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05.05.2016

Should any pertinent provisions of the law or regulations be modified in the future, DEA will issue a revised electronic version of this document, which will be posted on the DEA Diversion website.
Inquiries regarding topics within this document may be addressed to your local DEA Diversion Field Office (Appendix K) or the address above.
All material in this publication is in the public domain and may be reproduced without the express permission of the Drug Enforcement Administration. The Drug Enforcement Administration is pleased to provide you with the 2010 edition of the Pharmacist's Manual to assist you in understanding the provisions of the Controlled Substances Act (CSA) and its implementing regulations.
Your role in the proper dispensing of controlled substances is critical to the health of patients and helps protect society against drug abuse and diversion. The Drug Enforcement Administration (DEA) was established in 1973 to serve as the primary agency responsible for the enforcement of federal drug laws. Under the framework of the CSA, all controlled substance transactions take place within a a€?closed systema€? of distribution established by Congress. To carry out this mission effectively, DEA seeks to educate its registrants regarding their legal obligations.
Federal controlled substance laws are designed to function in tandem with state controlled substance laws.
In the event a state board revokes the license of a pharmacy, DEA will request a voluntary surrender of the pharmacya€™s DEA registration. In addition to the diversion of controlled substances, DEA is concerned with the diversion of certain chemicals used in the clandestine manufacture of controlled substances. Pharmacies that sell over the counter products containing ephedrine and pseudoephedrine must be a€?self-certifieda€? as required by the Combat Methamphetamine Epidemic Act of 2005 (CMEA).
DEA and the pharmacy profession have strong common interests in the appropriate use of controlled substances and SLCPs. The drugs and other substances that are considered controlled substances under the CSA are divided into five schedules. NOTE: Drugs listed in schedule I have no currently accepted medical use in treatment in the United States and, therefore, may not be prescribed, administered, or dispensed for medical use. Substances in this schedule have a high potential for abuse, have no currently accepted medical use in treatment in the United States, and there is a lack of accepted safety for use of the drug or other substance under medical supervision.
Some examples of substances listed in schedule I are: A heroin, lysergic acid diethylamide (LSD), marijuana (cannabis), peyote, methaqualone, and 3,4-methylenedioxymethamphetamine (a€?ecstasya€?).
Substances in this schedule have a high potential for abuse which may lead to severe psychological or physical dependence. Substances in this schedule have a potential for abuse less than substances in schedules I or II and abuse may lead to moderate or low physical dependence or high psychological dependence. Substances in this schedule have a low potential for abuse relative to substances in schedule III. Substances in this schedule have a low potential for abuse relative to substances listed in schedule IV and consist primarily of preparations containing limited quantities of certain narcotics.
An SLCP is defined as a product that contains ephedrine, pseudoephedrine, or phenylpropanolamine and may be marketed or distributed lawfully in the United States under the Federal Food, Drug, and Cosmetic Act as a nonprescription drug.
A pharmacy registration must be renewed every three years utilizing DEA Form 224a, Renewal Application for DEA Registration. To renew a registration, the most current information from the pharmacya€™s existing registration must be utilized. If the registrant has not renewed online approximately 50 days before the registration expiration date, a renewal application is sent to the registrant at the mailing address listed on the current registration.
NOTE: Once the expiration date has passed and no renewal has been received by DEA, the pharmacy has no authority to handle controlled substances.
Corporations that own or operate a chain of pharmacies may submit a single DEA Form 224b, Retail Pharmacy Registration Affidavit for Chain Renewal.
A pharmacy that moves to a new physical location must request a modification of registration. A pharmacy that discontinues business activities either completely or only regarding controlled substances must return its DEA registration certificate and unused official order forms (DEA Form 222) to the local DEA Registration Specialist (Appendix J). Unwanted controlled substances in the pharmacya€™s possession must be disposed of in accordance with DEA regulations (see Section IV, Transfer or Disposal of Controlled Substances).
On the day the controlled substances are transferred, a complete inventory must be taken and a copy of the inventory must be included in the records of both the person transferring the business and the person acquiring the business.
