Approval and Monitoring of Narcotic Treatment Programs: A Guide on the Roles of Federal and State Agencies
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Given that there are many Federal and State agencies involved in regulating, monitoring, researching, funding, and providing assistance to narcotic treatment programs, "who does what" can appear very confusing. Yet understanding the roles of various agencies is the key to operating your program according to the established standards. The responsibilities for approving and disapproving, monitoring, and setting standards for narcotic treatment programs are shared between State and Federal agencies (see exhibit B).
Each State is responsible for approving narcotic treatment program applications and monitoring compliance with State regulations, licensing, and other requirements. State approval and monitoring regulations must be at least as restrictive as the Federal regulations, but States may have any other regulations that fall within the authority of State law, as long as there is no conflict between Federal and State laws that prevents the two from standing together consistently. Many States have developed more stringent standards, and in some States methadone treatment is not available. Since each State may regulate methadone treatment, you may find that the rules governing methadone in your State differ from the Federal rules, and that the rules vary from State to State. Should you want to establish a program in more than one State, you will need to work with each State individually.
Each State choosing to permit a narcotic treatment program to
operate within its borders is required by FDA methadone regulations
to designate an SA. The SA's major role is determining the need for
approving and disapproving narcotic treatment programs within the
State. In most States, the SA is the agency that has responsibility
for planning and funding of substance abuse treatment services in
that State; however, this agency does not always have licensing or
regulatory authority. Your SA will review each program application
for its proximity to other programs and the service need in the
location of the proposed program. In many instances, CSAT can
provide technical assistance to the State in determining the need
for narcotic treatment services in a specific locality.
Your SA collaborates with FDA and DEA to ensure that a proposed program meets minimum quality standards. SA representatives are allowed to inspect your program for compliance with regulatory standards and, if necessary, to recommend revocation of approval to FDA. Also, FDA and DEA cannot approve your application unless your SA concurs. Experience has shown that in many instances successful narcotic treatment program applicants begin the process by gathering State information first, determining if their proposed program will meet State requirements, and then moving on to Federal standards.
The chief public health officer of each State is
responsible for certifying comprehensive methadone treatment
programs to provide interim maintenance treatment services to
patients who will be offered comprehensive maintenance services
within 120 days of seeking treatment. The chief public health
officer should involve the SA in this approval process. State
certification for interim maintenance treatment must occur before
FDA will act on a request for program approval.
In partial fulfillment of its responsibilities under the Federal Food, Drug, and Cosmetics Act, the FDA, which is situated within DHHS, must ensure the safety and effectiveness of narcotic drugs. Within the FDA, this responsibility is delegated to the Center for Drug Evaluation and Research. Day-to-day responsibilities are conducted by the Division of Scientific Investigations, Regulatory Management Branch.
The Regulatory Management Branch is responsible for confirming that all programs using narcotics are in compliance with Federal narcotic treatment regulations for maintenance and detoxification. It is this entity within the FDA that has the authority to approve or disapprove your application to establish a narcotic treatment program. Using procedures developed specifically for narcotic treatment programs, FDA field investigators monitor your services by conducting periodic inspection site visits.
Regulation of the diversion of controlled substances is one of the responsibilities delegated to the DEA, which is situated within the Department of Justice. With the 1974 Narcotic Addict Treatment Act, DEA became responsible for registering narcotic treatment programs that use methadone (or other approved narcotic drugs) in the treatment of narcotic addiction and ensuring that programs are in compliance with controlled substance laws. In addition to the usual registration of physicians and pharmacies, DEA requires that you register your program to prescribe, compound, or dispense controlled substances. DEA will also conduct site visits of your program to monitor compliance with controlled substance laws. These tasks are completed by the headquarters and regional field offices of the Office of Diversion Control within DEA.
NIDA was established in 1974 as one of the institutes of the Alcohol, Drug Abuse and Mental Health Admini- stration. Effective October 1, 1992, NIDA became a part of the National Institutes of Health (NIH). NIDA's role is to conduct research on the effectiveness of narcotic drugs used for maintenance and detoxification, in addition to quality-of-service issues. NIDA makes information available to the other Federal agencies on the results of research programs, including new information on treatment standards for methadone and other new medications to be used in the treatment of narcotic addiction. For example, the Narcotic Addict Treatment Act and regulations were revised to allow detoxification treatment to extend to 180 days. This revision was based on NIDA-supported research.
