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Pharmacist's Manual

Application of State and Federal Laws

Nothing in this manual shall be construed as authorizing or permitting any person to do any act which is not authorized or permitted under federal or state laws. In addition, none of the policy statements and information in this manual may be construed as authorizing or permitting any person to do any act which is not authorized. Use of a DEA controlled substance registration for activities not authorized under state law is a violation of both federal and state law.

Furthermore, this manual does not authorize a pharmacist to refuse to meet any requirements in the most recent publication of Title 21, Chapter II of the Code of Federal Regulations (21 CFR, Part 1300 to end). The CFR is the primary source for the Pharmacist’s Manual. Printed copies of the complete regulations implementing the Controlled Substances Act of 1970 may be obtained from:

Superintendent of Documents
U.S. Government Printing Office
Washington, D.C. 20402

Both the Code of Federal Regulations and the Federal Register (which includes proposed and finalized regulations implementing the CSA) are available on the Internet through the U.S. Government Printing Office (GPO) website. This site, which provides information by section, citation and key words, can be accessed at:

http://www.access.gpo.gov/nara/cfr/index.html

DEA registration grants pharmacies authority to dispense controlled substances. However, DEA registered pharmacies may only engage in those activities which are authorized under state law in the jurisdiction where the pharmacy is located. In many cases state law is more stringent than federal law, and must be complied with in addition to federal law. Pharmacists should make sure they understand their state and DEA controlled substance regulations.

Drug Enforcement Administration

The Drug Enforcement Administration (DEA) is the primary agency within the Federal Government responsible for the enforcement of the Controlled Substances Act (CSA). In cooperation with state authorities and other federal agencies, DEA is tasked with preventing the diversion of controlled substances for illicit purposes. In carrying out its mission, DEA complies with international treaty obligations, works closely with foreign as well as domestic state and local governments, private industry, and other organizations concerned with drug abuse and diversion.

The CSA, which became effective May 1, 1971, consolidates into one piece of legislation many diverse laws passed by Congress since the Harrison Narcotics Act of 1914, the first comprehensive federal legislation to control addicting drugs. Subsequent amendments to the CSA include the 1984 Diversion Control Amendments, the Controlled Substance Registrant Protection Act of 1984, the Narcotic Addict Treatment Act of 1984, the Chemical Diversion and Trafficking Act of 1988, the Domestic Chemical Diversion Control Act of 1993, and the Comprehensive Methamphetamine Control Act of 1996.

The provisions of the CSA are designed to improve the administration and regulation of the manufacture, import/export, distribution and dispensing of controlled substances by providing a "closed system" for distribution. Under this closed system, a controlled substance can be traced from the time it is manufactured to the time it is dispensed to the ultimate user. This system has proven effective in reducing the diversion of these substances from legitimate channels to the illicit market.

The controlled substances and their derivatives listed under the CSA can be found in the Code of Federal Regulations, Title 21 under "Part 1308--Schedules of Controlled Substances."

The drugs and drug products under the jurisdiction of the CSA are divided into five schedules. Controlled substances in Schedules II-V have an accepted medical use in the United States, and Schedule I substances do not. The characteristics and some examples of the drugs in each schedule are outlined below.

The substances in this schedule have a high abuse potential and no accepted medical use in the United States. This is the only schedule that includes drugs that are not available for prescribing, dispensing or administering. DEA does allow for research involving Schedule I substances. This requires a separate registration as a researcher.

Examples of substances classified as Schedule I narcotics include heroin, certain clandestinely made fentanyl analogs, and propiram Some hallucinogenic substances found in Schedule I include LSD, marijuana, and MDMA (Ecstasy).

Other examples of Schedule I substances are the depressants methaqualone and gamma hydroxybutyric acid (GHB) and the stimulant methcathinone.

Schedule II Substances

Substances in Schedule II have a high abuse potential with severe psychological or physical dependence liability, have an accepted medical use in the United States, and are available for practitioners to prescribe, dispense and administer.

Some examples of single entity Schedule II narcotics include morphine, codeine, hydrocodone, and opium. Other Schedule II narcotic substances and their common name brand products include: hydromorphone (Dilaudid®), methadone (Dolophine®), meperidine (Demerol®), oxycodone (Percodan®) and fentanyl (Sublimaze®).

Some examples of Schedule II stimulants include amphetamine (Dexedrine®), Adderall ®), methamphetamine (Desoxyn®) and methylphenidate (Ritalin®).

Other Schedule II substances include cocaine, amobarbital, glutethimide, pentobarbital and secobarbital.

The substances in this schedule have an abuse potential which is less than those in Schedule II, but more than Schedule IV substances.

Some examples of Schedule III narcotics include products containing less than 15 milligrams of hydrocodone per dosage unit (i.e., Vicodin®, Lorcet®, Tussionex®, and products containing not more than 90 milligrams of codeine per dosage unit (i.e., codeine with acetaminophen, aspirin or ibuprofen).

Other Schedule III substances include anabolic steroids benzphetamine (Didrex®) phendimetrazine, buprenorphine (Buprenex®) and any compound, mixture, preparation or suppository dosage form containing amobarbital, secobarbital, pentobarbital, dronabinol (Marinol ®) or ketamine.