To transfer schedule II controlled substances, the receiving registrant must issue an official order form (DEA Form 222) or an electronic equivalent to the registrant transferring the drugs. All controlled substance records required to be kept by the registrant-transferor shall be transferred to the registrant-transferee. If the registrant acquiring the pharmacy owns at least one other pharmacy licensed in the same state as the pharmacy being transferred, the registrant may apply for a new DEA registration prior to the date of transfer. A DEA registration application to transfer ownership of an existing pharmacy can be facilitated if the applicant includes an affidavit verifying that the pharmacy has been registered by the state licensing agency. The recommendation of the appropriate State licensing board or professional disciplinary authority. The applicanta€™s experience in dispensing or conducting research with respect to controlled substances. The applicanta€™s conviction record under federal or state laws relating to the manufacture, distribution, or dispensing of controlled substances. Compliance with applicable State, Federal, or local laws relating to controlled substances. Federal law requires any person who is engaged in the wholesale distribution of an SLCP to obtain a registration as a chemical distributor. Note: this would include those pharmacies that sell quantities of SLCPs to institutions, including long term care facilities, jails, and other institutional-type settings for non-patient specific use. Retail pharmacies that are registered to handle controlled substances need not obtain a separate DEA chemical registration for retail distribution of SLCPs. A pharmacy may hire an outside firm to inventory, package, and arrange for the transfer of its controlled substances to another pharmacy, the original supplier, or the original manufacturer. To transfer schedule II substances, the receiving registrant must issue an official order form (DEA Form 222) or an electronic equivalent to the registrant transferring the drugs.
If a pharmacy goes out of business or is acquired by a new pharmacy, it may transfer the controlled substances to another pharmacy. Any pharmacy may transfer controlled substances to the original supplier or the original manufacturer that is appropriately registered with the DEA. The DEA Form 222 or the electronic equivalent will be the official record for the transfer of schedule II controlled substances. A pharmacy may transfer controlled substances to a DEA registered reverse distributor who handles the disposal of controlled substances.
A pharmacy may forward controlled substances to a DEA registered reverse distributor who handles the disposal of controlled substances. On January 21, 2009, DEA published in the Federal Register an Advance Notice of Proposed Rulemaking (ANPRM), Disposal of Controlled Substances by Persons Not Registered with the Drug Enforcement Administration. Should a theft or significant loss of any controlled substance occur at a pharmacy, the following procedures must be implemented within one business day of the discovery of the theft or loss. The theft of controlled substances from a registrant is a criminal act and a source of diversion that requires notification to DEA.
DEA must be notified directly.A This requirement is not satisfied by reporting the theft or significant loss in any other manner.
If completing the paper version, the pharmacy should send the original DEA Form 106 to the local DEA Diversion Field Office (Appendix K) and keep a copy for its records. A listing of controlled substances missing, including the strength, dosage form, and size of container (in milliliters if liquid form) or corresponding National Drug Code numbers. If, after the initial notification to DEA, the investigation of the theft or loss determines no such theft or loss of controlled substances occurred, a DEA Form 106 does not need to be filed.
Further, the loss of a small quantity of controlled substances, repeated over a period of time, may indicate a significant problem for a registrant, which must be reported.
Local trends and other indicators of the diversion potential of the missing controlled substances. If it is determined that the loss is not significant, the registrant should place a record of the occurrence in a theft and loss file for future reference. When all or part of an in-transit shipment of controlled substances fails to reach its intended destination, the supplier is responsible for reporting the in-transit loss of controlled substances to DEA. Every pharmacy must maintain complete and accurate records on a current basis for each controlled substance purchased, received, stored, distributed, dispensed, or otherwise disposed of. All required records concerning controlled substances must be maintained for at least two years for inspection and copying by duly authorized DEA officials.
Records kept in such a manner that certain items are asterisked, redlined, or in some other manner visually identifiable apart from other items appearing on the records.
If a prescription is created, signed, transmitted, and received electronically, all records related to that prescription must be retained electronically.
Electronic records must be maintained electronically for two years from the date of their creation or receipt. Records regarding controlled substances must be readily retrievable from all other records. An a€?inventorya€? is a complete and accurate list of all stocks and forms of controlled substances in the possession of the registrant as determined by an actual physical count for schedule II controlled substances and an estimated count or measure of the contents of a schedule III, IV, or V controlled substance (unless the container holds more than 1,000 tablets or capsules in which case an exact count of the contents must be made). When issued a DEA registration, a registrant must take an initial inventory, which is an actual physical count of all controlled substances in their possession. A count of the substance - if the substance is listed in schedule II, an exact count or measure of the contents or if the substance is listed in schedules III, IV, or V, an estimated count or measure of the contents, unless the container holds more thanA 1,000 tablets or capsules in which case, an exact count of the contents is required.
