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Dental Practice Audits &
Regulatory Matters

As a dentist, you will likely need to be licensed with the Drug Enforcement Agency (DEA) to prescribe medication, including narcotic pain medication.  With the widespread attention surrounding prescription drug abuse, you may want to familiarize yourself with the requirements of the Controlled Substances act, which regulates the prescription of medication in the United States.  U.S.C.A. Title 21, Chapter 13; 21 CFR Chapter 2.

In addition to the federal Controlled Substances Act and associated regulations, Arizona also has laws governing the dispensing of prescription drugs, both in the Arizona Revised Statutes (ARS) and the Arizona Administrative Code (AAC).  A.R.S. § 32-1298; AAC Title 4, Chapter 11, Article 14.  The following are a just a few of the most common ways doctors can run into trouble under both state and federal law:

  • Prescribing Medication: The Arizona laws and regulations governing the act of prescribing medications can be found in A.R.S. § 32-1298(1) and A.A.C. R4-11-1401, 21 U.S.C.A. § 829 and C.F.R. 21 §1306.04. The most common violation of these sections, and also the one that can carry the stiffest penalties, is prescribing medication outside one’s scope of practice. An example of this would be a dentist who writes a prescription for a patient’s (or family member’s) chronic back pain.  The penalties for violating these provisions can be significant, up to and including the loss of your DEA license and possible disciplinary action by the medical or dental board.
  • Record Keeping: Federal and state regulations require dentists to keep detailed records of all medication prescribed to patients, as well as records of all medication stored on the premises. See A.C. R4-11-1404, 21 U.S.C.A. § 827, and C.F.R. 21 § 1304.  This includes keeping a documented inventory of all medications in your practice.  To manage this critical function, it may be helpful to dedicate a staff member to assist in recordkeeping, with occasional audits to ensure that inventory controls are maintained.  Doctors are also required to maintain these records for three years from the date dispensed and they must be kept on site for immediate review.
  • Storage: Arizona law requires all prescription-only drugs and devices to be stored in a secured area and all controlled substances in a locked cabinet or room. See A.C. R4-11-1403. Ideally, controlled substances should be stored using a “two lock” system: a locked cabinet/safe inside a locked room or closet.  Federal law mandates that the DEA registrant (the doctor) is responsible for storage of all controlled substances purchased under his or her registration number.  These precautions are necessary to prevent possible disciplinary action if a staff member or patient improperly accesses the controlled substances on site.
  • Disposal: Controlled substances are the only medications for which disposal is regulated by law, and those guidelines can be found in 21 C.F.R. § 1317. This section outlines the various methods by which you may dispose of or destroy expired, contaminated, or defective controlled substances.  The procedures that must be followed for on-site destruction of controlled substances are very specific, so the safest method of disposal is through the use of a DEA-registered reverse-distributor.

If you are found in violation of the regulations concerning prescription drugs, there can be serious repercussions.  In addition to the state disciplinary proceedings, the DEA can also suspend or revoke your DEA registration for any of the following reasons: (1) falsification of your DEA registration application; (2) suspension, revocation, or denial of your state license; (3) exclusion from participation in Medicare or Medicaid programs; (4) conviction of a felony related to a controlled substance; or (5) commission of an “act inconsistent with public interest.”  This last category is a “catch-all” that encompasses any of the violations above, as well as issues like repeatedly over-prescribing narcotic pain medication to patients.

Accordingly, if you are facing an audit there can be a lot at stake and it is not something that you should take lightly.

Arizona Attorney Patrick Stanley

Pat Stanley

Attorney for Arizona Dentists

(480) 219-5481

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