96-6220. Service Pharmacy, Inc.; Continued Registration  

  • [Federal Register Volume 61, Number 52 (Friday, March 15, 1996)]
    [Notices]
    [Pages 10791-10796]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 96-6220]
    
    
    
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    DEPARTMENT OF JUSTICE
    [Docket No. 94-55]
    
    
    Service Pharmacy, Inc.; Continued Registration
    
        On June 14, 1994, the Deputy Assistant Administrator, Office of 
    Diversion Control, Drug Enforcement Administration (DEA), issued an 
    Order to Show Cause to Service Pharmacy, Inc., (Respondent) of Marion, 
    North Carolina, notifying it of an opportunity to show cause as to why 
    DEA should
    
    [[Page 10792]]
    not revoke its DEA Certificate of Registration, AS3172157, and deny any 
    pending applications for renewal, under 21 U.S.C. 823(f) and 824(a)(4), 
    as being inconsistent with the public interest.
        On July 8, 1994, the Respondent, through counsel, filed a timely 
    request for a hearing, and following prehearing procedures, a hearing 
    was held in Asheville, North Carolina, on April 18 through April 19, 
    1995, before Administrative Law Judge Paul A. Tenney. At the hearing, 
    both parties called witnesses to testify and introduced documentary 
    evidence, and after the hearing, counsel for both sides submitted 
    proposed findings of fact, conclusions of law and argument. On July 31, 
    1995, Judge Tenney issued his Findings of Fact, Conclusions of Law, and 
    Recommended Ruling, recommending that the Deputy Administrator take no 
    action against the Respondent's registration. Neither party filed 
    exceptions to his decision, and on September 1, 1995, Judge Tenney 
    transmitted his opinion and the record of these proceedings to the 
    Deputy Administrator.
        The Deputy Administrator has considered the record in its entirety, 
    and pursuant to 21 CFR 1316.67, hereby issues his final order based 
    upon findings of fact and conclusions of law as hereinafter set forth. 
    The Deputy Administrator adopts, in full, the Opinion and Recommended 
    Ruling, Findings of Fact, Conclusions of Law and Decision of the 
    Administrative Law Judge, and his adoption is in no manner diminished 
    by any recitation of facts, issues and conclusions herein, or of any 
    failure to mention a matter of fact or law.
        The Deputy Administrator finds that the investigation of the 
    Respondent was initiated in February of 1990 after an investigator 
    (Investigator) from the North Carolina Board of Pharmacy (Pharmacy 
    Board) received information from the attorney for the Estate of James 
    Toney that the Respondent had billed the Estate for prescriptions that 
    the deceased's family did not believe to be properly authorized by the 
    deceased's physicians. The Investigator interviewed Mrs. Toney, the 
    deceased's wife, who related that her husband had had a friendship with 
    John Lowder and Bill Jordan, the original owners of the Respondent 
    pharmacy. James Segars had purchased Bill Jordan's half ownership 
    interest in the pharmacy in 1984. Mrs. Toney also related an incident 
    when she had confronted her husband about whether he used Halcion, and 
    Mr. Toney had started that he did take Halcion, and that ``the 
    pharmacists were taking care of him.'' Halcion is a brand name for a 
    product containing triazolam, a Schedule IV controlled substance 
    pursuant to 21 CFR 1308.14(c).
        The Investigator also jointly interviewed Mr. Toney's adult son and 
    daughter, who corroborated the information received from Mrs. Toney. 
    The son lived adjacent to Mr. Toney's home, believed that he had ``a 
    good feel'' for his father's affairs, and did not believe that his 
    father had been to any physicians recently. Also according to family 
    members, Mr. Toney had been very depressed prior to his death. In 
    addition, the Investigator received from the family prescription vials, 
    receipts, and canceled checks, indicating that the Respondent was the 
    source of the medication dispensed to Mr. Toney.
        Next, the Investigator apprised Mr. Segars of the information he 
    had received concerning Mr. Toney, and Mr. Segars denied any 
    wrongdoing. The Investigator then obtained various records and data 
