Laws
1970 Poison Prevention Packaging Act
The Poison Prevention Packaging Act of 1970 (PPPA) created standards that require prescriptions dispensed at retail pharmacies to be in child-resistant packaging.
SBOP and what does it overlook?
What is State Board of Pharmacy and it is the state-level agency that regulates pharmacies, pharmacy technicians, and pharmacists to keep patients safe?
DAW Code 0
What is no product selection indicated and generic substitution allowed?
DEA Code 41
Used to document the destruction of controlled substances (expired, damaged, or unwanted drugs).
What is the Accutane (isotretinoin) law?
the FDA's iPLEDGE program, a mandatory risk management plan that requires strict regulations due to the drug's potential to cause severe birth defects.
Patients must also attend all follow-up appointments and have regular blood tests, and must inform their doctor of any pre-existing conditions like mental health issues, inflammatory bowel disease, or other chronic diseases.
1983 Orphan Drug Act
The Orphan Drug Act of 1983 is a U.S. law that incentivizes pharmaceutical companies to develop drugs for rare diseases by providing financial incentives, including tax credits and market exclusivity.
FDA and the administration's purpose
Food and Drug Administration. It provides security of human and veterinary drugs, medical devices, the nation's food supply, and cosmetics.
DAW 9
What is generic not available, brand dispensed?
DEA Code 222
Required to order Schedule I and II controlled substances; ensures strict tracking of narcotics.
What is the dosage limit for pseudoepinephrine?
7.5 g per 30 days by mail order
3.6 g per calendar day
9 g per 30 days from a retailer
1962 Kefauver Harris Amendment
This amendment gave the FDA greater authority to regulate drug approval, mandated that drug advertisements disclose side effects, and required more rigorous standards for clinical trials. It passed largely in response to the thalidomide crisis.
DEA and its purpose
Drug Enforcement Agency and it's purpose is is to enforce the controlled substances laws and regulations of the United States.
DAW 6
What is override, special circumstances require brand or generic?
DEA Code 106
Used to report theft or significant loss of controlled substances to the DEA
How often should an inventory be done of all controlled substances?
Biennially
1990 Omnibus Budget Reconciliation Act
The Anabolic Steroids Control Act of 1990 is a U.S. federal law that placed anabolic steroids under Schedule III of the Controlled Substances Act (CSA).
OSHA and its purpose?
Occupational Safety And Health Act, its purpose is setting and enforcing workplace safety and health standards, providing training and assistance to employers and workers, and investigating worker complaints.
DAW 4
What is Pharmacist chooses generic even though substitution is allowed?
DEA Code 224
Application for new registration of pharmacies, hospitals, or practitioners to dispense controlled substances.
What segment of numbers on an NDC number identifies the drug product?
Second set of 4 digits
2013 Drug Quality and Security Act
The Drug Quality and Security Act (DQSA) was passed in 2013 to improve drug safety in the U.S. It has two main parts. The first part, called the Compounding Quality Act, gives the FDA more power to oversee drug compounding and creates a new type of facility called “outsourcing facilities” that must follow stricter rules.
The second part, called the Drug Supply Chain Security Act (DSCSA), sets up a nationwide system to track prescription drugs as they move through the supply chain, helping to stop counterfeit drugs.
This law was created after a deadly fungal meningitis outbreak in 2012 that was linked to contaminated compounded medicine.
What is HIPAA and what does it do?
Health Insurance Portability and Accountability Act of 1996, its purpose is to protect patient health information (PHI), implement administrative, physical, and technical safeguards, train staff, and handle patient rights requests.
DAW 2
What is Patient requests brand even though substitution is allowed?
What do the letters A, B, F, M stand for in front of all DEA form numbers?
DEA numbers start with a letter that shows what kind of provider they belong to.
A = first for doctors, but is now outdated.
B = hospitals and clinics, but it was replaced.
F = the standard for most doctors, pharmacies, and hospitals.
M = mid‑level providers like nurse practitioners and physician assistants.
They identify the type of registrant and help the DEA quickly verify who is authorized to handle controlled substances.
What law mandated adding this label, “Caution: Federal law prohibits dispensing without a prescription?”
1951 Durham-Humphrey Amendment