[Federal Register Volume 60, Number 155 (Friday, August 11, 1995)]
[Notices]
[Pages 41079-41082]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-19885]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95N-0193]


The Dr. Oscar E. Carter, Jr., Memorial Rehabilitation Center, 
Inc.; Proposal to Revoke Approval of a Narcotic Addiction Treatment 
Program; Opportunity for a Hearing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to revoke 
approval of an ``Application for Approval of Use of Methadone in a 
Treatment Program'' (Form FDA-2632) (renamed ``Application for Approval 
for Use of Narcotic Drugs in a Treatment Program'') held by The Dr. 
Oscar E. Carter, Jr., Memorial Rehabilitation Center, Inc. (Carter). 
The grounds for the proposed revocation are that the three most recent 
FDA inspections of the program revealed recurring violations of the 
Federal narcotic addiction treatment regulations, and the sponsor has 
failed to demonstrate adequately the ability or willingness to correct 
and prevent the violations. This document is intended to provide the 
sponsor an opportunity for a hearing to show why approval should not be 
revoked.
DATES: Submit a written request for a hearing by September 11, 1995; 
data and information in support of the hearing request by October 10, 
1995.

ADDRESSES: A written request for a hearing, supporting data, and other 
comments should be identified with Docket No. 95N-0193 and submitted to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Gerald R. Hajarian, Center for Drug 
Evaluation and Research (HFD-342), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1029.

SUPPLEMENTARY INFORMATION:

I. Background

    On September 12, 1974, FDA granted Carter approval to operate a 
narcotic addiction treatment program. Such programs are governed by the 
rules, standards, and procedures set forth in Sec. 291.505 (21 CFR 
291.505). Since the program received approval, FDA has conducted 
inspections to determine the program's compliance with Sec. 291.505. 
This notice will document the specific violations revealed in the three 
most recent inspections, and the events leading to this proposed 
revocation.
    FDA's inspection from September 12 through October 17, 1991, 
revealed violations of the narcotic addiction treatment regulation in 
the areas of urinalyses, attendance schedules, medical orders, 
admission evaluations, counseling, treatment plans, and drug 
dispensing.
    The specific violations were as follows:
    1. Failure to maintain drug dispensing records showing batch or 
code marks of the methadone dispensed, and failure to retain drug 
dispensing records for 3 years from the date of dispensing 
(Sec. 291.505(d)(13)(ii));
    2. Failure to maintain methadone daily dispensing records in 5 of 
20 patient records reviewed (Sec. 291.505(d)(13)(ii));
    3. Failure to conduct initial drug screening urinalyses for 
opiates,
 
[[Page 41080]]

