Questions & Answers
Long Term Care Facility (LTCF)
Records / Reports
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?
Long Term Care Facility (LTCF)
Answer: Yes. Schedules II-V controlled substance prescriptions may be transmitted by the practitioner or the practitioner’s agent to the dispensing pharmacy by facsimile. The facsimile serves as the original written prescription.
Question: Can an LTCF store controlled substances in an emergency kit without being registered with DEA?
Answer: DEA published the following Statement of Policy in the April 9, 1980 Federal Register regarding the placement of controlled substances in an emergency kit located in an LTCF.
STATEMENT OF POLICY
The placement of emergency kits containing controlled substances in non-federally registered Long Term Care Facilities (LTCF) shall be deemed to be in compliance with the Comprehensive Drug Abuse Prevention and Control Act of 1970, if the appropriate state agency or regulatory authority specifically approves such placement and promulgates procedures which delineate:
A. The source from which an LTCF may obtain controlled substances for emergency kits. The source of supply must be a DEA registered hospital/clinic, pharmacy, or practitioner.
B. Security safeguards for each emergency kit stored in the LTCF which include the designation of individuals who may have access to the emergency kits and a specific limitation of the type and quantity of controlled substances permitted to be placed in each emergency kit.
C. Responsibility for proper control and accountability of such emergency kits within the LTCF to include the requirement that the LTCF and the providing DEA registered hospital/clinic, pharmacy, or practitioner maintain complete and accurate records of the controlled substances placed in the emergency kit, the disposition of these controlled substances plus the requirement to take periodic physical inventories.
D. The emergency medical conditions under which the controlled substances may be administered to patients in the LTCF to include the requirement that medication be administered by authorized personnel only as expressly authorized by an individual practitioner and in compliance with the provisions of 21 CFR 1306.11 and 21 CFR 1306.21.
E. Prohibited activities which can result in the state revocation, denial, or suspension of the privilege of having or placing emergency kits, containing controlled substances, in an LTCF.
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 an LTCF). Most LTFCs are not licensed by their respective state to handle controlled substances and, therefore, are not registered with DEA. LTCFs 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.
Answer: If the 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 an 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 an 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)]
Records / Reports
Answer: The term "readily retrievable" means the record is kept or maintained in such a manner that it can be separated out from all other records in a reasonable time or that it is identified by an asterisk, redline, or some other identifiable manner such that it is easily distinguishable from all other records.
Answer: Each practitioner must maintain inventories and records of controlled substances listed in schedule II separately from all other records maintained by the registrant. Likewise, inventories and records of controlled substances in schedules III, IV, and V must be maintained separately or in such a form that they are readily retrievable from the ordinary business records of the practitioner. All records related to controlled substances must be maintained and be available for inspection for a minimum of two years.
A registered practitioner is required to keep records of controlled substances that are dispensed to the patient, other than by prescribing or administering, in the lawful course of professional practice. A registered practitioner is not required to keep records of controlled substances that are prescribed in the lawful course of professional practice, unless such substances are prescribed in the course of maintenance or detoxification treatment. A registered practitioner is not required to keep records of controlled substances that are administered in the lawful course of professional practice unless the practitioner regularly engages in the dispensing or administering of controlled substances and charges patients, either separately or together with charges for other professional services, for substances so dispensed or administered.
Question: What reports must be filed if a practitioner experiences a theft or significant loss of controlled substances?
Answer: The practitioner shall notify the local DEA office, in writing, of the theft or significant loss of any controlled substances within one business day of discovery of such loss or theft. The practitioner shall also complete and submit DEA Form 106 which may be found at www.DEAdiversion.usdoj.gov.
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 the 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.
Question: Are there any special security requirements a practitioner should follow if a stock of controlled substances is maintained 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: 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?
Answer: DEA strongly opposes the use of a DEA registration number for any purpose other than the one for which it was intended, to provide certification of DEA registration in transactions involving controlled substances. The use of DEA registration numbers as an identification number is not an appropriate use and could lead to a weakening of the registration system. Although DEA has repeatedly made its position known to industries such as insurance providers and pharmacy benefit managers, there is currently no legal basis for DEA to prevent or preclude companies from requiring or requesting a practitioner’s DEA registration number.
The Centers for Medicare and Medicaid Services has developed a National Provider Identification (NPI) number unique to each healthcare provider. The Final Rule for establishment of the NPI system was published in the Federal Register (FR 3434, Vol. 69, No. 15) by the Department of Health and Human Services on January 23, 2004. The effective date of this Final Rule was May 23, 2005; all covered entities were to begin using the NPI in standard transactions by May 23, 2007. A contingency extension was provided to covered entities unable to meet the 2007 deadline. Contingency plans were to not extend beyond May 23, 2008.