    from the pharmacy, with the help of one of its employees, and using the 
    data, compiled a computer printout of prescriptions filled by the 
    Respondent for Mr. Toney from January 1986 until January 1990.
        The Investigator then visited the offices of five physicians, Dr. 
    Van Blaricom, Dr. Croft, Dr. Hart, Dr. Larry Boyles, and Dr. Wayne 
    Boyles, who purportedly had issued prescriptions to Mr. Toney during 
    the time frame in question. He obtained an affidavit from Dr. Van 
    Blaricom, indicating that he had not authorized Mr. Toney's 
    prescriptions for Tylenol No. 3 on October 30, 1988, nor Valium, 5 mg., 
    on October 30, 1988, or on May 24, 1989. The parties stipulated to the 
    fact that Tylenol No. 3 is a Schedule III controlled substance pursuant 
    to 21 CFR 1308.13(e), and Valium is a brand name for a product 
    containing diazepam, a Schedule IV controlled substance pursuant to 21 
    CFR 1308.14(c).
        The Investigator also received an affidavit from Dr. Croft, stating 
    that the doctor had reviewed his record for Mr. Toney ``back to 1983'', 
    and from then until the date that he executed the affidavit, April 26, 
    1990, ``neither he nor any member of his staff prescribed or otherwise 
    authorized the Halcion .25 mg. or Amitriptyline 50 mg.'' to Mr. Toney. 
    The Respondent pharmacy, however, had filled prescriptions for 120 
    units of Halcion (.25 mg.), and 900 units of Amitriptyline (50 mg.) 
    between 1986 and 1990, that were purportedly authorized by Dr. Croft 
    for Mr. Toney.
        The Investigator also obtained an affidavit from Dr. Hart. He 
    denied authorizing prescriptions for 270 units of Tylenol No. 3 to Mr. 
    Toney, which were filled by the Respondents between November 1, 1987, 
    and June 13, 1988.
        After interviewing Dr. Larry Boyles, the Investigator obtained an 
    affidavit regarding his treatment of Mr. Toney. Dr. Larry Boyles denied 
    treating or prescribing any controlled substances for Mr. Toney since 
    July 21, 1986. The Investigator also interviewed and obtained an 
    affidavit from Dr. Wayne Boyles, who denied ever treating Mr. Toney or 
    authorizing any prescriptions for him. The Respondent pharmacy had 
    dispensed from December of 1986 to January of 1990, 840 units of 
    Halcion (.25 mg.) to Mr. Toney without authorization from either of 
    these two physicians.
        On April 6, 1990, the Investigator separately interviewed three of 
    the Respondent's pharmacy technicians. He testified that each 
    technician had ``characterized the pharmacist or pharmacy staff at the 
    Respondent pharmacy as being highly ethical. They estimated that the 
    pharmacy filled in excess of 300 prescriptions a day[,] and each denied 
    any knowledge of any illegal activity occurring at the store.''
        On April 9, 1990, the Investigator interviewed and obtained written 
    statements from Mr. Lowder, Mr. Seagars, and Mr. Jordan, all 
    pharmacists associated with the Respondent pharmacy. It was undisputed 
    that Mr. Toney was suffering from several debilitating medical 
    conditions. Both Mr. Lowder's and Mr. Jordan's statements characterized 
    Mr. Toney as a trusted friend with legitimate medical problems. Also, 
    Mr. Jordan acknowledged that he had filled a ``call-in type 
    prescription without checking with the physician'' based simply on the 
    representation that the physician wanted Mr. Toney to continue using a 
    particular medication. According to Mr. Lowder's statement, he also had 
    filled prescriptions for Mr. Toney without physician authorization and 
    based solely on Mr. Toney's representations.
        According to Mr. Segars' statement, he also had filled call-in type 
    prescriptions for Mr. Toney without checking with the physicians. He 
    wrote that, based on Mr. Jordan's and Mr. Lowder's trust in Mr. Toney, 
    he had relied on Mr. Toney's representation that the physician wanted 
    him to continue using the requested medication. Mr. Segars admitted 
    that ``where his name appears on the [prescription] profile [attached 
    to his written statement] as the dispensing pharmacist, he is 
    responsible for that dispening[,] and where his name appears as the 
    original dispensing pharmacist[,] he is responsible for creating that 
    prescription without
    