As a result of the 1974 Narcotic Addict Treatment Act, NIDA worked with FDA to develop medical standards for using narcotic medications to treat narcotic addiction. The two agencies jointly promulgated the methadone regulations that your program must follow.
CSAT, an agency of SAMHSA, has the principal function of improving treatment services for individuals who abuse drugs. CSAT provides financial support through the Substance Abuse Prevention and Treatment (SAPT) Block Grant; community demonstration grants; cooperative agreements; and technical assistance to States, communities, and treatment providers. These grant programs target resources to meet local or regional needs of targeted areas and special populations. CSAT also works with SAs and the other Federal agencies to identify programmatic and systemwide issues that require technical assistance or training interventions.
Through the Methadone Treatment Improvement Project (MTIP), CSAT provides technical assistance to the State alcohol and drug abuse agencies that are responsible for administering the SAPT block grant and narcotic treatment programs. In addition, CSAT is developing treatment guidelines and treatment improvement protocols for State program administrators and treatment providers. These initiatives are designed to assist you in developing and evaluating narcotic treatment services and in improving the quality of existing programs.
Before you pick the perfect program name and open or break ground on your new facility, you absolutely must make three phone calls. First, use the list in appendix G of this guide to identify the contact person at your SA. Call to request an application form, instructions, and any applicable State regulations. The SA will be able to tell you if there are other State offices that you need to communicate with regarding licensure or other State permit or site approval procedures. It is suggested that you thoroughly review your program plans with the SA staff to ensure that your program will comply with State regulations before initiating the Federal process. As noted earlier in this guide, FDA and DEA cannot approve your program without State concurrence.
Next, contact the FDA's Division of Scientific Investigations, Regulatory Management Branch, and ask for an application package for a methadone treatment program. (See appendix A)
Third, locate the closest local DEA Field Office Diversion Unit from the list in appendix B and call to get an application. When you call DEA it is a good idea to have a discussion with a Diversion Investigator about the requirements for security that will be applicable to your site. Although they are minimal, DEA security requirements vary with the geographic location, the patient population of each program, and the potential security risks of a particular site. You may find it helpful to inquire about DEA recordkeeping requirements as well.
Be sure to read the application instructions beforeyou begin!
Most likely, there will be differences between the State regulations and the Federal regulations. For example, some States place lower limits than the Federal regulations allow for the maximum dose of methadone that may be prescribed without special approval. Your program must be in compliance with both sets of regulations, and where one standard is more restrictive than another, you will be expected to follow the more restrictive requirement.
Federal regulations allow you to request an exemption to specific
Federal program standards provided that you submit a rationale for
the request with your application. FDA does not often grant
exemptions to the minimum program standards, so you will need to be
sure that your program meets the minimum programmatic and treatment
standards as fully explained in the regulations. The same is true
for DEA. You are free to apply for an exemption, but the minimum
standards must be met and exemptions are rarely granted. There are
several situations that are exempted by DEA, however, because they
do not require DEA registration. These exempted situations are as
follows:
Remember, both State and Federal approvals must be obtained before you can operate your program! Also, you must obtain approval for
every different site from which you will dispense medication. (See
definition of a medication unit 21 CFR 291.505 (a) (4).) If
you are a new provider, you may want to start with one site and
expand to multiple sites at a later date.
Approved comprehensive methadone treatment programs may seek authorization to provide interim maintenance treatment. Again, contact your SA for application instructions. Keep in mind that you must obtain certification from the chief public health officer of your State as part of the approval process. The SA will be able to tell you the appropriate person to contact in your State public health office. As indicated below, you still need to follow the applicable Federal regulations.
Each SA will have a different application process. Follow the instructions. Fill out all information completely and accurately, andif you have questions, contact your SA to get help. Your SA can tell you how many copies of the application are needed and where they should be sent. Typically, a State's package will include:
In addition, the State may send general information or application forms for Federal approvals or provide assistance by coordinating the Federal application process on your behalf.
Before FDA will grant approval for interim
maintenance services, you must obtain approval from your State's
chief public health officer and provide FDA with certification
that:
The Federal government expects States to give appropriate guidance to narcotic treatment programs in order to ensure that comprehensive maintenance treatment is not available within a reasonable geographic area before admitting an individual into interim maintenance treatment. Interim maintenance must be provided in a manner consistent with all applicable State and Federal laws and regulations. The chief public health officer may want to consider developing a procedure through which programs can fulfill their obligation to notify the State chief public health officer when a patient begins interim treatment, when a patient leaves interim treatment, and before the date of mandatory transfer to a comprehensive program.
