Controlled Substances Part 2: Ordering and Disposal

Question 1

Below are the DEA forms related to managing controlled substances:

Answer 1

• # 224: Registration form for retail pharmacies, hospitals/clinics, teaching institutions, practitioners or mid-level practitioners
• # 225: Registration form for drug manufacturers, distributors (eg, supplier/wholesaler), and researchers
• # 363: Registration form for narcotic (opioid) treatment centers
• # 510: Registration form for bulk chemical manufacturers and distributors
• # 222: Ordering form for schedule I and II drugs
• # 106: Reporting form for theft or significant loss of controlled substances
• # 41: Record of controlled substances destroyed

Question 2

Individuals must register with the DEA for authorization to prescribe controlled substances. An exception is medical residents in a healthcare facility, who can prescribe controlled substances for patients whin the institution by using the facility’s DEA number. Facilities participating in the:

Answer 2

manufacture, distribution, research, prescribing, and dispensing of controlled substances must also register with the DEA. The registration form used depends on the manner in which the applicant will manage controlled substances.

Question 3

The registration form used depends on the manner in which the applicant will manage controlled substances. After approval of the registration, the DEA will assign the individual or facility a unique DEA number. The DEA number will allow a physician to:

Answer 3

prescribe controlled substances or authorize a pharmacy to order and dispense controlled substances.

Question 4

Healthcare providers practicing at the following facilities can prescribe, administer, or dispense controlled substances without registering with the DEA:

Answer 4

• Federal Bureau of Prisons
• Indian Health Service
• U.S. Armed Forces (Air Force, Army, Coast Guard, Navy, Marine Corps, Space Force)
• U.S. Public Health Service

Providers that purchase or procure controlled substances (eg, pharmacists) at these facilities are not eligible for this exemption and must register with the DEA.

Question 5

Schedule III-V drugs can be obtained from a supplier/wholesaler by using a purchase order or through the Controlled Substance Ordering System (CSOS). The invoice or a packing slip (eg, receipt) is used to record the delivery date and to confirm that the correct items are received. The receipts must be readily available in the pharmacy and should contain the following information:

Answer 5

• Name of each controlled substance in the order
• Drug formulation (eg, oral solution)
• Number of dosage units in each container
• Number of packages ordered and delivered

Question 6

Before ordering schedule I and II drugs, the pharmacist-in-charge (ie. registrant) must first register with the DEA using Form 224. CSOS can be used to order schedule I-V drugs, while DEA Form 222 is…

Answer 6

limited to obtaining schedule I and II drugs

Question 7

DEA Form 222:

Answer 7

• Method of submission: Paper
• Limit of items per order: 10 items (triplicate form); 20 items (single-sheet form)
• Drugs that can be ordered: Schedule I, II
• Typical turnaround time: 2-5 business days
• Type of signature used: Handwritten
• Can the order be endorsed to another supplier: Yes
• When must the supplier report the transaction to the DEA? By the end of the month during which the order was filled

Question 8

CSOS:

Answer 8

• Method of submission: Electronic
• Limit of items per order: No limit
• Drugs that can be ordered: Schedules I-V
• Typical turnaround time: 1-2 business days
• Type of signature used: Digital signature
• Can the order be endorsed to another supplier: No
• When must the supplier report the transaction to the DEA? Within 2 business days of filling the order

Question 9

The DEA registrant can request copies of Form 222 or CSOS access on the initial DEA Form 224 or through the DEA website. Each pharmacy location has one designated registrant. This is the only pharmacist authorized to order schedule I or II drugs, unless…

Answer 9

the registrant grants a power of attorney (POA) to another individual, allowing them to place orders for schedule I and II drugs in his/her absence. A POA is a legal document that authorizes a designated individual to act in the registrant’s place.

Question 10

The following provisions apply to the use of POA:

Answer 10

• It can be granted to licensed or unlicensed pharmacy personnel
• The registrant can grant multiple POAs
• The registrant may terminate a POA at any time by executing a notice of revocation
• A new POA is only needed if a different person signs the renewal application
• The POA should be filed at the pharmacy with the executed DEA Form 222 and must be readily retrievable (it is not submitted to the DEA)

Question 11

Each time a schedule I or II drug changes location, DEA form 222 or the electronic alternative documents the movement. A copy of Form 222 will…

Answer 11

accompany the drug during distribution, purchase, or transfer.

Question 12

If CSOS is used, the electronic system will trace the drug’s movement. A record is needed when a schedule II drug moves from a wholesaler/supplier to a pharmacy, from a pharmacy to another pharmacy, or to a reverse distributor for destruction. This documentation is required for every drug movement, except in 2 situations:

Answer 12

• When a drug is dispensed or administered to a patient
• When a central fill pharmacy associated with a retail chain is filling schedule II drugs for one of the chain’s retail stores

Question 13

DEA Form 222 is available as both a single-sheet form and a triplicate form with 3 carbon copies (Copy 1, Copy 2, and Copy 3). The single-sheet Form 222 was released in 2019 to replace the triplicate form. The DEA is allowing a…

Answer 13

2-year transition period to the single-sheet form. The triplicate forms will not be accepted after October 31, 2021, requiring all registrants to use the single-sheet form or CSOS from that point forward.

