Learning Outcomes
After completing this chapter, you will be able to
Understand how the practice of pharmacy is regulated by federal and state laws and regulations and the role of state boards of pharmacy.
Discuss state pharmacy laws and regulations that govern pharmacy technicians, including permitted functions and the requirements for pharmacy technician registration or licensure.
Discuss the laws that regulate controlled substances, special requirements for pharmacy ordering and dispensing controlled substances, and the role of state prescription monitoring programs.
Describe the restrictions on the sales of products containing pseudoephedrine and ephedrine.
Describe the FDA approval process for drugs and the differences between brand name and generic drugs.
Discuss generic drug substitution and the means for prescribers to indicate if substitution is not authorized.
Discuss the difference between prescription drug inserts for prescribers and for patients.
Describe the concept of pharmaceutical care.
Define medication therapy management.
Discuss patient privacy in the pharmacy and the federal law that governs privacy of protected health information.
Key Terms
| biennial inventory | DEA-registered pharmacies are required by law to take an initial inventory of all controlled substances on hand upon commencing operations or upon change in ownership, with subsequent inventories conducted every two years thereafter. |
State Pharmacy Laws and Regulations
Schedules of Controlled Substances
Labeling of Controlled Substances
Dispensing Controlled Substances
Brand Name Drugs and Generic Drugs
Prescription Drug Labeling and Package Inserts
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The practice of pharmacy is extensively regulated by a number of laws and regulations. These laws and regulations cover essentially all aspects of pharmacy practice and establish permitted and prohibited conduct for pharmacies, pharmacists, and pharmacy technicians. States require pharmacies and pharmacists to be licensed. Many states have laws or regulations that require pharmacy technicians to be licensed or registered and meet other requirements, such as specific training and education, certification, and criminal history background checks. Pharmacy practice is also covered by ethical principles to provide a fundamental framework for interacting with patients. Examples of ethical principles are acting with honesty, integrity, compassion, and respect for patients.
Although states have the primary authority to regulate pharmacy practice, pharmacy is also subject to a number of federal laws. Examples of federal laws include the Food, Drug, and Cosmetics Act (FDCA) that regulates the safety of food, drugs, and cosmetics and the Controlled Substances Act that establishes requirements for the handling and dispensing of narcotics and other controlled substances. Another example is the Omnibus Budget Reconciliation Act of 1990 (commonly called “OBRA ’90”) that requires pharmacists to provide patient counseling as a condition of reimbursement when dispensing prescriptions to Medicaid patients. Table 2–1 provides a timeline of some of these and other important federal drug laws.
If state and federal laws or regulations differ, both must be followed, including the more stringent requirements, whether federal or state. For example, if a federal law has specific requirements for dispensing controlled substances, and a state pharmacy law has stricter requirements, the state law must be followed in addition to the federal requirements.
If the state and federal laws or regulations differ, both laws and regulations must be followed, including the more stringent requirements, whether federal or state.
Ethical Principles
Ethical principles exist in many areas of life. In health care, including pharmacy, they guide the performance of tasks and responsibilities so they fall within an ethical and moral framework. Pharmacy technicians’ interactions with patients and other health care professionals should conform to societal values. In simple terms, this equates to “doing the right thing,” such as being considerate of patients. Ethical principles include complying with laws and regulations, maintaining competency, and respecting patient privacy and confidentiality. Pharmacy technicians have their own set of ethical principles. The American Association of Pharmacy Technicians (AAPT) has developed a Code of Ethics for Pharmacy Technicians (See box 1–1 in Chapter 1 Introduction to Pharmacy).
State Pharmacy Laws and Regulations
State pharmacy laws and regulations set the requirements for pharmacies, pharmacists, pharmacy technicians, and the practice of pharmacy. Both laws and regulations are necessary to regulate the practice of pharmacy, including pharmacy technicians. State pharmacy laws establish the legal requirements, restrictions, and prohibitions for the practice of pharmacy. State laws are enacted by state legislatures through the legislative process; however, because laws are usually more general, regulations or rules are needed to provide the details to implement the law. While laws are enacted through the state legislative process, regulations or rules are issued and adopted by state regulatory agencies through the regulatory or rulemaking process. For pharmacy practice, the pharmacy laws are enacted by the state legislature and regulations are usually adopted through the state board of pharmacy.