You will receive a packet from FDA that contains all
the necessary Federal forms. These Federal forms, which are subject
to change, include the following:
FDA Form 2632:Application for Approval of Use of Narcotic Drugs in a Narcotic Addiction Treatment Program
FDA Form 2633:Medical Responsibility Statement for Use of Narcotic Drugs in a Treatment Program
FDA Form 2635:Consent to Treatment with an Approved Narcotic Drug
FDA Form 2636:Hospital Request for Methadone Detoxification Treatment
DEA Form 363:New Application for Registration Under Narcotic Addict Treatment Act of 1974
In addition to the forms, you will receive a checklist for completing the application. Use this checklist(see appendix A), because this is what the FDA reviewer will use to evaluate the completeness of your application!
FDA Forms 2632and 2636are the application forms. If you are
applying as a treatment program, use Form 2632; for hospital
detoxification, use Form 2636. At first glance, the forms seem very
short and quite simple to complete. This is because the form mainly
asks for assurances of intent to uphold Federal program standards.
However, as indicated on the checklist, there are several
attachments that become the body of the application. These
attachments include:
A list of the names and State license numbers of all
pharmacists, registered nurses, and practical nurseslicensed by
law to dispense narcotic drugs who will be working with the
program. If your program is in a hospital, you must also submit the
names of all persons responsible for receiving and securing
supplies of narcotic drugs. 
A list of the names and addresses of hospitalsproviding
medical services, laboratories providing drug testing or analyses,
and any facility other than the primary dispensing site where
methadone will be dispensed. A copy of FDA Form 2633must be completed and signed by every physician licensed by law to administer or dispense narcotic drugs at the primary dispensing location of your program. If the physician is serving as medical director, he or she must indicate this on the form. If your medical director is also the medical director for another treatment program, enclose a written justification for this arrangement and a statement of how the medical director will fulfill his/her time commitment to your program.
FDA Form 2635, Consent to Treatment with an Approved Narcotic Drug, is used by patients after the program is in operation. When you sign the application for program approval (FDA-3632), you are assuring that your program will use this consent form.
The completed application must demonstrate that your program meets several required conditions.
When you have gathered all of this information and packaged it in the order suggested on the checklist, send two sets to FDA (the address is on the application form) and two sets to your SA. Both FDA and the SA must each receive at least one application with an original signature.
FDA must authorize approved comprehensive programs to
provide interim maintenance treatment services. If you are a public
or private nonprofit methadone treatment program approved by FDA to
provide comprehensive maintenance treatment and there is a need to
provide interim treatment, you must submit a request to FDA that
includes a written certification of approval of interim services
from the chief public health officer of your State. The need for
interim maintenance means that your program is unable to place the
individual in comprehensive treatment within a reasonable
geographic area within 14 days of the time the individual attempts
to be admitted to the comprehensive program. The interim program
must establish and follow appropriate and reasonable criteria for
establishing priorities for transferring patients from interim
maintenance to comprehensive maintenance treatment. These transfer
criteria must be in writing and available for inspection by FDA.
Criteria must include, at a minimum, a preference for pregnant
women in admitting patients to interim maintenance and transferring
patients from interim maintenance to comprehensive maintenance
treatment. The program should also maintain documentation of
notifications to the State chief public health officer of when a
patient begins interim treatment, when a patient leaves interim
treatment, and before the date of mandatory transfer to a
comprehensive program.
Request for authorization as an interim maintenance treatment program should be submitted to FDA's Regulatory Management Branch, as is your original comprehensive maintenance application. (See appendix A.)
Should your State chief public health officer decertify interim maintenance treatment or should your program not maintain compliance with interim maintenance treatment standards, FDA will revoke your authorization for interim maintenance.
The DEA application is only one page in length. It is
included in the package sent to you by FDA or can be obtained from
your local DEA office. It is very simple to complete and requires
no attachments. An application fee must be submitted with the
application. The FDA approval number (item 5) should be left blank
because this number is assigned simultaneously with the
DEA-approved program registration, which is renewed annually, You
will be mailing your application to DEA headquarters (the address
is on the form). Keep the last copy of the triplicate form for your
files and send in the other two copies. One copy of the form will
be forwarded to the local DEA Field Office for your region.
