Rules for Storing and Dispensing Drugs

A dentist who dispenses or administers drugs, including controlled substances, must comply with federal and state laws for their storage and must maintain required documentation. There are limits on drug dispensing, required reporting and containers with dispensed drugs should be child-proof and labeled with specific information.

Storage and Record-Keeping

Drugs to be dispensed must be stored in a secure area. Controlled substances must be stored in a locked cabinet or drawer with access limited to the dentist and authorized staff. Document who in the dental practice has access to the key or combination. A drug log must be kept and maintained for three years.

An inventory of controlled substances must be taken at least once every two years. The inventory record may be handwritten, typewritten or on a printed form. It must be retained for at least two years from the date that the inventory was conducted. Each inventory record must contain the following information:

• Date of inventory and whether the inventory was taken at the beginning or close of business.

• Names of controlled substances.

• Each finished form of the substances (e.g., 100-milligram tablet).

• Number of dosage units of each finished form in the commercial container (e.g., 100-tablet bottle).

• Number of commercial containers of each finished form (e.g., four 100-tablet bottles).

• Disposition of the controlled substances.

Controlled substance samples provided by pharmaceutical companies must be included in the inventory record.

Dispensing

Drugs dispensed by a dentist must be necessary for the dentist’s treatment of the patient and not for any other purpose. Prior to dispensing, a dentist must provide a written disclosure that the patient has a choice between obtaining the drug from the dentist or a pharmacy of their choice.

A dentist must evaluate any potential adverse reactions with other medications the patient is taking. In addition, a dentist must advise the patient as to instructions for use and warn of any risks or hazards created by uses of the medication. A dentist who dispenses medication has the same obligations as a pharmacist in communicating information to a patient. Read further for information on container and label requirements.

A limited quantity of drug samples may be provided to patients at no charge if furnished in the original package provided by the manufacturer. Record the transaction in the patient record. If dispensing a Schedule II controlled substance to patients under their care, a dentist may not dispense an amount that exceeds a 72-hour supply in accordance with normal use. Dispensing of controlled substances must be reported to CURES.

Containers and Labels

When dispensing drugs to a patient, a dentist must:

• Use a childproof container unless the patient requests one not be used.

• Label the container as described below.

• Display on the container if the drug is an opioid a notice that states, “Caution. Opioid. Risk of overdose and addiction.”

• Inform the patient orally or in writing of possible side effects of the drug.

Label requirements are intended to provide patients with easy-to-read labels. The following elements must be printed in at least 12-point sans serif typeface, listed in the following order and clustered into one area of the label that comprises at least 50% of the label. This part of the label also must be highlighted in bold typeface or color or have blank space to set off the above items:

• Patient’s name.

• Drug name and strength.

• Directions for use.

• Purpose or condition for which the drug is prescribed.

The remaining required elements of the label must be printed so as not to interfere with the legibility of the four elements listed above. The remaining required elements are:

• Prescriber’s name and address.

• Date medication was dispensed.

• Quantity of medication dispensed.

• Expiration date of the effectiveness of the medication dispensed.

• Physical description of the dispensed medication, including its color, shape and identification code that appears on the tablets or capsules.

If a drug may impair a user’s ability to operate a vehicle or vessel or poses a substantial risk if consumed with alcohol, the container of the drug must have a written label indicating that the drug may impair a user’s ability to operate a vehicle or vessel or that the drug poses a substantial risk to the person consuming the drug when taken in combination with alcohol.

Upon the request of a patient or patient’s representative, a dentist who dispenses must provide translated directions for use on the prescription container, label or on a supplemental document. (An example of directions for use is “Take one pill at bedtime.”) The English-language version of the directions for use must also appear on the container or label (not on a supplemental document). The California State Board of Pharmacy has translated directions online at pharmacy.ca.gov/publications/translations.shtml in Chinese, Korean, Russian, Spanish and Vietnamese. A dentist may provide their own translated directions for use or can use the translations made available from the board of pharmacy. The prescriber dispenser is not obligated to provide translated directions for use beyond the languages that the board of pharmacy has made available or beyond the directions that the board has made available in translated form.

When applicable, directions for use must use one of the 16 directions listed in Section 1707.5 of Title 16 of the California Code of Regulations. The direction likely to be used by dental practices is:

If you have pain, take __ (insert appropriate dosage form — pill, caplet, capsule or tablet) at a time. Wait at least __ hours before taking again. Do not take more than __ (appropriate dosage form) in one day.

Reporting Theft or Loss of Drugs

The theft or loss of controlled substances from a prescriber’s premises must be reported to local law enforcement and to the DEA within one business day of discovering the theft or loss. Report the theft or loss to the DEA using Form 106.

Disposal of Drugs

Except for controlled substances, drugs used in a dental practice may be disposed as pharmaceutical waste, which is regulated in California as medical waste. Use appropriate containers and dispose within the proper time period. See “Dental Office Waste Management Options” on cda.org/practicesupport for more information.

Dispose of out-of-date, damaged or otherwise unusable or unwanted controlled substances, including samples, by transferring them to an entity that is authorized to receive such materials. These entities are referred to as “reverse distributors.” Contact your local DEA field office for names of reverse distributors or do an internet search for these vendors. Maintain copies of the records documenting the transfer and disposal of controlled substances for two years. A dentist or dental facility is required to update their DEA registration if they plan to take patients’ unused controlled substances for disposal.

Resources

California Health and Safety Code §11158 and 11165.3; Business and Professions Code §§4076 - 4078, 4081, 4170 - 4175, 4184; and 16 CCR §1707.5.

Regulatory Compliance appears monthly and features resources about laws that impact dental practices. Visit cda.org/practicesupport for more than 600 practice support resources, including practice management, employment practices, dental benefit plans and regulatory compliance.