Question 14

The following items are preprinted on Form 222:

Answer 14

• A serial number, in a consecutive number series
• The pharmacy name and address
• The pharmacy DEA number
• The drug schedules that the pharmacy is permitted to order (ie. schedules II, III, IV, and V)

Question 15

Each copy of the triplicate form must be retained by the appropriate patients. The table below describes who retains each copy for typical transactions. When using the single-sheet form, each entity involved in the transfer of schedule II drugs must…

Answer 15

retain a copy of Form 222 (eg, by making a photocopy of the form). Whoever is ordering/receiving the drugs keeps copy 3 (blue), then sends copies 1 and 2 (brown and green) to the supplier (copies must stay attached). The supplier will send copy 2 (green) to the DEA by the end of the month in which the order is filled.

Question 16

Single-Sheet Form 222 Differences:

Answer 16

• There are 20 lines on each form; a max of 20 items can be ordered
• The purchaser should make a copy of the form (readily-retrievable electronic copies are allowed) and keep it for 3 years; send the form to the supplier
• The supplier should keep the original for 2 years

Question 17

The Controlled Substance Ordering System (CSOS) is the electronic equivalent to Form 222 and allows for the electronic ordering of schedule I and II drugs. Each person authorized to place orders for schedule I and II drugs must…

Answer 17

obtain a personal digital certificate to sign orders (eg, the registrant and any individuals granted POA). Digital certificates cannot be shared.

Question 18

When using CSOS, the purchaser creates an electronic order using DEA-approved software. When the order is complete, the purchaser signs it with their unique digital certificate and electronically transmits it to the supplier. The supplier receives the order, verifies the certificate, and fills the order. The supplier must…

Answer 18

report the transaction to the DEA within 2 business days from the date the order was filled.

Question 19

Advantages of CSOS:

Answer 19

• Reduced ordering errors
• Decreased paperwork
• Reduced administrative costs
• Faster drug delivery (potential for next day delivery)
• Easy to use, allowing for more frequent ordering

Question 20

If a completed Form 222 is lost or stolen, the purchaser must resubmit the order with a new Form 222 and submit it to the supplier. The pharmacy must provide a statement to the distributor with the new Form 222 containing the following information:

Answer 20

• The serial # of the original form
• The date of the initial order
• A statement that the controlled substances were not received

• A pharmacy must keep a copy of this statement with a copy of the initial order and the second order.

Question 21

If unused forms are discovered to be lost or stolen, the pharmacy must immediately:

Answer 21

notify the local DEA Diversion Field Office. The serial # for each lost or stolen form must be provided unless an entire book or multiple books of forms are missing, and the serial numbers are unknown. If the serial numbers are unknown, then the pharmacy must provide the approximate date that the DEA issued the forms.

Question 22

If an electronic order is lost, the purchaser must provide a signed statement to the supplier stating that the fulfilled order was not received. The statement must contain the unique tracking number and the date of the lost order. If a replacement order is created, the purchaser must…

Answer 22

electronically link the new order with the record of the lost order and the signed statement

Question 23

A pharmacy can transfer controlled substances to another pharmacy, the original supplier or the manufacturer. A DEA from 222 or CSOS must be used to transfer schedule I and II drugs. An invoice or CSOS is used to transfer schedule III-V drugs and must contain the following information:

Answer 23

• Drug name, dosage form, strength, and quantity
• Date of controlled substance transfer
• Recipient’s name, address and DEA number

All records of these transfers (inventory, Form 222, invoice) must be kept for at least 3 years.

Question 24

If a pharmacy goes out of business or is acquired by new ownership, the pharmacy can transfer controlled substances to the new pharmacy, once the DEA number is confirmed. A complete inventory is taken and used as…

Answer 24

the transferring registant’s final inventory and as the initial inventory for the acquiring resistrant. The inventory is not sent to the DEA. Each pharmacy must maintain a copy of the inventory records for at least 3 years. Inventories are taken at either the opening or closing of the business days, and the time taken (opening or closing) must be records on the inventory.

Question 25

A pharmacy can sell controlled substances to other pharmacies or prescribers without registering as a distributor, provided both parties are registered with the DEA to dispense controlled substances. The total quantity sold cannot exceed 5% of the total quantity dispensed each year by the selling pharmacy. If a pharmacy is selling schedule II drugs, a Form 222 must be used. The pharmacy selling the schedule II drugs is responsible for...

Answer 25

forwarding Copy 2 of the Form 222 to the DEA by the end of the month.

