• What is a prescription?
• What information is required on a prescription for a controlled substance?
• Can controlled substance prescriptions be refilled?
• What receiving records must a practitioner/physician maintain if they plan on maintaining a stock of controlled substances for dispensing and administering to their patients?
• What is meant by "readily retrievable?"
• Are there any special security requirements that a practitioner/physician should take if they plan on maintaining a stock of controlled substances in their office for dispensing and administering?
• What reports must be filed if a practitioner/physician experiences a theft or significant loss of controlled substances?
• Faxing of Schedule II Prescriptions for Hospice Patients 
• Changes that Pharmacists are Allowed to Make on Controlled Substance Prescriptions
• Is it appropriate to provide a DEA registration number on prescriptions written for medications other than controlled substances?  
• Is it appropriate to provide a DEA registration number when purchasing items other than controlled substances such as prescription drugs, over-the-counter drugs, or medical supplies from a distributor?
• Is it permissible to dispense a prescription for a quantity less than the face amount prescribed resulting in the actual number of dispensings being greater than the number of refills indicated on the prescription? 
• Can a Long Term Care Facility store controlled substances in an emergency kit without being registered with DEA?
• Can an individual return their controlled substance prescription medication to a pharmacy? 
• Can a long term care facility (LTCF) return a resident’s unused controlled substance medication to a pharmacy?
• Can a patient in a Long Term Care Facility (LTCF) receive methadone for maintenance purposes?  
• Can a practitioner prescribe methadone for the treatment of pain? 
• As a DEA registrant, how do I report breakage or spillage of controlled substances?

Question: What is a prescription?

Answer – 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 (e.g., an order to dispense a drug to an inpatient for immediate administration in a hospital is not a prescription.). To be valid, a prescription for a controlled substance must be issued for a legitimate medical purpose by a practitioner acting in the usual course of sound professional practice.

Question: What information is required on a prescription for a controlled substance?

Answer – A prescription for a controlled substance must include the following information:

• Date of issue,
• Patient’s name and address,
• Practitioner’s name, address and DEA registration number,
• Drug name,
• Drug strength,
• Dosage form,
• Quantity prescribed,
• Directions for use,
• Number of refills (if any) authorized, and
• Manual signature of prescriber.

A prescription must be written in ink or indelible pencil or typewritten and must be manually signed by the practitioner. An individual may be designated by the practitioner to prepare the prescriptions for his/her signature. The practitioner is responsible for making sure that the prescription conforms in all essential respects to the law and regulation.

Prescriptions for Schedule II controlled substances must be written and be signed by the practitioner. In emergency situations, a prescription for a Schedule II controlled substance may be telephoned to the pharmacy and the prescriber must follow up with a written prescription being sent to the pharmacy within seven days. Prescriptions for Schedule III through V controlled substances may by written, oral or transmitted by fax.

Question: Can controlled substance prescriptions be refilled?

Answer: Prescriptions for Schedule II controlled substances cannot be refilled. A new prescription must be issued. Prescriptions for Schedule III and IV controlled substances may be refilled up to five (5) times in six (6) months. Prescriptions for Schedule V controlled substances may be refilled as authorized by the practitioner.

Question: What receiving records must a practitioner/physician maintain if they plan on maintaining a stock of controlled substances for dispensing and administering to their patients?

Answer: If the controlled substance is in Schedule II, procurement must be accomplished by using the DEA Form 222. If the drug preparation is in Schedule III through V, then a readily retrievable invoice is sufficient. These records should contain the date, drug type, dosage form, etc. The prescriber should also maintain an inventory of the drugs received and dispensed or administered.

Question: What is meant by "readily retrievable?"

Answer: The term means that the record is kept or maintained in such a manner that it can be separated out from all other records in a reasonable time and/or that it is identified by an asterisk, redline or some other identifiable manner such that it is easily distinguishable from all other records.

Question: Are there any special security requirements that a practitioner/physician should take if they plan on maintaining a stock of controlled substances in their office for dispensing and administering?

Answer: All controlled substances should be stored in a locked cabinet or other secure storage container with limited access by the office staff.

Question: What reports must be filed if a practitioner/physician experiences a theft or significant loss of controlled substances?

Answer: All thefts and any significant losses must be reported to the DEA immediately upon discovery of the theft or loss. Notification must be accomplished by completing and filing a DEA Form 106, Report of Loss or Theft. The form my be found on the Internet at www.DEAdiversion.usdoj.gov or may be obtained from your local DEA office. If the circumstances regarding the theft or loss need clarification before the form can be completed, the registrant can make an initial report via telephone or some other means and file the completed form as soon as the circumstances are known.

Question: Can controlled substance prescriptions for hospice patients be faxed to a pharmacy?

Answer: Yes. Schedule II-V controlled substance prescriptions, written for a patient enrolled in hospice, may be faxed to a pharmacy for dispensing. The hospice patient may reside in a personal residence or hospice facility.

DEA regulations allow for the transfer of a Schedule II prescription to a dispensing pharmacy by facsimile for patients enrolled in a Medicare certified or state licensed hospice. DEA’s intent is to provide for the hospice patient’s needs when a controlled substance is determined to be medically necessary. Therefore, controlled substance prescriptions for hospice patients residing at a personal residence may be faxed to a pharmacy.

