Federal Requirements Study Guide for the PTCB Exam

Other Regulations for Controlled Substances

Controlled substances are regulated in additional areas outside of the “movement” realm. Manufacturers, practitioners, and pharmacies are under scrutiny to make sure ethical practices and standards are followed.

DEA

The DEA is the Drug Enforcement Agency. It enforces the controlled substance laws and regulations in the United States in an aim to minimize the potential for drug diversion or illegal practices.

According to the Comprehensive Drug Abuse Prevention and Control Act of 1970, (also commonly referred to the Controlled Substances Act of 1970) handlers of all controlled substances need to maintain accurate and up-to-date records and inventory. A complete and accurate inventory of all controlled substances helps maintain the pharmacy’s inventory and keeps the pharmacy aligned with federal regulations. It can also help prevent drug diversion and misuse of medications. The regulations for record keeping can be broken up into three categories: Schedule II, Schedule III-V, and non-controlled substances.

Pharmacies and practitioners must be registered with the DEA for prescribing and dispensing a controlled substance. Each is given a unique DEA number, which can be verified manually. It is the responsibility of the pharmacist to verify a practitioner’s DEA number as being active. In general, the DEA number consists of two letters followed by seven numbers. The first letter identifies the type of DEA registrant and the second letter is the first letter of the prescriber’s last name.

To verify the DEA number, follow these steps:

Add the first, third, and fifth numbers together.
Add the second, fourth, and sixth numbers together.
Multiply the sum in the second step by 2.
Add the total from steps 1 and 3 together.
Verify that the second digit of the sum in step 4 is the same as the last digit of the prescriber’s DEA number.

In addition, practitioners as well as pharmacists must check the Prescription Monitoring Program (PMP) periodically to keep track of a patient’s complete controlled substance history. This monitoring helps to cut down on polypharmacy, doctor shopping, and early fills.

FDA

The Food and Drug Administration (FDA) is responsible for regulating the safety and efficacy of medical devices, drugs, and biologics. The FDA must approve of each medication before it can be put on the market. It also regulates the manufacturing, labeling, dispensing, and post-market surveillance.

The FDA requires some medications to have a black box warning on a medication’s packaging. Black box warnings aim to alert healthcare providers and consumers of serious potential adverse effects or life-threatening risks. Opioid analgesics contain a black box warning alerting the product’s high risk of abuse, misuse, and addiction in addition to the potential for life-threatening respiratory depression.

The FDA has also put into effect the Opioid Analgesic Risk Evaluation and Mitigation (REMS) program that requires adequate training be available for healthcare professionals who manage pain.

Additionally, the FDA provides post-marketing surveillance of medications to monitor safety and efficacy concerns after a medication has come to market. In 2019, the FDA required a label change on opioid medications to guide providers on dose tapering prior to discontinuation due to reports of harm caused by abrupt discontinuation. Medwatch is the FDA’s safety and adverse event reporting program.

Regulation Categories

As briefly mentioned, each step in the life cycle of a controlled substance is highly regulated. Each step must be followed accordingly and in compliance with federal and local pharmacy laws. If protocol is not followed or records are not kept in compliance, pharmacies can be audited, fined, put under investigation, and even shut down.

Receiving

Schedule II

After receiving an order, the pharmacist on duty must verify each item and document the date each was received on copy three of the original order form that accompanies the order. Copy three of each order form must be maintained in the pharmacy for at least two years.

Schedule III-V

There are no special requirements for receiving Schedule III-V drugs. Follow the rules for non-controlled drugs.

Storing

Controlled substances must be stored properly, as these medications are highly regulated. Schedule IIs must be kept under lock and key and in their own designated vault or cabinet. This vault or cabinet must be equipped with a proper locking mechanism in addition to having multiple cameras positioned on it at all times. Schedule III-Vs can either be dispersed throughout a pharmacy’s non-control medication inventory or in their own area of the locked vault. Either way, cameras must be positioned on these medications as well. It is the preference of the pharmacist in charge and pharmacy owner on how they decide the Schedule III-V should be stored.