The substances in this schedule have an abuse potential less than those listed in Schedule III and more than substances in Schedule V.

Some examples of Schedule IV narcotics include propoxyphene (Darvon®), butorphanol (Stadol®), and pentazocine (Talwin-NX®).

The following benzodiazepine substances are also found in Schedule IV. They include alprazolam (Xanax®), clonazepam (Klonopin®), clorazepate (Tranxene®), diazepam (Valium®), flurazepam (Dalmane®), halazepam (Paxipam®), lorazepam (Ativan®), midazolam (Versed®), orazepam (Serax®), prazepam (Verstran®), temazepam (Restoril®), triazolam (Halcion®), and quazepam (Doral®).

Other Schedule IV substances include barbital, phenobarbital, chloral hydrate, ethchlorvynol (Placidyl®), chlordiazepoxide (Librium®), ethinamate, meprobamate, paraldehyde, methohexital, phentermine, diethylpropion, pemoline (Cylert®), mazindol (Sanorex®), and sibutramine (Meridia®).

The substances in this schedule have an abuse potential less than those listed in Schedule IV and consist primarily of preparations containing limited quantities of certain narcotic and stimulant drugs generally for antitussive, antidiarrheal and analgesic purposes. Some examples are cough preparations containing not more than 200 milligrams of codeine per 100 milliliters or per 100 grams (Robitussin AC®), Phenergan with codeine®). 

Registration Requirements

Every pharmacy which dispenses any controlled substance must be registered with the DEA. Since DEA does not register pharmacists, they must obtain their license to practice pharmacy from their state regulatory authority. To obtain a DEA registration, a pharmacy can request a DEA Form-224 (Application for New Registration, see Appendix E) from any DEA Registration Field Office (see Appendix T) or from the DEA Headquarters Registration Unit in Washington, D.C. at 1-800-882-9539 (Registration Call Center). DEA Form 224 is also available online and in PDF format at www.DEAdiversion.usdoj.gov. The DEA Form 224 is fully interactive, including the acceptance of electronic credit card payments.

The completed DEA Form-224 must be submitted to:

Drug Enforcement Administration
Registration Unit
Central Station
P.O. Box 28083
Washington, D.C. 20038-8083

Pharmacy registrations must be renewed every three years. The cost of the registration is annotated on the application form. The certificate of registration must be maintained at the registered location and kept available for official inspection. If a person owns and operates more than one pharmacy, each place of business must be registered.

Every pharmacy currently registered with DEA will receive a renewal application approximately 45 days before the registration expiration date. The renewal application will be sent to the address listed on the current registration certificate. If the renewal form is not received within 30 days before the expiration date of the current registration, the pharmacy should contact the DEA registration unit for their state (see Appendix T), and request a renewal registration form.

Under DEA’s Chemical Control regulations there is an exemption from the registration requirement for a retail distributor. A retail distributor is defined as a grocery store, general merchandise store, drug store, or other entity or person whose activities as a distributor of legal drug products containing listed chemicals pseudoephedrine, phenylpropanolamine (PPA), combination ephedrine and single-entity ephedrine are limited almost exclusively to sales for personal use, both in number and volume of sales, either directly to walk-in customers or in face to face transactions. Personal use means the distribution of below "threshold quantities"⁴ in a single transaction to an individual for legitimate medical use.

Federal law requires any person who is engaged in the wholesale distribution of drug products containing List I chemicals to obtain a registration as a chemical distributor. A distributor who does not meet all the requirements for a retail distributor is a wholesale distributor.

Retail pharmacies that are registered to handle controlled substances need not obtain a separate DEA chemical registration for retail distribution of the drug products containing pseudoephedrine, phenylpropanolamine (PPA), combination ephedrine and single-entity ephedrine which are regulated as List I chemicals. If a pharmacy desires to engage in the wholesale distribution of bulk quantities of these drug products, the pharmacy will have to register with DEA as a Chemical Distributor because these activities fall outside of the definition of retail distributor. Therefore, the pharmacy would be subject to the registration requirements that apply to wholesale distributors.

To obtain a DEA Chemical Distributor registration, a pharmacy can request DEA Form-510 (Application for Registration, see Appendix M) from any DEA Registration Field Office (see Appendix T)

For additional information see Chemical Requirements: Comprehensive Methamphetamine Control Act of 1996.

⁴ The quantity of a particular chemical, above which recordkeeping and other control provisions of the CSA apply. See Appendix A "Number of Tablets that Equal a Threshold (Regulated) Transaction for Dosage Units of Marketed Products"

Pharmacies seeking to become registered for the first time must request a DEA Form-224 (Application for New Registration, see Appendix E) from any DEA Registration Field Office or the DEA Registration Unit in Washington, D.C. at the address listed under Registration Requirements.

Any pharmacy engaged in co-op buying of controlled substances must also register as a distributor with the DEA. To obtain this registration, a pharmacy must meet distributor (wholesaler) security and recordkeeping requirements.

