Page 3 Laws and Regulations Study Guide for the PTCB Pharmacy Technician Certification Exam

Pharmacy Personnel Roles

Regardless of the setting, the roles of each member of the pharmacy staff should be clearly defined. These roles are delineated from state and federal laws as well as the Joint Commission recommendations for healthcare workers. The Board of Pharmacy defines what each member of the team is able to do from a practical and legal perspective.


Pharmacists are responsible for the safety and accuracy of everything that happens within the pharmacy. As such, they are the person in charge and can further delegate responsibility to other pharmacy personnel. Pharmacy interns may have similar responsibilities as a pharmacist, but must be directly overseen by the pharmacist. Duties specific to the pharmacist include final prescription verification, prescription transfer, ordering of medications, and keeping accurate documentation. A pharmacist also performs the Drug Utilization Review (DUR) process which evaluates: therapeutic duplication, drug-disease contraindications, drug-drug interactions, incorrect drug dosage, incorrect duration of treatment, drug-allergy interactions, and clinical abuse/misuse of medication.

Pharmacy Technician

Pharmacy technicians can be involved in many aspects of pharmacy operations. Things technicians are not allowed to do include: Drug Utilization Review, patient counseling, transferring prescriptions, ordering and record keeping (all need pharmacist signature), and prescription verification (some states do allow tech-check-tech on a limited basis, however). All other aspects of pharmacy practice can involve technicians, including processing and filling prescriptions, compounding, maintaining inventory, and medication delivery.

Other Pharmacy Employees

Other people with access to the pharmacy and those working within the pharmacy should have defined roles. Without proper licensing as a technician, other personnel should not be involved in the medication distribution process except for performing cashier duties at the time of prescription sales. All confidentiality laws apply to all personnel working around sensitive patient information.

State vs. Federal Regulations

Although federal law covers all 50 states, each state may also have a specific set of laws to govern the practice of pharmacy. In some cases, the federal and state laws are not the same and may even conflict. In the event of a conflict, the more stringent law (whether it’s state or federal) prevails and should be followed.

Facility Requirements

All types of pharmacies have requirements for space and equipment which vary by the type of facility it is. The rules are governed by state boards of pharmacy and should be considered by all pharmacy personnel. A few standard requirements are also in place and are discussed below.


All pharmacies are required to keep a clean, uncluttered, working space. State Boards of Pharmacies have specific requirements about the size of the pharmacy as well as required amounts of counter space and storage space. Federal law leaves these requirements up to each state individually. Check with your State Board of Pharmacy for more specific information.


All pharmacies must have access to a cold and hot water supply within the pharmacy. There also needs to be a refrigerator for medication that requires temperature controlled storage. This must be separate from where all other types of perishables, such as lunches and beverages, are located. A safe or lockable device/area is required as well. Often this is used to store Schedule II controlled substances; however, C II medications do not have to be stored this way in all states. The pharmacy must also be equipped with a backup power supply in the event of a power failure.


Pharmacies should have the appropriate supplies for the type of setting. For example, a retail pharmacy needs to have vials, counting trays, spatulas, etc. There should also be an appropriate supply of medications to support the patients that use the pharmacy. Although it may not be feasible to have every possible drug option on hand, pharmacy staff should do their best to anticipate the medication needs of their patients.

Prescription File Storage

All prescriptions must be kept on-file at the pharmacy for a minimum of 5 years after the prescription was filled. There should be an electronic record as well as the hard copy of the prescriptions that are easily accessible. As such, prescriptions should be organized and separated, based on if they are written for controlled substances or non-controlled substances. There are three options for how to file prescriptions:

  • Three separate files:
    C III-V
    C II

  • Two separate files:
    Non-controlled + C III-V
    C II

  • Two separate files:
    All Controlled (C II-V)


Even though the hours of pharmacy operation may vary by setting, the pharmacy’s cleanliness must be maintained in all types of work environments. The following things should be done at least daily, if not more often:

  • dusting of equipment and medication storage areas

  • wiping down of keyboards, phones, all working surfaces, and tools used for medication preparation and dispensing

  • vacuuming or mopping the floors

  • removing trash from the pharmacy work area

  • cleaning patient areas (only some settings have direct patient care areas in or around the pharmacy)

Reference Materials

By law, all pharmacies are required to have specific reference materials on hand in order to legally operate. These can be available in print or electronic form and include all references that may be necessary for the pharmacist to adequately meet the needs of the patients served:

  • a list of all laws, rules, and regulations that impact the pharmacy’s practice

  • a reference on drug interactions.

  • the Orange Book

  • a reference on natural or herbal medicines.

Additional Pharmacy Laws

The following laws are also important for the practice of pharmacy to help ensure patient safety and prevent drug diversion.

Pure Food and Drug Act of 1906

This act states that drugs must be pure and unadulterated and have to be labeled accurately. It also extends to food and drinks being marketed. It is important to note that this law does not address medication safety such as adverse effects, only that the medication is pure. Under this law a rug does not need to list ingredients, directions, or safety warnings.

Federal Food, Drug and Cosmetic Act of 1938 (FFDCA)

This law was enacted to improve upon the Pure Food and Drug Act after multiple deaths for an unsafe ingredient within an elixir on the market. The act requires all products to include a list ingredients, directions, and safety warnings. It also states that all drugs must be approved by the FDA prior to being marketed and used by patients. It outlines the labeling requirements for all prescription and over-the-counter medications. The law better defined misbranded and adulterated drugs as listed below:

  • A product is considered misbranded if it is misrepresented on the label, contains unapproved color additives or ingredients, or does not comply with labeling and warning requirements as established by the FDA.

  • A product is considered to be adulterated if it fails to comply with the standards for quality, strength, or purity.

Poison Prevention Packaging Act of 1970 (PPPA)

This act defines the level of product security needed to prevent children from accessing medication containers. It resulted from accidental poisonings of children who accidentally ingested medications. The requirement for child-resistant containers is that if given to a child, only 20% of children could access the medication inside. It is important to note that not every single product has to meet these requirements, however. For example, if a product is clearly labeled “not child resistant” then it is an exception. Certain medications can also be exceptions in limited doses.

Combat Methamphetamine Epidemic Act of 2005 (CMEA)

The CMEA places restrictions on the sale, storage, and record requirements for products containing ephedrine, pseudoephedrine, and phenylpropanolamine. The maximum amount that can be bought by an individual customer is 3.6 grams per day and 9 grams in a 30-day period. Note that this refers to the base chemical, not the overall tablet strength of the product. The act also requires that any products containing ephedrine, pseudoephedrine, or phenylpropanolamine be kept behind the pharmacy counter to make sure all the required documentation is completed with the sale and to prevent theft. An electronic or written logbook must be kept detailing the personal information of the person purchasing the product and quantity, strength, date, and time of the product sale.