Federal Requirements for Controlled Substances!

Federal Requirements on the PTCB Exam

Federal requirements is one of the core knowledge domains for the 2022 PTCB exam. Here, we have put together a quick guide to legislation that governs pharmacies and medicines – registration, ordering, and documentation of controlled substances.

Legislation relates to laws – and its laws that govern standards.

Consistent standards are necessary to maximize safety and quality protocols. These standards are now in place because, at some point in the past, they were either not followed or adhered to. Often, it takes many mistakes – even tragedies – for laws to change – and it is this federal legislation for pharmacies and medicines that technicians are expected to have a rounded knowledge of. This is particularly true for controlled substances – all of which have abuse potential in some form.

For any pharmacy to operate, it must have a state license. Depending on what medicines the pharmacy dispenses, they may be required to obtain additional certification – such as those pharmacies that dispense controlled substances.

DEA Forms – Controlled Substances

There are many different forms to complete, depending on the task under review. Many of these forms are listed as DEA Forms – forms produced from the Drug Enforcement Administration; a federal agency formed and signed into existence in 1973 by President Richard Nixon. This agency is tasked with combating drug trafficking and distribution in the United States.

Pharmacies that dispense controlled substances must register with the DEA using Form 224; a form that can be found online or alternatively through the DEA itself. If approved as a controlled substance-dispensing pharmacy, the pharmacy must keep the certificate of authorization within the pharmacy, in a safe location and always available for review by an inspection authority. Authorized pharmacies carry this license for a period of 3-years, after which it can be renewed using DEA Form 224a (though pharmacies that wish to renew must do so at least 60-days before date of expiry).

Pharmacies that require a duplicate authorization certificate must instead fill out DEA Form 223. This may happen, for example, in cases where the pharmacy has already been approved as a controlled substance-dispensing pharmacy, but they wish to re-obtain the certificate of authorization that allows them to do so.

DEA Forms – Documenting Controlled Drugs

Pharmacies are required to adhere to strict regulations on documenting records and inventories of all controlled substances. These records can relate to:

• The purchase of controlled substances
• Medicines received to the pharmacy
• Medicines dispensed to patients
• Controlled substances that have been disposed of

Different forms are used depending on the type of controlled substance ordered. There are different regulations around each of these controlled substance schedules.

For example – DEA Form 222 must be used when ordering Schedule II controlled substances. This form is triplicate (first copy for the supplier, second copy for the DEA, and third copy held by the pharmacy) and must be completed either through handwritten means or through typing. The form must be completed with the DEA registrant at the pharmacy signing the copy – as well as including the pharmacy name and DEA number of the person receiving the order. However, an electronic means of ordering Schedule II drugs has since been introduced – the so-called CSOS, or Controlled Substance Ordering System. This system permits those registered with the DEA to electronically order Schedule II drugs without using Form 222. No more than 10 items may be purchased using Form 222, with the number of items purchased matching the total number specified at the bottom of the form. DEA form 222 is valid for 60-days.

When the controlled substance order arrives, the registered DEA purchaser must confirm the date of shipment arrival and confirm the total number of items received. For instance, this is important to establish that no items have gone missing or, worse, have landed into the wrong hands.

DEA Forms 222 should not be discarded, even if they have been partially completed or are difficult to read. Pharmacies are obliged to keep these incomplete or damaged forms within the pharmacy for a period of 2-years. Like Schedule II prescriptions, Schedule III, IV, and V prescriptions should also be kept for a period of 2-years within the pharmacy. Drugs within these three classes may be ordered online, through fax, or even over the phone. They are not as serious as Schedule II drugs though, that said, documentation must be kept. For example, invoices for Schedule III, IV, and V drugs must be signed, dated, and stamped (with a red C) and kept within the pharmacy for 2-years.

Maintaining Inventory

Federal requirements for maintaining controlled substance inventory includes the need to:

• Inventory records must be kept within the pharmacy for a period of 2-years.
• Federal legislation states that controlled drugs must be kept secure and locked away or, alternatively, dispersed between non-controlled drugs. This makes these drugs more difficult to find. Typically, pharmacies will keep Schedule II drugs locked up, and Schedule III through to V drugs dispersed throughout other non-controlled medicines.
• Any inventory review of Schedule II drugs must be done and filed separately from Schedule III-V drugs.
• Schedule II drugs must be manually counted. In contrast, Schedule III-to-V drugs can be estimated except if their total number of pills exceeds 1,000. In these exceptional cases, manual counting is required.
• Prescriptions for Schedule II drugs must be signed in ink (or have a digital signature) by the prescriber and handed in person to the pharmacy. The prescription must also contain a valid DEA number. In contrast, Schedule III-V drugs may be sent electronically.

Scheduled Drug Refills and Transfers

Schedule II prescriptions cannot be refilled.

Schedule III-V drugs are permitted to be refilled a maximum of 5-times within a 6-month period from the date of issuance. Partial dispensing is permitted, but the remaining quantity must be dispensed to the patient within a 72-hour window.  Prescriptions for Schedule III-V drugs may be transferred between pharmacies.

In these cases, the transferring pharmacy must write ‘void’ on the front of the prescription whilst including details of the receiving pharmacy on the back of the prescription. These details include the recipient’s DEA number, and name and address of the pharmacy, and name of the receiving pharmacist.

The receiving pharmacist should write ‘transfer’ on the front of the prescription and record details such as the number of refills (and refills remaining), original dispensing date of the prescription, and details of the pharmacy and pharmacist: name, address, DEA number of the receiving pharmacy. As with other forms, these transfers – both original and transferred – should be kept for a period of 2-years.

Controlled substances may be transferred between pharmacies using Form 222.

Controlled Substance Destruction

Damaged controlled substances must be destroyed and recorded using Form 41.

As part of DEA Form 41, various details will be requested – including:

• DEA number of the pharmacy
• the pharmacy name and address
• contact telephone number
• details of the controlled substance to be destroyed (quantity, strength, name, form, NDC number etc.), date/location and method of drug destruction, and the signature of two witnesses to the event.

If a controlled substance is stolen, DEA Form 106 must be completed in accordance with federal requirements. This must be done as soon as possible whilst contacting the nearest DEA authority and law enforcement officers. One of the copies of DEA Form 106 is retained by the pharmacy, with the duplicate sent to the DEA.

Final Thoughts

Federal Requirements forms an integral part of the 2022 PTCB test – comprising 12.5% of the entire exam.

Much of this study involves controlled substances, risk evaluation and mitigation strategies (REMS), specific pharmacy legislation, and the handling and disposal of hazardous and non-hazardous waste. Here, we have covered much of what you can expect on PTCB practice test questions for the controlled substances aspect of the exam.

If you are finding this section tough, it may be worth testing your knowledge and learning from detailed, explained answers. As part of our PTCB online course, we have put together the most comprehensive range of theory and questions to cover this and every other part of the exam. Take a few moments to learn more about our online pharmacy course.

Check back to our PTCB Test Prep blog soon for more content on federal requirements to help you master the 2022 exam and become a qualified, informed pharmacy technician in the United States.