Page 2 Laws and Regulations Study Guide for the PTCB Pharmacy Technician Certification Exam

Prescription Record

Proper record keeping is one of the most important aspects of pharmacy practice. It helps to ensure the accuracy of prescription processing, inventory, and all important aspects of pharmacy operation. Pharmacies are required to maintain and keep organized records for all prescriptions, including controlled substances.

Record Keeping and Documentation

All records should be kept in an organized and accurate fashion. Prescriptions records must have the patient’s name and address, drug name, strength, quantity, and date dispensed. Any controlled substance prescriptions should be marked as such and should be stored in accordance with state law. If unspecified by state law, there should be three separate files: C II, C III-V, and non-controlled.

Record Retention

Pharmacies must keep records of all prescriptions for a minimum of 5 years. They must be organized in such a way that they can easily be inspected by the DEA or state BOP.

Restricted Drugs

Some medications can be harmful if taken by the wrong patients, such as people who are pregnant or have a specific disease that would be a contraindication for use of that drug. As such, certain potentially harmful medications have specific criteria that must be met before the prescription can be filled. The Risk Evaluation and Mitigation Strategies (REMS) Program between the FDA and drug manufacturers helps limit inappropriate dispensing and protects patients.

Each drug has different criteria that must be met and this can include patient education, elements for safe use of the medication, a communication plan between healthcare providers and the patient, laboratory tests, etc. One example is isotretinoin, which can be very teratogenic if given to a pregnant women. The Isotretinoin Safety and Risk Management Act outlines the requirements to prevent disastrous effects. The law requires patients to have a blood test and be counseled on safe use before being given a prescription. The patient also has a 7-day time frame in which to fill his or her prescription and can only be given a 30-day supply.

Professional Standards

All personnel involved in pharmacy practice are required to uphold a level of professionalism consistent with the standards of practice. This includes a professional demeanor, respect for patients, and communication with other healthcare providers and the general public. These standards also extend to using discretion with sensitive medical information. All patient personal information needs to be protected and maintained properly.

Data Integrity

The integrity of all pharmacy records must be maintained accurately and in an organized manner so that specific records can easily be accessed. Maintaining the integrity of the data includes electronic records of all prescriptions, orders, invoices, controlled substances, etc. All records must also be retained in hard copy form to ensure proper archiving of data.


The security of medications and medication records is vital to protect sensitive patient information. All pharmacies need to have a monitored security system that signifies any type of intrusion in real time. It may also be wise to use video surveillance within the pharmacy to prevent drug diversion. All pharmacies should also be equipped with physical barriers that prevent entry into the pharmacy during non-operational hours. This may include barred doors and windows or a lockable steel gate.


All members of the pharmacy staff must keep all patient information confidential. They should only discuss information required to care for the patient and this should only occur in the pharmacy and out of hearing distance from any other patients.The Health Insurance Portability and Accountability Act (HIPAA) set the standards for disclosing sensitive patient information. The act states that any information that can be used to identify a patient must be protected. All pharmacy personnel must be trained on HIPAA laws and take steps to limit any use of personal patient information. If this information is released or used outside of the normal prescription process, that patient whose information was disclosed must be notified.

Consultation Requirements

As part of their practice, pharmacists are required to provide counseling to patients on their medications. The Omnibus Budget Reconciliation Act of 1990 (OBRA 90) defines the expectations for pharmacist consultation. OBRA 90 also dictates proper pharmacy record-keeping and requires drug utilization review of all prescriptions. It is important to note that while only a pharmacist can provide counseling, any member of the pharmacy staff can make the offer to counsel. This means that pharmacy technicians can ask the patient if they would like counseling but cannot perform the counseling. Topics pharmacists must cover during counseling include: drug name/description, how to take the medication and what it is for, common side effects or interactions with drugs or food, proper medication storage, refill information, and what to do in the event of a missed dose.

FDA Recall Classification

The Food and Drug Administration (FDA) may request a drug manufacturer to recall or remove a drug from the market for commercial use. There are a variety or reasons a drug can be recalled including problems with the dosage form or adverse reactions related to the specific medication. There are three types of FDA recalls:

  • Class I is the most severe type of recall and involves medication that is likely to cause severe adverse effects or even death. This can also occur if one drug is labeled as another drug.

  • Class II occurs when medication may cause temporary adverse health effects that are reversible or if there is a small risk of serious adverse effects.

  • Class III is the least severe type of recall. The medication in question is not likely to cause a patient to have adverse effects.

Infection Control

Infection control procedures are incredibly important because they can prevent the spread of bacterial, fungal, and viral infections in a variety of healthcare settings. Pharmacy technicians can play a large role in preventing the spread of infections to patients by using appropriate techniques and following regulations. The Occupational Safety and Health Administration (OSHA) sets the standards for the safety and protection of all personnel working in the pharmacy. Any contact with prescription products must have mechanism for personal protection as outlined in OSHA. Other guidelines of United States Pharmacopeia (USP) 797 and 795 outline the requirements for sterile and non-sterile compounding including work environment, maintaining sterility, and personal protective gear.


Three main sets of regulations set the standard for infection control related to pharmacy practice including OSHA, USP 795, and USP 797. Generally, these guidelines describe the techniques for drug manipulation, environmental standards, and personal protection related to sterile and non-sterile compounding.

  • OSHA outlines how to protect the person doing the drug manipulation such as a pharmacist or pharmacy technician. This includes personal protective equipment such as gloves, gowns, hair and beard covers, and eye protection.

  • USP 795 describes the techniques, equipment, and work area requirements for non-sterile compounding.

  • USP 797 describes the techniques, equipment, and work area requirements for sterile compounding. Appropriate personal cleaning and protective wear requirements are also a large part of the 797 guidelines.

Environmental Standards

Prior to any contact with prescription medications, pharmacy technicians must make sure the work area meets the standards appropriate as outlined in OSHA, USP 795, or USP 797. This includes verifying that the practice environment is clean. This could be as simple as cleaning counting trays or as complex as a full clean room for sterile compounding. Specifics for each type of compounding are listed below:

Non-sterile Compounding

  • Hand-washing: It should occur before putting on any gloves or personal protective equipment. It is the first step anytime you come into contact with prescription materials.

  • Clean equipment and counter: Having a clean workspace will prevent contamination of the medications you are dispensing. All equipment and work spaces should be cleaned before any work is done.

Sterile Compounding

  • Clean room: The clean room is a sterilized workspace specifically used for manipulation of medications and compounding. Pharmacy Technicians working in the clean room are required to wear appropriate protective equipment as described in USP 797. Due to the sterile nature of the clean room, pharmacy workers should try to avoid coming and going as much as possible to prevent unwanted dust or bacteria from entering the clean room.

  • Laminar flow hood: The flow hood is the sterile area of the clean room where drug compounding, such as making IV’s, occurs. Air is blown horizontally across the workspace to prevent bacteria or other materials from tarnishing the drug product.The High-efficiency Particulate Air filter (HEPA) is the key component of the laminar flow hood. Any particles are caught in the filter so they do not come in contact with the drug product

Product and Recall Records

In the event of a drug or product recall, the pharmacy must comply with the recall and keep accurate records to aid in the safety to patients that might have been effected. The state BOP and Joint Commission’s recommendations must be followed. The pharmacist needs to contact all patients who might have been affected and reconcile the need for the recall. All recall records should be maintained in a similar manner as that for prescriptions.