Petitioner, Department of Professional Regulation, Board of Dentistry. He has practiced dentistry in the State since 1958. On or about September 8, 1980, Respondent furnished one William R. Northlick, 101 North Grandview, Mount Dora, Florida, a written prescription for four-ounces of dimethvl sulfoxide (DMSO). Northlick had been a patient of Respondent for approximately ten years, had complained of severe elbow pain, and inquired as to the status of DMSO and where it could be obtained. Respondent told him it was available at a local drug store and advised he could try a small amount. At an undisclosed date in 1980, Respondent was approached by a professional golfer named Gary Weintz who commlained of golfers elbow and who asked about the availability of DMSO. Respondent is active in arranging golf functions on the Professional Golf Association-(PGA) tour and presumably met Weintz, uho is a member of the PGA, in that capacity. Respondent telephoned William Kennedy, a pharmacist at Thayer's Colonial Pharmacy in Orlando, Florida, and asked whether DMSO could be legally prescribed. Kennedy replied that he believed it permissible for Becker to assist Weintz in obtaining the drug and thereafter took a prescription for the same over the telephone. Before filling the prescription, Kennedy required Weintz to sign a patient release form acknowledging that DMSO was a veterinary product and releasing anyone from liability due to its use. Other than the two occasions referred to above, Becker has not prescribed DMSO at any time. He did not charge Northlick or Weintz for his assistance nor did he provide any follow-up care or treatment to either individual. Respondent has never personally used DMSO or applied it to any other patient or friend. Respondent has been a practicing dentist in Florida since 1958, and has lived in Winter Park, Florida, for the last eighteen years. His specialty is periodontics and he was the founder and first president of the Florida Society of Periodontics. He enjoys an excellent personal and professional reputation in the community. This was attested to by Dr. Neil G. Powell, immediate past president of the Florida Dental Association. Other than the present incident, Respondent's record has been exemplary, and he has never been subject to prior disciplinary action. Although Becker wrote the prescription for Northlick on a prescription pad, he did not consider it to be a prescription item". Rather, he considered it the same as when giving customers written instructions for obtaining water piks, electric toothbrushes and other non-prescription items. For this reason, he wrote the words "use as directed" on the prescription pad in lieu of the detailed instructions typically given when writing a normal prescription.

Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that Respondent be found guilty of violating Subsection 466.028(1)(z), Florida Statutes, as charged in the Administrative Complaint and that the remaining charge in paragraph 11a be dismissed. It is further RECOMMENDED that Respondent be issued a private reprimand. DONE and ENTERED this 22nd day of February, 1982, in Tallahassee, Florida. DONALD R. ALEXANDER Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 22nd day of February, 1982. COPIES FURNISHED: Theodore R. Gay, Esquire 130 North Monroe Street Tallahassee, Florida 32301 James F. Page, Jr., Esquire P.O. Box 3068 Orlando, Florida 32802 Salvatore A. Carpino, Esquire 130 North Monroe Street Tallahassee, Florida 32301

Florida Laws (2) 120.57466.028
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R & B PHARMACY, INC., AND BOARD OF PHARMACY vs. ALBERT HOLTZBERG, 77-000615 (1977)
Division of Administrative Hearings, Florida Number: 77-000615 Latest Update: Nov. 14, 1977

Findings Of Fact Holtzberg is a pharmacist holding a license issued by the Florida Board of Pharmacy. R & B Pharmacy, Inc. is a permittee holding a permit issued by the Florida Board of Pharmacy. Albert Holtzberg is the owner/operator of R & B Pharmacy, Inc. The drugs enumerated in the complaint were discovered on the premises of R & B Pharmacy by V. K. Bell, agent of the Board, during an inspection. These drugs were in containers which were not their original containers and which did not bear labels containing names and place of business of the manufacturer, packer, or distributor, and an accurate statement of the contents interms of weight, measure, or numerical count. The drugs found by Bell and enumerated in the complaint were purchased by Holtzberg for the purpose of resale and delivered to Holtzberg in plastic bags with the labels inside the bags. These labels had not been placed on the containers in which Holtzberg had placed the drugs.

Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, the Hearing Officer recommends that the Florida Board of Pharmacy suspend the license of Holtzberg for one year and that the permit of R & B Pharmacy, Inc. be suspended until Albert Holtzberg has satisfied the Board that a qualified pharmacist has been appointed in the manner required by law as manager of the prescription department of R & B Pharmacy. DONE and ORDERED this 6th day of October, 1977, in Tallahassee, Florida. STEPHEN F. DEAN Hearing Officer Division of Administrative Hearings 530 Carlton Building Tallahassee, Florida 32304 (904) 488-9675 COPIES FURNISHED: Harvey I. Silverman, Esquire 4620 West Commercial Boulevard Suite 2 Tamarac, Florida 33319 Michael Schwartz, Esquire Ellis Building Suite 201 1311 Executive Center Drive Tallahassee, Florida 32301

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LEMMON CO vs. BOARD OF PHARMACY AND BOARD OF MEDICINE, 89-002644RX (1989)
Division of Administrative Hearings, Florida Number: 89-002644RX Latest Update: Jul. 25, 1989

Findings Of Fact Section 465.025(2), Florida Statutes, states that, when filling prescriptions for medication, Florida pharmacists must substitute less expensive generically equivalent drugs for the physician-prescribed medication, unless the physician or patient requests otherwise. A "generically equivalent drug product" is defined at section 465.025(1)(b), Florida Statutes, to mean the same active ingredient, finished dosage form, and strength. For a physician to indicate that the prescription should be filled as written, the statute provides at section 465.025(2), Florida Statutes, that the doctor must write the words "medically necessary" on the prescription, or in the case of an oral prescription, so indicate to the dispensing pharmacist. Section 465.025(6), Florida Statutes, provides for the establishment of a "negative drug formulary." The formulary is a list of drug products which are determined by the Boards of Pharmacy and Medicine "to demonstrate clinically significant biological or therapeutic inequivalence and which, if substituted, would pose a threat to the health and safety of patients receiving prescription medication." Substitution by a pharmacist of a generic drug for a physician- prescribed brand name drug is prohibited in cases where the drug is included in the negative formulary. The Boards have established the formulary by Rule 215- 5.001 Florida Administrative Code. Neither the statute nor rule provide a definition of "clinically significant biological or therapeutic inequivalence." In the case of carbamazepine, it is clear that clinically significant biological or therapeutic inequivalence between brand Tegretol and the generic formulations would pose a serious threat to the health and safety of patients taking the medication. The rate at which active ingredients are dissolved and absorbed into the blood stream, and the time period during which such ingredients remain at therapeutic levels are critical in terms of properly titrating patient dosage levels. In the case of carbamazepine, the task is further complicated by the fact that carbamazepine affects its own elimination from the human body. On May 1, 1987, the Board of Pharmacy received a request from Ciba- Geigy, a pharmaceutical company, to add carbamazepine to the "negative drug formulary." Carbamazepine is the generic name for an anticonvulsant drug used in the treatment of epilepsy and other disorders. The effect of placing carbamazepine on the negative drug formulary would be to prohibit the substitution of generic carbamazepine for physician-prescribed "Tegretol," a Ciba-Geigy product. Carbamazepine was first marketed under thee brand name Tegretol, the so-called "innovator" form of the medication. Following the expiration of Ciba- Geigy's proprietary rights to the chemical formulation marketed as Tegretol, generic carbamazepine manufacturers began to produce the drug. Tegretol is still manufactured and marketed by Ciba-Geigy. In addition to Ciba-Geigy, there are six manufacturers of generic carbamazepine. Lemmon Company manufactures and markets "Epitol," one of the generic carbamazepine products. Tegretol and Epitol are conceded by the Respondent to be virtually identical. Lemmon Company manufactures and markets innovator and generic drugs distributed in Florida through sales to small independent pharmacies, wholesalers and chain pharmacies. Annual Epitol sales in Florida are estimated to be approximately $560,000. Ciba-Geigy, as justification for the request to add carbamazepine to tide negative formulary, asserts that the biological and therapeutic inequivalence between brand Tegretol and generic carbamazepine causes seizures or other side effects in patients who are switched from Tegretol to generic carbamazepine. However, the evidence does not establish clinically significant differences between Tegretol and generic carbamazepine which would support a finding of biological or therapeutic inequivalence. The evidence does not support a finding that alleged seizures or other side effects, where they have occurred, have resulted from the change in medication. The prohibition against the substitution, by a dispensing pharmacist, of a generic drug for a brand name drug is clearly beneficial to the branded drug's maker and detrimental to the manufacturers of the generic products. Because Tegretol, as the innovator, was the sole available formulation of carbamazepine for an extended period of time, prescribing physicians are more likely to be aware of, and to prescribe, the brand name Tegretol. Prohibition of generic substitutions undoubtedly impacts the sales of such generic drugs; thus Lemmon Company is