cocaine, methadone, amphetamines, and barbiturates in 17 of 20 patient 
records reviewed (Sec. 291.505(d)(2)(i));
    4. Failure of the program to document who conducted the urinalyses 
in all 20 patients for which ``Urinalysis Record'' forms showed results 
of testing for methadone, opiates/opioids, and other drugs 
(Sec. 291.505(d)(2)(i) and (d)(13)(iii));
    5. Failure to obtain FDA's approval of a change to an in-house 
laboratory for the detection of opiates and cocaine in human urine, and 
the failure to test patients for methadone, barbiturates, and 
amphetamines (Sec. 291.505(d)(2)(i));
    6. Failure to conduct monthly urinalyses on six patients with 6-day 
take-home privileges (Sec. 291.505(d)(2)(i));
    7. Failure to perform initial serological tests for syphilis and 
tuberculin skin tests in 19 of 20 patient records reviewed 
(Sec. 291.505(d)(3)(i));
    8. Failure to maintain current annual treatment plan evaluations by 
the program physician in 11 of 20 patient records reviewed 
(Sec. 291.505(d)(3)(v)(C));
    9. Failure to record vital signs (temperature, pulse, blood 
pressure, and respiratory rate) as part of the admission physical 
examination in 14 of 20 patient records reviewed 
(Sec. 291.505(d)(3)(i));
    10. Failure to ensure that the initial dose of methadone did not 
exceed 30 milligrams (mg) in 3 of the 20 patients whose records were 
reviewed (Sec. 291.505(d)(6)(i)(A));
    11. Failure to review, reevaluate, and alter as necessary treatment 
plans at least once each 90 days during the first year of treatment in 
4 of the 20 patient records reviewed (Sec. 291.505(d)(3)(v)(A));
    12. Failure of the program physician to sign one patient's 
medication order change and to record the correct date for another 
patient's medication order change (Sec. 291.505(d)(6)(i)(B)); and
    13. Failure to comply with the take-home medication requirements 
for 2 of the 20 patients whose records were reviewed 
(Sec. 291.505(d)(6)(iv));
    At the conclusion of the inspection, the FDA investigator presented 
a list of observations (Form FDA 483), and discussed the findings with 
the sponsor and his staff. Program management attributed the violations 
to a lack of good recordkeeping practices and the lack of knowledge of 
the regulation.
    FDA issued a warning letter on December 6, 1991, listing the 
violations. The program sponsor submitted a response on December 14, 
1991, listing a number of corrective measures that had been, or would 
be, implemented, and pledging that the violations would not recur.
    FDA and the Drug Enforcement Administration (DEA) conducted a joint 
inspection of the program from July 9 through July 28, 1992. This 
inspection revealed recurring violations in the areas of urinalyses, 
attendance schedules, medical orders, admission evaluations, 
counseling, treatment plans, and drug dispensing.
     The specific violations identified in this inspection were as 
follows:
    1. Failure to conduct monthly urinalyses on 5 patients with 6-day 
take-home privileges (Sec. 291.505(d)(2)(i));
    2. Failure of the program physician to document his review of 
initial drug screening reports in 5 of 10 patient records reviewed 
(Sec. 291.505(d)(1)(i)(C), (d)(2), and (d)(4)(ii)(C));
    3. Failure to provide counseling to patients whose urinalyses 
showed an absence of methadone and/or continued use of drugs of abuse 
in 5 of 10 patient records reviewed (Sec. 291.505(d)(3)(v) and 
(d)(13)(iii));
    4. Failure of the supervisory counselor to countersign treatment 
plans in 5 of 10 patient records reviewed (Sec. 291.505(d)(3)(iv)(C));
    5. Failure of the program physician to record the rationale for 
authorizing take-home medication, and failure to record medication 
orders in 4 of 10 patient records reviewed (Sec. 291.505(d)(4)(ii)(D) 
and (d)(6)(iv)(A));
    6. Failure to perform initial serological tests for syphilis in 3 
of 10 patient records reviewed (Sec. 291.505(d)(3)(i));
    7. Failure of program physician to ensure that initial serological 
tests for syphilis were reviewed in 3 of 10 patient records reviewed 
(Sec. 291.505(d)(4)(ii)(C));
    8. Failure to perform an initial tuberculin skin test and vital 
signs in 1 of 10 patient records reviewed (Sec. 291.505(d)(3)(i)); and
    9. Failure to maintain accurate drug dispensing records. For 
example, records failed to record dosages for five patients, which were 
given to the patients on the 31st of the month (in months with 31 
days). Also, records failed to contain batch or code marks of the 
methadone dispensed traceable to specific patients 
(Sec. 291.505(d)(13)(ii)).
    On the basis of recurring violations, FDA issued a ``Proposal To 
Revoke Narcotic Treatment Program Approval; Notice of Informal 
Conference'' on October 1, 1992, in accordance with Sec. 291.505(h)(2). 
The October 1, 1992, notice summarized the violations observed during 
the last three inspections and offered the sponsor an opportunity to 
appear at an informal conference and explain why the program approval 
should not be revoked. The notice also invited the sponsor to submit a 
``comprehensive action plan'' for correcting the deficiencies in the 
program.
    The informal conference was held on January 6, 1993, at FDA's New 
Orleans District Office. The sponsor did not submit a comprehensive 
written corrective action plan at the conference. The sponsor 
indicated, however, that steps had been taken to make necessary 
corrections and that he had requested that the State and the Center for 
Substance Abuse Treatment (CSAT) provide technical assistance to the 
program. FDA's District Office gave the sponsor until February 20, 
1993, to submit a written corrective action plan.
    In a February 23, 1993, letter to the district office, the sponsor 
presented a corrective action plan and timeframes for implementation. 
The action plan included: (1) Installing a computerized dispensing 
system, (2) hiring additional personnel, and (3) obtaining a commitment 
for technical assistance. The sponsor asked FDA for one final 
opportunity to implement the recommendations of the technical 
assistance group.
    FDA held its decision regarding revocation of approval in abeyance 
pending completion of the technical assistance from CSAT by June 30, 
1993, and pending a reinspection of the program. FDA agreed to give the 
program one final opportunity to achieve regulatory compliance.
    The most recent inspection of December 13, 1994, through January 
24, 1995, revealed recurring violations in the areas of urinalyses, 
attendance schedules, medical orders, admission evaluations, 
counseling, treatment plans, and drug dispensing.
    The specific violations were as follows:
    1. Failure to provide the required services for two patients 
regarding pregnancy evaluation, prenatal counseling, and treatment 
outcome of the patient and offspring (Sec. 291.505(d)(4)(i)(B));
    2. Failure to document in the 13 patient records reviewed that the 
program physician has considered, at a minimum, the following in 
determining whether a patient's frequency of clinic visits for observed 
drug ingesting may be reduced: Absence of recent drug abuse; regularity 
of clinic attendance; absence of behavioral problems; absence of recent 
criminal activity; stability of the patient; length of time in 
treatment; assurance that take-home medication can be safely handled by 
the patient; and whether the benefits of take-outs outweigh the risks 
of diversion (Sec. 291.505(d)(6)(iv)(B));
    3. Failure to document that two patients on 6-day, take-home 