An affidavit system for expediting pharmacy applications may be used to obtain a DEA registration number for a new pharmacy or for transferring ownership of an existing pharmacy. If the pharmacy has been registered by the state licensing agency, the applicant may include an affidavit (see Appendix P) to verify the existence of the state license with their application (21 CFR 1301.17).

Any time a pharmacy moves to a new physical location or the postal address changes at the same location, a new DEA certificate reflecting the new address must be obtained. It is the pharmacy's responsibility to notify DEA about a change of address before the effective date of the move. A written request for modification of registration should be sent to the DEA Registration Field Office responsible for their state (see Appendix T). If the modification is approved, DEA will issue a new certificate of registration and, if requested, new Schedule II order forms (DEA Form-222, Official Order Form). A Renewal Application for Registration (DEA Form-224a) will only be sent to the registered address on file with DEA. It cannot be forwarded.

Affidavit for Renewal of Retail/Chain Pharmacy Registration

Corporations that own or operate a chain of pharmacies may submit a single DEA Form-224b (Retail Pharmacy Registration Affidavit for Chain Renewal, see Appendix G) that covers all the chain's pharmacy registrants. This affidavit along with a list of the corporation's registrations is provided in lieu of a separate DEA application for each pharmacy registration. No registration may be issued unless the completed affidavit is received by DEA. The corporation should retain a copy of this affidavit with their readily retrievable records for the duration of the registration covered by the affidavit. The corporation must answer the questions listed on the affidavit as they pertain to each registrant.

The original affidavit along with the registration fee and the list of registrations should be mailed to:

Registration Chain Renewal
United States Department of Justice
Drug Enforcement Administration
Central Station
P.O. Box 28083
Washington, D.C. 20038-808

Diversion of legitimately manufactured controlled substances is a serious problem in the United States. Registrants serve as the nation's primary guardians for preventing diversion and controlling legitimate access to these drugs. The CSA provides the Federal Government with additional legal resources for taking action against those registrants who contribute to the diversion problem. The U.S. Attorney General has the authority to suspend or revoke a DEA registration upon a finding that the registrant has:

1. Materially falsified any application filed. 
2. Been convicted of a felony relating to a controlled substance or a List I Chemical. 
3. Had his/her state license or registration suspended, revoked or denied. 
4. Committed an act which would render his registration inconsistent with the public interest. 
5. Been excluded from participation in a Medicaid or Medicare program.

Denial of Registration in the Public Interest

The CSA gives the U.S. Attorney General authority to deny any application for DEA registration or renewal if it is determined that issuing a controlled substance registration would be inconsistent with the public interest. In determining the public interest, the CSA states the following factors will be considered:

1. The recommendation of the appropriate state licensing board or professional disciplinary authority. 
2. The applicant's experience in dispensing or conducting research with respect to controlled substances. 
3. The applicant's conviction record under federal or state laws relating to the manufacture, distribution or dispensing of controlled substances. 
4. Compliance with applicable state, federal or local laws relating to controlled substances. 
5. Such other conduct which may threaten the public health and safety.

Any registrant who discontinues his/her business or transfers it to another person must notify the nearest DEA Registration Field Office (see Appendix T) in writing before terminating the pharmacy's registration. Along with the notification of termination of registration, the pharmacist should send the DEA Certificate of Registration and any unused Official Order Forms (DEA Form-222). The pharmacist should write or stamp the word "VOID" across the face of each Official Order Form before returning them to DEA. The notification to DEA should also indicate where the controlled substance inventories and records will be kept and how the controlled substances were transferred or destroyed. Records involving controlled substances must be kept available for two years for inspection and copying by the DEA. This requirement applies even though the business has been discontinued.

A registrant transferring a pharmacy business to another registrant shall notify the nearest DEA Registration Field Office at least 14 days before the date of the proposed transfer and provide the following information:

1. The name, address, registration number of the registrant discontinuing business; 
2. The name, address, registration number of the registrant acquiring the pharmacy; 
3. Whether the business activities will be continued at the location registered by the current business owner or moved to another location. If the latter, give the address of the new location. 
4. The date on which the controlled substances will be transferred to the person acquiring the pharmacy (see Transfer of Controlled Substances on page 10).

On the day the controlled substances are transferred, a complete controlled substances 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. Procedures for transferring the ownership of a pharmacy and a model format for an affidavit to expedite the process are outlined in Appendix Q.

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. 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.

A DEA registration application for transferring ownership of an existing pharmacy can be expedited if the applicant includes an affidavit (see Appendix Q) verifying that the pharmacy has been registered by the state licensing agency. The affidavit verifying the existence of the state license should be attached to the initial application for registration.

Disposal of Controlled Substances

The pharmacy may hire an outside firm to inventory, package and arrange for the transfer of its controlled substances to another pharmacy, supplier or manufacturer. The pharmacy is responsible for the actual transfer of the controlled substances and for the accuracy of the inventory and records. The pharmacy may also transfer the drugs to a distributor registered with DEA to destroy drugs (reverse distributor). The pharmacy may not turn over any controlled substances to a distributor unless the reverse distributor is registered to destroy controlled substances. The pharmacy is responsible for verifying that the reverse distributor is registered with DEA.