substantially affected by the action of the Respondent in placing carbamazepine on the negative drug formulary. Following receipt of the Ciba-Geigy request, the Director of the Board of Pharmacy referred the issue to the Negative Formulary Study Committee for review. The study committee includes consultants to the board from the University of Florida Colleges of Pharmacy and Medicine. The review process apparently provides for initial consideration by the study committee which makes recommendations to the Negative Formulary Committee which, in turn, makes recommendations to the Boards of Pharmacy and Medicine. On July 1, 1987, the study committee considered the Ciba-Geigy request, including information submitted by Ciba-Geigy apparently consisting of limited anecdotal data, and thereafter elected not to recommend carbamazepine for inclusion on the negative drug formulary. The rationale for the determination was that the anecdotal information provided by Ciba-Geigy was not persuasive, and that there was no well-controlled clinical evidence demonstrating therapeutic differences between carbamazepine brands. On September 22 and November 25, 1987, the study committee met and again considered the Ciba-Geigy request. Additional anecdotal information had been received, primarily letters from physicians supporting inclusion of carbamazepine on the negative drug formulary. Further, Ciba-Geigy had submitted information related to six European studies purporting to establish the inequivalence of various carbamazepine formulations. The study committee found the information to contain "considerable inconsistency" and again elected not to recommend placement of carbamazepine on the negative drug formulary. The study committee suggested deferral of further consideration pending completion of a controlled study (the "Penry" study, which remains in progress) which may provide additional information related to alleged inequivalence of Tegretol and generic carbamazepine. On May 31, 1988, the study committee met and again declined to recommend that carbamazepine be included on the negative drug formulary. The study committee considered information, apparently erroneous, related to the Veteran's Administration Hospital System, but nonetheless chose to await the results of the Penry study. On November 1, 1988, four members of the Negative Formulary Committee, met by telephone conference call. The Negative Formulary Committee includes members of the Boards of Pharmacy and Medicine. At that time, the committee decided to recommend, to both boards, that carbamazepine be included in the negative formulary. There is limited evidence indicating the basis upon which this committee took the action. The committee may have considered the anecdotal information contained in letters submitted by physicians supporting the placement of carbamazepine on the formulary. It may have also considered a prior recall of a substantial number of generic carbamazepine dosages which apparently failed to meet FDA standards for tablet dissolution. The committee may have reviewed copies of adverse drug reports (ADRs) provided by Ciba-Geigy purporting to show adverse patient reactions to generic carbamazepine. At least one member of the committee may have considered telephone conversations with randomly selected physicians in his vicinity. Notice of the intent to add carbamazepine to the negative drug formulary was published in the December 16, 1988 edition of Florida Administrative Weekly. The Board of Pharmacy met on January 10, 1989. The Board of Medicine met on February 5, 1989. Both boards considered essentially the same materials and evidence related to the issue of placing carbamazepine on the negative drug formulary. Both boards elected to place carbamazepine on the negative drug formulary. Materials considered by the boards included physician letters, ADRs, and scientific articles relating to carbamazepine equivalency studies. The boards were aware of the recall of a significant quantity of generic carbamazepine tablets. There was discussion related to FDA standards and testing methods, and concern expressed related to interchangeability between carbamazepine products. There was discussion of Florida's Medicaid program, apparently, at least in part, based upon erroneous information, and on the carbamazepine-related issues being considered in at least one other state. Standards and specifications relating to the quality and purity of drugs available in the U.S. are established by the United States Pharmacopeia (USP), an independent entity, which has established such standards for carbamazepine. There is no evidence which would suggest that USP standards for carbamazepine are inadequate or erroneous. Such standards are found to be reasonable. The U.S. Food and Drug Administration (FDA) has responsibility for evaluation and control of prescription and generic drug products marketed in this country. The FDA utilizes the specifications and standards developed by the USP. As part of this responsibility, the FDA monitors the therapeutic equivalency of innovator and generic drugs marketed in the U.S., and makes specific findings as to such equivalence. Such findings are identified in the publication, Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referred to as the "Orange Book." Drug products considered to be therapeutic equivalents by the FDA are pharmaceutical equivalents that can be expected to have the same therapeutic effect when administered to patients under the conditions specified in the labeling. As stated in the Orange Book, the FDA evaluates as therapeutically equivalent those products that meet the following general criteria: they are pharmaceutical