Federal Requirements Study Guide for the PTCB Exam

General Information

Of the four areas of study covered in the PTCB exam, questions about federal requirements occupy only about 18.75% of the entire test, but you’ll still need to know this material well. Note that this percentage is about 6% greater than that of the 2020 exam.

Storage, Handling, and Disposal of Pharmacy Substances and Waste

You should always use extreme caution when handling or disposing of hazardous material. When near or in contact with any of these types of materials, you need to use personal protective wear as outlined in the safety data sheet for that specific product.

Hazardous Materials

Hazardous materials are defined as any chemical or drug that poses potential harm to the person who prepares or comes in contact with it. Hazardous materials are noted on the P-list, which is published by the Environmental Protection Agency (EPA). The Occupational Safety and Health Administration (OSHA) also has standards to protect employees who work with hazardous materials. This includes proper personal protective equipment (PPE) and procedures for dealing with and disposing of different types of hazardous substances.

Often, manufacturers of such products send written documentation, known as a safety data sheet (SDS), that outlines appropriate handling, storage requirements, and cleanup procedures for the hazardous product. Hazardous materials and chemicals should be stored separately from other materials. Many times, they can be stored in a negative pressure room where they will later be handled. This type of material also needs to be stored in a leakproof container that is labeled as “hazardous drug waste” until it is disposed of safely.

In case of accidental exposure, you should be aware of the equipment available in your workplace to emergently help minimize exposure and injury. This could include an eyewash station, shower, or other emergency cleaning mechanism. Follow the instructions on the SDS for the specific product you are working with. Follow all instructions for cleanup of the hazardous materials, including the use of specific spill kits that allow you to safely eliminate the product. It is also important to report any incidents to your supervisor.

Non-Hazardous Materials

Non-hazardous materials should also be handled and disposed of in the correct manner, even though they may not pose potential harm to the individual. Although PPE is not required with such materials, they should still be handled with care. Non-hazardous waste may not pose a risk of potential harm to the individual but may pose a risk to the environment if not disposed of correctly.

These materials also have the potential to cause harm if dumped down the drain, which inevitably may end up in our waterways. Depending on the material, they will either end up in a solid landfill or be destroyed by incineration. Non-hazardous waste can range from materials used to prepare a compounded product to products that have passed their intended expiration date.

Pharmaceutical Substances

A pharmaceutical substance is any substance used for therapeutic treatment. To simplify it, pharmaceutical substances are medications or the ingredients used to make them. All pharmaceutical substances must be approved by the Food and Drug Administration (FDA) as both safe and effective before being available on the US market. However, it was not always this way. The Federal Food, Drug, and Cosmetic Act (FFDCA), a milestone legislation passed in 1938, ensures that all drugs receive FDA approval prior to being marketed or used by patients, to ensure that each pharmaceutical substance is both safe and effective. The FFDCA also requires that drug products have regulated labeling requirements, such as a list of ingredients, safety concerns, directions, etc.

Another important piece of legislation that significantly improved patient safety and strengthened the pharmaceutical industry was the Pure Food and Drug Act of 1906. This act was the first major legislation to protect consumers. It prohibited the sale of both food and drug products that were misbranded or adulterated. Adulteration occurs when a drug fails to meet quality standards. For example, a medication is considered adulterated if it is not pure or is a different strength than it’s stated to be. Misbranding occurs when a product is misrepresented by its label. All of the following are examples of misbranding: labeling noncompliance, ingredients not listed on the label, and label misrepresentation of what is actually in the container.

Drug products that are considered hazardous are still used in pharmacy practice, but they have regulations that must be followed. Examples of substances identified on the P-list include warfarin, mitomycin, nicotine, epinephrine, and physostigmine. These medications must be handled and disposed of properly to minimize risk to patients, staff, and the environment. For example, empty warfarin bottles/containers can be disposed of in regular waste. However, unwanted or expired warfarin pills must not be thrown away in the trash or flushed down the toilet, as they are considered acutely toxic and pose a risk to the environment.

The EPA publishes guidance on general safety and disposal of P-list substances, including the following key components:

• Storage must be in leak-proof containers.
• Waste containers must be less than or equal to one quart.
• Empty containers are also considered hazardous waste, unless otherwise noted.
• Material stored must be labeled as “hazardous waste.”
• Waste must be stored securely, segregated, and have proper ventilation.

Medications like tretinoin, misoprostol, finasteride, and methotrexate appear on the hazardous pharmaceutical substance list, per the National Institute of Occupational Safety and Health (NIOSH). These medications must also be handled with extra care to prevent any unwanted exposure to medical staff, as well as to patients. For example, methotrexate is a medication with cytotoxic properties that can cause harm to one’s reproductive system. Although not on the P-list, these medications must be handled properly to avoid potential exposure to those for whom the medication is not prescribed.

Non-hazardous pharmaceutical substances include drugs like amoxicillin, diphenhydramine, ranitidine, and atorvastatin. Expired pharmaceutical substances can be sent back to the manufacturer for reverse distribution. Vaccines, syringes, and needles must be disposed of in a sharps container to prevent an accidental needle stick.

Controlled Substances

Controlled substances are medications that carry a high risk for abuse and misuse. These types of medications are highly regulated by the Drug Enforcement Administration (DEA) and are categorized into schedules based on their level of potential abuse and misuse. Each pharmacy contains a designated area, such as a vault or locked cabinet, where certain controlled medications are segregated to maintain accurate inventory and reduce the potential for diversion.