    [[Page 10793]]
    authorization of a physician and dispensing that product to Mr. Toney 
    at the normal fee for that product.''
        On May 9, 1990, the Investigator conducted a drug accountability 
    audit at the Respondent pharmacy. Mr. Lowder did not contest the audit. 
    Employees of the Respondent assisted in conducting the audit, which 
    covered the seven products received by Mr. Toney. Based on his audit, 
    the Investigator prepared a computation chart. The pharmacy had either 
    an overage or a shortage of each product, with the discrepancies 
    ranging from a 0.99 percent shortage for Valium (5 mg.) to a 39.9 
    percent overage for Halcion (.125 mg.). The Investigator testified that 
    the discrepancies were significant enough to cause him concern.
        The Investigator also testified that he had noticed, among other 
    problems, that there were ``numerous occasions where prescriptions had 
    been refilled beyond their authorized or lawful limits. There had been 
    numerous occasions of quantities of products dispensed in excess of 
    what had been authorized on the original prescription.''
        Next the Investigator profiled and reviewed patient information for 
    eight customers of the pharmacy, for whom he had noted some 
    irregularities. Based on his review, the Investigator testified that he 
    had ascertained that there had been unauthorized dispensing to six of 
    the eight customers. For example, the Investigator's review revealed 
    that the Respondent had dispensed approximately 816 units of Valium (5 
    mg.) and 1620 units of Ativan (1 mg.) to a patient without a 
    physician's authorization. The parties have stipulated that Ativan is a 
    brand name for a product containing lorazepam, a Schedule IV controlled 
    substance pursuant to 21 CFR 1308.14(c).
        On July 2, 1990, the Investigator conducted second interviews with 
    Mr. Segars and Mr. Lowder, to discuss the patients other than Mr. 
    Toney. In response to the ``excessive refills and excessive 
    quantities.'' Mr. Segars and Mr. Lowder asserted that ``they had 
    checked with the physicians before dispensing either the additional 
    prescription or the additional amount on a prescription.'' Other 
    accountability problems were attributed to a deficient computer system.
        On August 7, 1990, the Investigator again interviewed pharmacy 
    technicians, who testified that out of the approximately 300 
    prescriptions filled per day by the Respondent pharmacy, the 
    technicians had witnessed Pharmacists Segars and Lowder fill 
    unauthorized prescriptions two to three times a week. The technicians 
    also stated that the pharmacy had received samples from two physicians, 
    and that these samples had been punched out of the manufacturer's 
    packaging and combined with the pharmacy's inventory. On August 29, 
    1990, Pharmacists Segars and Lowder admitted the conduct concerning the 
    samples, for they admitted that the pharmacy had received samples from 
    two physicians, and that non-outdated samples were combined with the 
    store's common stock and eventually sold to customers.
        On May 17, 1991, the Pharmacy Board issued a written notice of an 
    administrative hearing to determine whether or not Pharmacists Jordan, 
    Lowder, and Segars, and the Respondent pharmacy, had violated North 
    Carolina law, and if so, what action to take. The Investigator had 
    compiled all of the information obtained during his investigation into 
    a chronological report, and he had submitted it to the Pharmacy Board.
        On July 16, 1991, a hearing was held, the parties proposed that the 
    Pharmacy Board enter a consent order, and the Board agreed. In the 
    Consent Order, the Pharmacy Board found that (1) from March 1986 
    through January 1990, Pharmacists Lowder and Segars and ``dispensed 
    Schedules III and IV controlled substances to James Toney without a 
    physician's authorization;'' (2) that Pharmacist Jordan had dispensed 
    Tylenol No. 3 to Mr. Toney, also without physician's authorization, on 
    two occasions; (3) that unauthorized prescriptions had been filled for 
    the same specific patient identified by the Investigator, and that 
    excessive refills had been dispensed to that patient; (4) that 
    Pharmacists Lowder and Segars had dispensed Schedules III and IV 
    controlled substances to five patients in excess of the number of 
    refills shown on the prescription; (5) that the pharmacy's computer 
    system was lacking; (6) that samples had been combined with the normal 
    pharmacy stock; and (7) that a drug accountability audit had revealed 
    shortages of controlled substances. Based on its findings, the Pharmacy 
    Board concluded that the pharmacists and the Respondent pharmacy had 
    violated both Federal and State law. Therefore, the Pharmacy Board 
    ordered revocation of Mr. Lowder's and Mr. Segars' licenses, but stayed 
    that revocation for a period of ten years and imposed the following 
    conditions on each of their licenses: (1) An active suspension of their 
    licenses for 120 days each; (2) successful completion of the Board's 
    jurisprudence exam; (3) successful completion of the University of 
    Kentucky College of Pharmacy's course on prescribing and use of 
    controlled substances, or the equivalent thereof; and (4) no violations 
    of any laws governing the practice of pharmacy or the distribution of 
    drugs, nor of any regulations or rules of the Pharmacy Board, during 
    the ten-year stay period. Pharmacist Jordan's license was placed on 
    probation for five years.
        In addition, the license of the Respondent pharmacy was actively 
    suspended for seven days, and revocation thereof was stayed for ten 
    years. The following conditions were imposed on the pharmacy by the 
    Consent Order: (1) During the seven-day active suspension, the pharmacy 
    was ordered to display signs provided by the Pharmacy Board, notifying 
    the public of the suspension; (2) the pharmacy was ordered to give 30 
    days' advance notice to its customers before the suspension went into 
    effect; and (3) the pharmacy was ordered not to violate any laws 
    governing the practice of pharmacy or the distribution of drugs, or any 
    regulations or rules of the Board, during the ten-year stay period.
        Both the United States Department of Justice and the North Carolina 
    State authorities declined to prosecute the pharmacists. Although the 
    Investigator informed the DEA of the Pharmacy Board's findings and 
    provided a copy of his report and the consent order in August of 1991, 
    the DEA conducted no independent investigation of the pharmacy. In 
    February of 1993, a DEA Diversion Investigator visited the Respondent's 
    location and asked Mr. Lowder to voluntarily surrender the DEA 
    registration, but upon advice of counsel, Mr. Lowder refused. Before 
    Judge Tenney, the DEA Investigator testified that the sole basis for 
    the revocation of the Respondent's registration was the state 
    investigator's investigation and the resulting consent order of July 
    1991.
        At the hearing before Judge Tenney, Mr. Segars admitted that he had 
    violated the law prior to 1991, that information was handled poorly at 
    the pharmacy, and that the pharmacists did not confirm medication 
    prescriptions as required by law. He also testified that he, the other 
    pharmacists, and the pharmacy have carried out all of the terms and 
    conditions of the consent order. Both Mr. Segars and Mr. Lowder had 
    attended and completed a five-day course at the University of Kentucky 
    in compliance with the order. Judge Tenney noted in his opinion:
    