equivalents in that they contain identical amounts of the same active drug ingredient in the same dosage form, and meet compendial or other applicable standards of strength, quality, purity, and identity; they are bioequivalent in that they do not present a known or potential bioequivalence problem, and they meet an acceptable in vitro standard, or if they do present such a known or potential problem, they are shown to meet an appropriate bioequivalence standard matching both rate and extent; they are adequately labeled; and they are manufactured in compliance with Current Good Manufacturing Practice regulations. According to the FDA Orange Book, drug products are considered pharmaceutical equivalents if they contain the same active ingredients and are identical in strength or concentration, dosage form, and route of administration, and meet the same or comparable standards, as to strength, quality, purity, and identity. They may differ in characteristics such as color, flavor, shape, scoring configuration, packaging, preservatives; expiration time, and, within certain limits, labeling. Bioequivalent drug products are those which display comparable bioavailability when studied under similar experimental conditions. Bioavailability describes the rate and extent to which the active drug ingredient or therapeutic ingredient is absorbed from a drug product. Drugs are considered to be bioequivalent when the rate and extent of absorption of the test drug do not show a significant difference from the rate and extent of absorption of the reference drug, when such drugs are administered at the same therapeutic ingredient dose under similar experimental conditions. (There are further, unrelated standards by which bioavailabilty may be determined which are not relevant to this proceeding.) The FDA does not compare generic drugs for equivalency between generics, the assumption being that if the generics are biologically and therapeutically equivalent to the innovator reference, they will be equivalent among themselves. The greater weight of the evidence indicates that the assumption is reasonable. The FDA utilizes a series of two letter codes to identify therapeutic equivalency evaluation findings. The first letter of the code identifies whether a drug is considered to be therapeutically equivalent; the second letter identifies the basis for the equivalence evaluation. The drug products are listed in the Orange Book according to active ingredient, dosage form and strength. The FDA Orange Book identifies the 200 mg. oral tablet generic carbamazepine formulations and the 200 mg. oral tablet Tegretol brand carbamazepine, as being "AB" rated. As stated in the Orange Book, the AB evaluation generally denotes products that contain an active ingredient in a dosage form for which the submission of bioavailability or clinical data is required for approval or to permit therapeutic equivalence evaluations, and for which the applicant has provided adequate studies to establish the bioavailability and bioequivalence of its product. Otherwise stated, the generic carbamazepine products and Tegretol meet FDA therapeutic equivalence standards. The FDA finding of bioequivalence is based upon controlled tests performed on healthy live subjects. Such tests measure the maximum drug concentration in the blood stream (the "C-max") and the time required for the drug to reach such concentration levels (the "T-max"). Such statistical information is plotted, with the resulting graphic display (the "AUC," or "area under the curve") visually indicating the therapeutic effect the drug may be expected to provide. The generic drug test results are compared to the innovator brand test results. The suggestion that FDA tests should be performed on unhealthy persons so as to monitor effects in such situations was not supported by the greater weight of the evidence. The purpose of the tests is apparently to evaluate the expected therapeutic effect as measured by the C-max, T-max, and AUC, without complications induced by illness. In light of the purpose of the testing program, such evaluation procedures are reasonable. The FDA guidelines provide that a generic drug is considered bioequivalent when, at least 90% of the time the tests are performed (the "90% confidence interval"), the statistical indicators are within a 20% range of the innovator drug reference point. The permissible variance appears to reflect the use of live subjects for testing purposes and the fact that, even in tightly controlled situations, test results may be affected by factors related to individual body chemistry or metabolism. Even the same formulation may produce differing statistical data depending on extrinsic variables. The greater weight of the evidence establishes that the FDA guidelines utilized in determining therapeutic equivalence are reasonable. Although the FDA is reviewing the means by which determinations of equivalency for generic drugs are made, the evidence does not support a finding that the current FDA conclusions are erroneous or otherwise invalid. The evidence does not support a finding that the manner is which the FDA establishes therapeutic equivalence is unreasonable or inappropriate. The testing program utilized by the FDA in ascertaining equivalence is reasonable. Section 465.025(6)(a), Florida Statutes, provides that the party requesting the boards to include a drug on the negative formulary has the burden of proof to show why such inclusion should be made. In attempting to establish the alleged biological or therapeutic inequivalence between Tegretol and generic carbamazepine, Ciba-Geigy likely encouraged physicians to contact the boards through letter, and may otherwise