Exhibit E—Questions Often Asked About FDA Regulations

What are the minimum staffing requirements for program approval?

Each program must designate a medical director who is responsible for administering medical services performed by the program. The medical director must be a physician licensed in your State. Other program staff are required based on the number of patients and the complexity of their problems. (Federal regulations require narcotic drugs to be administered and dispensed by practitioners licensed under State law, so be sure to check the State regulations related to program staffing.) 21 CFR 291.505(a)(3); (d)(4)(ii); (d)(5)(i); (d)(6)(c)(ii)

What are the most important recordkeeping requirements that I should know about?

Each program is required to maintain a confidential and "adequate" patient record. Here, adequate means a comprehensive record that includes documentation of appropriateness for admission to the program and documentation of the services provided to the patient in the form of a treatment plan, progress notes, history, and medical information. In addition, the program must completely document medication dispensing, drug testing, and urinalysis results, and the patient record must contain FDA's patient consent form. Various signatures are required for the physician and counselors, as well as documentation of the review of the treatment plan, and lab results. 21 CFR 291.505 (d)(3)(ii); (d)(6)(v)(A)(3); (d)(13)(i)

Does FDA have requirements for a patient to be admitted to a program?

Yes. FDA methadone regulations establish minimum standards for admission that state that a patient may be admitted only if the program's physician determines that the person is physiologically dependent on a narcotic drug and has been dependent for at least 1 year. This 1 year of dependence may be continual or episodic. If it is impossible to determine the date that dependence started, the program physician may use reasonable clinical judgment to determine that there was a 1-year physiologic dependence and may approve admission of the patient. There are exemptions to these standards for incarcerated persons and pregnant women. 21 CFR 291.505 (d)(1)(i)

Are there limitations on the dosage of narcotics that can be given to patients?

Yes. A patient may not receive more than 30 mg of methadone as an initial dose, and the total dose for the first day may not exceed 40 mg unless the medical director documents that 40 mg did not suppress opiate abstinence symptoms. Any dose greater than 100 mg must be justified by the program's physician, and ingestion must be observed at least 6 days per week. If a patient is to receive take-home medication greater than 100 mg for more than 1 day, approval must be obtained from FDA and the State. (Some States have more stringent dosage requirements so be sure to review the State regulations.) 21 CFR 291.505 (d)(6)(i)(A); (d)(6)(i)(C); (d)(6)(v)(D)

Are there requirements for maintaining a treatment plan for each patient?

Yes. An initial treatment plan that outlines short-term goals and behavioral tasks a patient must perform to complete the goals must be completed within 4 weeks of admission to the program. This treatment plan must be reviewed and evaluated at least once each 90 days during the first year of treatment and twice a year thereafter. 21 CFR 291.505 (d)(3)(iv)(A)(1); (d)(3)(v)(A)

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