DEA Pharmacists Manual
Lost or Stolen DEA Forms 222 If the first DEA Form 222 is subsequently received by the supplier to whom it was directed, the supplier must mark upon the face "____ ____" and return the original DEA Form 222 to the purchaser, who must attach it to the statement. 21 CFR 1305.16(a).
"Not Accepted"
Lost or Stolen Triplicate DEA Forms 222 If the first triplicate DEA Form 222 is subsequently received by the supplier to whom it was directed, the supplier must mark upon the face "____ ____" and return Copies 1 and 2 to the purchaser, who must attach it to Copy 3 and the statement. 21 CFR 1305.20(f)(1). However, if the registrant no longer can use triplicate forms, then the registrant shall proceed by issuing a new single-sheet form in accordance with 21 CFR 1305.16. 21 CFR 1305.20(f)(1).
"Not Accepted"
Cancellation and Voiding of Electronic Orders A supplier may void all (or part) of an electronic order by notifying the purchaser of the voiding. If the entire order is voided, the supplier must make an electronic copy of the order and indicate "____" on the copy and return it to the purchaser. The supplier is not required to retain a record of orders that are not filled. 21 CFR 1305.28(a). The purchaser must retain an electronic copy of the voided order. 21 CFR 1305.28(b). Should a supplier partially void an order, the supplier must indicate in the linked record that nothing was shipped for each item voided. 21 CFR 1305.28(c).
"Void"
Cancellation and Voiding a Triplicate DEA Form 222 A purchaser may cancel an order (or part of an order) on a triplicate DEA Form 222 by notifying the supplier in writing. 21 CFR 1305.20(i)(1). The supplier must indicate the cancellation on Copies 1 and 2 of the triplicate DEA Form 222 by drawing a line through the canceled item(s) and printing "_____" in the space provided for the number of items shipped. 21 CFR 1305.20(i)(1).
"cancelled"
Once executed, Form 222s are valid for ____ - days
60 days
For a schedule II controlled substance, an oral order is only permitted in an emergency situation. 21 CFR 1306.11(d). Within ___ days after authorizing an emergency oral prescription, the prescribing individual practitioner shall cause a written prescription for the emergency quantity prescribed to be delivered to the dispensing pharmacist.
7 days
Lost Electronic Orders If the supplier to whom the order was directed subsequently receives the first order, the supplier must indicate that it is "____ ____" and return it to the purchaser. The purchaser must link the returned order to the record of that order and the statement. 21 CFR 1305.26(c).
:Not Accepted"
Lost or Stolen DEA Forms 222 If a purchaser ascertains that an unfilled DEA Form 222 has been lost, the purchaser must execute another and attach a statement containing the order form number and date of the lost form, and stating that the goods covered by the first DEA Form 222 were not received through loss of that DEA Form 222.
A copy of the second form and a copy of the statement must be retained with a copy of the DEA Form 222 first executed. 21 CFR 1305.16(a). A copy of the statement must be attached to a copy of the second DEA Form 222 sent to the supplier.
A prescription for a controlled substance must be dated and signed on the date when issued. The prescription must include the patient's full name and address, and the practitioner's full name, address, and DEA registration number. 21 CFR 1306.05(a). Under 21 CFR 1306.05(a), 1306.22(b), the prescription must also include: 1. Drug name 2. Drug strength 3. Dosage form 4. Quantity prescribed 5. Directions for use 6. Number of refills authorized (if any)
A corresponding liability rests upon the pharmacist, including a pharmacist employed by a central fill pharmacy, who fills a prescription not prepared in the form prescribed by DEA regulations.
Examples of schedule ____ non-narcotics include benzphetamine (Didrex), phendimetrazine, ketamine, and anabolic steroids such as oxandrolone (Oxandrin).
III
Unaccepted and Defective Electronic Orders Under 21 CFR 1305.25(a), an electronic order for controlled substances may not be filled if any of the following occurs: 1. The required data fields have not been completed. 2. The order is not signed using a digital certificate issued by DEA. 3. The digital certificate used has expired or been revoked prior to signature. 4. The purchaser's public key will not validate the digital certificate. 5. The validation of the order shows that the order is invalid for any reason.
If an order cannot be filled, the supplier must notify the purchaser and provide a statement as to the reason (e.g., improperly prepared or altered). A supplier may, for any reason, refuse to accept any order. If a supplier refuses, a statement that the order is not accepted is sufficient. 21 CFR 1305.25(b).
The _____ Act requires that ALL DEA registrants that distribute controlled substances report suspicious orders to DEA. True or False: Reverse distributors and exporters are not affected by this ______ Act requirement.