Movement

The movement of controlled substances from the manufacturer to the pharmacy and from the pharmacy to the patient is highly regulated by the DEA. Each step in the life cycle of a controlled substance must be traceable to ensure proper handling and minimize any potential for diversion or unethical practices.

New Prescriptions

Schedule II (CII) prescriptions must be sent electronically from the practitioner to the pharmacy or handwritten on a secure prescription blank if the practitioner has a waiver on file (dependent on the jurisdiction). Faxes are only acceptable for hospice or long-term care patients. Telephonic emergency Schedule II prescriptions are limited to a 72-hour supply or enough to cover the emergency period, depending on the jurisdiction. Verbal emergency Schedule II prescriptions must be followed up with an electronic or hard copy per DEA regulations.

To combat the current opioid crisis, some states limit the day’s supply and amount of opioids that can be prescribed to 100 morphine milliequivalents (MME) per day. Anything above this amount would require a certain exemption and ICD-10 code. Nothing on a Schedule II prescription can be altered, even with confirmation from the practitioner. A new prescription must be sent if the initial prescription is found to be erroneous or not written correctly. The expiration date is based on your state’s regulations, typically within 90 days of the written date, as federal regulations do not suggest a specific time limit.

Remember, with regard to pharmacy regulations, pharmacies must follow both federal and state laws. However, when each is different (e.g., the expiration of a Schedule II prescription), the stricter of the two must be followed. Schedule IIs (and drugs for chronic pain) are typically limited to a 30-day supply maximum per state regulations.

Schedule III-V (CIII-CV) prescriptions can be handwritten, electronically sent, faxed, and even taken over the phone. These have a lesser risk for abuse compared to the Schedule II classification. These prescriptions are valid for six months from the date written and are limited to a 90-day supply maximum per fill.

Refills

Schedule II prescriptions are not permitted to be written with any refills. If a patient’s insurance has specific quantity limits or the patient does not want to fill the entire quantity of a Schedule II, the remainder is forfeited and cannot be refilled. Hospice patients are eligible to partially fill a Schedule II in increments, and such a prescription expires 60 days from the written date. Schedule III-IV prescriptions are limited to a maximum of five refills or six months. Under federal statute, Schedule V prescriptions can be refilled as authorized by the prescriber. However, some states may have stricter controlled substance laws, which means the stricter law should be followed.

Controlled substances cannot be filled early. Typically, a one to two-day leeway period is acceptable; however, some insurance companies will reject the pharmacy claim until the actual day the refill is due.

Transfer of Prescription

Schedule II medications cannot be transferred from one pharmacy to another. Even if the pharmacies share a common database (for example, one Walmart to another Walmart), a transfer is not allowed by law.

Schedule III-Vs can be transferred between pharmacies one time only, unless the pharmacies share an online, real-time database. In that case, the prescription can be transferred between the two locations until it expires or no refills are remaining.

All transfers must occur between two pharmacists. The prescription should be voided by the original pharmacy after transfer, and a notation that it is a transferred prescription should be written by the current pharmacy.

Schedule III-V transfers are indicated by law for refill purposes only. This means that if the prescription was never initially filled, it is non-transferable. The following needs to be included when transferring a prescription:

• original prescription date and dispensing date
• number of refills remaining
• the name of the transferring pharmacist
• the DEA number, name, and address of the transferring pharmacy

DEA Controlled Substance Schedules

As briefly mentioned above, the DEA categorizes controlled substances into certain schedules based on their potential for abuse and misuse. Schedule I drugs have the highest abuse potential but are not on the market as they are not acceptable medical treatments and lack therapeutic benefit. Schedule II drugs have the highest abuse potential for medications currently on the market. The risk for abuse and misuse lessens as the schedule number increases, so Schedule V drugs have the lowest risk.

Calculations Involved

Since controlled prescriptions have quantity and day supply limitations, it is important to know how to calculate a prescription’s day supply. As mentioned above, some states also require that opioid prescriptions do not exceed 100 MME (combined in the case of multiple prescriptions), unless a special exemption is listed. Although the pharmacist is ultimately responsible for making sure each prescription coincides with federal and state regulations, the pharmacy technician should also be knowledgeable to catch inconsistencies before reaching the pharmacist for the final check.

Here are a few of the most common opioids seen in pharmacy practice and their MME conversion factors:

• morphine—1
• oxycodone—1.5
• hydrocodone—1
• codeine—0.15

For a printable resource with more information about controlled substances, visit this CDC website.

Here are two examples of calculations involving controlled medications:

Prescription #1

Oxycodone 5 MG tablet
1 tablet by mouth 3 times daily as needed for chronic pain #84 (eighty-four) tablets

Is this prescription valid for dispensing? Well, there are actually two questions to answer. First, is the prescription within the permitted day supply, and is it within 100 MME? You can answer these questions with these calculations:

84 tablets total/3 tablets daily = 28-day supply
5 MG x 3 tablets daily = 15 MG of oxycodone daily
15 MG x 1.5 MME Factor = 22.5 MME

This prescription is valid as it does not exceed 100 MME/day and is written for a 28-day supply, which is less than the 30-day max limit for chronic pain.

Prescription #2

Lorazepam 0.5 MG tablet 1 tablet by mouth twice daily as needed for anxiety #60 tablets 5 refill authorized

This prescription has already been filled twice. How many more times can it be filled?

This prescription is authorized for the original fill plus five refills, so six total fills. So, it’s a simple matter of subtracting two from six, which means there are four refills remaining.