Pharmacist's Manual - SECTION IX-XIV
To dispense controlled substances, a pharmacist must know the requirements for a valid prescription which are described in this section. 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 (i.e., an order to dispense a drug to an inpatient for immediate administration in a hospital is not a prescription).
A prescription for a controlled substance must be dated and signed on the date when issued. The prescription must include the patient’s full name and address, and the practitioner’s full name, address, and DEA registration number.
The prescription must also include:
- Drug name
- Dosage form
- Quantity prescribed
- Directions for use
- Number of refills authorized (if any)
A prescription must be written in ink or indelible pencil or typewritten and must be manually signed by the practitioner on the date when issued. An individual (i.e., secretary or nurse) may be designated by the practitioner to prepare prescriptions for the practitioner’s signature. The practitioner is responsible for ensuring the prescription conforms to all requirements of the law and regulations, both federal and state.
Who May Issue
A prescription for a controlled substance may only be issued by a physician, dentist, podiatrist, veterinarian, mid-level practitioner, or other registered practitioner who is:
- Authorized to prescribe controlled substances by the jurisdiction in which the practitioner is licensed to practice, and
- Registered with DEA or exempted from registration (e.g., Public Health Service, Federal Bureau of Prisons, military practitioners), or
- An agent or employee of a hospital or other institution acting in the normal course of business or employment under the registration of the hospital or other institution which is registered in lieu of the individual practitioner being registered, provided that additional requirements as set forth in the C.F.R. are met.
Purpose of Issue
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 professional practice. The practitioner is responsible for the proper prescribing and dispensing of controlled substances.
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.
A pharmacist also needs to know there is a corresponding responsibility for the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is an invalid prescription within the meaning and intent of the CSA (21 U.S.C. § 829). The person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.
A pharmacist is required to exercise sound professional judgment when making a determination about the legitimacy of a controlled substance prescription. Such a determination is made before the prescription is dispensed. The law does not require a pharmacist to dispense a prescription of doubtful, questionable, or suspicious origin. To the contrary, the pharmacist who deliberately ignores a questionable prescription when there is reason to believe it was not issued for a legitimate medical purpose may be prosecuted along with the issuing practitioner, for knowingly and intentionally distributing controlled substances. Such action is a felony offense, which may result in the loss of one’s business or professional license (see United States v. Kershman, 555 F.2d 198 [United States Court Of Appeals, Eighth Circuit, 1977]).
On March 31, 2010 the DEA published in the Federal Register an interim final rule Electronic Prescriptions for Controlled Substances which became effective June 1, 2010. The rule revises DEA regulations to provide practitioners with the option of writing prescriptions for controlled substances electronically. The regulations also permit pharmacies to receive, dispense, and archive these electronic prescriptions. These regulations are an addition to, not a replacement of, the existing rules.
Persons who wish to dispense controlled substances using electronic prescriptions must select software that meets the requirements of this rule. As of June 1, 2010, only those electronic pharmacy applications that comply with all of DEA’s requirements as set forth in 21 C.F.R. §1311 may be used by DEA-registered pharmacies to electronically receive and archive controlled substances prescriptions and dispense controlled substances based on those prescriptions.
A registered pharmacy may process electronic prescriptions for controlled substances only if the following conditions are met:
- The pharmacy uses a pharmacy application that meets all of the applicable requirements of 21 C.F.R. §1311, and
- The prescription is otherwise in conformity with the requirements of the CSA and 21 C.F.R. §1311.
A pharmacy cannot process electronic prescriptions for controlled substances until its pharmacy application provider obtains a third party audit or certification review that determines that the application complies with DEA’s requirements and the application provider provides the audit/certification report to the pharmacy. The audit report the pharmacy will receive from the pharmacy application provider will indicate if the application is capable of importing, displaying, and storing DEA-required prescription information accurately and consistently. If the third-party auditor or certification organization finds that a pharmacy application does not accurately and consistently import, store, and display the information related to the name, address, and registration number of the practitioner, patient name and address, and prescription information (drug name, strength, quantity, directions for use), the indication of signing, and the number of refills, the pharmacy must not accept electronic prescriptions for the controlled substance.
If the third-party auditor or certification organization finds that a pharmacy application does not accurately and consistently import, store, and display other information required for prescriptions, the pharmacy must not accept electronic prescriptions for controlled substances that are subject to the additional information requirements. For example, until the audit or certification report indicates that the pharmacy application can import, display, and store both a hospital DEA number and the individual practitioner’s extension number, the pharmacy must not accept electronic prescriptions that include only a hospital DEA registration number. The pharmacy may, however, use the application to process other controlled substance prescriptions if the audit or certification report has found that the pharmacy application meets all other requirements.
The pharmacy must determine which employees are authorized to enter information regarding the dispensing of controlled substance prescriptions and annotate or alter records of these prescriptions (to the extent such alterations are permitted under DEA regulations). The pharmacy must ensure that logical access controls in the pharmacy application are set so that only such employees are granted access to perform these functions.
When a pharmacist fills a prescription in a manner that would require, under 21 C.F.R. §1306, the pharmacist to make notation on the prescription if the prescription were a paper prescription, the pharmacist must make the same notation electronically when filling an electronic prescription and retain the annotation electronically in the prescription record or linked files. When a prescription is received electronically, the prescription and all required annotations must be stored electronically.
When a pharmacist receives a paper or oral prescription that indicates that it was originally transmitted electronically to the pharmacy, the pharmacist must check the pharmacy’s records to ensure that the electronic version was not received and the prescription dispensed. If both prescriptions were received, the pharmacist must mark one as void.
When a pharmacist receives a paper or oral prescription that indicates that it was originally transmitted electronically to another pharmacy, the pharmacist must check with that pharmacy to determine whether the prescription was received and dispensed. If the pharmacy that received the original electronic prescription had not dispensed the prescription, that pharmacy must mark the electronic version as void or cancelled. If the pharmacy that received the original electronic prescription dispensed the prescription, the pharmacy with the paper version must not dispense the paper prescription and must mark the prescription as void.
Verification of Practitioner Registration
A pharmacist has a responsibility to ensure that a prescription has been issued by an appropriately registered or exempt practitioner (see above, Who May Issue). As such, it is helpful to be familiar with how a DEA registration number is constructed and to whom such registrations are issued.
Construction of Valid DEA Registration Number for Practitioners
Knowing how a DEA registration number is constructed can be a useful tool for recognizing a forged prescription (see Appendix D, Pharmacist’s Guide to Prescription Fraud). Prior to October 1, 1985, DEA registration numbers for physicians, dentists, veterinarians, and other practitioners started with the letter A. New registration numbers issued to practitioners after that date begin with the letter B or F. Registration numbers issued to mid-level practitioners begin with the letter M. The first letter of the registration number is almost always followed by the first letter of the registrant’s last name (e.g., J for Jones or S for Smith) and then a computer generated sequence of seven numbers (such as MJ3614511).
Practitioner’s Use of a Hospital’s DEA Registration Number
Practitioners (e.g., intern, resident, staff physician, mid-level practitioner) who are agents or employees of a hospital or other institution, may, when acting in the usual course of business or employment, administer, dispense, or prescribe controlled substances under the registration of the
hospital or other institution in which he or she is employed, in lieu of individual registration, provided that:
- The dispensing, administering, or prescribing is in the usual course of professional practice.
- The practitioner is authorized to do so by the state in which they practice.
- The hospital or institution has verified that the practitioner is permitted to administer, dispense, or prescribe controlled substances within the state.
- The practitioner acts only within the scope of employment in the hospital or institution.
- The hospital or institution authorizes the practitioner to administer, dispense, or prescribe under its registration and assigns a specific internal code number for each practitioner.
An example of a specific internal code number is depicted below:
A current list of internal codes and the corresponding individual practitioners is to be maintained by the hospital or other institution. This list is to be available at all times to other registrants and law enforcement agencies upon request for the purpose of verifying the authority of the prescribing individual practitioner. Pharmacists should contact the hospital or other institution for verification if they have any doubts in filling such a prescription.