SUPPORT Act True
Heroin, lysergic acid diethylamide (LSD), marijuana (cannabis), peyote, methaqualone, and 3,4- methylenedioxymethamphetamine ("MDMA") are examples of drugs in this schedule
Schedule I 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.
Examples of schedule ____ narcotics include morphine, codeine, and opium. Other schedule ____ narcotic substances and their common name brand products include: any combination products containing hydrocodone (Maxidone, Zydone, Vicodin, Lortab, Vicoprofen, Reprexain), hydromorphone (Dilaudid), methadone (Dolophine), meperidine (Demerol), oxycodone (OxyContin), and fentanyl (Sublimaze or Duragesic).
Schedule II
Examples of schedule ____ stimulants include: amphetamine (Dexedrine, Adderall), methamphetamine (Desoxyn), methylphenidate (Ritalin), and lisdexamfetamine (Vyvanse). Other schedule ____ substances include: cocaine, amobarbital, and glutethimide.
Schedule II
Substances in this schedule have a potential for abuse less than substances in schedules I or II, have a currently accepted medical use in treatment in the United States, and abuse may lead to moderate or low physical dependence or high psychological dependence.
Schedule III
Examples of schedule III narcotics include morphine combination products containing not more than ____ milligrams of morphine per ____ milliliters or per ____ grams, with one or more active, non-narcotic ingredients in recognized therapeutic amounts, and products containing not more than ____ milligrams of codeine per dosage unit with an equal or greater quantity of an isoquinoline alkaloid of opium (Tylenol with codeine). Also included are ____ products used to treat opioid addiction.
Schedule III narcotics are not to contain more than 50mg of morphine per 100mL or per 100g 90mg of codeine per dosage unit buprenorphine
Examples of schedule III non-narcotics include benzphetamine (Didrex), phendimetrazine, ketamine, and anabolic steroids such as oxandrolone (Oxandrin).
Schedule IV An example of a schedule IV narcotic is Tramadol (Ultram). Other schedule IV substances include: alprazolam (Xanax), clonazepam (Klonopin), clorazepate (Tranxene), diazepam (Valium), lorazepam (Ativan), midazolam (Versed), temazepam (Restoril), and triazolam (Halcion). 21 U.S.C. 812(c), schedule IV and
Substances in this schedule have a low potential for abuse relative to substances listed in schedule IV, have a currently accepted medical use in treatment in the United States, and abuse may lead to limited physical dependence or psychological dependence relative to substances in schedule IV. They consist primarily of preparations containing limited quantities of certain narcotics. These are generally used for antitussive, antidiarrheal, and analgesic purposes.
Schedule V
SLCP stands for ____. 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 non-prescription drug.
Scheduled Listed Chemical Product
Ordering Schedules III-V Controlled Substances Pursuant to 21 CFR 1304.22(c), 1304.22(a)(2), such receipts must also contain the following information: 4/5. The number of commercial _____ distributed to other persons, including the date of and number of ____ in each reduction from inventory, and the name, address, and registration number of the person to whom the containers were distributed;
containers; containers
Ordering Schedules III-V Controlled Substances Pursuant to 21 CFR 1304.22(c), 1304.22(a)(2), such receipts must also contain the following information: 2/5. Each finished ____ (e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter) and the number of units or volume of finished ____ in each commercial container (e.g., 100-tablet bottle or 3-milliliter vial);
form; form
CSOS uses Public Key Infrastructure (PKI) technology, which requires CSOS users to obtain a CSOS digital certificate for electronic ordering. The electronic orders must be signed using a digital signature issued by the Certification Authority (CA) run by DEA. True or False: Digital certificates can be obtained only by the person who signed the most recent DEA registration application or renewal application, a person authorized to sign a registration application, or a person granted power of attorney by a DEA registrant to sign orders for one or more schedules of controlled substances.
True
Completing Triplicate DEA Forms 222 The executed triplicate DEA Form 222 must be maintained separately from the pharmacy's other business records. 21 CFR 1305.20(g)(3). True or False: If a purchaser has several registered locations, the purchaser must retain Copy 3 of the executed triplicate DEA Form 222 and any attached statements or other related documents at the registered location printed on the triplicate DEA Form 222. 21 CFR 1305.20(g)(3).
True
1. If a renewal application is submitted in a timely manner prior to expiration, the practitioner may continue operations, authorized by the registration, beyond the expiration date until final action is taken on the application. 2. DEA policy allows the reinstatement of an expired registration for ___ calendar month after the expiration date. If the registration is not renewed within that calendar ____, an application for a new DEA registration is required. 3. Regardless of whether a registration is reinstated within the calendar month after expiration, federal law prohibits the handling of controlled substances for any period of time under an expired registration.