Answer: The pharmacist may add the patient’s address or change the patient’s address upon verification. The pharmacist may change or add the dosage form, drug strength, drug quantity, directions for use, or issue date only after consultation with and agreement of the prescribing practitioner. Such consultations and corresponding changes should be noted on the prescription as well as the patient’s medical record. Pharmacists and practitioners must comply with any state/local laws, regulations, or policies prohibiting any of these changes to controlled substance prescriptions.

The majority of changes can be made only after the pharmacist contacts the prescribing practitioner.

After consultation with the prescribing practitioner, the pharmacist is permitted to add or change the dosage form, drug strength, drug quantity, directions for use, and issue date.

The pharmacist is permitted to make information additions that are provided by the patient or bearer, such as the patient’s address, and such additions should be verified.

The pharmacist is never permitted to make changes to the patient’s name, controlled substance prescribed (except for generic substitution permitted by state law) or the prescriber’s signature.

Question: Is it permissible to dispense a prescription for a quantity less than the face amount prescribed resulting in the actual number of dispensings being greater than the number of refills indicated on the prescription?

Answer: Yes. Partial refills of Schedule III and IV controlled substance prescriptions are permissible under federal regulations provided that each partial filling is dispensed and recorded in the same manner as a refilling (i.e., date refilled, amount dispensed, initials of dispensing pharmacist, etc.), the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed and no dispensing occurs after six months past the date of issue.

Question: Can an individual return their controlled substance prescription medication to a pharmacy?

Answer: No. An individual patient may not return their unused controlled substance prescription medication to the pharmacy. Federal laws and regulations make no provisions for an individual to return their controlled substance prescription medication to a pharmacy for further dispensing or for disposal. There are no provisions in the Controlled Substances Act or Code of Federal Regulations (CFR) for a DEA registrant (i.e., retail pharmacy) to acquire controlled substances from a non-registrant (i.e. individual patient).

The CFR does have a provision for an individual to return their unused controlled substance medication to the pharmacy in the event of the controlled substance being recalled or a dispensing error has occurred.

An individual may dispose of their own controlled substance medication without approval from DEA. Medications should be disposed of in such a manner that does not allow for the controlled substances to be easily retrieved. In situations where an individual has expired, a caregiver or hospice staff member may assist the family with the proper disposal of any unused controlled substance medications.

Question: Can a long term care facility (LTCF) return a resident’s unused controlled substance medication to a pharmacy?

Answer: No. There are no provisions in the Controlled Substances Act for a DEA registrant (i.e., retail pharmacy) to acquire controlled substances from a non-registrant (i.e., resident of a LTCF). Most long term care facilities are not licensed by their respective state to handle controlled substances and therefore are not registered with DEA. Long term care facilities act in a custodial capacity, holding controlled substances that, pursuant to a prescription, have been dispensed to and belong to the resident of the LTCF. Federal laws and regulations make no provisions for controlled substances that have already been dispensed to patients, regardless of the packaging method, to be returned to a pharmacy for further dispensing or disposal.

Question: Can a patient in a Long Term Care Facility (LTCF) receive methadone for maintenance purposes?

Answer: If a LTCF is registered with DEA as a hospital/clinic, it need not be separately registered as a Narcotic Treatment Program (NTP) to administer or dispense methadone as an adjunct to medical treatment of conditions other than addiction. [21 CFR 1306.07(c)]

If a LTCF that is not registered with DEA has a patient who is also currently enrolled in a licensed NTP, the NTP may transfer medication to the LTCF with the approval of the State Methadone Authority. (www.samhsa.gov/centers/csat/content/opat/statemeth.html)

If an individual is not currently enrolled in an NTP and is in a LTCF that is not registered with DEA, a practitioner may administer narcotic drugs to the individual for relieving acute withdrawal symptoms when necessary while arrangements are being made for referral for treatment. No more than one day’s medication may be administered to the individual or for the individual’s use at one time. Such emergency treatment may be carried out for no more than three days and may not be renewed or extended. [21 CFR 1306.07(b)]

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Question: Can a practitioner prescribe methadone for the treatment of pain?

Answer: Federal law and regulations do not restrict the prescribing, dispensing, or administering of any schedule II, III, IV, or V narcotic medication, including methadone, for the treatment of pain, if such treatment is deemed medically necessary by a practitioner acting in the usual course of professional practice.

Confusion often arises due to regulatory restrictions concerning the use of methadone for the maintenance or detoxification of opioid addicted individuals, in which case the practitioner is required to be registered with the DEA as a Narcotic Treatment Program (NTP).

Question: As a DEA registrant, how do I report breakage or spillage of controlled substances?

Answer: Breakage of controlled substances does not constitute a "loss" of controlled substances. When there is breakage, damage, spillage or some other form of destruction, any recoverable controlled substances must be disposed of according to DEA requirements. Damaged goods may be disposed of through shipment to a "reverse distributor" or by a DEA approved process. The DEA recommends that any registrant seeking to dispose of controlled substances first contact the nearest DEA Diversion Field Office for disposal instructions. In no case should drugs be forwarded to the DEA unless the registrant has received prior approval from the DEA.

If the breakage or spillage is not recoverable, the registrant must document the circumstances of the breakage in their inventory records. Two individuals who witnessed the breakage must sign the inventory records indicating what they witnessed. The submission of a DEA Form 41, Registrants Inventory of Drugs Surrendered is not required for non-recoverable controlled substances.

The DEA procedures established for the destruction of controlled substances shall not be construed as altering in any way the state laws or regulations for the disposal of controlled substances. When this disposal occurs, it must be reported to the DEA on a DEA Form 41.