have mobilized and demonstrated support for their position that carbamazepine should be placed on the negative formulary. A number of physicians sent letters to the Respondent addressing the issue of placing carbamazepine in the negative drug formulary. The letters provide anecdotal allegations of instances where therapeutic failures, generally seizures or side effects, are attributed to use of generic medication instead of Tegretol. The letters provide little evidence upon which a scientific determination can be based. There is no reason to presume that the anecdotal information contained within the letters is false. Although such anecdotal information gives cause for concern, concerned physicians can assure that brand Tegretol is used in filling prescriptions simply by writing "medically necessary" on the prescription, or by orally communicating such instructions in oral prescriptions. The letters are not sufficient to establish clinically significant biological or therapeutic inequivalence between Tegretol or generic carbamazepine. The Adverse Drug Reports (ADRs) do not establish that the alleged adverse reactions were related to the use of carbamazepine or substitution of the generic drug for Tegretol. Such reports are filed on a voluntary basis when a patient on medication experiences an unusual occurrence or incident which may by some means be related to use of the medication. ADRs are completed and submitted to the FDA by physicians or pharmacists who choose to do so. The FDA investigates the reports and monitors for trends which could indicate problems in manufacturing or equivalence. In fact, a reported adverse reaction may have no relationship to medication. The evidence did not establish that the FDA has identified biological or therapeutic equivalence concerns related to carbamazepine ADRs. Although the ADRs supplied by Ciba-Geigy to the boards imply that the alleged reactions resulted from substitutions of generic carbamazepine for Tegretol, no information is provided which specifically establishes a connection between the alleged reaction and the use of, or substitution of, generic carbamazepine. The bioequivalence of carbamazepine formulations is the subject of current scientific research, as reflected by a number of scholarly articles published in reputable medical journals, which suggest that various formulations may or may not be therapeutically equivalent. One of the studies compared liquid carbamazepine suspension to tablet form and concluded that the formulations were not equivalent due to absorption rates. However, the evidence indicates that the liquid suspension and the tablet formulation would not be classified as generically equivalent drugs in that they are not the same finished dosage form. Other studies have compared United States formulations of carbamazepine to other formulations which are not available within the United States or to formulations for which insufficient identification prevents determining availability. The evidence suggests that such foreign formulations are not commercially available within the U.S. Substitution by a Florida pharmacist of such a foreign formulation for a physician-prescribed carbamazepine product would be improper. The articles do not establish clinically significant biological or therapeutic inequivalence between generically equivalent carbamazepine products which may be used by a Florida pharmacist in dispensing medication. A recall of the generic carbamazepine tablets due to manufacturing difficulties does not establish biological or therapeutic inequivalence. It is possible for any pharmaceutical company to encounter problems related to manufacturing or storage which require the recalling of previously shipped dosages, as was apparently the case with the recall considered by the boards. Such recalls do not establish that the formulation of a drug is, in a clinically significant manner, biologically or therapeutically inequivalent. There is no clinically significant evidence which would establish that all generically equivalent carbamazepine products, containing the same active ingredient, finished dosage form, and strength are biologically or therapeutically inequivalent. The action of the Boards of Pharmacy and Medicine in placing carbamazepine on the negative drug formulary was arbitrary or capricious. The economic impact statement prepared as part of the Board of Pharmacy's rule adoption process clearly fails to address, or even mention, the economic impact to manufacturers and consumers of carbamazepine products. The summary of the estimated economic impact published in the December 16, 1988 edition of Florida Administrative Weekly minimally identifies the impact on consumers and manufacturers, however, the economic impact statement, contrary to statutory requirement, fails to properly include the estimated cost or economic benefit to all persons directly affected by rule adoption. The evidence indicates no more than cursory review of the economic impact of the rule adoption on manufacturers and consumers of the drug. The rule as adopted erroneously listed the referenced drug as carbomazepine, rather than the correctly spelled carbamazepine. There is no evidence that there was any confusion or harm resulting from the erroneous spelling, which apparently was the result of scrivener's error.

Florida Laws (4) 120.52120.54120.56465.025
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DEPARTMENT OF HEALTH, BOARD OF PHARMACY vs LEONARD KERSTEIN, 00-001020 (2000)
Division of Administrative Hearings, Florida Filed:Fort Lauderdale, Florida Mar. 06, 2000 Number: 00-001020 Latest Update: Oct. 03, 2024
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