1 calendar month
When a prescription for any controlled substance in schedules III or IV is refilled, the following information must be entered on either the back of the prescription, another appropriate document, or an electronic prescription record (3 items):
1. The dispensing pharmacist's initials, 2. The date the prescription was refilled, and 3. The amount of drug dispensed on the refill. 21 CFR 1306.22(b) and (c). If the pharmacist only initials and dates the back of the prescription, the pharmacist will be deemed to have dispensed a refill for the full face amount of the prescription. 21 CFR 1306.22(d).
DEA has granted three exceptions to the facsimile prescription requirements for schedule II controlled substances. The facsimile of a schedule II prescription may serve as the original prescription as follows:
1. A practitioner prescribing a schedule II narcotic controlled substance to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion may transmit the prescription by facsimile. 2. Practitioners prescribing schedule II controlled substances for residents of Long-Term Care Facilities may transmit, or direct their authorized agent to transmit, a prescription to the dispensing pharmacy by facsimile. 3. A practitioner prescribing a schedule II narcotic controlled substance for a patient enrolled in a hospice care program certified and/or paid for by Medicare under Title XVIII or a hospice program which is licensed by the state, may transmit, or direct his or her authorized agent to transmit, a prescription to the dispensing pharmacy by facsimile.
Under 21 CFR 1306.12(b)(1), an individual practitioner may issue multiple prescriptions authorizing the patient to receive a total of up to a 90-day supply of a schedule II controlled substance provided the following conditions are met:
1. Each separate prescription must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice. 21 CFR 1306.12(b)(1)(i). 2. The individual practitioner must provide written instructions on each prescription (other than the first prescription, if the prescribing practitioner intends for that prescription to be filled immediately) indicating the earliest date on which a pharmacy may fill each prescription. 21 CFR 1306.12(b)(1)(ii). 3. The individual practitioner concludes that providing the patient with multiple prescriptions in this manner does not create an undue risk of diversion or abuse. 21 CFR 1306.12(b)(1)(iii). 4. The issuance of multiple prescriptions is permissible under applicable state laws. 21 CFR 1306.12(b)(1)(iv). 5. The individual practitioner complies fully with all other applicable requirements under the CSA and CFR, as well as any additional requirements under state law. 21 CFR 1306.12(b)(1)(v).
When a purchaser receives an unaccepted electronic order from the supplier, the purchaser must electronically link the statement of non-acceptance to the original order. The original statement and all linked records for that order must be retained for ____ years. 21 CFR 1305.25(c), 1305.27(a). Neither a purchaser nor a supplier may correct a defective order. The purchaser must issue a new order for the order to be filled.
2-years
Reports of Theft or Significant Loss (DEA Form ___) Registrant Record of Controlled Substances Destroyed or for reporting non-recoverable breakage and spillage (DEA Form ____)
106; 41
A registrant desiring to maintain shipping and financial records (but not executed official order forms) at a central location rather than the registered location must submit written notification of its intention by registered or certified mail, return receipt requested, in triplicate, to the Special Agent in Charge of the local DEA Diversion Field Office in which the registrant is located (Appendix K). Unless the registrant is informed by DEA that permission to keep central records is denied, the registrant may begin maintaining central records ____ days AFTER the DEA receives this notification.
14 days
Pursuant to 21 CFR 1301.52(d), a pharmacy registrant that desires to transfer its business operations to another pharmacy registrant must submit in person or by registered or certified mail, return receipt requested, to the Special Agent in Charge in his or her area, at least ____ days in advance of the date of the proposed transfer (unless the Special Agent in Charge waives this time limitation in individual instances), the following information (see flip side for details):
14-days advanced notice 1. The name, address, registration number, and authorized business activity of the registrant discontinuing the business (registrant-transferor); AND of the person acquiring the business (registrant-transferee); 2. Whether the business activities will be continued at the location registered by the person discontinuing business, or moved to another location (if the latter, the address of the new location should be listed); and 3. The date on which the transfer of controlled substances will occur.
DEA Forms 222 must be maintained separately from all other records of the registrant. 21 CFR 1305.17(c). DEA Forms 222 are required to be kept available for inspection for a period of ____ years. 21 CFR 1305.17(c).
2 years
If a prescription is created, signed, transmitted, and received electronically, all records related to that prescription must be retained electronically. 21 CFR 1311.305(a). Electronic records must be maintained electronically for ____years from the date of their creation or receipt. However, this record retention requirement shall not preempt 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. 21 CFR 1311.305(b).