        Mr. Segars volunteered that the course at the University of 
    Kentucky, which focused on doctors with abuse problems, ``was not as 
    beneficial'' as he had hoped it would be * * *. This candid 
    statement, among others,
    
    [[Page 10794]]
    leads me to conclude that Mr. Segars was honest and forthright in 
    his testimony. In addition, Mr. Segars' positive attitude regarding 
    present and future compliance, and his conduct since 1990, are 
    deemed representative of the Respondent pharmacy. Pharmacist 
    [Lowder] is too sick to work now, and Pharmacist Jordan has retired 
    and only works occasionally.
    
        Also, according to the testimony of the Investigator, a relief 
    pharmacist had ``characterized the computer system at the store [as of 
    September 1990] as being confusing.'' However, Mr. Segars testified 
    that immediately after the consent order was executed, a new computer 
    system was acquired for the pharmacy to ensure better record-keeping. 
    Further, Mr. Segars attended seminars on how to use this computer 
    equipment. The pharmacy's software has been updated to make internal 
    reports easier, and Mr. Segars now knows how to utilize the software 
    features.
        However, when asked what had caused the problems that were not 
    attributable to the pharmacy's prior computer system, Mr. Segars also 
    testified:
    
        ``We--I believed too many things, I accepted too many people's 
    word and I'm not sure that they were actually misleading me or lying 
    to me trying to get unauthorized medicines, but until I placed the 
    call and got it on a patient's record that I did call and did get a 
    refill authorized, then it is an illegal prescription. I was 
    negligent in not following up on things as I should have.''
    