DEA recommends, but does not require, an inventory record include the name, address, and DEA registration number of the registrant, and the signature of the person or persons responsible for taking the inventory. Following the initial inventory, the registrant is required to take a biennial inventory (every two years), which requires the same information as the initial inventory (see list above) of all controlled substances on hand.
When a drug not previously listed as a controlled substance is scheduled or a drug is rescheduled, the drug must be inventoried as of the effective date of scheduling or change in scheduling.
Only schedules I and II controlled substances are ordered with an official order form, DEA Form 222, or the electronic equivalent (see below, Controlled Substance Ordering System (CSOS) – Electronic Order Forms). When a controlled substance has been moved by DEA from schedule II to another schedule at the federal level, in many states it may remain a schedule II controlled substance pending any legislative or administrative action that may result from the federal action.
When ordering schedule II controlled substances, the purchaser is responsible for filling in the number of packages, the size of the package, and the name of the item.
The executed DEA Form 222 must be maintained separately from the pharmacya€™s other business records.
DEA policy does not preclude the substitution of identical products differing in packaging size from those initially ordered, provided that the actual quantity received does not exceed the amount initially ordered and that the National Drug Code number reflected is that of the actual product shipped.
A purchaser may cancel an order (or partial order) on a DEA Form 222 by notifying the supplier in writing.


A supplier may void part or all of an order on a DEA Form 222 by notifying the purchaser in writing. Any registrant (pharmacy) may authorize one or more individuals, whether or not they are located at the registered location, to obtain and execute DEA Forms 222 by granting a power of attorney to each such individual.
The power of attorney may be revoked at any time by the person who granted and signed the power of attorney. I, _______________________(name of attorney-in-fact), hereby affirm that I am the person named herein as attorney-in-fact and that the signature affixed hereto is my signature. The foregoing power of attorney is hereby revoked by the undersigned, who is authorized to sign the current application for registration of the above-named registrant under the Controlled Substances Act.
A pharmacy, upon discovery of the loss or theft of used or unused order forms, must immediately report the loss to the local DEA Diversion Field Office (Appendix K) and provide the serial numbers of each lost or stolen order form. Any registrant permitted to order schedule II controlled substances may do so electronically via the DEA Controlled Substance Ordering System (CSOS) and maintain the records of these orders electronically for two years.
Digital certificates can be obtained only by registrants and individuals granted power of attorney by registrants to sign orders. When a purchaser receives an unaccepted electronic order from the supplier, the purchaser must electronically link the statement of nonacceptance to the original order. A supplier may void all (or part) of an electronic order by notifying the purchaser of the voiding. If a purchaser determines that an unfilled electronic order has been lost before or after receipt, the purchaser must provide, to the supplier, a signed statement. The registrant must keep a receipt (invoice or packing slip) on which it records the date the drugs were received and confirm that the order is accurate. A This manual will answer questions you may encounter in the practice of pharmacy and provide guidance in complying with the CSA regulations. A Your adherence to the CSA, together with its objectives and your compliance, is a powerful resource for protecting the public health, assuring patient safety, and preventing the diversion of controlled substances and drug products containing listed chemicals. The Controlled Substances Act (CSA) and its implementing regulations establish federal requirements regarding both illicit and licit controlled substances. Within this a€?closed systema€? all legitimate handlers of controlled substances – manufacturers, distributors, physicians, pharmacies, and others, must be registered with DEA (unless exempt) and maintain strict accounting for all controlled substance transactions. It is DEAa€™s goal to maintain a positive working relationship with all of its registrants, including pharmacies.
DEA works in cooperation with state professional licensing boards and state and local law enforcement officials to make certain that pharmaceutical controlled substances are prescribed, administered, and dispensed for a legitimate medical purpose in the usual course of professional practice. If the pharmacy refuses to surrender its registration, DEA will seek administrative action to revoke its DEA registration based on lack of state authorization. Chemicals such as ephedrine and pseudoephedrine contained in over the counter and prescription substances are immediate precursors used in the illicit manufacture of methamphetamine and amphetamine. An effective working relationship to ensure compliance with CSA requirements will continue to produce lasting benefits on a national scale. In contrast, drugs listed in schedules II-V have some accepted medical use and may be prescribed, administered, or dispensed for medical use.