You will probably save some time and money if you clarify DEA
security, safety, and recordkeeping requirements for your site
before submitting your application. You can call DEA staff, or send
proposed blueprints or other documentation, but it is better to
arrange an appointment with a DEA field investigator to review the
needs of your specific site. As mentioned earlier, the specific
requirements for security and safety at your facility are based on
the location and the expected patient population. When your
application reaches the DEA Field Office, your program will be
scheduled for a preregistration investigation site visit. If your
site is fully functional, with all security systems and diversion
control procedures operational when your application is submitted,
the DEA approval process can be expedited.
It is also important to clarify your plans for preparing and dispensing methadone. If you plan to compound methadone on site for use at the site or transporting to another site, you will need to apply as both a treatment program and a compounder.
If you plan to conduct research involving patients served by your program, you will need to comply with Federal Protection of Human Research Subjects regulations (45 CFR 46). Should your research involve the use of an unapproved drug, you will need to submit a separate application to FDA for approval to use the drug. Do not use the Investigational New Drug (IND) process to request exemptions from the minimum program standards!
DEA also has a separate registration process for programs that will
conduct research. This separate registration does not exempt a
program from meeting the basic standards required for all
programs. If you plan to do any research that involves the use of
medications, you will need to submit a separate application for
registration. Obtaining approval for using medications in a
research protocol can be a very complicated process depending on
the specifications of your project, so be sure to clarify your
plans with DEA before you begin.
Be prepared for the fact that parts of your application will be reviewed separately by the three regulatory sources—the SA, FDA, and DEA. Each will concentrate on different aspects of the program. The SA will review your application for compliance with State regulations and usually will examine your program's geographic proximity to other programs as a means of assessing the need for the service in your area. FDA will review your program for compliance with Federal Health and Human Service regulations 21 CFR 291.505 and Federal Public Health Service confidentiality regulations 42 CFR Part 2, focusing on treatment and programmatic aspects. DEA checks compliance with the Federal Department of Justice regulations, 21 CFR 1300. DEA staff will look at drug security and drug control issues and ensure that your program meets the requirements of the Controlled Substances Act. Each application review is separate, but as stated earlier, program approval is dependent on the applicant's receiving the approval of all three agencies. If you are not in compliance with the requirements of any one set of standards, your total application will be denied.
As with the application, each SA has its own process for reviewing applications. You should ask your SA contact for specifics of your State's review process, but you can at least expect that your application will be assigned to an SA staff person and reviewed for completeness, accuracy, and available service need in the area of your program. The reviewer will ensure that your application documents your intention to comply with all applicable State regulations for narcotic treatment programs.
Your application can make it through the FDA review process in as little as 2 weeks, assuming that all information submitted is complete and meets the minimum requirements. When your application arrives at the FDA Regulatory Management Branch it will be assigned to a reviewer. Your application reviewer will log your application onto the FDA computer tracking system. In addition, FDA will notify the SA and DEA that your application has been received. The reviewer then looks at your material to be sure that you have included everything on the checklist and that the items submitted meet the standards of the Federal Government. If you are missing items from the application or if you need to make corrections to meet regulations, the reviewer will contact you by letter. The letter will specify which items are missing or deficient and the corrective actions needed to solve any problems. You will not be given a stringent time line to resubmit missing or corrected items, but the faster things get in, the faster the application moves through the FDA process.
If you have questions about the application, you should call FDA for clarification, and the reviewer will assist you over the telephone in completing the form or send out samples of the types of information required.
Once your application is complete, the FDA reviewer will send you
a letter indicating that you have met the requirements of FDA and
that full approval of the program can be granted only after approval is granted by DEA and the SA. FDA then waits to hear from
your SA and DEA regarding approval or denial of your application.
If your application is approved by all three reviewing agencies,
FDA assigns a program number and issues an official program
approval letter. Also, FDA provides manufacturers and the public
with the names and locations of approved programs. Once approved,
your program will be added to the FDA Narcotic Treatment Program
Directory.
When you receive your approval letter with your FDA program number from FDA, you are cleared to open your program. However, you should confirm your State approval directly with your SA before you begin operating your program!