        Mr. Segars also related an instance when he had received a doctor's 
    request for a controlled substance, and unsure of the propriety of the 
    request, he had called the Pharmacy Board for assistance. He testified 
    that he now calls the Pharmacy Board whenever he is in doubt about 
    dispensing a particular medication in a particular situation. Mr. 
    Segars also testified that he had physically rearranged the interior of 
    the pharmacy to ensure greater supervision therein, and to insure that 
    no ``mistakes'' would be made at the Respondent pharmacy.
        The investigator testified that he had no information of wrongdoing 
    by the Respondent pharmacy since the entry of the consent order in 
    1991. Also, the Investigator's supervisor, by affidavit, wrote that the 
    pharmacy and its pharmacists appear to be in full compliance with the 
    consent order, and that his office has received no new reports of any 
    violations of the laws governing the practice of pharmacy or the 
    distribution of drugs by any of the individual pharmacists ``or the 
    Pharmacy itself.'' Also, to renew their pharmacist licenses each year, 
    Mr. Segars, Mr. Lowder, and Mr. Jordan must complete 10 hours annually 
    of continuing education.
        Numerous witnesses from Marion, North Carolina, and its surrounding 
    areas, testified before Judge Tenney on behalf of the Respondent and 
    its pharmacists. The witnesses, including a Sheriff's Detective, the 
    President of the McDowell Technical Community College, a Pastor, and a 
    customer, testified to the good character of the pharmacists and to the 
    excellent reputation of the Respondent pharmacy. As noted by Judge 
    Tenney, ``[s]ome of the witnesses emphasized the importance of the 
    pharmacy's free-delivery policy and the fact that it sells products on 
    store credit. The pharmacists' familiarity with customers' allergies 
    and their concerns over drug interactions were also identified as 
    important safeguards provided by the pharmacy. [The] Pastor [    ] 
    testified about the pharmacy's role in providing medicine to indigents 
    in affiliation with the First United Methodist Church.'' Also, several 
    of the Respondent's character witnesses expressed the opinion that the 
    pharmacists are the type of people who learn from their mistakes and 
    correct their ways. Even the Investigator testified that the 
    pharmacists exhibited a receptiveness to changing their ways.
        The Respondent also submitted twenty additional affidavits by 
    medical doctors who serve or served the community, and the affiants 
    attested to the good reputation of the pharmacy and its pharmacists. 
    The pharmacy's free-delivery policy was cited as providing a valuable 
    service to the community's elderly and shut-ins.
        Pursuant to 21 U.S.C. 823(f) and 824(a)(4), the Deputy 
    Administrator may revoke or suspend a DEA Certificate of Registration 
    if he determines that the continued registration would be inconsistent 
    with the ``public interest.'' Section 823(f) requires that the 
    following factors be considered in determining the ``public interest:''
        (1) The recommendation of the appropriate State licensing board or 
    professional disciplinary authority.
        (2) The applicant's experience in dispensing, or conducting 
    research with respect to controlled substances.
        (3) The applicant's conviction record under Federal or State laws 
    relating to the manufacture, distribution, or dispensing of controlled 
    substances.
        (4) Compliance with applicable State, Federal, or local laws 
    relating to controlled substances.
        (5) Such other conduct which may threaten the public health or 
    safety.
        These factors are to be considered in the disjunctive; the Deputy 
    Administrator may rely on any one or a combination of factors and may 
    give each factor the weight he deems appropriate in determining whether 
    a registration should be revoked or an application for registration 
    denied. See Henry J. Schwarz, Jr., M.D., Docket No. 88-42, 54 FR 16422 
    (1989).
        In this case, all five factors are relevant in determining whether 
    the Respondent's continued registration would be inconsistent with the 
    public interest. As to factor one, ``recommendation of the appropriate 
    State licensing board, * * *'' the Pharmacy Board, through the consent 
    order, reviewed the thorough investigation report of the Investigator, 
    and determined, despite the documented violations, that the pharmacy 
    and the pharmacists should continue in operation, after a short 
    suspension period and with stringent rehabilitative requirements. The 
    Investigator's supervisor affirmed that the pharmacy and the 
    pharmacists have complied with the consent order, and that his office 
    has received no new reports of any violations of the laws governing the 
    practice of pharmacy or the distribution of drugs. Despite the 
    Investigator's statement of his opinion, that the Respondent's 
    continued registration would be inconsistent with the public's 
    interest, Judge Tenney noted:
    
        In light of the incongruous nature of [the] Investigator ['s] [  
      ] personal opinion and the actions and mandate of the North 
    Carolina Board of Pharmacy, together with a perceived lack of 
    conviction with which [the] Investigator [    ] stated his opinion. 
    Little weight is assigned to his opinion that continued registration 
    of the pharmacy is inconsistent with the public interest.
        Thus, although no formal recommendation has been made by the 
    North Carolina Board of Pharmacy, the fact that the Board has 
    permitted the Respondent to continue dispensing controlled 
    substances to the public amounts to an assessment by the Board that 
    the pharmacy no longer ``present[s] a danger to the public health, 
    safety and welfare.'' This fact weighs in favor of the Respondent.
    