[[Page 41081]]
    medication had monthly drug screening urinalyses for opiates, 
methadone, amphetamines, cocaine, barbiturates, and other drugs of 
abuse performed by a certified clinical laboratory 
(Sec. 291.505(d)(2)(i));
    4. Failure to justify medication in excess of a 6-day, take-home 
supply given to three patients; failure to require two patients to 
complete 3 consecutive years of maintenance treatment at the program 
before being permitted to reduce their attendance for observation to 
once weekly; and failure to place one patient, who was receiving a 6-
day supply of take-home medication, on probation for 3 months after his 
urinalysis was positive for a drug of abuse (Sec. 291.505(d)(4)(ii)(F), 
(d)(6)(v)(A)(3), and (d)(6)(v)(B)(2));
    5. Failure of the program to have a licensed physician record, 
date, and sign in 2 of 13 records reviewed a change in each patient's 
dosage schedule (Sec. 291.505(d)(6)(i)(B));
    6. Failure to document drug addiction and conduct physical 
examinations on two patients and failure to ensure that a transferring 
patient received a physical examination and documentation of addiction 
prior to administering the initial dose of methadone 
(Sec. 291.505(d)(1)(i)(C), (d)(4)(ii)(A), and (d)(4)(ii)(B));
    7. Failure to ensure that the initial dose of methadone dispensed 
to two patients did not exceed 30 mg (Sec. 291.505(d)(6)(i)(A));
    8. Failure of the program physician to document his review of 
initial drug screening urinalysis reports with his signature for two 
patients; and failure to document the review of random drug-screening 
urinalysis reports for five patients (Sec. 291.505(d)(2) and 
(d)(4)(ii)(C));
    9. Failure of the program's counselors to document that three 
patients received counseling regarding drug-screening urinalyses that 
showed continued use of illicit drugs or the absence of methadone in 
these patients while undergoing methadone treatment 
(Sec. 291.505(d)(13)(iii));
    10. Failure to obtain a signed ``Consent to Treatment With an 
Approved Narcotic Drug'' Form from two patients prior to admission to 
the program (Sec. 291.505(d)(1)(ii));
    11. Failure to document that five patients received counseling on 
HIV disease upon admission or readmission for treatment 
(Sec. 291.505(d)(4)(i)(C));
    12. Failure of the admitting physician to document his review of 
tuberculin skin test reports with his signature in the patient record 
for four patients; failure of the program physician to include the 
results of initial serological tests for syphilis in the patient 
records for nine patients (Sec. 291.505(d)(3)(ii));
    13. Failure of the primary counselor and/or the program physician 
to countersign treatment plans for eight patients; failure to properly 
date treatment plan for one patient; failure to have an initial 
treatment plan on file for readmission of one patient; and failure of 
the primary counselor or program physician to prepare and review the 
periodic treatment plan for one patient within the proper timeframes 
(Sec. 291.505(d)(3)(iv) and (d)(3)(v));
    14. Failure of the program to maintain drug dispensing records that 
permit traceability of drug lot numbers to specific patients on those 
days when a change from one lot number to another occurs 
(Sec. 291.505(d)(13)(ii));
    15. Failure of the program physician to document that he requested 
from the physician or hospital to which the program referred two 
pregnant patients a summary of the delivery outcome for the patients 
and the offspring (Sec. 291.505(d)(1)(iii)(B)(3) and (d)(4)(i)(B)(2));
    16. Failure to require that a patient, who had only been admitted 
to the program for 1 month, demonstrate adherence to the program's 
rules for at least 2 years before allowing the patient to decrease his 
personal attendance to twice weekly (Sec. 291.505(d)(6)(v)(A)(2)); and
    (17) Failure of the program to account for, and require the return 
of, six extra doses of take-home medication dispensed to a patient for 
use during out-of-town travel that was subsequently postponed 
(Sec. 291.505(d)(13)(ii) and (d)(14)).
    At the conclusion of the inspection, the FDA investigator presented 
a list of observations (Form FDA 483), and discussed the inspectional 
findings with the sponsor and his staff. The program sponsor promised 
to respond to the inspectional findings in writing, but has failed to 
do so.