Other schedule II substances include: A cocaine, amobarbital, glutethimide, and pentobarbital. If the renewal form is not received by the 30th day before the expiration date of the current registration, the pharmacy should contact the local DEA Registration Specialist (Appendix J) or DEA Headquarters at 1-800-882-9539 and request a renewal registration form.
This affidavit, along with a list of the corporation's registrations, is provided in lieu of a separate registration application for each pharmacy registration.
If the change of address involves a change in state, the proper state issued license and, if applicable, controlled substances registration must be obtained prior to the approval of modification of the federal registration. In addition, DEA may ask for the location of where inventories, prescriptions, and other required controlled substance records will be stored during the requisite two-year retention period. This inventory will serve as the final inventory for the registrant going out of business and transferring the controlled substances.
The transfer of schedules III-V controlled substances must be documented in writing to show the drug name, dosage form, strength, quantity, and date transferred.
Responsibility for the accuracy of records prior to the date of transfer remains with the transferor, but responsibility for custody and maintenance shall be upon the transferee.
DEA will issue a registration which will authorize the registrant to obtain controlled substances at the time of transfer, but the registrant may not dispense controlled substances until the pharmacy has been issued a valid state pharmacy license.
The affidavit verifying the existence of the state license should be attached to the initial application for registration. However, a regulated seller must self-certify with DEA pursuant to federal law (see Section XIV, Self-Certification). A distributor who does not meet all the requirements for a regulated seller of SLCPs, or who does not meet the requirements for distributors required to submit a€?mail-ordera€? reports, is a wholesale distributor.
If a pharmacy desires to engage in the wholesale distribution of bulk quantities of SLCPs, the pharmacy is required to register with DEA as a chemical distributor because these activities fall outside the definition of a regulated seller.
The pharmacy is responsible for the actual transfer of the controlled substances and for the accuracy of the inventory and records.
On the day the controlled substances are transferred, a complete inventory must be taken which documents the drug name, dosage form, strength, quantity, and date transferred. The pharmacy should contact the local DEA Diversion Field Office (Appendix K) for an updated list of DEA registered reverse distributors. A When a pharmacy transfers schedule II controlled substances to a reverse distributor for destruction, the reverse distributor must issue an official order form (DEA Form 222) or the electronic equivalent to the pharmacy.
A pharmacy must notify in writing the local DEA Diversion Field Office (Appendix K) within one business day of discovery of a theft or significant loss of a controlled substance. For example, a corporation which owns or operates multiple registered sites and wishes to channel all notifications through corporate management or any other internal department responsible for security, must still provide notice directly to DEA in writing within one business day upon discovery and keep a copy of that notice for its records.A The notice must be signed by an authorized individual of the registrant. The DEA Form 106 is used to document the actual circumstances of the theft or significant loss and the quantities of controlled substances involved. Please see the Guidelines for Completing the DEA Form 106 (Appendix I) for additional guidance.
However, the registrant must notify DEA in writing of this fact in order to resolve the initial report and explain why no DEA Form 106 was filed regarding the incident. A Whether a a€?significant lossa€? has occurred depends, in large part, on the business of the pharmacy and the likelihood of a rational explanation for a particular occurrence. The burden of responsibility is on the registrant to identify what is a significant loss and make the required report to DEA. Miscounts or adjustments to inventory involving clerical errors on the part of the pharmacy should not be reported on a DEA Form 106, but rather should be noted in a separate log at the pharmacy managementa€™s discretion. A When there is breakage, damage, or spillage or some other form of destruction, any recoverable controlled substances must be disposed of according to DEA requirements.
A These records are required to provide accountability of all controlled substances from the manufacturing process through the dispensing pharmacy and to the ultimate user. Records and inventories of schedule II controlled substances must be maintained separately from all other records of the registrant.
Unless the registrant is informed by the DEA that the permission to keep central records is denied, the registrant may begin maintaining central records 14 days after DEA receives this notification.
If there is a conflict between federal and state requirements for filing prescriptions, DEA recognizes that the pharmacy must choose a filing system that would comply with both federal and state law.