2-years; So if UT requires a longer retention period (5 years), best abide by the more stringent law (UT)
Examples of schedule V drugs include cough preparations containing not more than ____ milligrams of codeine per ____ milliliters or per ____ grams (Robitussin AC and Phenergan with Codeine).
200mg codeine per 100mL or per 100g
A pharmacy registration must be renewed every ____ years utilizing a DEA Form 224a. The most expeditious method to renew a DEA registration is online, but it may be completed by paper application no earlier than ____ days prior to the current expiration date
3 years; 60 days Pharmacies will receive a renewal notification at the mailing address associated with the current registration approximately 60 days prior to the expiration date in accordance with 21 CFR 1301.13(e)(3). DEA will subsequently send an electronic reminder to the email address associated with DEA registration approximately 20 days prior to the expiration date if the renewal has not been received or completed.
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. 21 CFR 1305.05(a). Pursuant to 21 CFR 1305.05(d), the power of attorney must be signed by: 1. The registrant, if an individual; a partner of the registrant, if a partnership; or an officer of the registrant, if a corporation, corporate division, association, trust or other entity; 2. The person to whom the power of attorney is being granted; and 3. ____ witnesses.
3. Two witnesses fun fact: A power of attorney executed under this section may be signed electronically, by any or all of the persons required to sign. 21 CFR 1305.05(f).
Schedules III and IV controlled substances may be refilled if authorized on the prescription. However, the prescription may only be refilled up to ____ times within six months after the date of issue.
5 times; After five refills or after six months, whichever occurs first, a new prescription is required.
Completing DEA Forms 222: The purchaser must retain a copy of each executed DEA Form 222 and all copies of unaccepted or defective forms with each statement attached. 21 CFR 1305.17(a). The supplier must retain the original DEA Form 222 for the supplier's files in accordance with 21 CFR 1305.17(c).
Completing DEA Forms 222: Any supplier who is not required to report acquisition/disposition transactions to the Automation of Reports and Consolidated Orders System (ARCOS) under 1304.33(c) (such as a practitioner) must make and submit a copy of the original DEA Form 222 to DEA, either by mail to the Registration Section, or by email to [email protected]. The copy must be forwarded at the close of the month during which the order is filled. If an order is filled by partial shipments, the copy must be forwarded at the close of the month during which the final shipment is made or the 60-day validity period expires.
Completing DEA Forms 222: A purchaser must prepare and execute a DEA Form 222 by use of a typewriter, computer printer, pen, or indelible pencil. 21 CFR 1305.12(a). Only one item may be entered on each numbered line. An item must consist of one or more commercial or bulk containers of the same finished or bulk form and quantity of the same substance. The number of lines completed must be noted on that form at the bottom of the form, in the space provided 21 CFR 1305.12(b). The purchaser should record the name and address from whom the controlled substances are being ordered must be entered on the form 21 CFR 1305.12(c). If the purchaser does not have this information then the supplier should ensure it is on the form.
Completing DEA Forms 222: The purchaser must make a copy of the original DEA Form 222 for its records and then submit the original to the supplier. 21 CFR 1305.13(a). The purchaser does not have the option of retaining the original. The copy retained by the purchaser may be in paper or electronic form. 21 CFR 1305.13(a). 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.) 21 CFR 1305.12(d). When the items are received, the purchaser must document on the purchaser's copy the actual number of commercial or bulk containers received and the date received.
Any registrant permitted to order schedule II controlled substances may do so electronically via the DEA's CSOS (which stands for what?) and maintain the records of these orders electronically for ____- years.
Controlled Substance Ordering System; 2-years Fun Facts: The use of electronic orders is optional; registrants may continue to issue orders on a paper DEA Form 222. CSOS allows for secure electronic transmission of controlled substance orders without the supporting paper DEA Form 222. CSOS is the only electronic means of ordering schedule II controlled substances between controlled substance manufacturers, distributors, pharmacies, and other DEA authorized entities.
Triplicate Form 222 Colors: Copy 1 (____) Supplier. Copy 2 (___) DEA (submitted by supplier to DEA Field Division) Copy 3 (___) Purchaser or registration holder.