Question 26

A healthcare practitioner cannot write a Rx to obtain controlled substances for the purpose of stocking them for "office use" or to dispense directly to patients. The practitioner would need to...

Answer 26

purchase the controlled substances from a pharmacy or wholesaler.

Question 27

A purchaser can cancel all or part of a controlled substance order by notifying the supplier in writing. The supplier must...

Answer 27

indicate the cancellation on Form 222 (Copies 1 and 2 of the triplicate form) by drawing a line through the canceled item/s and writing "canceled" in the space for the number of items shipped.

Question 28

A supplier can void part or all of an order by notifying the purchaser in writing. The supplier must draw a line through the canceled items on Form 222 (Copies 1 and 2 on the triplicate form) and print "void" in the space for the number of items shipped. Alternatively, if the supplier cannot fulfill an order, they can endorse (i.e. transfer) the order to another supplier that can fulfill it. This only applies if...

Answer 28

the order was placed using a paper Form 222. If Form 222 is illegible, incomplete or altered, the supplier returns Copies 1 and 2 to the purchaser with the rationale for not filling the order. The purchaser must keep the original Form 222 (all 3 copies of the triplicate form).

Question 29

An electronic order is invalid if any required data field is empty, if it is not signed with a DEA sactioned digital certificate, if the digital certificate is expired or if the purchaser's digital signature is not validated. The supplier can..

Answer 29

refuse to fill an order for any reason and must provide the purchaser with a statement of the occurrence. The purchaser must electronically link this statement to the original order. Invalid electronic orders cannot be corrected; the purchaser must submit a new order. The supplier is not required to keep a record of unfilled orders, but the purchaser must keep an electronic copy of the voided order. If a supplier partially voids an order, the supplier must indicate nothing was shipped for each voided item in the linked record.

Question 30

A pharmacy must report a significant loss or theft of controlled substances to the local DEA office, in writing, within 1 business day of discovery. After initially notifying the DEA, the pharmacy must...

Answer 30

conduct an investigation and submit Form 106 to the DEA with the findings. If the investigation determines that theft or loss did not occur, then Form 106 does not need to be submitted. Instead, the registrant must notify the DEA in writing that there was no theft or loss.

Question 31

Considerations to determine if loss or theft is significant:

Answer 31

* The specific substances lost or stolen and their likelihood for diversion * The quantity lost in relation to the type of business * The individuals with access to the lost or stolen drug * History or pattern of losses or local diversion issues * Unique circumstances surrounding the loss or theft

Question 32

Pharmacists must also report all controlled substance drug losses to the California Board of Pharmacy within 14 calendar days for losses due to licensed employee theft or 30 calendar days for...

Answer 32

any other type of loss. A copy of the DEA Form 106 can be sent to the board of pharmacy.

Question 33

The loss or theft of controlled substances in-transit (i.e. deliveries) must be reported to the DEA verbally immediately and in writing within 3 days. The supplier is responsible for...

Answer 33

reporting this loss to the DEA. The pharmacy is only responsibe for making the report if the registrant has already signed for the delivery and subsequently notices that some or all of the controlled substances are missing. The report must include the date of the shipment and the name of the carrier or the delivery personnel.

Question 34

A registrant (eg, pharmacy or dispensing prescriber) should not send drugs to the DEA for disposal unless they have received prior approval from the local DEA field office. Otherwise, controlled substances should be disposed of using one of the methods discussed below:

Answer 34

* returning controlled substances to the supplier | * sending controlled substances to a reverse distributor

Question 35

Pharmacists can return controlled substances to the drugs supplier or manufacturer. The pharmacist must maintain a written record of the return showing:

Answer 35

* The date of the transaction * The name, strength, dosage form and quantity of the controlled substance * The supplier or manufacturer's name, address, and registration # A new Form 222 or its electronic equivalent must accompany the return of schedule II drugs. The supplier or manufacturer receiving the controlled substances must initiate the order. If the triplicate form is used, the supplier or manufacturer will keep Copy 3 and send Copies 1 and 2 to the pharmacy, which is acting as the "supplier." The pharmacy will forward Copy 2 to the DEA.

Question 36

A reverse distributor is a company that disposes of controlled substances. A pharmacy can send controlled substances to a reverse distributor for disposal, provided the reverse distributor is registered with the DEA. The reverse distributor must issue Form 222 or the electronic equivalent to a pharmacy that is transferring schedule II drugs for disposal. If the triplicate form is used, the reverse distributor will keep Copy 3 and send Copies 1 and 2 to the pharmacy, which is acting as the "supplier." The pharmacy will forward Copy 2 to the DEA. If the pharmacy is transferring schedule III-V drugs, then a record (eg, a receipt or invoice) must be maintained with the following information:

Answer 36

* drug name * dosage form * strength * quantity * date transferred

Question 37

DEA Form 41 is used to document the destruction of controlled substances. The reverse distributor will submit Form 41 to the DEA once...

Answer 37

the controlled substances have been destroyed