However, this record retention requirement shall not pre-empt any longer period of retention which may be required now or in the future, by any other Federal or State law or regulation, applicable to pharmacists or pharmacies.
Electronic records must be easily readable or easily rendered into a format that a person can read.
The electronic application must be capable of printing out or transferring the records in a format that is readily understandable to an Administration or other law enforcement agent at the registered location.
A The CSA also requires that all inventory records be maintained at the registered location in a readily retrievable manner for at least two years for copying and inspection. If there are no stocks of controlled substances on hand, the registrant should make a record showing a zero inventory. A The biennial inventory may be taken on any date which is within two years of the previous inventory date. A DEA Form 222 is required for each distribution, purchase, or transfer of a schedule II controlled substance.
Many states require transactions that involve substances they classify as schedule II be made via official order forms (DEA Form 222) or the electronic equivalent. When requesting additional DEA Forms 222 online, a valid DEA registration number, business name, and contact telephone number are required.
Each pharmacy is provided a maximum of six books at one time unless its needs exceed this limit.
Each DEA Form 222 must be signed and dated by a person authorized to sign a registration application or a person granted power of attorney (see below, Power of Attorney to Sign an Official Order Form). However, this does not preclude a registrant from attaching a copy of the supplier's invoice to the related DEA Form 222. For example, a distributor may substitute five bottles of 100, 2 milligram tablets for one bottle of 500, 2 milligram tablets or any variation thereof. The supplier must indicate the cancellation on Copies 1 and 2 of the DEA Form 222 by drawing a line through the cancelled item(s) and printing a€?cancelleda€? in the space provided for the number of items shipped. The supplier must indicate the voiding in Copies 1 and 2 of the DEA Form 222 by drawing a line through the cancelled item(s) and printing a€?voida€? in the space provided for the number of items shipped. The power of attorney must be signed by the same person who signed the most recent application for registration or renewal registration, as well as the individual being authorized to obtain and execute the DEA Forms 222. Only if the renewal application is signed by a different person is it necessary to grant a new power of attorney when the pharmacy completes a renewal registration.
A Written notice of this revocation has been given to the attorney-in-fact ____________________________ this same day.
If the original order form has been lost or stolen, the pharmacist must complete a second order form so the supplier can fill the original order. A If an entire book or multiple books of order forms are lost or stolen, and the serial numbers of the missing forms cannot be identified, the pharmacist must report the approximate date of issuance (in lieu of the serial numbers) to the DEA. The use of electronic orders is optional; registrants may continue to issue orders on a paper DEA Form 222. A registrant must appoint a CSOS coordinator who will serve as that registrant's recognized agent regarding issues pertaining to issuance of, revocation of, and changes to, digital certificates issued under that registrant's DEA registration. Applicants can download the Diversion PKI CSOS Enrollment document and the CSOS Subscribera€™s Manual for assistance on the enrollment process.
If the entire order is voided, the supplier must make an electronic copy of the order and indicate a€?Voida€? on the copy and return it to the purchaser.
This statement must include the unique tracking number and date of the lost order and state that the goods covered by the first order were not received through loss of that order. These receipts must also contain the name of each controlled substance, the finished form, the number of dosage units of finished form in each commercial container, and the number of commercial containers ordered and received.


A This edition has been updated to include information on the provisions of the Combat Methamphetamine Epidemic Act of 2005, the Ryan Haight Online Pharmacy Consumer Protection Act of 2008, and the Interim Final Rule entitled Electronic Prescriptions for Controlled Substances. With respect to pharmaceutical controlled substances, DEAa€™s responsibility is twofold: to prevent diversion and abuse of these substances while ensuring an adequate and uninterrupted supply is available to meet the countrya€™s legitimate medical, scientific, and research needs.
DEA understands that it can best serve the public interest by working with the pharmacy community to prevent the diversion of pharmaceutical controlled substances and scheduled listed chemical products (SLCPs) into the illicit market. Within this framework, the majority of investigations into possible violations of controlled substance laws are carried out by state authorities.
Additional administrative remedies that may be utilized to correct a lack of compliance include a letter of admonition or an administrative hearing.