Ordering

Schedule II

Schedule II drugs must be ordered using a DEA 222 form. This form is specific to Schedule II drugs, must be completed in triplicate, and can be handwritten or typed. The three copies are retained by different stops in the supply chain to ensure consistency. The top copy is for the supplier of the Schedule II medications, the middle copy is sent to the DEA, and the bottom copy is sent back to the purchaser. Once filled out, the DEA 222 form is valid only for 60 days. A maximum of 10 different medications can be ordered on one form, and the form must be signed by the pharmacist who is registered with the DEA. The registrant pharmacist is typically the pharmacist in charge or the pharmacy manager.

Alternatively, a Controlled Substance Ordering System (CSOS) can be used in place of a DEA 222 form for ordering Schedule II drugs. The pharmacy must meet specific electronic requirements to ensure digital security when using the CSOS. CSOS has largely replaced the use of paper DEA 222 forms due to convenience and ease of use.

As of October 2019, the DEA has ruled in favor of a single copy DEA 222 form to replace the previous triplicate format. The previous triplicate format can be used in a transition period of up to two years following the ruling date. When the single form is being used, the purchaser must retain a copy and send the original to the supplier. If a pharmacy or practitioner is the supplier, they must also send a copy by mail or email to the DEA.

Schedule III-V

There are no special ordering requirements for Schedule III-V drugs. They can be ordered through the same mechanism as non-controlled medications.

Labeling

The following must be on the pharmacy labeling of a controlled substance to be compliant with federal regulations:

Fill date
Pharmacy name & address
Prescription number
Patient name
Prescribing practitioner
Drug name, strength, dosage form, quantity, and number of fills (if CIII-V)
Directions for use & any applicable cautionary verbiage

The FDA also requires the following warning to be present on the label: “Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.”

Dispensing

A prescription is only valid and able to be dispensed if it is written for a legitimate medical purpose under the usual scope of practice of the prescribing practitioner. Once a controlled prescription’s validity and therapeutic benefit is confirmed, it is ready to be dispensed to the patient.

The medication must legally be dispensed to the patient or a member of their household. If the controlled substance is dispensed to anyone else, it is not considered dispensing, but instead distribution.
Typically, a valid form of federally-issued identification is recorded by the pharmacy upon pickup. This is to document the identity of the individual picking up the prescription and help limit diversion.
Although there is no federal quantity limit on controlled prescriptions, state law depending on jurisdiction typically limits Schedule II dispensing to a 30-day supply and Schedule III-V to a 90-day supply.
In the increased attempt to combat the opioid epidemic, some states are limiting narcotic Schedule II fills to a 7-day supply for acute pain and 30-day supply for chronic pain.

Reverse Distribution

Reverse distribution occurs when a pharmacy sends outdated, unusable drug product back to the drug manufacturer or other authorized distributor for processing or disposal. This may occur when drugs are returned by patients or the drugs are expired.

Outdated, damaged, or unwanted controlled substances may be destroyed under the authorization of the DEA. To destroy the medications, the pharmacy or distributor must fill out a DEA 41 form. The form must contain:

Dates, location, and method of destruction
The NDC, name, strength, dosage form, and quantity of the medications being destroyed
Signatures of two witnesses of the destruction (should be employees)

Take Back Programs

Take back programs are a great way to safely dispose of unwanted prescription medications, regardless of being controlled or non-controlled. These programs occur a few times a year, typically at your local police station or university. These programs are beneficial as unwanted medications are voluntarily donated and disposed of correctly. In return, this inevitably makes the community a safer place since such unwanted medications do not end up in the wrong hands or our local waterways.

Loss and Theft

In the event of lost or stolen controlled substances in Schedules II-V, the DEA and local law enforcement must be notified immediately. The pharmacist must then fill out a DEA 106 form that details the medications involved in the theft. The original form is sent to the DEA and a copy should be retained for the pharmacy’s records. Spilling a small amount of a liquid or breaking a few tablets does not need to be reported. Only a “significant” loss of controlled substances requires a DEA 106 form.