Copy 1: Brown Copy 2: Green Copy 3: Blue
Unaccepted and Defective Triplicate DEA Forms 222 21 CFR 1305.20(e) requires that, for orders using the triplicate DEA Form 222, an order must not be filled if the order is not complete, legible, or properly prepared, executed, or endorsed, or if the order shows any alteration, erasure, or change of any description. If an order cannot be filled, the supplier must return copies 1 [Color:_____& whose copy] AND 2 [Color:____& whose copy] of the triplicate DEA Form 222 to the purchaser with a statement explaining the reason the order could not be filled (e.g., illegible or altered). 21 CFR 1305.20(e)(2). A supplier may refuse to accept an order for any reason. 21 CFR 1305.20(e)(3). True or False: If a supplier refuses to accept an order, a statement that the order is not accepted is sufficient.
Copy 1=Brown; Supplier copy Copy 2=Green; the copy the supplier sends to DEA Copy 3=Blue; purchasers copy True
Completing Triplicate DEA Forms 222 Each triplicate DEA Form 222 must be signed and dated by a person authorized to sign a registration application or a person granted power of attorney. 21 CFR 1305.20(b)(4). When the items are received, the purchaser must document on the purchaser's copy (copy three; color:_____) the actual number of commercial or bulk containers received and the date received. 21 CFR 1305.20(c)(5).
Copy 3 is retained by the purchaser Copy 3 is Blue in color
On the day the controlled substances are transferred, a complete inventory must be taken in accordance with 21 CFR 1304.11 which documents the drug name, dosage form, drug strength, quantity, and date transferred. 21 CFR 1301.52(e)(1). In addition, DEA Form ___ or the electronic equivalent must be prepared to document the transfer of schedule II controlled substances.
DEA Form 222 This inventory serves as the final inventory for the registrant going out of business and transferring the controlled substances. It also serves as the initial inventory for the registrant acquiring the controlled substances. A copy of the inventory must be included in the records of each pharmacy. It is not necessary to send a copy of the inventory to DEA unless requested by the Special Agent in Charge. 21 CFR 1301.52(e)(1). The pharmacy acquiring the controlled substances must maintain all records involved in the transfer of the controlled substances for two years. 21 U.S.C. 827(b) and 21 CFR 1304.04(a).
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 ___) to the local DEA Registration Program Specialist (Appendix K). 21 CFR 1301.52(c). In addition, DEA may ask for the location where inventories, prescriptions, and other required controlled substance records will be stored during the requisite ___ -year retention period.
DEA Form 222; 2-year record retention period
The following are factors that can be considered by the DEA for what purpose? 1. The recommendation of the appropriate state licensing board or professional disciplinary authority. 2. The applicant's experience in dispensing 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.
Denial of registration in the public interest
Lost or Stolen DEA Forms 222 A pharmacy, upon discovery of the loss or theft of used or unused order forms, must immediately report the loss or theft to the local DEA Diversion Field Office (Appendix K) and provide the serial numbers of each lost or stolen order form. 21 CFR 1305.16(b). If any DEA Forms 222 are lost or stolen, and the purchaser is unable to provide the order form numbers of DEA Forms 222, the purchaser must report, in lieu of numbers of the forms, the date or approximate date of issuance. 21 CFR 1305.16(d). If an unused order form reported stolen or lost is later recovered or found, the pharmacy must immediately notify the local DEA ____ Field Office (Appendix K). 21 CFR
Diversion
Cancellation and Voiding DEA Forms 222 A purchaser may cancel part or all of an order on a DEA Form 222 by notifying the supplier in writing of the cancellation. 21 CFR 1305.19(a). The supplier must indicate the cancellation on the original DEA Form 222 sent by the purchaser by drawing a _____ through the canceled items and printing "____" in the space provided for the number of items shipped. 21 CFR 1305.19(a).
Drawing a line through the canceled items "cancelled"
If Federal Government practitioners wish to maintain a DEA registration for a private practice, which would include prescribing for private patients, these practitioners must obtain a registration for such private activities. 21 CFR 1301.23(c) and 21 U.S.C.
Fact
Unaccepted and Defective Triplicate DEA Forms 222 When a purchaser receives an unaccepted order, Copies 1 and 2 of the triplicate DEA Form 222 and the statement must be attached to Copy 3 and retained in the files of the purchaser. 21 CFR 1305.20(e)(4). A defective triplicate DEA Form 222 may not be corrected; it must be replaced by a new triplicate DEA Form 222 for the order to be filled. 21 CFR 1305.20(e)(4). The purchaser must retain Copy 3 of each executed triplicate DEA Form 222 and all copies of unaccepted or defective forms with each statement attached. 21 CFR
Facts
Cancellation and Voiding a Triplicate DEA Form 222 True or False: A supplier may void part or all of an order on a triplicate DEA Form 222 by notifying the purchaser in writing. 21 CFR 1305.20(i)(1). The supplier must indicate the voiding on Copies 1 and 2 of the triplicate DEA Form 222 by drawing a line through the canceled item(s) and printing "void" in the space provided for the number of items shipped.