The records involving the transfer or destruction of controlled substances must be kept readily available for two years for inspection and copying by the DEA. The two primary methods for disposing of controlled substances are transfer to another registrant or destruction as explained in the following section.

If a pharmacy goes out of business or is acquired by a new pharmacy, it may transfer the controlled substances to another pharmacy, supplier, manufacturer or distributor registered to dispose of controlled substances.

To transfer Schedule II substances, the receiving registrant must issue an Official Order Form (DEA Form-222, U.S. Official Order Forms - Schedules I & II) to the registrant transferring the drugs.

The transfer of Schedule III-V controlled substances must be documented in writing to show the drug name, dosage form, strength, quantity and date transferred. The document must include the names, addresses and DEA registration numbers of the parties involved in the transfer of the controlled substances.

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. In addition DEA Form-222 (Official Order Form) must be prepared to document the transfer of Schedule II controlled substances. This inventory will serve as the final inventory for the registrant going out of business and transferring the controlled substances. It will also serve as the initial inventory for the registrant acquiring the controlled substances. A copy of the inventory must be included in the records of each person. It is not necessary to send a copy of the inventory to the DEA. The person acquiring the controlled substances must maintain all records involved in the transfer of the controlled substances for two years.

⁵ See also the section entitled "Controlled Substance Distribution by Pharmacy".

Any pharmacy may transfer controlled substances to a supplier or a manufacturer. The pharmacist must maintain a written record showing:

1. The date of the transaction. 
2. The name, strength, form and quantity of the controlled substance. 
3. The supplier’s or manufacturer’s name, address, and, if known, registration number. 
4. The DEA Form-222 will be the official record for the transfer of Schedule II substances.

Any pharmacy may forward controlled substances to DEA-registered reverse distributors who handle the disposal of drugs. For further instructions see, Disposal of Controlled Substances.

DEA recommends that any pharmacy seeking to dispose of controlled substances first contact the nearest DEA Diversion Field Office (see Appendix T) for disposal instructions. In no case should drugs be forwarded to the DEA unless the registrant has received prior approval from the DEA. The DEA procedures established for the destruction of controlled substances shall not be construed as altering in any way the state laws or regulations for the disposal of controlled substances. Requests from registrants seeking authorization to destroy controlled substances without DEA presence, or requests from non-registrants desiring to dispose of controlled substances will be handled as follows:

Once-a-Year DEA Authorization for Destruction

Once each calendar year retail pharmacies may request DEA authorization to destroy damaged, outdated or otherwise unwanted controlled substances. The pharmacy must complete DEA Form-41 (Registrants Inventory of Drugs Surrendered, see Appendix I), listing all drugs to be destroyed. In addition, the pharmacy must prepare a letter requesting permission to destroy the controlled substances, proposing a date and method of destruction, and listing the names of at least two people who will witness the destruction. The witnesses should be either a licensed physician, pharmacist, mid-level practitioner, nurse, or a state or local law enforcement officer. Both documents must be received by the nearest DEA Diversion Field Office at least two weeks prior to the proposed destruction date. After reviewing all available information, the DEA office will then notify the registrant in writing of its decision. Once the controlled substances have been destroyed, signed copies of the DEA Form-41 must be forwarded to DEA. The pharmacist should contact local environmental authorities prior to implementing the proposed method of destruction to ascertain that hazards are not associated with the destruction.

Prior DEA authorization to destroy controlled substances is not necessary when an authorized member of a state law enforcement authority or regulatory agency witnesses the destruction. Copies of a DEA Form-41 or state controlled substance destruction form must be forwarded to the local DEA Diversion Office after the destruction.

Reverse Distributors Authorized to Destroy Controlled Substances

A pharmacy may at any time forward controlled substances to DEA registered reverse distributors who handle the disposal of drugs. The pharmacist may contact their local DEA Diversion Field Office for an updated list of those reverse distributors in their area. When a pharmacy transfers Schedule II substances to a reverse distributor for destruction, the distributor must issue an Official Order Form (DEA Form-222) to the pharmacy. When Schedule III-V controlled substances are transferred to a reverse distributor for destruction, the pharmacy should document in writing the drug name, dosage form, strength, quantity and date transferred. The DEA registered reverse distributor who will destroy the controlled substances is responsible for submitting a DEA Form-41 to DEA when the drugs have been destroyed. A DEA Form-41 should not be used to record the transfer of controlled substances between the pharmacy and the registered reverse distributor disposing the drugs

DEA will issue a "Blanket Authorization" for destruction of controlled substances on a very limited basis to those registrants who are associated with hospitals, clinics or other registrants having to dispose of used needles, syringes or other injectable objects only. This limited exception is granted because of the probability that those objects have been contaminated by hazardous bodily fluids. The pharmacist should contact their local DEA Diversion Field Office for information about how to request such an authorization. DEA will evaluate requests for a blanket authorization based on the following guidelines:

1. Frequency of destruction (i.e., daily, weekly) and volume of drugs involved that warrant such authorization. 
2. Method of destruction. Drugs must be destroyed in such a manner that they are beyond reclamation. 
3. Registrant’s past history. 
4. Security at the pharmacy or registered location. 
5. Name and position of the individual responsible for the destruction.