    The Deputy Administrator agrees with Judge Tenney's findings regarding 
    this factor.
        As to factor two, the Respondent's ``experience in dispensing * * * 
    controlled substances,'' the Respondent's pharmacists knowingly 
    dispensed a significant quantity of controlled substances without 
    physician authorization during the timeframe of 1983 to 1990. The 
    pharmacists also refilled prescriptions beyond their authorized or 
    lawful limits, and
    
    [[Page 10795]]
    dispensed excess quantities. Further, sample products were illegally 
    combined with the pharmacy's common stock for sale to the public, and 
    inaccurate records were maintained, as evidenced by the overages and 
    shortages revealed by the Investigator's May 1990 audit.
        However, the Respondent's conduct since 1991 is also relevant under 
    factor two. Specifically, after entry of the Consent Order in 1991, 
    steps were taken to insure better record-keeping, to include the 
    purchase, installation, and use of a new computer system. Also, the 
    pharmacists took remedial training in handling controlled substances. 
    The Investigator testified that he had no information of any wrongdoing 
    by the pharmacy or its pharmacists since the entry of the Consent Order 
    in 1991. He also testified that the pharmacists were receptive to 
    changing their ways.
        As to factor three, ``the applicant's conviction record under 
    Federal or State laws * * *'', it is uncontradicted that neither the 
    Respondent nor any of the pharmacists has been convicted under Federal 
    or State laws relating to the dispensing of controlled substances.
        As to factor four, the Respondent's ``[c]ompliance with applicable 
    State, Federal, or local laws relating to controlled substances,'' the 
    Deputy Administrator concurs with Judge Tenney's finding that ``[m]ost 
    of the conduct discussed under factor (2) is indicative of 
    noncompliance with State and Federal laws relating to controlled 
    substances. For instance, by dispensing Schedule III and IV controlled 
    substances without physician authorization, the Respondent pharmacy 
    violated 21 CFR 1306.21(a) (requiring practitioner authorization either 
    via written, facsimile, or oral prescription).'' Further, the 
    Respondent's acts of combining and selling samples as common stock 
    violate the Federal Prescription Drug Marketing Act. See 21 U.S.C. 301, 
    331(t) and 353(c)(1). In the Consent Order, the Pharmacy Board also 
    concluded that the Respondent's actions violated Federal and State law.
        As to factor five, ``[s]uch other conduct which may threaten the 
    public health or safety,'' Judge Tenney noted that the Government 
    contended that ``[w]here, as in this case, a pharmacist abdicates [his 
    responsibility to use common sense and professional judgment], either 
    intent[ional]ly or negligently, it jeopardizes the public health and 
    welfare * * *.'' However, Judge Tenney concluded, and the Deputy 
    Administrator concurs, that ``[a]pparently the Government is 
    reiterating the same conduct under factor (5) that has been discussed 
    at length under factors (2) and (4). As this does not constitute `other 
    conduct,' the discussion under factors (2) and (4) shall suffice. 
    Factor (5) is not deemed significant in assessing the public interest 
    in this case.''
        In viewing these factors as a whole, the Deputy Administrator finds 
    that the Government has established a prima facie case that continued 
    registration of the Respondent by the DEA is inconsistent with the 
    public interest. However, also relevant is the Respondent's evidence of 
    rehabilitation. First, at the hearing before Judge Tenney and before 
    the Pharmacy Board, the pharmacists took responsibility for their 
    misconduct. They have also acted in compliance with the consent order, 
    and actually have exceeded those requirements by installing a new 
    computer system and taking classes to more competently operate the 
    system to improve their defective record-keeping. Further, Mr. Segars 
    testified that when he now has doubts about dispensing a medication, he 
    calls the Pharmacy Board for guidance. He also acknowledged that 
    ``until [he] placed the call [to the physician] and got it on a 
    patient's record that [he] did call and did get a refill authorized, 
    then it is an illegal prescription.''
        Further, there is no evidence of wrongdoing after 1991 by the 
    pharmacy or its pharmacists. In fact, the Investigator testified that 
    the pharmacists were receptive to changing their ways, and the 