Exemption of Federal Government Practitioners from Registration
The requirement of registration is waived for any official of the U.S. Army, Navy, Marine Corps, Air Force, Coast Guard, Public Health Service, or Bureau of Prisons, who is authorized to administer, dispense, or prescribe, but not to procure or purchase controlled substances in the course of his or her official duties. Such officials must follow procedures set forth in 21 C.F.R. part 1306 regarding prescriptions, but must also state the branch of service or agency (e.g., "U.S. Army" or "Public Health Service") and the service identification number of the issuing official in lieu of the registration number required on prescription forms. The service identification number for a Public Health Service employee is his or her Social Security identification number.
If federal government practitioners wish to maintain a DEA registration for a private practice, which would include prescribing for private patients, these practitioners must be fully licensed to handle controlled substances by the state in which they are located.
Registration Requirements for Mid-Level Practitioners
Mid-level practitioners (MLPs) are registered and authorized by the DEA and the state in which they practice to dispense, administer, and prescribe controlled substances in the course of professional practice (see Appendix B, Definitions). Examples of MLPs include, but are not limited to, nurse practitioners, nurse midwives, nurse anesthetists, clinical nurse specialists, physician assistants, optometrists, ambulance services, animal shelters, euthanasia technicians, nursing homes, and homeopathic physicians.
MLPs may apply for an individual DEA registration granting controlled substance privileges. However, such registration is contingent upon the authority granted by the state in which they are licensed. The DEA may register MLPs whose states clearly authorize them to prescribe, dispense, and administer controlled substances in one or more schedules.
It is incumbent upon the pharmacist who fills the prescription to ensure that the MLP is prescribing within the parameters established by the state in which he/she practices. MLP authority to prescribe controlled substances varies greatly by state. Pharmacists should check with the state licensing or controlled substances authority to determine which MLP disciplines are authorized to prescribe controlled substances in the state. Pharmacists may also visit the DEA Diversion website at www.DEAdiversion.usdoj.gov for a chart indicating the prescribing authority of MLPs by state (click on Registration Support and scroll down to Mid-Level Practitioners Authorization by State).
For electronic prescriptions written by mid-level practitioners, if required by State law, a supervisor’s name and DEA number may be listed on the prescription, provided the prescription clearly indicates who is the supervisor and who is the prescribing practitioner.
Schedule II Controlled Substances
Schedule II controlled substances require a written prescription which must be manually signed by the practitioner or an electronic prescription that meets all DEA requirements for electronic prescriptions for controlled substances. There is no federal time limit within which a schedule II prescription must be filled after being signed by the practitioner. However, the pharmacist must determine that the prescription is still needed by the patient. While some states and many insurance carriers limit the quantity of controlled substances dispensed to a 30-day supply, there are no express federal limits with respect to the quantities of drugs dispensed via a prescription. However, the amount dispensed must be consistent with the requirement that a prescription for a controlled substance be issued only for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. For a schedule II controlled substance, an oral order is only permitted in an emergency situation (see Section X, Emergency Dispensing).
The refilling of a prescription for a controlled substance listed in schedule II is prohibited (21 U.S.C. § 829(a)).
Issuance of Multiple Prescriptions for Schedule II Controlled Substances
The DEA has revised its regulations regarding the issuance of multiple prescriptions for schedule II controlled substances. Under the new regulation, which became effective December 19, 2007, an individual practitioner may issue multiple prescriptions authorizing the patient to receive a total of up to a 90-day supply of a schedule II controlled substance provided the following conditions are met:
- Each prescription must be issued on a separate prescription blank.
- Each separate prescription must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice.
- The individual practitioner must provide written instructions on each prescription (other than the first prescription, if the prescribing practitioner intends for that prescription to be filled immediately) indicating the earliest date on which a pharmacy may fill each prescription.
- The individual practitioner concludes that providing the patient with multiple prescriptions in this manner does not create an undue risk of diversion or abuse.
- The issuance of multiple prescriptions is permissible under applicable state laws.
- The individual practitioner complies fully with all other applicable requirements under the CSA and C.F.R., as well as any additional requirements under state law.
It should be noted that the implementation of this change in the regulation should not be construed as encouraging individual practitioners to issue multiple prescriptions or to see their patients only once every 90 days when prescribing schedule II controlled substances. Rather, individual practitioners must determine on their own, based on sound medical judgment, and in accordance with established medical standards, whether it is appropriate to issue multiple prescriptions and how often to see their patients when doing so.
Facsimile Prescriptions for Schedule II Controlled Substances
In order to expedite the filling of a prescription, a prescriber may transmit a schedule II prescription to the pharmacy by facsimile. The original schedule II prescription must be presented to the pharmacist and verified against the facsimile at the time the controlled substance is actually dispensed. The pharmacist must make sure the original document is properly annotated and filed with the records that are required to be kept.
Exceptions for Schedule II Facsimile Prescriptions
DEA has granted three exceptions to the facsimile prescription requirements for schedule II controlled substances. The facsimile of a schedule II prescription may serve as the original prescription as follows:
- A practitioner prescribing a schedule II narcotic controlled substance to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion may transmit the prescription by facsimile. The pharmacy will consider the facsimile prescription a “written prescription” and no further documentation is required. All normal requirements of a legal prescription must be followed.
- Practitioners prescribing schedule II controlled substances for residents of Long Term Care Facilities may transmit a prescription by facsimile to the dispensing pharmacy. The facsimile prescription serves as the original written prescription for the pharmacy. No further documentation is required.
- A practitioner prescribing a schedule II narcotic controlled substance for a patient enrolled in a hospice care program certified and/or paid for by Medicare under Title XVIII or a hospice program which is licensed by the state, may transmit a prescription to the dispensing pharmacy by facsimile. The practitioner will note on the prescription that it is for a hospice patient. The facsimile serves as the original written prescription. No further documentation is required.
Schedules III-V Controlled Substances
A pharmacist may dispense directly a controlled substance listed in Schedule III, IV, or V only pursuant to either a paper prescription signed by a practitioner, a facsimile of a signed paper prescription transmitted by the practitioner or the practitioner's agent to the pharmacy, an electronic prescription that meets DEA’s requirements for such prescriptions, or a call-in as indicated below (see Telephone Authorization for Schedules III-V Controlled Substances).
Schedules III and IV controlled substances may be refilled if authorized on the prescription. However, the prescription may only be refilled up to five times within six months after the date of issue. After five refills or after six months, whichever occurs first, a new prescription is required.
When a prescription for any controlled substance in schedules III or IV is refilled, the following information must be entered on the back of the prescription: the dispensing pharmacist’s initials, the date the prescription was refilled, and the amount of drug dispensed on the refill. If the pharmacist only initials and dates the back of the prescription, the pharmacist will be deemed to have dispensed a refill for the full face amount of the prescription.
Electronic Recordkeeping of Schedules III-IV Prescription Information
A pharmacy is permitted to use an electronic recordkeeping system for documenting refills as an alternative to the manual method for the storage and retrieval of original paper prescription orders for schedules III and IV controlled substances.
The electronic system must provide online retrieval of original prescription information for those prescriptions which are currently authorized for refill. The information must include, but is not limited to: the original prescription number; date of issuance; full name and address of the patient; the prescriber’s name, address, and DEA registration number; the name, strength, dosage form and quantity of the controlled substance prescribed (and quantity dispensed if different from the quantity prescribed); and the total number of refills authorized by the prescriber.
In addition, the electronic system must provide online retrieval of the current refill history for schedules III or IV controlled substance prescriptions. This information must include, but is not limited to: the name of the controlled substance, the date of refill, the quantity dispensed, the dispensing pharmacist’s identification code or name/initials for each refill, and the total number of refills dispensed to date for that prescription.