False: The supplier must indicate the voiding on Copies 1 and 2 of the triplicate DEA Form 222 by drawing a line through the canceled item(s) and printing "canceled" in the space provided for the number of items shipped.
Return of Unused DEA Forms 222 True or False: If the registration of any purchaser terminates (because the purchaser dies, ceases legal existence, discontinues business or professional practice, or changes the name or address as shown on the purchaser's registration) or is suspended or revoked under 21 CFR 1301.36 for all schedule I and II controlled substances for which the purchaser is registered, the purchaser must destroy all unused DEA Forms 222.
False: the purchaser must return all unused DEA Forms 222 to the Registration Section. 21 CFR 1305.18.
True or False: Electronic copies of DEA Forms 222 need to be stored on a different server or electronic system from a registrant's other records. True or False: The requirement to store DEA Forms 222 separately from all other records may be met, for electronic copies, by storing them in such a way that they can be readily retrieved separately from all other (electronic) records.
False; True
When a controlled substance has been moved by DEA from schedule I or schedule II to another schedule at the federal level, in many states it may remain a schedule I or schedule II controlled substance pending any legislative or administrative action that may result from the federal action. True or False: States may not require transactions that involve substances they classify as schedule I or schedule II to be made via DEA Form 222 or the electronic equivalent.
False; If states still recognize schedule I or II drugs that have been rescheduled federally into lower schedules, they may require DEA Form 222 for transactions
Corporations that own or operate a chain of pharmacies may submit a single DEA Form ____, Retail Pharmacy Registration Affidavit for Chain Renewal. This affidavit, along with a list of the corporation's registrations, is provided in lieu of a separate registration application for each pharmacy registration.
Form 224b DEA requests corporations with 50 or more retail pharmacy registrations to enroll the chain renewal program.
Ordering Schedules III-V Controlled Substances Pursuant to 21 CFR 1304.22(c), 1304.22(a)(2), such receipts must also contain the following information: 5/5. The number of units of finished forms and/or commercial containers distributed or disposed of in any other manner by the registrant (e.g., by distribution of complimentary samples or by destruction), including the date and manner of distribution or disposal, the name, address, and registration number of the person to whom distributed, and the quantity in finished form distributed or disposed.
Fun Fact; In addition, these receipts must be maintained either separately from all other records of the registrant or in such form that the information required is readily retrievable from the ordinary business records of the registrant.
Only schedule I and II controlled substances are ordered with an official paper order form, DEA Form 222, or the electronic equivalent (See below, Controlled Substance Ordering System (CSOS) - Electronic Order Forms.) A DEA Form 222 is required for each distribution or transfer of a schedule I or schedule II controlled substance unless exempted. 21 CFR 1305.03, 1307.11(a)(1)(iii), 1301.52(e)(1).
Fun Facts
The power of attorney may be revoked at any time by the person who signed the most recent application for DEA registration or reregistration AND two witnesses. 21 CFR 1305.05(e). 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. 21 CFR 1305.05(e). The power of attorney should be filed with executed DEA Forms 222 if applicable, and must be available for inspection. 21 CFR 1305.05(a). The power of attorney is not submitted to DEA.
Fun Facts
Return of Unused Triplicate DEA Forms 222 If the registration of any purchaser terminates (because the purchaser dies, ceases legal existence, discontinues business or professional practice, or changes the name or address as shown on the purchaser's registration) or is suspended or revoked under 21 CFR 1301.36 of this chapter for all schedule I and II controlled substances for which the purchaser is registered, the purchaser must return all unused triplicate DEA Forms 222 to the Registration Section. 21 CFR 1305.20(h).
More truth
A CSOS digital certificate is valid until the DEA registration under which it is issued expires or until the CSOS CA is notified that the certificate should be revoked. 21 CFR 1311.30(e), 1311.40(a). 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.
More truth bombs
Registrants may continue to use existing stocks of the triplicate DEA Form 222 until [This Date]. In any case, as soon as a registrant's supply of triplicate DEA Forms 222 is exhausted, the registrant must use the new single-sheet DEA Form 222. 21 CFR 1305.20.
October 31st 2021
Completing Triplicate DEA Forms 222 A purchaser must prepare and execute a triplicate DEA Form 222 simultaneously by means of interleaved carbon sheets that are part of the triplicate DEA Form 222. Triplicate DEA Forms 222 must be prepared by use of a typewriter, pen, or indelible pencil. 21 CFR 1305.20(b)(1). Only ____ item may be entered on each numbered line. An item must consist of one or more commercial or bulk containers of the same finished or bulk form and quantity of the same substance. True or False: The number of lines completed must be noted on that form at the bottom of the form, in the space provided.