Those registrants granted blanket authorization to destroy controlled substances must complete DEA Form-41 (Registrants Inventory of Drugs Surrendered, see Appendix I).

The DEA requires pharmacies to keep Schedules II, III, IV and V controlled substances in a locked cabinet or dispersed through the non-controlled stock to deter theft. An electronic alarm system is recommended.

A pharmacy registrant (i.e., the registrant or corporation which owns the pharmacy) must not employ in a position which allows access to controlled substances, anyone who has been convicted of a felony relating to controlled substances, or who, at any time, has had an application for DEA registration denied, revoked, or surrendered for cause. "For cause" means surrendering a registration in lieu of, or as a consequence of, any federal or state administrative, civil or criminal action resulting from an investigation of the individual’s handling of controlled substances.

However, pharmacies desiring to employ an individual who meets this definition may request an exception to this requirement (see 21 CFR 1307.03) from DEA. The employer must have a waiver approved before hiring the applicant. A waiver request should be sent to DEA Headquarters, Office of Diversion Control, Washington, D.C. 20537.

A pharmacy registrant who applies for such a waiver should understand that the following factors will be considered:

1. A detailed description of the nature and extent of the applicant’s past controlled substances violations.  
2. Activities of the applicant since the violation.  
3. Current status of the applicant’s state licensure.  
4. Extent of applicant’s proposed access to controlled substances.  
5. Registrant’s proposed physical and professional safeguards to prevent diversion by the applicant if employed.  
6. Status of employing registrant regarding handling of controlled substances. 
7. Other pertinent information uncovered by DEA in its investigation of the applicant’s or registrant’s handling of controlled substances. 
8. Such a waiver should not be considered unless there are valid reasons to believe that diversion is unlikely to occur.

Immediately upon discovery of a theft or significant loss of controlled substances, a pharmacy, as required by regulation, must contact the nearest DEA Diversion Field Office (see Appendix T) by telephone, facsimile or by a brief written message explaining the circumstances. A pharmacy should also notify the local police as may be required by state law. 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.

DEA must be notified directly. This requirement is not satisfied by reporting the theft or significant loss in any other manner. For example, a corporation which owns/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 "upon discovery" and keep a copy for its records.

A pharmacy shall also complete a DEA Form-106 (Report of Theft or Loss of Controlled Substances). To obtain a DEA Form-106 (see Appendix J), contact the nearest DEA Diversion Field Office (see Appendix T). The DEA Form-106 will formally document the actual circumstances of the theft or significant loss and the quantities of controlled substances involved, once this information has been determined conclusively. The pharmacy should send the original DEA Form-106 and a copy to the DEA Diversion Field Office and keep a copy for its records.

The DEA Form 106 must include the following information:

1. Name and address of firm (pharmacy) 
2. DEA registration number 
3. Date of theft 
4. Name and telephone number of local police department notified 
5. Type of theft (night break in, armed robbery, etc.) 
6. Listing of symbols or cost code used by pharmacy in marking containers (if any) 
7. Listing of controlled substances missing from theft or significant loss

If after an investigation of the circumstances surrounding the theft or significant loss it is determined that no such theft or significant loss occurred, no DEA Form-106 need be filed.

However, the registrant should 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.

Although the CSA regulations do not define the term "significant loss," it is the responsibility of the registrant to use his/her best judgment to take appropriate action. A significant loss depends, in large part, on the business of the pharmacy and the likelihood of a rational explanation for a particular occurrence. What would constitute a significant loss for a pharmacy may be viewed as comparatively insignificant for a hospital or distributor.

Further, the loss of a small quantity of controlled substances, repeated over a period of time, may indicate a significant problem for a registrant, a problem which must be reported to DEA, even though the individual amounts of missing controlled substances are not, in and of themselves, significant. Registrants must report a loss upon discovery. In particular, a pharmacist should be alert for suspicious or unexplained losses. Any signs of a break in, physical entry or armed robbery should be reported. The burden of responsibility is on the registrant to identify what is a significant loss and make the required report to DEA.

Some factors to consider for determining significant loss include:

1. The schedule of the missing items. 
2. The abuse potential of the missing items. 
3. The abuse potential in your area of the missing substance. 
4. The quantity missing (one tablet vs. one bottle or container). 
5. Is this the first time this loss has occurred? Has a similar loss occurred before? 
6. Was this loss reported to local law enforcement authorities? 
7. If there is a question as to whether a loss is significant, a registrant should err on the side of caution and report it to DEA.

If it is determined that the loss is not significant, place a record of the occurrence in your theft and loss file for future reference.

In-Transit Loss

When all or part of a shipment disappears, or never reaches its intended destination, the supplier is responsible for reporting the in-transit loss of controlled substances to DEA. A pharmacy is responsible for reporting any loss of controlled substances after a pharmacist has signed for or taken custody of a shipment. If it’s discovered after that point that an in-transit loss or theft has occurred, the pharmacist must submit a DEA Form-106.