The pharmacist must verify and document that the refill data entered into the system is correct. All computer generated prescription/refill documentation must be stored in a separate file at the pharmacy and must be maintained for a period of two years from the dispensing date. To meet the C.F.R. recordkeeping requirements, the pharmacy’s electronic system must comply with the following guidelines:
- If the system provides a hard copy printout of each day’s controlled substance prescription refills, each pharmacist who refilled those prescriptions must verify his/her accuracy by signing and dating the printout as he/she would sign a check or legal document.
- The printout must be provided to each pharmacy that uses the computer system within 72 hours of the date on which the refill was dispensed. The printout must be verified and signed by each pharmacist who dispensed the refills.
- In lieu of such a printout, the pharmacy must maintain a bound logbook or a separate file in which each pharmacist involved in the day’s dispensing signs a statement, verifying that the refill information entered into the computer that day has been reviewed by him/her and is correct as shown.
- A pharmacy’s electronic system must have the capability of printing out any refill data which the pharmacy must maintain under the CSA. For example, this would include a refill-by-refill audit trail for any specified strength and dosage form of any controlled substance, by either brand or generic name or both, dispensed by the pharmacy. Such a printout must include:
- Prescribing practitioner’s name
- Patient’s name and address
- Quantity and date dispensed on each refill
- Name or identification code of the dispensing pharmacist
- Original prescription number
In any electronic system employed by a user pharmacy, the central recordkeeping location must be capable of providing a printout to a requesting pharmacy of the above information within 48 hours.
- In case a pharmacy's electronic system experiences downtime, the pharmacy must have a back-up procedure to document in writing refills of schedules III or IV controlled substances. This procedure must ensure that refills are authorized by the original prescription, that the maximum number of refills has not been exceeded, and that all required data is retained for online entry as soon as possible.
A pharmacy may use only one of the two systems described (i.e., manual or electronic) for storage and retrieval of prescription order refill information of schedules III or IV controlled substances.
Facsimile Prescriptions for Schedules III-V Controlled Substances
Prescriptions for schedules III-V controlled substances may be transmitted by facsimile from the practitioner or the practitioner’s agent to the dispensing pharmacy. The facsimile is considered to be equivalent to an original prescription as long as the practitioner has manually signed the prescription.
Telephone Authorization for Schedules III-V Prescriptions
A pharmacist may dispense a controlled substance listed in schedules III, IV, or V pursuant to an oral prescription made by an individual practitioner and promptly reduced to writing by the pharmacist containing all information required for a valid prescription except for the signature of the practitioner (see Appendix D, Pharmacist’s Guide to Prescription Fraud).
Transfer of Schedules III-V Prescription Information
A DEA registered pharmacy may transfer original prescription information for schedules III, IV, and V controlled substances to another DEA registered pharmacy for the purpose of refill dispensing between pharmacies, on a one time basis only. However, pharmacies electronically sharing a real-time, online database may transfer up to the maximum refills permitted by law and the prescriber’s authorization.
Transfers are subject to the following requirements:
- Write the word “VOID” on the face of the invalidated prescription; for electronic prescriptions, information that the prescription has been transferred must be added to the prescription record.
- Record on the reverse of the invalidated prescription the name, address, and DEA registration number of the pharmacy to which it was transferred and the name of the pharmacist receiving the prescription information; for electronic prescriptions, such information must be added to the prescription record.
- Record the date of the transfer and the name of the pharmacist transferring the information.
For paper prescriptions and prescriptions received orally and reduced to writing by the pharmacist, the pharmacist receiving the transferred prescription information must write the word “transfer” on the face of the transferred prescription and reduce to writing all information required to be on a prescription and include:
- Date of issuance of original prescription.
- Original number of refills authorized on original prescription.
- Date of original dispensing
- Number of valid refills remaining and date(s) and locations of previous refill(s).
- Pharmacy’s name, address, DEA registration number, and prescription number from which the prescription information was transferred.
- Name of pharmacist who transferred the prescription.
- Pharmacy’s name, address, DEA registration number, and prescription number from which the prescription was originally filled.
For electronic prescriptions being transferred electronically, the transferring pharmacist must provide the receiving pharmacist with the following information in addition to the original electronic prescription data:
- The date of the original dispensing
- The number of refills remaining and the date(s) and locations of previous refills
- The transferring pharmacy’s name, address, DEA registration number, and prescription number for each dispensing.
- The name of the pharmacist transferring the prescription.
- The name, address, DEA registration number, and prescription number from the pharmacy that originally filled the prescription, if different.
The pharmacist receiving a transferred electronic prescription must create an electronic record for the prescription that includes the receiving pharmacist’s name and all of the information transferred with the prescription (listed above).
The original and transferred prescription(s) must be maintained for a period of two years from the date of last refill.
Pharmacies electronically accessing the same prescription record must satisfy all information requirements of a manual mode for prescription transferal.
The procedure allowing the transfer of prescription information for refill purposes is permissible only if allowable under existing State or other applicable law.
Pharmacies electronically sharing a real time, online database may transfer up to the maximum refills permitted by law and the prescriber’s authorization.
Prescription Monitoring Programs
A prescription monitoring program is a state-administered data collection system used to gather prescription information. This information may be made available to state and federal investigators on a need-to-know basis.
Many states have established an electronic prescription drug monitoring program because it has proven to be an effective tool for detecting pharmaceutical diversion and for developing pharmacist and physician medical education programs. These programs heighten awareness about diversion, prescription drug abuse, drug trends, and are useful for tracking prescription medication dispensed within a state. In some states, the data can be used by pharmacists to identify potential "doctor shoppers" and those who attempt to obtain controlled substances by fraud, forgery, or deceit.
In the states that have adopted these programs, a large part of their success has been attributed to the pharmacists’ participation. The DEA strongly endorses prescription monitoring programs.
Required Information for Prescription Labels
The pharmacist dispensing a prescription for a controlled substance listed in schedules II, III, IV, or V must affix to the package a label showing date of filling, the pharmacy name and address, the serial (prescription) number, the name of the patient, the name of the prescribing practitioner, and directions for use and cautionary statements, if any, contained in such prescription or required by law. If a prescription is filled at a central fill pharmacy, the central fill pharmacy must affix to the package a label showing the retail pharmacy name and address and a unique identifier (i.e., the central fill pharmacy's DEA registration number) indicating that the prescription was filled at the central fill pharmacy.
Federal Food and Drug Administration regulations require that the label of any drug listed as a "controlled substance" in schedules II, III, or IV of the CSA must, when dispensed to or for a patient, contain the following warning: CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed. In addition, a pharmacist who receives a prescription for a controlled substance must dispense that prescription to the patient or a member of the patient’s household. To provide the controlled substance to anyone other than the patient or a member of the patient’s household is distribution, not dispensing.
Schedule II Controlled Substance Prescriptions
A pharmacist may dispense a schedule II controlled substance, which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act, only pursuant to a written prescription signed by the practitioner, except in an emergency situation as described below.
An “emergency prescription” in this context, is defined to mean that the immediate administration of the drug is necessary for proper treatment of the intended ultimate user, that no alternative treatment is available (including a drug which is not a schedule II controlled substance), and it is not possible for the prescribing practitioner to provide a written prescription for the drug at that time. In a bona fide emergency, a practitioner may telephone a schedule II prescription to the pharmacist who may then dispense the prescription. The prescribing practitioner must provide a written and signed prescription to the pharmacy within seven days and meet the below requirements:
- The drug prescribed and dispensed must be limited to the amount needed to treat the patient during the emergency period. Prescribing or dispensing beyond the emergency period must be pursuant to a written prescription order.
- The prescription order must be immediately reduced to writing by the pharmacist and must contain all information, except for the prescribing practitioner’s signature.
- If the prescribing individual practitioner is not known to the pharmacist, he/she must make a reasonable effort to determine that the oral authorization came from a registered individual practitioner, which may include a call back to the prescribing individual practitioner using his or her telephone number as listed in the telephone directory and/or other good faith efforts to insure his or her identity.