II. Conclusion, Findings, and Proposed Action

    As discussed above, the three most recent inspections of Carter 
conducted by FDA from September 12 through October 17, 1991; July 9 
through July 28, 1992; and December 13, 1994, through January 24, 1995, 
revealed recurring violations of the Federal narcotic addiction 
treatment regulation, which sets forth the standards for use of 
narcotic drugs for medical treatment of narcotic addiction. In letters 
of December 14, 1991, December 9, 1992, and February 23, 1993, and 
during the January 6, 1993, informal conference, the sponsor made 
promises to correct the violations. However, as the December 13, 1994, 
through January 24, 1995, inspection demonstrated, the sponsor has 
failed to abide by all of the narcotic addiction treatment regulations, 
has failed to monitor the activities of those employed in the program 
adequately, and has generally failed to correct the program's recurring 
problems.
    Accordingly, as provided by Sec. 291.505(h)(3) and (i), the 
Director, Center for Drug Evaluation and Research, proposed revocation 
of Carter's program approval to the Associate Commissioner for 
Regulatory Affairs. The Associate Commissioner for Regulatory Affairs 
has evaluated the available information and finds that the program 
sponsor has failed to submit adequate assurances justifying continued 
approval of the program.

III. Notice of Opportunity for a Hearing

    Notice is hereby given to the sponsor of the Narcotic Treatment 
Program listed above, and to all other interested persons, that the 
Associate Commissioner for Regulatory Affairs, under authority 
delegated to him (21 CFR 5.20) proposes to issue an order under 
Sec. 291.505(h)(3) revoking approval of the ``Application for Approval 
for Use of Narcotic Drugs in a Treatment Program'' (Form FDA-2632) held 
by The Dr. Oscar E. Carter, Jr., Memorial Rehabilitation Center, Inc., 
5500 North Johnson St., New Orleans, LA 70117, on the grounds stated 
above. In accordance with part 314 (21 CFR part 314), the sponsor is 
hereby given an opportunity for a hearing to show why approval should 
not be revoked.
    The sponsor who decides to seek a hearing shall file: (1) On or 
before September 11, 1995, a written notice of appearance and request 
for a hearing, and (2) on or before October 10, 1995, information and 
analyses relied on to demonstrate that there is a genuine issue of 
material fact to justify a hearing. Any other interested person may 
also submit comments on this notice. The procedures and requirements 
governing this notice of opportunity for a hearing, a notice of 
appearance and request for a hearing, submissions of data, information, 
and analyses to justify a hearing, other comments, and the granting or 
denial of a hearing are contained in Sec. 314.200.
    The failure of the applicant to file a timely written notice of 
appearance and request for a hearing, as required by Sec. 314.200, 
constitutes an election by that person not to use the opportunity for a 
hearing concerning the action proposed, and a waiver of any contentions 
concerning the legal status of that 

[[Page 41082]]
person's narcotic addiction treatment program.
    A request for a hearing may not rest upon mere allegations or 
denials, but must present specific facts showing that there is a 
genuine and substantial issue of fact that requires a hearing. If it 
conclusively appears from the face of the data, information, and 
factual analyses in the request for a hearing that there is no genuine 
and substantial issue of fact that precludes the revocation of approval 
of the application, or when a request for a hearing is not made in the 
required format or with the required analyses, the Commissioner of Food 
and Drugs will enter summary judgment against the person who requests 
the hearing, making findings and conclusions, and denying a hearing.
    All submissions pursuant to this notice of opportunity for a 
hearing are to be filed in six copies. Except for data and information 
prohibited from public disclosure under 42 CFR part 2, the submissions 
may be seen in the Dockets Management Branch (address above) between 9 
a.m. and 4 p.m., Monday through Friday.

    Dated: August 4, 1995.
Gary Dykstra,
Acting Associate Commissioner for Regulatory Affairs.
[FR Doc. 95-19885 Filed 8-10-95; 8:45 am]
BILLING CODE 4160-01-F