| Year | Act | Purpose |
| 1906 | Food and Drug Act | Outlaws states from buying and selling food, drinks, and drugs that have been mislabeled and tainted |
| 1912 | Sherley Amendment | Outlaws labeling drugs with fake medical claims meant to trick the buyer |
| 1930 | FDA | Food and Drug Administration is named |
| 1938 | Cosmetic (FDC) Act of 1938 | Requires new drugs to be proven safe prior to marketing; starts a new system of drug regulation; requires safe limits for unavoidable poisonous substances; and allows for factory inspections |
| 1951 | Durham-Humphrey Amendment | Defines the type of drugs that cannot be used safely without medical supervision and limits the sale to prescription only by medical professionals |
| 1962 | Kefauver Harris Drug Amendments | Requires manufacturers to prove that their drugs are effective prior to marketing |
| 1972 | Over-the-Counter Drug Review | Nonprescription medications must be safe, effective, and appropriately labeled |
| 1982 | Packaging Regulations | Makes it a crime to tamper with packaged products and requires tamper-proof packaging |
| 1984 | Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act) | Allowed FDA to approve generic versions of brand-name drugs without repeating research to prove safety and efficacy; allowed brand-name drugs to apply for up to 5 years of additional patent protection for new drugs to make up for time lost while their products were going through the FDA approval process |
| 1988 | Prescription Drug Marketing Act | Designed to eliminate diversion of products from legitimate channels of distribution and requires wholesalers to be licensed |
| 1997 | Food and Drug Administration Modernization Act | Expands scope of agency activities and moves agency to the Department of Health and Human Services (DHHS) |
| 2003 | Medicare Prescription Drug Improvement and Modernization Act of 2003 | Includes Medicare Part D which increases access to medications through private insurers |
Adapted from U.S. Food and Drug Administration, Center for Drug Evaluation and Research.
Because each state enacts legislation and adopts regulations for pharmacy, the particular requirements may vary from state to state. For example, the requirements for pharmacy technicians vary by state. Nonetheless, an important and universal distinction for pharmacy technicians to understand is that they work under the supervision and direction of pharmacists and may perform only the tasks permitted under state law.
State pharmacy laws and regulations distinguish between the tasks and responsibilities that pharmacists perform and those that pharmacy technicians are permitted to perform. State pharmacy laws do not permit pharmacy technicians to perform pharmacy tasks and responsibilities that are limited to pharmacists and require the professional judgment, education, and training of a pharmacist.
State pharmacy laws do not permit pharmacy technicians to perform pharmacy tasks and responsibilities that are limited to pharmacists and require the professional judgment, education, and training of a pharmacist.
State Boards of Pharmacy
State boards of pharmacy are responsible for regulating the practice of pharmacy including pharmacies, pharmacists, pharmacy interns, and pharmacy technicians. The state boards of pharmacy have regulatory authority over a number of areas, such as licensing pharmacies and pharmacists; registering or licensing pharmacy technicians; inspecting pharmacies; issuing rules and regulations; investigating complaints; and disciplinary actions against pharmacies, pharmacists, and pharmacy technicians for violations of pharmacy laws and regulations. Information on the various state boards of pharmacy is available through the National Association of Boards of Pharmacy (NABP) Web site at www.nabp.net.
Pharmacy Licensure
Every state requires pharmacies to have a valid current pharmacy license or permit in order to operate the pharmacy. State pharmacy laws and regulations set the requirements for pharmacy licensure. Pharmacies must satisfy many requirements which include record keeping requirements, security, a pharmacist-in-charge, and a licensed pharmacist on duty while the pharmacy is open. State requirements vary as to whether the pharmacy technicians may or may not remain in the pharmacy during a pharmacist’s break period. State boards of pharmacy conduct pharmacy inspections to verify that the pharmacy meets the licensure requirements and also perform periodic pharmacy inspections at other times.
Many states have more than one category of pharmacy license. The different licensure categories that states may identify include retail, community, institutional, hospital, nuclear, mail-order, and long-term care. Some states also use categories for special or limited-use pharmacies and sterile-compounding pharmacies. Another category used by states is for nonresident pharmacies. Most states require pharmacies that are located in another state (i.e., nonresident pharmacies) to be licensed in the state if they mail, ship, dispense, or deliver prescription drugs to residents of the state.
Pharmacy Technicians
Many states have enacted laws and adopted regulations establishing requirements that pharmacy technicians must meet to be able to assist pharmacists. However, the requirements for pharmacy technicians vary from state to state. The state board of pharmacy in each state is the best resource for obtaining the current requirements. Nonetheless, although they are variable, there are several common requirements. These include a requirement for pharmacy technician registration or licensure (and the accompanying qualifications), permitted tasks, and prohibited conduct. Some states require criminal background checks. Regardless of whether licensure or registration is required, these requirements allow states to assure that pharmacy technicians meet certain requirements, to regulate the tasks that pharmacy technicians may perform, and to allow for disciplinary actions against pharmacy technicians for violations of state pharmacy laws and regulations including loss of licensure or registration if appropriate. The qualifications for pharmacy technician registration or licensure generally include a minimum age, high school graduation or the equivalent, completion of a training program including pharmacy employer training programs, and an examination. Some states allow pharmacy technician certification to satisfy the education or training requirements (see Chapter 1 Introduction to Pharmacy for more information on licensure, registration, and certification).
The qualifications for pharmacy technician registration or licensure generally include a minimum age, high school graduation or the equivalent, completion of a training program, including pharmacy employer training programs, and an examination.