- Within seven days after authorizing an emergency telephone prescription, the prescribing practitioner must furnish the pharmacist a written, signed prescription for the controlled substance prescribed. The prescription must have written on its face “Authorization for Emergency Dispensing” and the date of the oral order. The written prescription may be delivered to the pharmacist in person or by mail, but if delivered by mail, it must be postmarked within the seven day period. Upon receipt, the dispensing pharmacist must attach this written prescription to the oral emergency prescription which had earlier been reduced to writing by the pharmacist. By regulation, the pharmacist must notify the local DEA Diversion Field Office (Appendix K) if the prescriber fails to provide a written prescription within seven days. Failure of the pharmacist to do so will void the authority conferred on the pharmacy to dispense the controlled substance without a written prescription of a prescribing practitioner.
- For electronic prescriptions, the pharmacist must annotate the record of the electronic prescription with the original authorization and date of the oral order.
A prescription for a schedule II controlled substance may be partially dispensed if the pharmacist is unable to supply the full quantity of a written or emergency oral (telephone) prescription, provided the pharmacist notes the quantity supplied on the front of the written prescription, on a written record of the emergency oral prescription, or in the electronic prescription record. The remaining portion may be dispensed within 72 hours of the first partial dispensing. However, if the remaining portion is not or cannot be filled within the 72 hour period, the pharmacist must notify the prescribing practitioner. No further quantity may be supplied beyond 72 hours without a new prescription.
Partial Filling of Schedule II Prescriptions for Terminally Ill or Long Term Care Facility Patients
A prescription for a schedule II controlled substance written for a patient in a Long Term Care Facility (LTCF) or for a patient with a medical diagnosis documenting a terminal illness, may be filled in partial quantities to include individual dosage units. If there is any question whether a patient may be classified as having a terminal illness, the pharmacist must contact the practitioner prior to partially filling the prescription. Both the pharmacist and the prescribing practitioner have a corresponding responsibility to assure that the controlled substance is for a terminally ill patient.
The pharmacist must record on the prescription whether the patient is "terminally ill" or an "LTCF patient." A prescription that is partially filled and does not contain the notation "terminally ill" or "LTCF patient" must be deemed to have been filled in violation of the CSA. For each partial filling, the dispensing pharmacist must record on the back of the prescription (or on another appropriate record, uniformly maintained, and readily retrievable) the date of the partial filling, quantity dispensed, remaining quantity authorized to be dispensed, and the identification of the dispensing pharmacist. The total quantity of schedule II controlled substances dispensed in all partial fillings must not exceed the total quantity prescribed. Schedule II prescriptions for patients in an LTCF or terminally ill patients are valid for a period not to exceed 60 days from the issue date unless sooner terminated by the discontinuance of medication.
Schedules III-V Controlled Substance Prescriptions
A pharmacist may dispense a controlled substance in schedules III, IV, or V having received either a paper prescription signed by a practitioner, a facsimile of that prescription transmitted by the practitioner or their agent to the pharmacy, an electronic prescription that meets DEA’s requirements for such prescriptions, or an oral prescription made by an individual practitioner. The pharmacist must promptly reduce the oral prescription to writing, including all required information except the signature of the prescribing practitioner.
A pharmacist may partially dispense a prescription for schedules III-V controlled substances provided that each partial filling is recorded in the same manner as a refilling, the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed, and no dispensing occurs beyond six months from the date on which the prescription was issued.
Dispensing Without a Prescription
Dispensing a controlled substance without a prescription is outlined in 21 C.F.R. § 1306.26.
The regulation states that a controlled substance listed in schedules II, III, IV, or V which is not a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act, may be dispensed by a pharmacist without a prescription to a purchaser at retail, provided that:
- Such dispensing is made only by a pharmacist and not by a non-pharmacist employee even if under the supervision of a pharmacist (although after the pharmacist has fulfilled his or her professional and legal responsibilities, the actual cash, credit transaction, or delivery, may be completed by a non-pharmacist);
- Not more than 240 cc. (8 ounces) of any such controlled substance containing opium, nor more than 120 cc. (4 ounces) of any other such controlled substance, nor more than 48 dosage units of any such controlled substance containing opium, nor more than 24 dosage units of any other such controlled substance, may be dispensed at retail to the same purchaser in any given 48-hour period;
- The purchaser is at least 18 years of age and the pharmacist requires every purchaser of a controlled substance under this section not known to him or her to furnish suitable identification (including proof of age where appropriate);
- A bound record book (which must be maintained in accordance with the recordkeeping requirement of 21 C.F.R. § 1304.04) for dispensing of controlled substances is maintained by the pharmacist, which contains the name and address of the purchaser, the name and quantity of the controlled substance purchased, the date of each purchase, and the name or initials of the pharmacist who dispensed the substance to the purchaser;
- The prescription is not required for distribution or dispensing of the substance pursuant to any other Federal, State or local law; and
- Central fill pharmacies may not dispense controlled substances at the retail level to a purchaser.
Delivery of a Controlled Substance to Persons in Other Countries
Controlled substances that are dispensed pursuant to a legitimate prescription may not be delivered or shipped to individuals in other countries without proper authorization. Any such delivery or shipment is an export under the CSA and cannot be conducted unless the person sending the controlled substances:
- Has registered with DEA as an "exporter" (see 21 C.F.R. §§ 1301 and 1309).
- Has obtained the necessary permit(s), or submitted the necessary declaration(s) for export (21 C.F.R. §§ 1312 or 1313).
Summary of the Act’s Major Provisions
On October 15, 2008, the President signed into law the Ryan Haight Online Pharmacy Consumer Protection Act of 2008, often referred to as the Ryan Haight Act. This law amends the CSA by adding a series of new regulatory requirements and criminal provisions designed to combat the proliferation of so-called “rogue Internet sites” that unlawfully dispense controlled substances by means of the Internet. The Ryan Haight Act applies to all controlled substances in all schedules.
This law became effective April 13, 2009. As of that date, it is illegal under federal law to deliver, distribute, or dispense a controlled substance by means of the Internet unless the online pharmacy holds a modification of DEA registration authorizing it to operate as an online pharmacy. Thus, any person who knowingly or intentionally dispenses a controlled substance by means of the Internet that does not have a modification of DEA registration allowing such activity is in violation of 21 U.S.C. § 841(h)(1) and subject to potential criminal prosecution and (in the case of DEA registrants) loss of DEA registration.
Note: The information contained in this section is meant to summarize the Ryan Haight Act but should not be relied upon as setting forth all the requirements. As is always the case, pharmacies are responsible for complying with the actual text of the CSA and DEA regulations.
Definition of an Online Pharmacy
An online pharmacy is a person, entity, or Internet site, whether in the United States or abroad, that knowingly or intentionally delivers, distributes, or dispenses, or offers or attempts to deliver, distribute, or dispense, a controlled substance by means of the Internet. Examples of an online pharmacy include (but are not limited to) the following:
- Any website that sells, or offers to sell, any controlled substance or a prescription therefor to a person in the United States.
- Any person who operates such a website.
- Any person who pays a practitioner to write prescriptions for controlled substances for customers of such a website.
- Any person who pays a pharmacy to fill prescriptions for controlled substances that were issued to customers of such a website.
- Any pharmacy that knowingly or intentionally fills prescriptions for controlled substances that were issued to customers of such a website.
- Any person who sends an e-mail that:
- offers to sell a controlled substance or a prescription for a controlled substance in a manner not authorized by the Act;
- directs buyers to a website operating in violation of the Act;
- or otherwise causes or facilitates the delivery, distribution, or dispensing of a controlled substance in a manner not authorized by the Act.
Online Pharmacy Registration Exemptions
The following are exempt from the Ryan Haight Act's definition of an “online pharmacy” so long as their activities are limited solely to the exemptions provided:
- Manufacturers or distributors registered under 21 U.S.C. § 823(a), (b), (d), or (e) who do not dispense controlled substances to nonregistrants.
