Friday, May 11, 2012

Consulting Applicable Law: Federal and State

Both the state and the federal laws need to be consulted when dealing with compound medications.  An example of this is when one is dealing with "office use" or "office administration" of medications--both medications for humans and medications for animals.  In general, "office use"  or "office administration" of medications refers to "limited" or "reasonable" quantities and for administration in the office, institution or hospital.  This does not mean a doctor or veterinarian can dispense the medication to the patient.  To determine specifically if one is complying with applicable law, first consult your State Board of Pharmacy rules and regulations regarding "office use."  

Second, one should consult the state rules and regulations of any state where medications will be shipped or delivered to, if the medication, is not being shipped or delivered to one's home state.   For example, Oklahoma's rules allow the "office use" of compounded medications except for controlled substances as written in their state rules, which is the same as the United States Drug Enforcement Administration (DEA), patient-specific, controlled substance prescription requirement, which is discussed below.  Missouri's rules, on the other hand, strictly forbid the "office use" of compounded medications.  Whereas, Texas' rules allow the "office use" of compounded medications, but requires a specific contract between pharmacy and practitioner. 

Third, you must consult any applicable federal law.  For example, 21 CFR § 1306.04 relates to the purpose of issue of prescription.  That section provides:
Section 1306.04 Purpose of issue of prescription.
(a) A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.

(b) A prescription may not be issued in order for an individual practitioner to obtain controlled substances for supplying the individual practitioner for the purpose of general dispensing to patients.

(c) A prescription may not be issued for “detoxification treatment” or “maintenance treatment,” unless the prescription is for a Schedule III, IV, or V narcotic drug approved by the Food and Drug Administration specifically for use in maintenance or detoxification treatment and the practitioner is in compliance with requirements in §1301.28 of this chapter.

[36 FR 7799, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 39 FR 37986, Oct. 25, 1974; 70 FR 36343, June 23, 2005]

The DEA does not recognize compounded, controlled substance medications ordered for "office use" or "office administration." Thus, controlled substance cannot be shipped to a doctor's office, but must be patient-specific and delivered directly to patients. 

What law applies to compounded medications is a tricky and developing area of the law.  It is essential that all involved in the chain dealing with compounded medications consult both state and federal law to ensure compliance with all applicable laws.

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