    Respondent's character witnesses testified that the pharmacists are 
    individuals who learn from their mistakes and do not repeat them. Judge 
    Tenney concluded that ``[a]ll of the foregoing rehabilitation evidence 
    leads to the conclusion that notwithstanding the illegal conduct prior 
    to 1991, the Respondent can now be trusted with a DEA Certificate of 
    Registration. It follows that continued registration by the DEA is not 
    inconsistent with the public interest under 21 U.S.C. 823 and 824.''
        Judge Tenney also noted that there ``was never any evidence that 
    the pharmacy [had] filled unauthorized prescriptions to facilitate the 
    illegal resale of drugs by customers, nor any evidence that the 
    pharmacy's motivation was monetary gain. For instance, Mr. Toney, the 
    principal recipient of unauthorized prescriptions, had numerous medical 
    ailments, and the medications at issue were legitimately prescribed on 
    occasion. Although this does not diminish the seriousness of the 
    pharmacists' behavior, it does evidence a humanitarian motive rather 
    than greed or hedonism.'' Further, the Respondent presented evidence of 
    its community service, to include free delivery and credit policies 
    which benefit the public by assisting the elderly and the poor.
        As Judge Tenney rightly noted, ``[a]lthough these services are 
    commendable, they would not prohibit revocation or suspension of the 
    Respondent's Certificate of Registration if a threat still existed that 
    the Respondent would fill unauthorized prescriptions or otherwise 
    violate the law.'' However, the Deputy Administrator agrees with Judge 
    Tenney's conclusions, that ``notwithstanding [that] the Respondent's 
    past conduct would justify outright revocation in the absence of 
    credible rehabilitation evidence, such evidence is present in this 
    case. Pharmacist Segars' understanding of the Respondent's illicit 
    behavior, his remorse for that past conduct, the rehabilitative steps 
    taken, and the Respondent's `apparent commitment to a more responsible 
    future lead to the conclusion that revocation would not be 
    appropriate.' '' Steven W. Patwell, M.D., 59 FR 26814 (1994).
        Further, safeguards already exist to monitor the Respondent's 
    future conduct, for the Respondent, Mr. Segars, and Mr. Lowder remain 
    on probation by the North Carolina Board of Pharmacy. The Deputy 
    Administrator agrees with Judge Tenney's observation that, ``in light 
    of the thoroughness with which the Board conducted its investigation 
    and the Board's mandate to protect the `public health, safety and 
    welfare,' the Board reasonably can be expected to lift the stay of 
    revocation in the highly unlikely event that the Respondent's past 
    violations recur. Under such circumstances, the pharmacy would lack 
    State authority to handle controlled substances, and the DEA would not 
    have the authority to maintain the pharmacy's registration under the 
    Controlled Substance Act.''
        Again, the Deputy Administrator emphasizes that the conclusion to 
    continue the Respondent's registration in no way endorses the past 
    misconduct of the Respondent. Rather, in determining whether continuing 
    the Respondent's registration would be inconsistent with the public's 
    interest, the Deputy Administrator has determined that, (1) given the 
    commitment of the Respondent's pharmacists to future compliance, (2) 
    the evidence of consistent compliance since 1991, and (3) the other 
    rehabilitative actions taken, the public's interest is best served in 
    this case by
    
    [[Page 10796]]
    continuing the Respondent's registration.
        Therefore, the Deputy Administrator finds that the public interest 
    is best served by continuing the DEA Certificate of Registration, 
    AS3172157, issued to Service Pharmacy, Inc. Accordingly, the Deputy 
    Administrator of the Drug Enforcement Administration, pursuant to the 
    authority vested in him by 21 U.S.C. 823 and 824, and 28 C.F.R. 
    0.100(b) and 0.104, hereby orders that the Respondent's DEA Certificate 
    of Registration be, and it hereby is, continued. This order is 
    effective March 15, 1996.
    
        Dated: March 4, 1996.
    Stephen H. Greene,
    Deputy Administrator.
    [FR Doc. 96-6220 Filed 3-14-96; 8:45 am]
    BILLING CODE 4410-09-M
    
    

Document Information

Published:
03/15/1996
Department:
Justice Department
Entry Type:
Notice
Document Number:
96-6220
Pages:
10791-10796 (6 pages)
Docket Numbers:
Docket No. 94-55
PDF File:
96-6220.pdf