One item may be entered on each numbered line. True
Pursuant to 21 CFR 1304.04(h), controlled substance prescriptions must be filed in one of the following ways: Paper Prescriptions Records Option 1: 1. A file for schedule II controlled substances dispensed. 2. A file for schedules III, IV and V controlled substances dispensed. What is the other option?
Paper Prescriptions Records Option 2: 1. A file for all schedule II controlled substances dispensed. 2. A file for all other drugs dispensed (non-controlled and those in schedules III, IV and V). If this method is used, a prescription for a schedule III, IV or V drug must be made readily retrievable by use of a red "C" stamp not less than one inch high.
Exemption of Federal Government Practitioners from Registration The service identification number for a Public Health Service employee is his or her ____ ____ ____ number.
Social Security identification number
The Unique Identification Number (UIN) or "X" number authorizes a DEA registered, Qualified Practitioner (e.g., a physician) under the Drug Addiction Treatment Act of 2000 or Qualifying Other Practitioner (i.e., nurse practitioner, physician's assistant, clinical nurse specialists, certified registered nurse anesthetists, or certified nurse midwives) under the Comprehensive Addiction and Recovery Act of 2016 and the SUPPORT for Patients and Communities Act of 2018, to prescribe schedule III-V narcotic controlled substances approved by the Food and Drug Administration specifically for maintenance and detoxification treatment.
The Qualifying Practitioner or the Qualifying Other Practitioner will be issued only one UIN. The UIN can be used with multiple DEA registration numbers in any state as long as the DEA registration number with which it is associated remains valid. Pursuant to DEA policy, the UIN number consists of two letters and seven numbers; the first letter is always an X, and is commonly referred to as the "X" number. For example, AB1234567 would have a UIN of XB1234567.
True or False: DEA Registration is not required for regulated sellers of scheduled listed chemical products (SLCPs). 21 U.S.C. 823(h) and 802(39)(A)(iv-v). However, a regulated seller must selfcertify with DEA pursuant to federal law (See Section XIII, Combat Methamphetamine Epidemic Act of 2005.) 21 U.S.C. 830(e)(1)(B)(i), 21 CFR 1314.40(a). A regulated seller is a retail distributor (including a pharmacy or a mobile retail vendor) of SLCPs, except that the term does not include an employee or agent of the distributor.
True
True or False: DEA no longer issues triplicate forms.
True
True or False: Digital certificates can be obtained only by the person who signed the most recent DEA registration application or renewal application, a person authorized to sign a registration application, or a person granted power of attorney by a DEA registrant to sign orders for one or more schedules of controlled substances.
True
True or False: Electronic copies of DEA Forms 222 may be stored on a system at a location different from the registered location, provided such copies are readily retrievable at the registered location.
True
True or False: If a pharmacy has an electronic record keeping 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, the requirement to mark the hard copy with a red "C" is waived. 21 CFR 1304.04(h)(4).
True
True or False: The prescribing individual practitioner must personally communicate the emergency oral prescription to the pharmacist; An agent may not call in an oral prescription for a schedule II controlled substance on behalf of a practitioner even in an emergency circumstance.
True
True or False: The refilling of a prescription for a controlled substance listed in schedule II is prohibited.
True
True or False: If a pharmacy desires to engage in the 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. 21 CFR 1309.21(a)(2). To obtain a DEA chemical distributor registration, a pharmacy may complete the DEA Form ___
True DEA Form 510
Lost or Stolen Triplicate DEA Forms 222 If a purchaser ascertains that an unfilled triplicate DEA Form 222 has been lost, the purchaser must execute another in triplicate and attach a statement containing the serial number and date of the lost form, and stating that the goods covered by the first triplicate DEA Form 222 were not received through loss of that triplicate DEA Form 222. 21 CFR 1305.20(f)(1). True or false: Copy 3 of the second form and a copy of the statement must be retained with Copy 3 of the triplicate DEA Form 222 first executed. 21 CFR 1305.20(f)(1). A copy of the statement must be attached to Copies 1 and 2 of the second triplicate DEA Form 222 sent to the supplier.
True;
True or False: If a purchaser has several registered locations, the purchaser must retain a copy of the executed DEA Form 222 and any attached statements or other related documents at the registered location printed on the DEA Form 222. 21 CFR 1305.17(c).