These products may be purchased or stolen from retail outlets, including pharmacies, for use in clandestine laboratories. SLCPs are products containing ephedrine, pseudoephedrine, or phenylpropanolamine that may be marketed or distributed lawfully in the United States as a non-prescription drug under the Food, Drug, and Cosmetic Act. The certificate of registration must be maintained at the registered location and kept available for official inspection. No registration may be issued unless the completed affidavit is received by DEA.A The corporation should retain a copy of this affidavit with their readily retrievable records for the duration of the registrations covered by the affidavit. If the modification is approved, DEA will issue a new certificate of registration and, if requested, new schedule II order forms (DEA Form 222). It will also serve as the initial inventory for the registrant acquiring the controlled substances. A The document must include the names, addresses, and DEA registration numbers of the parties involved in the transfer of the controlled substances. A A regulated seller is defined as a grocery store, general merchandise store, drug store, or other entity engaged in over-the-counter sales of ephedrine (both single-entity and combination products), pseudoephedrine, or phenylpropanolamine products, directly to walk-in customers or in face-to-face transactions by direct sales. Therefore, the pharmacy would be subject to the registration requirements that apply to wholesale distributors for those distribution activities, and subject to the pharmacy requirements for its pharmacy activities. The records involving the transfer of controlled substances must be kept readily available by the pharmacy for two years for inspection by the DEA.
In addition, DEA Form 222 or the electronic equivalent must be prepared to document the transfer of schedule II controlled substances.
A In no case should drugs be forwarded to the DEA unless the registrant has received prior approval from the DEA. When schedules III-V controlled substances are transferred to a reverse distributor for destruction, the pharmacy must maintain a record of distribution that lists the drug name, dosage form, strength, quantity, and date transferred. DEA was interested in the possible options that would enable nonregistrants to dispose of unwanted controlled substances, while also protecting public health and public safety, and minimizing the possibility of diversion. The employer must have a waiver approved before allowing such an employee or prospective employee to have access to controlled substances. Although not specifically required by federal law or regulations, the registrant should also notify local law enforcement and state regulatory agencies.
A What would constitute a significant loss for a pharmacy may be viewed as comparatively insignificant for a hospital or manufacturer. If it is discovered after that point that an in-transit loss or theft has occurred; the purchaser must then submit a DEA Form 106. When this disposal occurs, it must be reported to DEA on a DEA Form 41 (Registrants Inventory of Drugs Surrendered). All records and inventories of schedules III, IV, and V controlled substances must be maintained either separately from all other records or in such a form that the information required is readily retrievable from the ordinary business records.
If a pharmacy has an electronic recordkeeping system for prescriptions which permits identification by prescription number and retrieval of original documents by prescribera€™s name, patienta€™s name, drug dispensed, and date filled, the requirement to mark the hard copy with a red a€?Ca€? is waived. Electronic copies of prescription records must be sortable by prescriber name, patient name, drug dispensed, and date filled.
In addition, the inventory records of schedule II controlled substances must be kept separate from all other controlled substances. A When federal law or regulations differ from state law or regulations, a pharmacy is required to abide by the more stringent aspects of both the federal and state requirements. The registrant may also request DEA Forms 222 by calling the DEA Headquarters Registration Section at 1-800-882-9539 or by contacting the local DEA Registration Specialist (Appendix J). In such a case, the pharmacy should contact the local DEA Registration Specialist (Appendix J) to request additional books. When the items are received, the pharmacist must document on the purchasera€™s copy (copy three) the actual number of packages received and the date received.
For a discussion of the circumstances in which an electronic order must not be filled see below, Controlled Substance Ordering System (CSOS) – Electronic Order Forms. If a supplier refuses to accept an order, a statement that the order is not accepted is sufficient. For information regarding cancelled electronic orders, see below, Controlled Substance Ordering System (CSOS) – Electronic Order Forms. A The power of attorney should be filed with executed DEA Forms 222 as a readily retrievable record.
A I hereby ratify and confirm all that said attorney shall lawfully do or cause to be done by virtue hereof. The pharmacist must also prepare a statement which includes the first order forma€™s serial number and date, and verify that the drugs ordered were never received. If an unused order form reported stolen or lost is later recovered or found, the pharmacy must immediately notify the local DEA Diversion Field Office.
CSOS allows for secure electronic transmission of controlled substance orders without the supporting paper DEA Form 222. A CSOS digital certificate will be valid until the DEA registration under which it is issued expires or until the CSOS CA is notified that the certificate should be revoked. DEA maintains a support line to assist applicants and subscribers with issues pertaining to certificate enrollment, issuance, revocation, and renewal. If the purchaser executes a new order to replace the lost order, the purchaser must electronically link an electronic record of the second order and a copy of the statement with the record of the first order and retain them both.
