Controlled Substances Part 2: Ordering and Disposal Flashcards
Below are the DEA forms related to managing controlled substances:
- # 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
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:
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.
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:
prescribe controlled substances or authorize a pharmacy to order and dispense controlled substances.
Healthcare providers practicing at the following facilities can prescribe, administer, or dispense controlled substances without registering with the DEA:
- 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.
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:
- 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
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…
limited to obtaining schedule I and II drugs
DEA Form 222:
- 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
CSOS:
- 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
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…
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.
The following provisions apply to the use of POA:
- 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)
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…
accompany the drug during distribution, purchase, or transfer.
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:
- 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
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…
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.
The following items are preprinted on Form 222:
- 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)
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…
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.