Tech Medication Handling: Florida's Strict C2 Laws

In the United States, the Drug Enforcement Administration (DEA) is responsible for regulating controlled substances, including the partial filling of prescriptions for Schedule II controlled substances, often referred to as C2 medications. While the DEA sets the overarching framework, individual states, such as Florida, may have their own specific laws and regulations that further govern the dispensing of C2 medications. This includes the role and responsibilities of pharmacy technicians (techs) in handling and dispensing these controlled substances, which can vary from state to state and even between different pharmacies.

Techs can count C2 meds

Whether techs can count C2 medications depends on the company and the state. For example, in Michigan, techs can count C2 medications, but pharmacists retrieve and double-count them. In Kansas, all techs can count C2 medications, but some stores limit this to Certified Pharmacy Technicians (CPHTs). In Mississippi, techs at CVS cannot handle C2 medications, but those at Walmart can. Techs at hospitals in Mississippi can also count C2 medications.

Some pharmacists do not allow technicians to count C2 medications because they are highly regulated and require a lot of paperwork and documentation. They want to ensure that if a mistake occurs, it is solely their fault and not the fault of the techs. Other pharmacists are happy for techs to count C2 medications, as long as they double-check the count themselves. In some cases, pharmacists will retrieve the medication from a locked cabinet or safe and hand it to the tech to count.

There are also differences between companies in terms of whether techs are allowed to mix C2 medications. Some companies only allow certified techs to mix suspensions, while others allow uncertified techs to do so.

Company policies vary

It's important to note that even if a pharmacy technician is allowed to fill C2 medications, they may still be subject to certain restrictions or requirements, such as additional training, supervision, or documentation. These requirements are put in place to ensure patient safety and compliance with state and federal laws and regulations.

Additionally, company policies may outline specific procedures for handling C2 medications, including storage, dispensing, and record-keeping practices. These policies are designed to maintain the security and integrity of controlled substances, prevent diversion, and ensure that patients receive the correct medication and dosage.

Furthermore, companies may have different policies regarding the partial filling of C2 medications. While federal law allows for partial filling under certain conditions, companies may have their own guidelines or restrictions on this practice. For example, a company may require that partial filling requests be approved by a pharmacist or that specific documentation be completed for each partial fill.

It's always important to refer to the specific company's policies and procedures, as well as state and federal laws and regulations, to ensure compliance and patient safety when dealing with C2 medications.

DEA regulations

The Drug Enforcement Administration (DEA) is amending its regulations to conform to the Comprehensive Addiction and Recovery Act of 2016 (CARA), which became law on July 22, 2016. CARA amended the Controlled Substances Act (CSA) to allow for the partial filling of prescriptions for Schedule II controlled substances under certain conditions. This provides flexibility to both prescribers and patients.

The DEA has to allow both the patient and the practitioner to request partial fills. However, the DEA can also create regulations to direct the manner in which the partial fill is requested and recorded. This is because the DEA has been granted the authority to fill in gaps not addressed by CARA.

The DEA's regulations on the transfer of electronic prescriptions (EPCS) for controlled substances between pharmacies do not alter a pharmacy's responsibilities to ensure the validity of a controlled substance prescription. The DEA requires each registrant to maintain complete and accurate records of controlled substances. Once a controlled substance prescription is created electronically, it must remain in its electronic format, and all related records must be retained electronically.

The DEA acknowledges that some pharmacies may need to coordinate with their pharmacy technology vendors to have certain SCRIPT transactions incorporated into their pharmacy applications. The cost associated with this incorporation is beyond the scope of the DEA's authority.

In terms of the specific question of whether a tech can fill C2 meds, this appears to depend on the company and state in question. Some companies, such as CVS, do not allow techs to touch C2s, while others, such as Walmart, do. In hospitals, techs count C2 meds as well.

State laws

In the United States, the Comprehensive Addiction and Recovery Act of 2016 (CARA) amended the Controlled Substances Act (CSA) to allow for the partial filling of prescriptions for Schedule II controlled substances (CII medications) under certain conditions. This provision of CARA provides flexibility to prescribers and patients.

According to federal law, a pharmacist can partially fill a prescription for a Schedule II controlled substance if requested by the prescribing practitioner or the patient. However, for this partial filling to be lawful, certain conditions must be met. These conditions include:

• The partial filling must not be prohibited by state law.
• The prescription must be written and filled in accordance with the CSA, DEA regulations, and state law.
• The total quantity dispensed in all partial fillings must not exceed the total quantity prescribed.

It is important to note that the DEA has clarified that patient requests for partial fills do not need to be made in person and can be made verbally over the phone or through a signed note. Additionally, the DEA will authorize requests from parents or legal guardians for minor children or caregivers named in the medical power of attorney for adult patients.

Partial fills

On July 22, 2016, the Comprehensive Addiction and Recovery Act (CARA) was signed into law. This act amended the Controlled Substances Act (CSA) to allow for the partial filling of prescriptions for schedule II controlled substances under certain conditions. This amendment was made to provide flexibility to prescribers and patients.

The CARA amended 21 U.S.C. 829 by adding a new subsection (f), which allows a pharmacist to partially fill a prescription for a schedule II controlled substance when requested by the prescribing practitioner or the patient. However, for such partial filling to be lawful under the CSA, the following conditions must be satisfied:

• The partial filling must not be prohibited by state law.
• The prescription must be written and filled in accordance with the CSA, DEA regulations, and state law.
• The total quantity dispensed in all partial fillings must not exceed the total quantity prescribed.
• After the first partial fill, any additional partial fill(s) must occur within 30 days after the prescription is written, unless it is an emergency oral prescription, in which case the remaining portion must be filled within 72 hours.
• The pharmacist must record the identification of the dispensing pharmacist, the prescribing practitioner, the patient, the LTCF (if applicable), and the medication authorized, including the dosage form strength and quantity.
• The prescription record must be updated in real time each time the prescription is partially filled.

In addition to the above, the DEA has clarified that the patient's request for a partial fill does not have to be made in person. For example, it can be made verbally over the phone or through a signed note delivered by a family member. The DEA will also authorize a request from a parent or legal guardian for minor children or the caregiver named in the medical power of attorney for an adult patient.

The last situation where a pharmacist may partially fill CII controlled substances is for patients in LTCFs or with a medical diagnosis documenting a terminal illness. For these patients, schedule II prescriptions may be partially filled to allow for the dispensing of individual dosage units but for no longer than 60 days from the date of issuance.

It is important to note that the partial filling of prescriptions for schedule II controlled substances is not allowed in all states, and even within states, it may depend on the company and their specific policies.

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