In addition, these receipts must be maintained in a readily retrievable manner for inspection by the DEA. In carrying out this mission, DEA works closely with state and local authorities and other federal agencies. DEA focuses its investigations on cases involving violators of the highest level or most significant impact. DEA may also pursue civil or criminal sanctions if there is sufficient evidence to justify a prosecution. The retail provisions of the CMEA went into effect on September 30, 2006 and require, among other things, employee training, self certification, placement of SLCPs out of customer reach, required identification, sales logbooks, sales and purchase limits, and others. A A controlled substance is placed in its respective schedule based on whether it has a currently accepted medical use in treatment in the United States and its relative abuse potential and likelihood of causing dependence. If a person owns and operates more than one pharmacy, each place of business must be registered. A responsible individual must answer the questions listed on the affidavit on behalf of the corporation as they pertain to each registrant. The registrant should maintain the new certificate with the old certificate until expiration.
It is not necessary to send a copy of the inventory to the DEA unless requested by the Special Agent in Charge. A mobile retail vendor is defined as a person or entity that makes sales at retail from a stand that is intended to be temporary or is capable of being moved from one location to another. The DEA procedures established for the disposal of controlled substances must not be construed as altering in any way the state laws or regulations for the disposal of controlled substances.
The DEA registered reverse distributor who will destroy the controlled substances is responsible for submitting a DEA Form 41 (Registrants Inventory of Drugs Surrendered) to the DEA when the controlled substances have been destroyed. A Prompt notification to enforcement agencies will allow them to investigate the incident and prosecute those responsible for the diversion. If the purchaser does not take custody of the shipment and instead returns it to the supplier, it is the suppliera€™s responsibility for reporting any loss of controlled substances in the original shipment. Damaged goods may also be disposed of through shipment to a reverse distributor or by a DEA approved process as defined in Section IV, Transfer or Disposal of Controlled Substances. Recordkeeping requirements for prescriptions are detailed in Section VI, Prescription Records.
A When the use of DEA Form 222 or the electronic equivalent for the transfer of a controlled substance is not required under federal law, its use as mandated by these states does not violate federal law and is therefore permitted. A If an order is refused, the supplier must return copies one and two of the DEA Form 222 to the purchaser with a statement explaining the reason the order was refused.
The pharmacy must attach a copy of the statement to the second order form that is sent to the supplier. The adoption of the CSOS standards is the only allowance for the electronic transmission of schedule II controlled substance orders between controlled substance manufacturers, distributors, pharmacies, and other DEA authorized entities. Certificates will be revoked if the certificate holder is no longer authorized to sign schedule II orders for the registrant, if the information on which the certificate is based changes, or if the digital certificate used to sign electronic orders has been compromised, stolen, or lost. If the supplier to whom the order was directed subsequently receives the first order, the supplier must indicate that it is a€?not accepteda€? and return it to the purchaser.
A Renewal Application for Registration (DEA Form 224a) will only be sent to the mailing address on file with DEA. A DEA Form 41 should not be used to record the transfer of controlled substances between the pharmacy and the reverse distributor disposing of the drugs. If there is a question as to whether a theft has occurred or a loss is significant, a registrant should err on the side of caution and report it to DEA and local law enforcement authorities. In addition, when a retail pharmacy contracts with private, common or contract carriers to retrieve filled prescriptions from a central fill pharmacy, the retail pharmacy is responsible for reporting in-transit losses upon discovery using a DEA Form 106.
For electronic orders, the supplier must notify the purchaser and provide a statement as to the reason (see below, Controlled Substance Ordering System (CSOS) – Electronic Order Forms).
A In addition, the pharmacist must keep a copy of the statement with copy three from the first and second order forms. CSOS uses Public Key Infrastructure (PKI) technology, which requires CSOS users to obtain a CSOS digital certificate for electronic ordering. Should a supplier partially void an order, the supplier must indicate in the linked record that nothing was shipped for each item voided. A The electronic orders must be signed using a digital signature issued by a Certification Authority (CA) run by the DEA. A The pharmacy acquiring the controlled substances must maintain all records involved in the transfer of the controlled substances for two years.



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