- Nonpharmacy practitioners who are registered under 21 U.S.C. § 823(f) and whose activities are authorized by that registration, provided that any website operated by such nonpharmacy practitioners complies with 21 C.F.R.§ 1304.50, which requires the website to post in a visible and clear manner on its homepage, or on a page directly linked thereto in which the hyperlink is also visible and clear on the homepage, a list of the DEA-registered nonpharmacy practitioners who are affiliated with the website.
- Any hospital or other medical facility registered under 21 U.S.C. § 823(f) that is operated by an agency of the United States (including the Armed Forces).
- A health care facility owned or operated by an Indian tribe or tribal organization carrying out a contract or compact under the Indian Self-Determination and Education Assistance Act.
- Any agent or employee of any hospital or facility that is operated by an agency of the United States, and any agent or employee of any hospital or facility owned or operated by an Indian tribe or tribal organization carrying out a contract or compact under the Indian Self-Determination and Education Assistance Act, provided such agent or employee is lawfully acting in the usual course of business or employment, and within the scope of the official duties of such agent or employee, with such hospital or facility, and, with respect to agents or employees of such health care facilities only to the extent such individuals are furnishing services pursuant to those contracts or compacts.
- Mere advertisements that do not attempt to facilitate an actual transaction involving a controlled substance.
- A person, entity, or Internet site that is not in the United States and does not facilitate the delivery, distribution, or dispensing of a controlled substance by means of the Internet to any person in the United States.
- A pharmacy registered under 21 U.S.C. § 823(f) whose dispensing of controlled substances via the Internet consists solely of "refilling prescriptions for controlled substances in schedule III, IV, or V," as that term is defined in 21 C.F.R. § 1300.04(k). (This definition is set forth at the end of this section.)
- A pharmacy registered under 21 U.S.C. § 823(f) whose dispensing of controlled substances via the Internet consists solely of "filling new prescriptions for controlled substances in schedule III, IV, or V," as that term is defined in 21 C.F.R. § 1300.04(d). (This definition is set forth at the end of this section.)
- Any registered pharmacy whose delivery, distribution, or dispensing of controlled substances by means of the Internet consists solely of filling prescriptions that were electronically prescribed in a manner authorized by the CSA.
- Any registered pharmacy whose delivery, distribution, or dispensing of controlled substances by means of the Internet consists solely of the transmission of prescription information between a pharmacy and an automated dispensing system located in a Long Term Care Facility when the registration of the automated dispensing system is held by that pharmacy as described in 21 C.F.R §§ 1301.17 and 1301.27 and the pharmacy is otherwise complying with the DEA regulations.
Thirty days prior to offering a controlled substance for sale, delivery, distribution, or dispensing by means of the Internet, the online pharmacy shall notify DEA and the State boards of pharmacy in any States in which the online pharmacy offers to sell, deliver, distribute, or dispense controlled substances. Completion of the Application for Modification of Registration for Online Pharmacies serves as the notification requirement to DEA.
The online pharmacy must make a separate thirty-day advance notice to the State boards of pharmacy in each State in which it intends to offer to sell, deliver, distribute, or dispense controlled substances. Online pharmacies that apply for the modification of registration are required to certify that the applicable State boards of pharmacy have been notified.
How to Register as an Online Pharmacy
To operate legally as an online pharmacy, the online pharmacy must first be registered with DEA as a pharmacy. Once registered with DEA as a pharmacy, the pharmacy may apply for a modification of registration to operate as an online pharmacy. To apply for a modification of registration, complete the Application for Modification of Registration for Online Pharmacies online at www.DEAdiversion.usdoj.gov. There is no fee to apply to modify a DEA registration to an online pharmacy.
If the modification of registration is approved, the pharmacy will be issued a modified DEA Certificate of Registration with the new business activity listed as online pharmacy. The registrant will keep the same DEA registration number. A pharmacy may perform the activities of a retail pharmacy and an online pharmacy at the same time.
State Licensure Requirements
An online pharmacy must comply with the requirements of all applicable State laws concerning the licensure of pharmacies in each State from which it, and in each State to which it, delivers, distributes, or dispenses, or offers to deliver, distribute, or dispense, controlled substances by means of the Internet. In addition, online pharmacies must certify they are in compliance with these requirements when completing the Application for Modification of Registration for Online Pharmacies.
The requirement that an online pharmacy list the States in which it is licensed to dispense controlled substances is designed to ensure that an online pharmacy only dispenses controlled substances to patients in States in which it is authorized to practice pharmacy. Dispensing beyond the scope of State licensure is one of the recurring transgressions of some rogue online pharmacies and generally violates State law. Under this Act, a State may bring civil action in federal court to enjoin any violation of the Ryan Haight Act – not merely those violations of State law – and to obtain other appropriate legal or equitable relief. 21 U.S.C. § 882(c).
Online Pharmacy Website Requirements
When a pharmacy applies for a modification of registration to become an online pharmacy, it must display on its homepage a declaration that it has done so. This declaration must state the following:
“In accordance with the Controlled Substances Act and the DEA regulations, this online pharmacy has made the notifications to the DEA Administrator required by 21 U.S.C. § 831 and 21 C.F.R. § 1304.40.”
Once approved to operate as an online pharmacy, the online pharmacy must display at all times on the homepage of its Internet site a declaration of compliance with the requirements of 21 U.S.C. § 831 with respect to the delivery or sale or offer for sale of controlled substances. This statement must include the name of the pharmacy as it appears on the DEA Certificate of Registration.
An online pharmacy is required to post Internet Pharmacy Site Disclosure Information on the homepage of each Internet site it operates. It must be posted in a visible and clear manner and contain the following information:
- The name and address of the pharmacy as it appears on the pharmacy’s DEA Certificate of Registration.
- The pharmacy’s telephone number and e-mail address.
- Name of pharmacist-in-charge, professional degree, States of licensure, and telephone number.
- List of State(s) in which the pharmacy is licensed to dispense controlled substances.
- Certification that the pharmacy is registered to deliver, distribute, or dispense controlled substances by means of the Internet.
- The name, address, telephone number, professional degree, and States of licensure of any practitioner who has a contractual relationship to provide medical evaluations or issue prescriptions for controlled substances, through referrals from the website or at the request of the owner or operator of the website, or any employee or agent thereof.
- The following statement must be visible on the website:
“This online pharmacy is obligated to comply fully with the Controlled Substances Act and DEA regulations. As part of this obligation, this online pharmacy has obtained a modified DEA registration authorizing it to operate as an online pharmacy. In addition, this online pharmacy will only dispense a controlled substance to a person who has a valid prescription issued for a legitimate medical purpose based upon a medical relationship with a prescribing practitioner. This includes at least one prior in-person medical evaluation in accordance with section 309 of the Controlled Substances Act (21 U.S.C. § 829), or a medical evaluation via telemedicine in accordance with section 102(54) of the Controlled Substances Act (21 U.S.C. § 802(54)).”
If at any time an online pharmacy should change its Internet site web address, the online pharmacy must notify DEA at least thirty days in advance of this change.
Each online pharmacy must submit a monthly report to DEA of the total quantity of each controlled substance that the online pharmacy has dispensed the previous calendar month. The report is required for every month in which the total amount of dispensing of controlled substances by the pharmacy is either (i) over 100 prescriptions filled or (ii) 5,000 or more dosage units dispensed of all controlled substances combined. Should an online pharmacy’s total quantity of dispensed controlled substances fall below both of the thresholds listed above, a report is still required that indicates a negative response for that given month.
The report must include the total amount of such dispensing by any means including all controlled substances dispensed via Internet transactions, mail-order transactions, face-to-face transactions, or any other means. It is not required that the online pharmacy identify the means of the dispensing in its report. Reporting will be by National Drug Code (NDC) numbers. Report the total number of dosage units dispensed for each NDC number.