If your application is complete when it arrives at
DEA headquarters, it is accepted for filing. If there are minor
problems, the application will be accepted with a request for more
information. If the application is considered defective and is not
accepted for filing, it will be returned to you with a statement of
the reasons why it has not been accepted. You are free to make
corrections and resubmit the application at any time.
The bulk of the DEA review is conducted at the preregistration investigation site visit. Prior to the investigation, however, DEA staff will review all existing information about your program, sponsor, and medical director. DEA staff will check to see if anyone associated with the program has had a history of violations related to drug issues. The investigator will also check with FDA and the SA to learn of any problems related to FDA or State regulations. Once the investigator is satisfied that there are no outstanding problems, a site visit will be conducted (see "The Inspectors Are Here!").
Generally, the registration process can be completed in 4 to 6 weeks, depending on how well you have prepared your site. If you need to make improvements on security, safety, or recordkeeping procedures to meet DEA requirements, the investigator will provide technical assistance as necessary and will schedule another time to come to conduct the preregistration investigation. The DEA registration is the last approval you will receive for your program because FDA and SA approvals are prerequisites to DEA registration.
Any one of the application reviewers—FDA, DEA, or the SA—can deny approval of your application for a variety of reasons. If your application is denied, your FDA letter will indicate which agency denied the application and why your program was denied. If you have any questions, contact that agency directly to request clarification.
Given that each SA has its own application denial process, contact your SA directly should problems with the SA review be the cause of denial of your application. SAs can deny your application if the program does not comply with State regulations, but they can also deny your program if there is no documented need for the program in the area of its location. If you are applying to open a second program, the SA may deny this application if you have had a history of problems with your first program. This includes any problems reported to the SA by FDA or DEA. In most cases, your SA will offer technical assistance.
It is rare that a new application is denied by FDA.
This is because FDA allows each applicant as many opportunities as
necessary to submit the correct application materials. However,
should your application be denied, your letter from FDA will
indicate the reasons for denial of approval and will offer you an
opportunity to explain any issues through an informal conference or
in writing. If the reasons for denial can be corrected, the denial
of approval can be reversed.
The DEA registration process focuses on security and
control issues, but DEA has the authority to deny registration
based on failure to comply with all regulations including FDA and
State requirements. Should DEA conduct a preregistration
investigation and find your program in violation of FDA or State
regulations, DEA is authorized to cite these issues as part of the
DEA investigation report. 
Should your application be denied, DEA will issue an order to show cause as to why the application should not be denied. The order to show cause will document the reasons for denial of the application and will ask you to present further information at a hearing. During this hearing, you will have the "burden of proof" to demonstrate that you are qualified to operate the program. DEA will expect you to address all issues, including any problems cited by the SA or FDA.
Once you have opened your program, you can expect to be inspected by each regulatory authority at some point in time. The best thing to do is to be prepared at all times because these inspections can, and usually will, occur unannounced. As many experienced providers know, one of the hardest things to do is to maintain compliance with every standard all of the time, but this should be your goal!
Most SAs have some form of on-site visit before the program begins or within a short time after the program opens its doors. Since each SA inspection process is specific to the State, contact your SA to get details about how to prepare for its visit. Typically, SA staff will review your physical facility, medication storage and administration policies and procedures, recordkeeping practices, medical procedures, and treatment program. Most likely the SA inspector will look at a sample of client records and interview staff and patients. In addition, the inspector may observe medication administration, urine collection, counseling or case conference sessions, and staff meetings.
The SA inspector will conduct an exit interview with clinical and management staff to discuss the findings of the visit. Usually, the SA will follow up with written communication that identifies any problem areas.
Through the network of local district FDA offices,
FDA will assign a field investigator to your program. Within the
constraints of staffing at each local office, FDA will try to
inspect your program within 1 year of program approval, and
biannually thereafter. In addition, FDA is mandated to inspect
programs that have had a history of problems to ensure that
promised corrections have been made. It is the policy of FDA to
make unannounced inspections.
The job of the investigator is to examine the program's operations and compare them with the regulations. It is important to remember that the Federal regulations are considered minimal standards.
When the investigator arrives, she or he will present FDA
credentials. The investigator will then ask to see the most
responsible person on site; ideally this would be the program
sponsor or the medical director. At this time, the investigator
will issue two FDA forms, a "Notice of Inspection" and a "Routine
Notice" form. These documents formally introduce the inspection
process and assure the confidentiality of any patient information
that the investigator will see. The investigator will look at your
physical facility and examine patient records.