Breakage/Spillage

DEA further wishes to clarify that the breakage of controlled substances does not constitute a "loss" of controlled substances. 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. Damaged goods may be disposed of through shipment to a "reverse distributor" or by a DEA approved process as defined in (Destruction of Controlled Substances). When this disposal occurs, it must be reported to DEA on a DEA Form-41 (Registrants Inventory of Drugs Surrendered, see Appendix I).

Robberies, burglaries and assaults on pharmacists and other registrants by those seeking controlled substances are a serious problem in the United States. These crimes result in property loss, serious injury to professionals and bystanders, and trafficking which serves to fuel the drug abuse problem.

Federal Investigation

The Controlled Substances Registrant Protection Act of 1984 (CSRPA) provides for the federal investigation of pharmaceutical thefts and robberies if any of the following conditions are met:

1. Replacement cost of the controlled substances taken is $500 or more. 
2. A registrant or other person is killed or suffers "significant" bodily injury during the commission of the robbery or theft of a controlled substance. 
3. Interstate or foreign commerce is involved in planning or executing the crime.

The perpetrator convicted of violating the CSRPA’s provisions is subject to the following penalties:

1. Conviction for commission of burglary or robbery can result in a maximum $25,000 fine and/or 20 years imprisonment.
    
2. Conviction for use of a dangerous weapon in the commission of the crime can result in a maximum $35,000 fine and/or 25 years imprisonment.
    
3. If death results from the crime, the convicted person can receive a maximum $50,000 fine and/or life imprisonment.

Every pharmacy must maintain complete and accurate records on a current basis for each controlled substance purchased, received, distributed, dispensed or otherwise disposed of. All records of controlled substances must be maintained for two years. This recordkeeping system allows a controlled substance to be tracked from the time it is manufactured to the time it is dispensed to the ultimate user. (Recordkeeping requirements for List I Chemicals are contained in the Chemical Requirements section.)

All records concerning controlled substances must be maintained for at least two years for inspection and copying by duly authorized DEA officials. Records and inventories of Schedule II controlled substances must be maintained separately from all other records of the registrant. All records and inventories of Schedule 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. (Recordkeeping requirements for prescriptions are detailed in the Prescription Records section.)

Readily retrievable means that:

1. Certain records are kept by automatic data processing systems or other electronic or mechanized recordkeeping systems in such a manner that they can be separated out from all other records in a reasonable time. 
2. And/or records are kept on which certain items are asterisked, redlined or in some other manner visually identifiable apart from other items appearing on the records.

1. Official Order Forms (DEA Form-222).⁶ 
2. Power of Attorney authorization to sign Order Forms. 
3. Receipts and invoices for Schedule III, IV, and V controlled substances as well as "threshold quantities"⁷ of List I chemicals. 
4. All inventory records of controlled substances, including the initial and biennial inventories. 
5. Records of controlled substances distributed or dispensed (i.e., prescriptions) and threshold amounts of List I chemicals distributed. 
6. Report of Theft or Loss (DEA Form-106). 
7. Inventory of Drugs Surrendered for Disposal (DEA Form-41). 
8. Records of transfers of controlled substances between pharmacies. 
9. DEA registration certificate.

⁶ DEA's Official Order Forms are the required records of receipt and sale for Schedule II controlled substances.

⁷ The quantity of a particular chemical, above which recordkeeping and other control provisions of the CSA apply. See Appendix B "List I Chemicals with Domestic Threshold Amounts" .

A registrant desiring to maintain shipping and financial records at a central location other than the registered location must notify the nearest DEA Diversion Field Office (see Appendix T). 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 notifying DEA. Central recordkeeping requirements are described in 21 CFR, 1304.04. Central recordkeeping permits are no longer issued by the DEA.

Pharmacies have three options for filing prescription records under the Code of Federal Regulations. 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 (Title 21 USC, Section 903).

All prescription records must be readily retrievable for DEA inspection. Controlled substance prescriptions must be filed in one of the following three ways:

Option 1 (Three separate files)

• A file for Schedule II drugs dispensed, 
• A file for Schedule III, IV and V drugs dispensed, and 
• A file for prescription orders for all noncontrolled drugs dispensed.

Option 2 (Two separate files)

• A file for all Schedule II drugs dispensed, 
• A file for all other drugs dispensed (noncontrolled and those in Schedule III, IV and V). If this method is used, a prescription for a Schedule III, IV and V drug must be made readily retrievable by use of a red "C" stamp not less than one inch high.⁸

Option 3 (Two separate files)

• A file for all Schedule II-V controlled substances. If this method is used, a prescription for a Schedule III, IV and V drug must be made readily retrievable by use of a red "C" stamp not less than one inch high.⁸ 
• A file for prescription orders for all noncontrolled drugs dispensed.

⁸ If a pharmacy has an electronic recordkeeping system for prescriptions which permits identification by prescription number and retrieval of original documents by prescriber's name, patient's name, drug dispensed and date filled, then the requirements to mark the hard copy prescription with a red "C" is waived.