True; (not including unexecuted DEA Forms 222, which may be kept elsewhere under 21 CFR 1305.12(e)),
True or False: The requirement of registration is waived for any official of the U.S. Army, Navy, Marine Corps, Air Force, Coast Guard, Public Health Service, or Bureau of Prisons, who is authorized to administer, dispense, or prescribe, but not to procure or purchase controlled substances in the course of his or her official duties.
True; Such officials must follow procedures set forth in 21 CFR Part 1306 regarding prescriptions, but must also state the branch of service or agency (e.g., "U.S. Army" or "Public Health Service") and the service identification number of the issuing official in lieu of the registration number required on prescription forms.
A prescriber may transmit a schedule II prescription to the pharmacy by facsimile. True or False: The original schedule II prescription must be presented to the pharmacist and verified against the facsimile prior to the actual dispensing of the controlled substance.
True; The pharmacist must make sure the original document is properly annotated and filed with the records that are required to be kept. 21 CFR 1306.11(a), 1304.04(h).
Records of electronic prescriptions for controlled substances shall be maintained in an application that meets the requirements of 21 CFR Part 1311 and 21 CFR 1304.04(h)(5). The computers on which the records are maintained may be located at another location, but the records must be readily retrievable at the registered location if requested by a DEA or other law enforcement agent. The electronic application must be capable of printing out or transferring the records in a format that is readily understandable to a DEA or other law enforcement agent at the registered location. Electronic copies of prescription records must be sortable by prescriber name, patient name, drug dispensed, and date filled. 21 CFR 1304.04(h)(5).
Truth
True or False: 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 may 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. 21 CFR 1301.17(b).
Truth
Every pharmacy that dispenses a controlled substance must be registered with DEA. A state license must be obtained. Federal agencies are exempt from the state license requirement. To register as a new pharmacy, the DEA Form ____ must be completed. The cost of the application fee is indicated on the application form. The Certificate of Registration (DEA Form ___) must be maintained at the registered location and kept available for official inspection. True or False: If a person owns and operates more than one pharmacy, each place of business must be separately registered with DEA.
Use Form 224 to register with DEA; DEA Form 223=Certificate of Registration True
On September 30, 2019, DEA issued a final rule entitled New Single-Sheet Format for U.S. Official Order Form for Schedule I and II Controlled Substances (DEA Form 222), which implements a new single-sheet format for DEA Form 222, used by DEA registrants to order schedule I and II controlled substances. 84 FR 51368. The rule became effective on October 30, 2019, and provides for a two-year transition period, during which the existing triplicate version of the forms may continue to be used. DEA registrants will be allowed to exhaust their supply of the current forms as part of the transition to using the new single-sheet form. When a registrant's supply of triplicate forms is depleted, DEA will issue new single-sheet forms to the registrant. This rule includes a "sunset date" of October 30, 2021—the date after which use of the triplicate forms will not be allowed.
Whoa!
Whenever any used or unused triplicate DEA Forms 222 are stolen or lost (other than in the course of transmission) by any purchaser or supplier, the purchaser or supplier must immediately upon discovery of the theft or loss, report the theft or loss to the Special Agent in Charge of the Drug Enforcement Administration in the local DEA Diversion Field Office. 21 CFR 1305.20(f)(2).
Words to live by
Knowing how a DEA registration number is constructed can be a useful tool for recognizing a forged prescription. Prior to October 1, 1985, DEA policy provided that DEA registration numbers for physicians, dentists, veterinarians, and other practitioners started with the letter A. i. New registration numbers issued to practitioners after that date begin with the letter ____ or ____. ii. Registration numbers issued to mid-level practitioners begin with the letter ____ iii. The first letter of the registration number is almost always followed by the first letter of the registrant's _____ _____ and then a computer generated sequence of ____ numbers
i. B or F ii. M iii. last name; seven; i.e. MJ3614511
Ordering Schedules III-V Controlled Substances 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. 21 CFR 1304.21(a) and (d). Pursuant to 21 CFR 1304.22(c), 1304.22(a)(2), such receipts must also contain the following information: 1/5. The ____ of the substance;
name
Ordering Schedules III-V Controlled Substances Pursuant to 21 CFR 1304.22(c), 1304.22(a)(2), such receipts must also contain the following information: 3/5. The number of units of finished forms and/or commercial containers acquired from other persons, including the date of and number of units and/or commercial containers in each acquisition to inventory and the ____, ____, & ____ number of the person from whom the units were acquired;
name, address, & registration number
Lost Electronic Orders 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. This statement must include the unique tracking ____ and ____ of the lost order and state that the goods covered by the first order were not received through loss of that order.
tracking number and date; 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.