The investigator has the right to review all records pertaining to
patients. He or she will select a sample of patient records that
represent a variety of patients, such as pregnant patients,
patients on exemption, patients with reduction in pick-up
schedules, and so forth. The investigator will review
confidentiality issues. He or she will want to see that your
patient records are properly stored. Should the inspector find
problems, he or she will make copies of sections of records that
document deficiencies.
During the review of the physical facility, the investigator will
go into the medication station and talk to the nurses about the
program's procedures for administering and recording medication. He
or she will check to be sure that take- home doses are properly
labeled and in the right kind of containers. The investigator will
check for tracking of lot numbers of methadone. Although he or she
will look at drug security issues, FDA generally leaves the major
review of this matter to DEA inspectors. The FDA investigator will
look at how returned bottles are handled and disposed of. He or she
will review your procedures for drug screening and testing to be
sure that you have ways of minimizing the possibility of
falsification. Investigators will also look at general life safety
code and health issues, such as operational smoke detectors and the
availability of toilet paper in the bathrooms.
Some investigators will discuss issues with program staff as they conduct the inspection; others may wait until the conclusion of the visit to release any information. This is really a matter of style for each investigator. In either case, the findings of the site visit will be issued on FDA Form 483. FDA-483 lists the results of the investigator's inspection with regard to any problems with the program. In addition, the investigator will write a narrative that states any deviations from the regulations. These issues must be documented, however, so that anyone reviewing the information will have references to the deficiencies. When FDA-483 is issued, the investigator will request a conference with the most responsible person on site. At this time, you will be given an opportunity to respond to the findings by producing additional records that provide explanations for the findings or address the issues raised. The conclusions of this discussion are also included in the investigator's narrative Establishment Inspection Report (EIR), which discusses the contents of FDA-483 in greater detail. In addition, you will have an opportunity to respond to the findings in writing. Should any problems arise during the inspection that seem serious enough, FDA may ask you to attend an informal meeting with the local district office. In this case, you will be sent a letter requesting your attendance at such a meeting. At the meeting you will be asked to justify the findings of the inspections and offer corrective action plans.
If regulatory action may be taken against your program, it is a good idea to obtain a copy of the EIR, which is available from FDA through the Freedom of Information Act.
DEA uses regional field office staff to conduct
investigations. These visits are always unannounced. You can expect
to be inspected by DEA during the registration application process
and periodically thereafter. DEA will inspect your program more
often if there are problems that need to be reviewed or if there
have been allegations of impropriety filed about your program. DEA
requires that the program comply with all security and
recordkeeping regulations. Security includes the review of
adherence to FDA standards of effective medical and counseling
interventions established to minimize diversion by individual
patients. DEA considers violations of these FDA standards in
determining the appropriate action required to bring the program
into compliance.
It is important to note that DEA considers the control of your drug supply and the potential for diversion to be a serious programmatic issue. DEA feels that the program is responsible for monitoring and controlling diversion. Not only does this mean that security measures must be effective, it also means that you must have effective medical and counseling interventions that minimize diversion by individual patients. In addition, security and control issues do not stop at the front door of your program. DEA will expect you to employ all possible means to control the actions of patients and staff in your program to prevent diversion.
In preparation for your site visit, the investigator will examine all past reports and available information about your program. He or she will monitor your progress on correcting old deficiencies. DEA staff will also check with FDA and SA staff to discuss any issues that FDA or the SA have identified during their inspections.
The DEA review is based on the following physical security and handling requirements that will vary with the specifications of your site:
When the investigator arrives, he or she will present agency
credentials and a written Notice of Inspection, DEA Form 82.
While on site, the investigator will examine security, safety, and
recordkeeping practices and procedures. Specifically, the
investigator will review inventory records, make a physical count
of all the methadone on hand and verify this with inventory
records, review narcotic order forms, and review dispensing
records. The investigator will review the storage capacity and
security system for the storage of narcotics and will test all
alarm systems. The investigator will also review your procedures
for delivery and receipt of methadone and the list of persons
authorized to receive deliveries.
Following the site visit, the investigator will meet with management staff from the program to review results of the site visit. The investigator will help identify possible solutions to any identified problem areas. At this meeting, the program director will have a chance to provide any missing information, answer remaining questions from the investigator, and discuss corrective action plans. Following the site visit, the investigator will contact your narcotic suppliers to verify your purchase of medications. If your program is a compounder for other sites, the investigator will also verify delivery to other locations.