Inventory means 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. The CFR also requires that all inventories be maintained at the registered location in a readily retrievable manner for at least two years for copying and inspection. In addition, the inventory of Schedule II controlled substances must be kept separate from those for all other controlled substances.

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. If there are no stocks of controlled substances on hand, the registrant should make a record showing a zero inventory. There is no requirement to submit a copy of the inventory to the DEA.

The Code of Federal Regulations (CFR) requires that the inventory include:

1. The inventory date. 
2. The time the inventory is taken (i.e., opening or close of business). 
3. The drug name. 
4. The drug strength. 
5. The drug form (e.g., tablet, capsule, etc.). 
6. The number of units/volume. 
7. The total quantity.

DEA recommends that the inventory record include:

1. The name, address and DEA registration number of the registrant. 
2. 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. The biennial inventory may be taken on any date which is within two years of the previous inventory date. There is no requirement to submit a copy of the inventory to DEA.

When taking the inventory of Schedule II controlled substances, an actual physical count must be made. For the inventory of Schedules III, IV and V controlled substances, an estimated count may be made. An actual physical count must be made if the container holds more than 1,000 dosage units and has been opened.

Inventorying Newly Scheduled Controlled Substances

When a drug not previously controlled is scheduled, the drug must be inventoried as of the effective date of scheduling.

Each controlled substance that is (1) damaged, defective, or impure and is awaiting disposal, (2) held for quality control purposes, or (3) maintained for extemporaneous compoundings, must be inventoried.

The Code of Federal Regulations (CFR) requires that the inventory include:

1. The inventory date. 
2. The drug name. 
3. The drug strength. 
4. The drug form (e.g., tablet, capsule, etc.).  
5. The total quantity or total number of units/volume. 
6. The reason why the substance is being maintained. 
7. Whether substance is capable of being used in the manufacture of any controlled substance in finished form.

Only Schedule I and II controlled substances are ordered with a DEA Form-222 (Official Order Form, see Appendix H). An Official Order Form is required for each distribution, purchase or transfer of a Schedule II controlled substance.

When a controlled substance has been transferred by DEA from Schedule II to another Schedule at the federal level, in many states it remains in Schedule II pending any legislative or administrative actions that may result from the federal action. Many states require that transactions involving substances that they classify as Schedule II be made via DEA Form-222 Official Order Forms. Where federal and state laws or regulations conflict, the stricter applies. When the use of DEA Form-222 Official Order Forms 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.

Official Order Forms can be initially requested by checking "block 3" on the application for new registration (DEA Form-224). There is no charge. Send the form to:

Drug Enforcement Administration
Registration Unit
Central Station
P.O. Box 28083
Washington, D.C. 20038-8083

Once a registrant has received Official Order Forms (DEA Form-222), a separate requisition form (DEA Form-222a) will be mailed to the registrant to request additional Official Order Forms. The registrant may also request Official Order Forms by calling either the DEA Headquarters Registration Unit (toll free: 1-800-882-9539) or the nearest DEA Registration Field Office (See Appendix T).

Each book of DEA Official Order Forms consists of seven sets of forms. Each pharmacy is provided a maximum of six books at one time unless its needs exceed this limit. In such a case, the pharmacy should contact the DEA Registration Field Office serving their state (Appendix T).

When ordering Schedule II substances, the pharmacist is responsible for filling in the number of packages, the size of the package and the name of the item. Each Official Order Form must be signed and dated by a person authorized to sign a registration application. (See Power of Attorney to Sign an Official Order Form) When the items are received, the pharmacist must document on the purchaser’s copy (copy 3) the actual number of packages received and the date received.

Official Order Forms must be maintained separately from the pharmacy’s other business records. However, this does not preclude a registrant from attaching a copy of the supplier's invoice to the related Order Form.

The Code of Federal Regulations requires that the Official Order Form must be "complete, legible, and properly prepared, with no signs of alteration, erasure or change of any description." A supplier may refuse to accept an order for any of these reasons. However, DEA has acknowledged some minor changes or alterations may be accepted by a supplier. For example, suppliers may correct Official Order Forms that have:

Minor errors, which lack inconsequential information or
An incorrect date unintentionally annotated by the purchaser.

If an order is refused, the supplier should return Official Order Form copies 1 and 2 to the purchaser with a statement explaining the reason the order was refused.

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. For example, a distributor may substitute 5 bottles of 100, 2mg tablets for 1 bottle of 500, 2mg tablets or any variation thereof.

Any registrant (pharmacy) may authorize one or more individuals, whether or not they are located at the registered location, to obtain and execute Official Order Forms by granting a power of attorney to each such individual. 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 Official Order Forms. The power of attorney may be revoked at any time by the person who signed the power of attorney. It is necessary to grant a new power of attorney when the pharmacy completes a renewal registration, only if the renewal application is signed by a different person. The power of attorney should be filed with executed Official Order Forms as a readily retrievable record. The power of attorney is not submitted to DEA.