This report is due on or before the 15th day of the following month. For example, an online pharmacy would submit its report for the month of January no later than February 15th. Reports must be submitted electronically via online reporting, electronic upload, or other means as approved by DEA. All reports must be kept for at least two years and be readily retrievable for inspection.
Should an online pharmacy revert back to a retail pharmacy, the pharmacy is still required to report the monthly sales for the month in which it changes back to a retail pharmacy.
In order for a prescription to be valid, it must be issued for a legitimate medical purpose in the usual course of professional practice by a practitioner who has conducted at least one in-person medical evaluation of the patient or by a covering practitioner. An in-person medical evaluation is a medical evaluation that is conducted with the patient in the physical presence of the practitioner, without regard to whether portions of the evaluation are conducted by other health professionals.
Definition of Prescription Terms
A pharmacy website is exempted from the Ryan Haight Act's definition of an "online pharmacy" if its Internet-facilitated activity relating to controlled substances is limited to filling new and/or refilling prescriptions for controlled substances in schedules III, IV, or V. If the pharmacy is so exempted from the definition of an "online pharmacy," it is not required under the Act to obtain a modification of its DEA registration authorizing it to operate as an online pharmacy. Thus, it is important to understand precisely the definitions of the following terms.
Filling New Prescriptions for Controlled Substances in Schedules III-V
As stated in 21 C.F.R. § 1300.04 (d), the term "filling new prescriptions for controlled substances in schedule III, IV, or V" means filling a prescription for an individual for a controlled substance in schedule III, IV, or V, if:
The pharmacy dispensing that prescription has previously dispensed to the patient a controlled substance other than by means of the Internet and pursuant to the valid prescription of a practitioner that meets the applicable requirements of [21 U.S.C. § 829(b) and (c)] and [21 C.F.R. §§ 1306.21 and 1306.22] (for purposes of this definition, such a prescription shall be referred to as the “original prescription”);
The pharmacy contacts the practitioner who issued the original prescription at the request of that individual to determine whether the practitioner will authorize the issuance of a new prescription for that individual for the controlled substance described in [paragraph (1) of this definition] (i.e., the same controlled substance as described in [paragraph (1)]); and
The practitioner, acting in the usual course of professional practice, determines there is a legitimate medical purpose for the issuance of the new prescription.
Refilling Prescriptions for Controlled Substances in Schedules III-V
As stated in 21 C.F.R. § 1300.04(k), the term "refilling prescriptions for controlled substances in schedule III, IV, or V”:
Means the dispensing of a controlled substance in schedule III, IV, or V in accordance with refill instructions issued by a practitioner as part of a valid prescription that meets the requirements of [21 U.S.C. § 829(b) and (c)] and [21 C.F.R. §§ 1306.21 and 1306.22], as appropriate; and
Does not include the issuance of a new prescription to an individual for a controlled substance that individual was previously prescribed.
Central Fill Pharmacy
A "central fill pharmacy” (see Appendix B, Definitions) fills prescriptions for controlled substances on behalf of retail pharmacies with which it has a contractual agreement to provide such services or with pharmacies who share a common owner. When one retail pharmacy receives a prescription and a second pharmacy prepares and subsequently delivers the controlled substance medication to the first retail pharmacy for dispensing to the patient, the second pharmacy is engaging in a "central fill” activity. Records must be maintained by both the central fill pharmacy and the retail pharmacy that completely reflect the disposition of all controlled substance prescriptions dispensed. Central fill pharmacies are required to comply with the same security requirements applicable to retail pharmacies including the general requirement to maintain effective controls and procedures to guard against theft and diversion of controlled substances. Retail pharmacies that also perform central fill activities are allowed to do so without a separate DEA registration, separate inventories, or separate records.
Central fill pharmacies are permitted to prepare both initial and refill prescriptions, subject to all applicable state and federal regulations. Only a licensed pharmacist may fill the prescription. Both the retail and central fill pharmacists have a corresponding responsibility to ensure that the prescription was issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice and otherwise in the manner specified by DEA regulations.
Prescription information may be provided to an authorized central fill pharmacy by a retail pharmacy for dispensing purposes. Prescriptions for controlled substances listed in schedules II, III, IV, or V may be transmitted electronically from a retail pharmacy to a central fill pharmacy including via facsimile. The retail pharmacy transmitting the prescription information must:
- Write the word "CENTRAL FILL" on the face of the original prescription and record the name, address, and DEA registration number of the central fill pharmacy to which the prescription has been transmitted and the name of the retail pharmacy pharmacist transmitting the prescription, and the date of transmittal;
- Ensure that all information required to be on a prescription is transmitted to the central fill pharmacy (either on the face of the prescription or in the electronic transmission of information);
- Maintain the original prescription for a period of two years from the date the prescription was last refilled;
- Keep a record of receipt of the filled prescription, including the date of receipt, the method of delivery (private, common, or contract carrier) and the name of the retail pharmacy employee accepting delivery;
- For schedules III-V prescriptions, indicate in the information transmitted the number of refills already dispensed and the number of refills remaining (refills for schedule II prescriptions are not permitted).
The central fill pharmacy receiving the transmitted prescription must:
- Keep a copy of the prescription (if sent via facsimile) or an electronic record of all the information transmitted by the retail pharmacy, including the name, address, and the DEA registration number of the retail pharmacy transmitting the prescription;
- Keep a record of the date of receipt of the transmitted prescription, the name of the licensed pharmacist filling the prescription, and dates of filling or refilling of the prescription; and
- Keep a record of the date the filled prescription was delivered to the retail pharmacy and the method of delivery (i.e. private, common, or contract carrier).
Central fill pharmacies must affix to the package a label showing the retail pharmacy name and address and a unique identifier (i.e. the central fill pharmacy's DEA registration number) indicating that the prescription was filled at the central fill pharmacy. Central fill pharmacies must comply with the provisions of the C.F.R. when selecting private, common, or contract carriers to transport filled prescriptions to a retail pharmacy (and likewise for retail pharmacies retrieving filled prescriptions from a central fill pharmacy) for delivery to the ultimate user.
For electronic prescriptions, the name, address, and DEA registration number of the central fill pharmacy to which the prescription has been transmitted, the name of the retail pharmacy pharmacist transmitting the prescription, and the date of transmittal must be added to the electronic prescription record.
Long Term Care Facilities
A Long Term Care Facility (LTCF) is defined in the C.F.R. as a nursing home, retirement care, mental care, or other facility or institution, which provides extended health care to resident patients. In most cases, these facilities are not registered with DEA, yet these health care facilities routinely maintain controlled substances issued via prescription to their residents. These controlled substances are already outside the CSA’s closed drug distribution system since they have been dispensed to the ultimate user.
LTCFs frequently need to dispose of unused medications due to a change in the resident’s medication or the resident’s death. Accordingly, LTCFs should contact the local DEA Diversion Field Office (Appendix K) for drug disposal instructions. The DEA is aware of issues currently facing LTCFs concerning the dispensing and handling of controlled substances, which are affected by a variety of state laws and circumstances. Pharmacists should check with their state agency for guidelines concerning controlled substances at LTCFs.
Regulations concerning LTCFs can also be found under:
- Section IX, Exceptions for Schedule II Facsimile Prescriptions
- Section X, Partial Filling of Schedule II Prescriptions for Terminally Ill or Long Term Care Facility Patients
Use of Automated Dispensing Systems by Retail Pharmacies at Long Term Care Facilities
If state law or regulations permit, the DEA will allow a retail pharmacy to register at the site of the LTCF and store controlled substances in an Automated Dispensing System (ADS) as outlined in 21 C.F.R. § 1301.27. In an ADS, a pharmacy stores bulk drugs in the machine in separate bins or containers. The pharmacy programs and controls the ADS remotely. Only authorized LTCF staff are allowed access to its contents, which are dispensed on a single-dose basis at the time of administration pursuant to a valid prescription. The ADS electronically records each dispensing, thus maintaining dispensing records for the pharmacy. Because the drugs are not considered dispensed until the system provides them, drugs in the ADS are counted as pharmacy stock. A registered retail pharmacy that possesses additional registrations for ADS machines at LTCFs may keep all records required for those additional registered sites at the retail pharmacy or other approved central location.