Be sure to take notes during the site visit summary session because you will not receive a copy of the summary report on the investigation. The DEA Report of Investigation is maintained at the field office and a copy forwarded to headquarters in Washington, D.C. for review or action.
All regulatory authorities offer opportunities to correct problems they have identified during an inspection. They are trained to be sensitive to the fact that, at times, compliance problems may be the result of larger issues, such as staffing shortages. The regulatory authorities, however, are there to monitor compliance with program standards. If problems are apparent, they are authorized to take action against your program.
Again, each SA will have its own set of procedures that are specific to your State. Should you receive notification of an action against your program by your SA, get in touch with your SA contact. Usually, an SA will give progressively more stringent warnings before taking action against your program. Most SAs specify a formal grievance process in their State regulations. Typically, an SA will give you an opportunity to respond to written warnings within a given time period. SA staff will normally reinspect your program to ensure that changes have been made. If investigations reveal significant problems, the SA is authorized to take action against your program, such as issuing a moratorium on admissions or removing your State program approval.
Please note that your SA is authorized to recommend revocation of your program approval to FDA and DEA. Both FDA and DEA give these recommendations serious consideration in determining their courses of action with regard to your program!
The FDA Regulatory Management Branch (the
organization that originally approved your application) has the
power to approve or deny regulatory action against your program. If
problems are grave enough, they have the authority to
administratively or judicially enforce sanctions against you,
including seizure of medication supplies, injunctions, approval
revocation, recommendation of revocation of your DEA registration,
civil fines, and even criminal prosecution. The Regulatory
Management Branch can initiate this without notice! However,
notice is usually provided through several means.
Notice of violations is first given verbally by the investigator at the conclusion of the inspection. Written notification is then provided on FDA-483. Should the identified problems seem great enough to involve the Regulatory Management Branch, you could be issued a "warning letter." This letter will specify the sections of the regulations that have been violated, describe the facts establishing these violations, and state a period of time for you to submit a corrective action statement as a response. FDA will most likely conduct a second inspection visit to ensure that corrective actions have been implemented. If your corrective action statement is not submitted in a timely fashion or is unacceptable, you can be sure that a second site visit will ensue.
It is an indication of a good faith attempt to correct violations cited in the warning letter if your response to the letter is comprehensive, specific, and presented point by point. If you disagree with a charge, it should be stated clearly and respectfully with supportive documentation. Be careful not to make any commitment in your response letter that you do not intend to fully implement, because the follow-up inspection will look closely at how you implemented your proposed corrections.
If the problems with your program are even worse, or if they are
found to be intentional, flagrant, part of a history of similar
violations, or indicative of a callous disregard for the health and
safety of your patients, FDA may conclude that administrative or
judicial action should be taken immediately. If this should happen,
you will be notified in writing of the action to be taken and
offered an opportunity for an informal conference. You will be
required to justify approval of your program, or revocation action
may be immediately initiated. If your approval is revoked, this
decision can be reversed if you can justify your application to the
Commissioner of FDA's Center for Evaluation and Research. If your
program is a multisite program, you should be aware that if
approval is revoked at the primary site, approval will also be
revoked at all medication unit locations.
Just as with FDA, DEA has authority to take action against your program should investigators find violations of regulatory standards. The DEA action may include an Investigative Warning or Letter of Admonition for less serious violations; and an Administrative Hearing, Order to Show Cause, and civil or criminal actions against the program sponsor, stockholders, or key staff for serious violations or those reflecting a continuing disregard for the regulations. In all cases, DEA will document evidence of noncompliance with various regulations.
DEA has the authority to proceed civilly or criminally against violators of law. If problems indicate a threat to the health and safety of patients or document significant breaks of security or diversion of narcotics, DEA can take immediate action against your program. This means the agency can issue an Immediate Suspension Order and revoke your registration, close the program, seize supplies of medications, and recommend that FDA and the SA revoke their approvals of your program. If registration is revoked, DEA will issue an order for this action that specifies the reasons for revocation, the facts documenting this action, and the date that revocation is to take effect. Following this action, however, you are entitled to an Order to Show Cause hearing, at which time you may appeal the Immediate Suspension Order.