Suggested formats for granting and revoking power of attorney follow:

_________________________(Name of registrant)
_________________________(Address of registrant)
_________________________(DEA registration number)

I, _______________________________________________(name of person granting power), the undersigned, who is authorized to sign the current application for registration of the above named registrant under the Controlled Substances Act or Controlled Substances Import and Export Act, have made, constituted, and appointed, and by these present, do make, constitute, and appoint _________________________________(name of attorney-in-fact), my true and lawful attorney for me in my name, place, and stead, to execute applications for books of official order forms and to sign such order forms in requisition for Schedule I and II controlled substances, in accordance with Section 308 of the Controlled Substances Act (21 U.S.C. 828) and part 1305 of Title 21 of the Code of Federal Regulations. I hereby ratify and confirm all that said attorney shall lawfully do or cause to be done by virtue hereof.

(Signature of person granting power) 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.

Witnesses:

1. _______________________
2. _______________________

Signed and dated on the ____ day of ______________in the year_____ at _______________________________.

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 or the Controlled Substances Import and Export Act. Written notice of this revocation has been given to the attorney-in-fact ____________________________ this same day. (Signature of person revoking power)

Witnesses:

1. ______________________
2. ______________________

Signed and dated on the _____ day of _______________, in the year_____ at _____________________________.

When the pharmacist has not received a shipment of controlled substances, he/she should first contact the supplier to determine whether the original DEA Form-222 was received. 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. The pharmacist must also prepare a statement which includes the first order form’s serial number and date, and verify that the drugs ordered were never received. Attach a copy of the statement to the second order form that is sent to the supplier. The pharmacist must keep a copy of the statement with copy 3 from the first and second order forms.

A pharmacy, upon discovery of the loss or theft of unused order forms, must immediately report the loss to the nearest DEA Diversion Field Office (Appendix T), and provide the serial numbers of each lost or stolen order form. 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. If an unused order form reported stolen or lost is later recovered or found, the pharmacy must immediately notify the nearest DEA Diversion Field Office.

The registrant (pharmacy) must keep a receipt (i.e., invoice or packing slip) on which they record the date the drugs were received and confirm that the order is accurate. These receipts must be maintained in a readily retrievable manner for inspection by the DEA.

Prescription Requirements

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 (e.g., 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 name, address, and registration number. The prescription must also include the drug name, strength, dosage form, quantity prescribed, directions for use, and number of refills. Where an oral prescription is not permitted, a prescription must be written in ink or indelible pencil or typewritten and must be manually signed by the practitioner. An individual (i.e., secretary or nurse) may be designated by the practitioner to prepare prescriptions for his/her signature. The practitioner is responsible for making sure that the prescription conforms in all essential respects to the law and regulations.

A prescription order for a controlled substance may be issued only by a physician, dentist, podiatrist, veterinarian, mid-level practitioner or other registered practitioner who is:

1. Authorized to prescribe controlled substances by the jurisdiction in which he/she is licensed to practice; and 
2. Registered with DEA or exempted from registration (i.e., Public Health Service and Bureau of Prison physicians).

Construction of Valid DEA Registration Numbers for Practitioners

Knowing how a DEA registration number is constructed can be a useful tool for recognizing a forged prescription. (For additional information regarding forged prescriptions, see Appendix O) 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. Registration numbers issued to mid-level practitioners begin with the letter M. The first letter of the registration number is 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). (See Mid-Level Practitioner [MLP], regarding their authority to prescribe controlled substances.)

An individual practitioner (e.g., intern, resident, staff physician, mid-level practitioner) who is an agent or employee 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, provided that:

1. The dispensing, administering, or prescribing is in the usual course of professional practice;
    
2. The practitioner is authorized to do so by the state in which he or she is practicing;
    
3. The hospital or institution has verified that the practitioner is permitted to dispense, administer or prescribe controlled substances within the state;
    
4. The practitioner acts only within the scope of employment in the hospital or institution;
    
5. The hospital or institution authorizes the practitioner to dispense or prescribe under its registration and assigns a specific internal code number for each practitioner so authorized (See example of a specific internal code number below); 

6. A current list of internal codes and the corresponding individual practitioners is to be kept 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 dispensing such a prescription.

Purpose of Issue

Facsimile Prescriptions for Schedule II Substances

1. If the system provides a hard copy printout of each day’s controlled substance prescription refills, each pharmacist who refilled those prescriptions shall verify their accuracy by signing and dating the printout as he/she would sign a check or legal document.
    
2. This printout must be provided to each pharmacy which 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.
    
3. In lieu of such a printout, the pharmacy shall maintain a bound log book, or 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.
    
4. A pharmacy computer system shall have the capability of printing out any refill data which the pharmacy must maintain under the Controlled Substances Act. 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:

5. In case a pharmacy's computer system experiences downtime, the pharmacy must have a back-up procedure to document in writing refills of Schedule III, IV and V 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 on-line entry as soon as possible.
    
6. A pharmacy may use only one of the two systems described (i.e., manual or computer).

Required Information for Prescription Labels

Schedule II Substances

Schedule III-V Controlled Substance Prescriptions