DEA registered pharmacies wishing to operate an ADS at an LTCF must contact the DEA Office of Diversion Control, Registration Section, at 1-800-882-9539 for registration instructions. Additional requirements for maintaining an ADS can be found online at www.DEAdiversion.usdoj.gov.
Emergency Kits for Long Term Care Facilities
The DEA has issued a policy statement which provides individual state licensing and regulatory boards with general guidelines for establishing specific rules concerning controlled substances used in emergency kits at Long Term Care Facilities (see Appendix H, Guidelines for Emergency Kits in Long Term Care Facilities).
Opioid (Narcotic) Addiction Treatment Programs
The Narcotic Addiction Treatment Act of 1974 and the Drug Addiction Treatment Act (DATA) of 2000 amended the CSA with respect to the use of controlled substances in the medical treatment of opioid addiction. These laws established the procedures for approving and licensing practitioners involved in the treatment of opioid addiction as well as improving the quality and delivery of that treatment to the segment of society in need.
Practitioners wishing to prescribe and dispense FDA approved schedule II controlled substances (i.e., methadone) for maintenance and detoxification treatment must obtain a separate DEA registration as a Narcotic Treatment Program via a DEA Form 363 which may be completed online at www.DEAdiversion.usdoj.gov. In addition to obtaining this separate DEA registration, this type of activity also requires the approval and certification by the Center for Substance Abuse Treatment (CSAT) within the Substance Abuse and Mental Health Services Administration (SAMHSA) of the U.S. Department of Health and Human Services as well as the applicable state methadone authority.
If a practitioner wishes to prescribe or dispense schedules III, IV, or V controlled substances approved by the FDA for addiction treatment (i.e., Suboxone® or Subutex® drug products), the practitioner must request a waiver from CSAT which will then notify DEA of all waiver requests. These practitioners are referred to as DATA waived practitioners.
DATA waived practitioners may treat 30 or 100 patients at any one time, dependent on individual authorization from CSAT. Upon authorization by CSAT, DEA will issue a new DEA certificate of registration bearing (1) the DEA registration number, (2) a unique identification number, and (3) the corresponding business activity to identify whether the physician is authorized to treat 30 or 100 patients. Pursuant to 21 C.F.R. §1301.28(d), the practitioner is required to include the identification number on all records when dispensing and on all prescriptions when prescribing Schedules III, IV, or V narcotic controlled drugs for use in maintenance or detoxification treatment. The listing of the identification number on a prescription is in addition to all other information required on a valid prescription to include the practitioner’s DEA registration number (see Section IX, Valid Prescription Requirements).
Dispensing Controlled Substances for the Treatment of Pain
On September 6, 2006, the DEA published in the Federal Register a Policy Statement, Dispensing Controlled Substances for the Treatment of Pain. The purpose of the Policy Statement was to make clear the longstanding requirement under the law that physicians may prescribe controlled substances only for a legitimate medical purpose in the usual course of professional practice. In no way should this interfere with the legitimate practice of medicine or cause any physician to be reluctant to provide legitimate pain treatment. The second purpose of the Policy Statement was for the DEA to dispel the mistaken notion among a small number of medical professionals that the agency has embarked on a campaign to “target” physicians who prescribe controlled substances for the treatment of pain or that physicians must curb their legitimate prescribing of pain medications to avoid legal liability.
To achieve these aims, the document summarized the relevant legal principles and provided an explanation of DEA’s role with respect to the regulation of controlled substances. The document also addressed specific issues and questions that have been raised on a recurring basis by physicians who seek guidance on the subject of dispensing controlled substances for the treatment of pain.
To review the Policy Statement, it may be accessed at www.DEAdiversion.usdoj.gov. Click on Info & Legal Resources, then Federal Register Notices, then Notices 2006, then Policy Statement: Dispensing Controlled Substances for the Treatment of Pain, September 6, 2006. For additional guidance on the responsibilities of the pharmacist where it pertains to the treatment of pain, see Section IX, Corresponding Responsibility.
Controlled Substance Distribution by a Pharmacy – “Five Percent Rule”
A pharmacy registered to dispense controlled substances may distribute such substances (without being registered as a distributor) to another pharmacy or to a registered practitioner for the purpose of general dispensing by the practitioner to patients, provided that the following conditions are met:
- The pharmacy or practitioner that will receive the controlled substances is registered under the CSA to dispense controlled substances;
- The distribution is recorded by the distributing practitioner in accordance with 21 C.F.R. § 1304.22(c) and the receipt is recorded by the receiving practitioner in accordance with 21 C.F.R. § 1304.22(c);
- If the pharmacy distributes a schedule II controlled substance, it must document the transfer on an official order form (DEA Form 222) or the electronic equivalent. For instructions on completing this form, see Section VIII, Ordering Controlled Substances.
- “Five Percent Rule” - total number of dosage units of all controlled substances distributed by a pharmacy may not exceed five percent of all controlled substances dispensed by the pharmacy during a calendar year. If at any time the controlled substances distributed exceed five percent, the pharmacy is required to register as a distributor.
United States Postal Service Mailing Requirements for Controlled Substances
United States Postal Services regulations permit the mailing of controlled substances by drug manufacturers or their agents, pharmacies, or other authorized handlers when distribution is lawful under DEA regulations and if the mailer or the addressee meets one of the following conditions:
- The mailer or the addressee is registered with DEA.
- The mailer or the addressee is exempt from DEA registration as permissible by law.
United States Postal Service regulations permit mailing of any controlled substance, provided it is not outwardly dangerous and will not cause injury to a person’s life or health, and if the following preparation and packaging standards are met:
- The inner container of any parcel containing controlled substances is marked and sealed as required by the provisions of the CSA and its implementing regulations, and is placed in a plain outer container or securely wrapped in plain paper.
- If the controlled substance consists of prescription medicines, the inner container is also labeled to show the name and address of the pharmacy, practitioner, or other person dispensing the prescription.
- The outside wrapper or container is free of markings that would indicate the nature of the contents.
Summary of the Act’s Major Provisions
In March 2006, the President signed the Combat Methamphetamine Epidemic Act of 2005 (CMEA). As a result of the new law, the DEA issued an Interim Final Rule in the Federal Register on September 26, 2006, which outlined the retail provisions of the CMEA.
Under the CMEA, regulated sellers must follow new requirements for retail sales of over-the-counter products containing the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine (PPA), which can be used to manufacture methamphetamine illegally. The CMEA defined "regulated seller" to mean a retail distributor (including a pharmacy and mobile retail vendors) and "at retail" to mean sale or purchase for personal use.
Scheduled Listed Chemical Products
The CMEA created a new category of products called “scheduled listed chemical product (SLCP).” It includes any product that may be marketed or distributed lawfully in the United States under the Federal Food, Drug, and Cosmetic Act as a nonprescription drug that contains ephedrine, pseudoephedrine, or PPA (includes salts, optical isomers, and salts of optical isomers) (21 U.S.C. § 802(45)). This applies to nonprescription drug products only, not prescription drug products. Retail sales of SLCPs are excluded from the definition of a “regulated transaction” and from the registration requirement under 21 U.S.C. § 823, but are subject to a separate system of retail sales controls under 21 U.S.C. § 830.
Other requirements of the law include:
- Requirement of regulated sellers to place the products behind the counter or in locked cabinets.
- Requirement of regulated sellers to check the identity of purchasers and maintain a log of each sale that includes the purchaser's name and address, signature of the purchaser, product sold, quantity sold, date, and time.
- Requirement of regulated sellers to maintain the logbook for at least two years.
- Requirement of regulated sellers to train employees in the requirements of the law and certify to DEA that the training has occurred.
- Places a quantity limit of each of the chemicals that may be sold to an individual in a day to 3.6 grams of the chemical (base) without regard to the number of transactions.
