March 2019 Volume LIV Number 2

 
 
 
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Litch’s Law Log: DEA and the Dental Office

November 2012 Volume XLVIII Number 6

Among the myriad federal and state laws and regulations that impact a dental practice, one area not to overlook is that of the Drug Enforcement Administration (DEA), which is under the U.S. Department of Justice. The DEAs mission is to

". . . enforce the controlled substances laws and regulations of the United States and bring to the criminal and civil justice system

of the United States, or any other competent jurisdiction, those organizations and principal members of organizations, involved in the growing, manufacture, or distribution of controlled substances appearing in or destined for illicit traffic in the United States; and to recommend and support non-enforcement programs aimed at reducing the availability of illicit controlled substances on the domestic and international markets."

Because "[m]any problems associated with drug abuse are the result of legitimately made controlled substances being diverted from their lawful purpose into illicit drug traffic," the DEAs Office of Diversion Control program has a mission to:

". . . prevent, detect, and investigate the diversion of controlled pharmaceuticals and listed chemicals from legitimate sources while ensuring an adequate and uninterrupted supply for legitimate medical, commercial, and scientific needs."

Drug Enforcement Administration License

As described in the AAPDs publication The New Pediatric Dentists Guide to Beginning Practice, "to prescribe and dispense controlled substances, you will need to obtain a state and federal DEA number." Your state board of dentistry can assist in obtaining the applications. The current federal DEA fee is $731 for a three-year license.1

 

In a group practice, the DEA notes that:

"An individual practitioner who is an agent or employee of another practitioner (other than a mid-level practitioner) registered to dispense controlled substances may, when acting in the normal course of business or employment, administer or dispense (other than by issuance of prescription) controlled substances if and to the extent

that such individual practitioner is authorized or permitted to do so by the jurisdiction in which he or she practices, under the registration of the employer or principal practitioner in lieu of being registered him/ herself."

Key Issues for Dentists

All dentists should be familiar with the DEAs Practitioners Manual.2

Note that under the Controlled Substances Act, the term "practitioner" is defined as a physician, dentist, veterinarian, scientific investigator, pharmacy, hospital, or other person licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which the practitioner practices or performs research, to distribute, dispense, conduct research with respect to, administer, or use in teaching or chemical analysis, a controlled substance in the course of professional practice or research.

Protection of Controlled Substances

Security and protection of controlled substances in the dental office is one important requirement. Title 21, CFR (Code of Federal Regulations) Section 1301.71(a), requires that all registrants provide effective controls and procedures to guard against theft and diversion of controlled substances. A list of factors is used to determine the adequacy of these security controls. Practitioners are required to store stocks of Schedule II through V controlled substances in a securely locked, substantially constructed cabinet. Further:

 

"Registrants should not employ as an agent or employee who has access to controlled substances:

Any person who has been convicted of a felony offense related to controlled substances

Any person who has been denied a DEA registration

Any person who has had a DEA registration revoked

Any person who has surrendered a DEA registration for cause."

Practitioners should also notify the DEA, upon discovery, of any thefts or significant losses of controlled substances and complete a DEA Form 106 regarding such theft or loss.

 

Safeguarding the Prescription Process

In addition to the required security measures, DEA recommends practitioners utilize additional measures to ensure security in the prescription process:

Keep all prescription blanks in a safe place where they cannot be stolen; minimize the number of prescription pads in use.

Write out the actual amount prescribed in addition to giving a number to discourage alterations of the prescription order.

Use prescription blanks only for writing a prescription order and not for notes.

Never sign prescription blanks in advance.

Assist the pharmacist when they telephone to verify information about a prescription order; a corresponding responsibility rests with the pharmacist who dispenses the prescription order to ensure the accuracy of the prescription.

Contact the nearest DEA field office

. . . to obtain or to furnish information regarding suspicious prescription activities.

Use tamper-resistant prescription pads.

A prescription is an order for medication which is dispensed to or for an ultimate user. A prescription is not an order for medication which is dispensed for immediate administration to the ultimate user (for example, an order to dispense a drug to an inpatient for immediate administration in a hospital is not a prescription).

Maintaining Certain Drugs in the Office

Sometimes it is necessary to have medications stockpiled in the dental office for use in common situations, such as sedation. The general DEA rule is that:

 

"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."3

However, an arrangement can be made with a pharmacist under the following conditions:

"A practitioner who is registered to dispense a controlled substance may distribute (without being registered to distribute) a quantity of such substance to another practitioner for the purpose of general dispensing by the practitioner to his or its patients provided that:

The practitioner to whom the controlled substance is to be distributed is registered under the Act to dispense that controlled substance;

The distribution is recorded by the distributing practitioner in accordance with Sec. 1304.22(c) of this chapter and by the receiving practitioner in accordance with Sec. 1304.22(c) of this chapter;

If the substance is listed in Schedule I or II, an order form is used as required in part 1305 of this chapter;

 

 

The total number of dosage units of all controlled substances distributed by the practitioner pursuant to this section and Sec. 1301.25 of this chapter during each calendar year in which the practitioner is registered to dispense does not exceed 5 percent of the total number of dosage units of all controlled substances distributed and dispensed by the practitioner during the same calendar year."4

 

If a patient requires a drug for treatment the same day as the planned dental service, and assuming the dentist does not maintain a supply in the office, an acceptable protocol is to give the prescription to the patients parent or guardian, and have it immediately filled and brought back to the clinic.

For further information, please contact Chief Operating Officer and General Counsel C. Scott Litch at (312) 337-2169, ext. 29, or slitch@aapd.org.

 

See: http://www.deadiversion.usdoj.gov/fed_regs/rules/2012/reg_csa_fees/registration_fees_fact_sheet.pdf

The latest edition, from 2006, is available at : http://www.deadiversion.usdoj.gov/pubs/manuals/pract/pract_manual012508.pdf

21 CFR Section 1306.04 (b).

21 CFR Section 1307.11.

 

 

 

 

 

 

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