As indicated earlier, following each inspection, the investigator will meet with program management staff to review the results of the inspection. DEA expects that corrective actions will be implemented within a reasonable amount of time. Should follow-up site visits show that no changes have been made, or that new violations are discovered, DEA will proceed with additional administrative action as deemed necessary to bring you into compliance.
For violations not warranting serious action, DEA gives notice and you are allowed to take corrective action. If you have serious repeat and/or multiple violations, you will receive either a Letter of Admonition or DEA may request a hearing. The Letter of Admonition is written to advise you of any violations that are alleged to have occurred and documents them in written form. You must respond to this letter with a written corrective action plan.
The hearing provides an opportunity for you and DEA to discuss the
necessary corrective action(s). DEA is authorized to indicate
violations of FDA or State standards as evidence of noncompliance.
DEA may ask you to sign a memorandum of understanding that
documents the corrective actions required and the potential for
registration suspension, civil or criminal action, or revocation of
registration that could result if you do not make changes.
After your program is operating, you may find it necessary to make changes in the original program design, or, over time, you will have changes in staffing, vendors, or suppliers with whom you work. Some of these changes will need to be communicated to the regulatory authorities, and some will need their approval before you implement the change.
SAs have different processes for approving program changes that vary by State. Be sure to check with your SA contact before you make any changes. You can expect that the SA will at least require notification of changes in key staff or program location. In most States, a change in location will warrant a new application for approval, and a site visit. In addition, SAs require notification of temporary and permanent changes in your program's protocols, such as the hours of operation. With changes that impact on patients, the SA usually requires a written statement that documents how they will be affected by the change and how their needs will be met. The SA customarily responds with a written acknowledgment and a review of the change at the next site visit.
You must notify FDA when you make certain changes to
your program, but you may make them without FDA approval. These
changes include the following:
FDA can be notified by telephone, but be sure to follow up with a letter.
A variety of other situations also require notification and
approval by FDA. These situations include the following:
Temporarily changing program hours of operation because
of holidays, and so forth. Requests for approval of these exemptions to the regulations can usually be processed over the telephone by calling the Regulatory Management Branch. In such instances, FDA will follow up its approval by sending you a letter as soon as possible. FDA logs all program approvals that it grants. This process serves as the official documentation of the granting of an approval for an exemption. Any program changes that are not properly communicated or approved will be cited as deficiencies on your next inspectional visit.
After you are registered with DEA, any modifications to your
registration must be made via a written request to the DEA field
office prior to implementation. Your registration is specific to
the approved location and is void if you move. If you plan to move
your program, contact the DEA field office well in advance to
ensure that you fully understand the safety and security
requirements specific to the new location.
Generally, programs close for one of two reasons: either they want to, or they have to. Programs that want to close should work with the SA to develop plans that will ensure an orderly transfer of patients, records, and assets. Programs that are required to close should expect to receive instructions from the SA.
Contacts with Federal agencies in regard to program closures are
straightforward. Programs that decide voluntarily to discontinue
business should contact the local DEA office prior to taking such
action. The DEA registration certificate and any unused Narcotic
Order Forms (DEA Form 222) will need to be returned to DEA, and
arrangements will have to be made to dispose of the controlled
substances properly.
In regard to programs that are closed involuntarily, the FDA regulations are silent on the procedures that need to be followed after program approval has been revoked; DEA regulations in these situations speak only to that program's responsibility for securing and disposing of controlled substances. It is the State AOD agency that is likely to have policies, guidelines, or regulations to govern this type of program closure, and it is usually this entity that oversees and monitors the event.
The role and responsibility of the SA relative to program closure varies from State to State. For example, in some States, the SA may assume all the responsibility for handling the closure; while in others, it may be a shared responsibility with a local or regional office of the State agency. In some States, county officials may also be involved.
Although the circumstances surrounding program closures may vary, the foremost concern should be to ensure continuity of care for patients. They will need to be referred to other programs for treatment; with signed consent, their records will have to be transferred to these programs as well. State agency personnel may facilitate and assist in this process. In localities where other methadone treatment programs are not readily available, the State agency should attempt to make alternative arrangements.
Records of patients who are no longer in treatment will need to be secured and maintained for a specified period of time. Policies governing the location and ownership of these records vary from State to State; you should contact your SA to determine the procedures you will need to follow.
Finally, publicly funded programs are likely to have assets, for example furniture and equipment, that were purchased with Federal and State dollars. These assets may be confiscated by the State and redistributed throughout the treatment system.
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