- For nonliquids, product packaging is limited to blister packs containing no more than 2 dosage units per blister. Where blister packs are not technically feasible, the product must be packaged in unit dose packets or pouches.
- For individuals, purchases in a 30-day period are limited to 9 grams, of which not more than 7.5 grams may be imported by means of a common or contract carrier or the U.S. Postal Service.
While many states have enacted their own legislation regarding the regulation of these products, the federal law also requires regulated sellers to complete a self-certification process with the DEA that includes training their employees on the new regulations and procedures. The self-certification process must be completed online at www.DEAdiversion.usdoj.gov. If state law differs from federal law regarding the regulation of these products, retail outlets are to adhere to the stricter provisions of both.
Copies of the Interim Final Rule are available at www.DEAdiversion.usdoj.gov (click on the Combat Meth Act of 2005, then Interim Final Rule – Retail Sales of Scheduled Listed Chemical Products). Details on specific provisions of the CMEA that may impact a pharmacy that engages in retail sales of SLCPs are outlined below.
Regulated sellers are required to maintain a written (bound logbook) or electronic list of sales that identifies the transactions with the following information:
- The name of the purchaser
- The address of the purchaser
- The date and time of the sale
- The amount of product sold
The logbook requirement does not apply to any purchase by an individual of a single sales package that contains not more than 60 milligrams of pseudoephedrine.
Concurrently, purchasers are required to:
- Present a photo identification issued by a State or the Federal Government (see Proof of Identity Requirements below for a complete list of acceptable forms of identification).
- Sign a logbook and enter his or her name, address, date, and time of sale.
Once identification of the purchaser is presented to the seller, the seller is required to:
- Determine that the name in the logbook corresponds to the name on the identification and that the date and time are correct.
- Enter into the logbook the name of the product and the quantity sold.
The logbook must include a notice to purchasers that entering false statements or misrepresentations in the logbook may subject purchasers to criminal penalties under 18 U.S.C. § 1001. Sellers must maintain each entry in the logbook for not fewer than two years after the date on which the entry is made.
Loss or Theft of SLCPs
A report should be made orally to the local DEA Diversion Field Office (Appendix K) in the area where the pharmacy is located. Per 21 C.F.R. § 1314.15(c), a written report of losses must be filed within 15 days after the pharmacist becomes aware of the loss or theft. A written report should include the DEA registration number (if applicable), name, business address, date of loss, type of loss, and a description of the circumstances of the loss (e.g., in-transit, theft from premises).
Proof of Identity Requirements
The CMEA requires an individual to present an identification card that includes a photograph and is issued by a State or the Federal Government or a document considered acceptable under 8 C.F.R. § 274a.2(b)(1)(v)(A) and (B). Those documents currently include the following:
- United States passport;
- Alien Registration Receipt Card or Permanent Resident Card, Form I-551;
- An unexpired foreign passport that contains a temporary I-551 stamp, or temporary I–551 printed notation on a machine-readable immigrant visa;
- An Employment Authorization Document which contains a photograph (Form I–766);
- In the case of a nonimmigrant alien authorized to work for a specific employer incident to status, a foreign passport with form I-94 or Form I-94A bearing the same name as the passport and containing an endorsement of the alien's nonimmigrant status, as long as the period of endorsement has not yet expired and the proposed employment is not in conflict with any restrictions or limitations identified on the Form;
- A passport from the Federated States of Micronesia (FSM) or the Republic of the Marshall Islands (RMI) with Form I–94 or Form I–94A indicating nonimmigrant admission under the Compact of Free Association Between the United States and the FSM or RMI;
- In the case of an individual lawfully enlisted for military service in the Armed Forces under 10 U.S.C. § 504, a military identification card issued to such individual may be accepted only by the Armed Forces.
For individuals 16 years of age or older:
- A driver's license or identification card containing a photograph, issued by a state or an outlying possession of the United States. If the driver's license or identification card does not contain a photograph, identifying information shall be included such as: name, date of birth, sex, height, color of eyes, and address;
- School identification card with a photograph;
- Voter's registration card;
- U.S. military card or draft record;
- Identification card issued by federal, state, or local government agencies or entities. If the identification card does not contain a photograph, identifying information shall be included such as: name, date of birth, sex, height, color of eyes, and address;
- Military dependent's identification card;
- Native American tribal documents;
- United States Coast Guard Merchant Mariner Card;
- Driver's license issued by a Canadian government authority.
For individuals under age 18 who are unable to produce a document from the list above, the following documents are acceptable to establish identity only:
- School record or report card;
- Clinic doctor or hospital record;
- Daycare or nursery school record.
NOTE: The list of acceptable forms of identification, as cited in the CMEA, may change ("in effect on or after the date of enactment"). The DEA has no discretion to alter the list.
SLCPs must be stored behind the counter or, if in an area where the public has access, in a locked cabinet. Although DEA is not including cabinet specifications in the rule, a locked cabinet should be substantial enough that it cannot be easily picked up and removed. In a store setting, the cabinet should be similar to those used to store items, such as cigarettes, that can be accessed only by sales staff.
As part of the requirements of CMEA, an annual self-certification is required for all regulated sellers of SLCPs. A regulated seller must not sell SLCPs unless it has self-certified with DEA. In self-certifying, the regulated seller is confirming:
- The employees who will be engaged in the sale of SLCPs have undergone training regarding provisions of CMEA.
- Records of the training are maintained.
- Sales to individuals do not exceed 3.6 grams of ephedrine, pseudoephedrine, or phenylpropanolamine per day.
- Nonliquid forms are packaged as required.
- SLCPs are stored behind the counter or in a locked cabinet.
- A written or electronic logbook containing the required information on sales of these products is properly maintained.
- The logbook information will be disclosed only to Federal, State, or local law enforcement and only to ensure compliance with Title 21 of the United States Code or to facilitate a product recall.
The only way to self-certify is through DEA’s Diversion website at www.DEAdiversion.usdoj.gov. Self-certification can be accomplished on any computer (e.g., at the store, at home, at the library, or at any other location).
A certificate will be generated by DEA upon receipt of the self-certification application. The regulated seller may print this certificate, or if the regulated seller is unable to print it, DEA will print and mail the certificate to the regulated seller. Chain stores wishing to file self-certifications for more than 10 locations must print or copy the form electronically and submit the information to DEA by mail. DEA will work with these persons to facilitate this process. Persons interested in this self-certification option should contact DEA for assistance at 1-800-882-9539. For current DEA registrants, the system will pre-populate the form with basic information if the registrant enters his DEA registration number in the field provided.
The regulated seller must self-certify to DEA as described above on an annual basis. It is the responsibility of the regulated seller to ensure that all employees have been trained prior to self-certifying each time.
It is the regulated seller’s responsibility to annually renew before the certificate expires if the regulated seller intends to continue selling SLCPs at retail. The certificate contains a self-certification number in the upper right corner. The expiration date of the certificate is listed under the self-certification number. Regulated sellers may verify the expiration date of their certificate at www.DEAdiversion.usdoj.gov.
The self-certification requirement is subject to the provisions of 18 U.S.C. § 1001. A regulated seller who knowingly or willfully certifies to facts that are not true is subject to fines and imprisonment.
Training materials designed by DEA must be used, although a regulated seller may include information in addition to that provided by DEA. DEA training materials may be found at www.DEAdiversion.usdoj.gov.
Each employee of a regulated seller who is responsible for delivering SLCPs to purchasers or who deals directly with purchasers by obtaining payment for the SLCPs must undergo training and must sign an acknowledgement of training received prior to selling SLCPs. This record must be kept in the employee's personnel file.
On December 29, 2008, the DEA published a Final Rule in the Federal Register entitled Combat Methamphetamine Epidemic Act of 2005: Fee for Self-Certification for Regulated Sellers of Scheduled Listed Chemical Products. The rule established a self-certification fee for regulated sellers of SLCPs that are not DEA pharmacy registrants.