Regulations and Laws
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What are the responsibilities of the FDA?
- approving new drug entities
- regulating drug package inserts
- regulating the advertising of drug entities
- issuing recalls on affected medications and medical supplies
Responsibilities of the DEA (Drug Enforcement Administration)?
- To enforce controlled substance laws
- Bring to justice illicit drug trafficing
What is the significance of the CSA (Controlled Substance Act)
It regulates drugs into 5 "schedules" 1 being the most dangerous drugs and 5 being the least harmful drugs.
What are 3 legislatives that the BOP (State Board of Pharmacy) puts in place?
- Pharmacy Practice Act- rules involved in the practice of pharmacy
- Administrative code- Disciplinary guidelines
- States Controlled Substances Act- the drugs that the state considered to be controlled
What was the Federal Food and Drug Act (1906)?
Law that made manufacturers state exactly what was in their products.
The ammendment in 1912 made them also present scientific proof that what they were selling was exactly what they said it was.
What is the Federal Drug and Cosmetic Act (FDCA) (1938)?
This law replaced the Federal Food and Drug Act and added that before a drug could be approved, it had to have been proven to be safe.
What is the Durham-Humphrey Ammendment (1951)?
- This ammendment created legend drugs (prescription drugs)
- It also determined that drugs require safety instructions that must be clearly printed on the bottle.
What is The Kefauver-Harris Amendment (1962)?
Ammendment that required for there to not only be proof of safety, but also proof of effectiveness before the drugs can be advertised.
What is the Medical Device Ammendment (1976)?
Manufacturers of certain medical devices were required to get pre-market approval from the FDA
What is the Harrison Narcotic Act (1916)?
- The Harrison Act employed taxation on the narcotic drugs.
- Following the Act, all narcotics sold legally were to have "tax stamps"
- If a product was found without tax stamps, it was subject to seizure.
What is the Drug Abuse Control Ammendment (1965)?
- This expanded on the Harrison Act.
- There were no longer any stamps
- Included barbiturates and stimulant drugs
What is The Bureau of Narcotics and Dangerous Drugs (1968)?
In 1968, the Harrison Act and the DACA were combined under the jurisdiction of the newly formed Bureau of Narcotics and Dangerous Drugs. In 1973, The bureau was renamed to The Drug Enforcement Administration.
What is The Comprehensive Drug Abuse Prevention and Control Act (CSA) (1970)?
This was the last major change in controlled drug legislation. It is also known as the Controlled Substances Act (CSA). The CSA repealed and replaced Harrison and DACA, but like DACA it relied on Congress' regulation of interstate trade for its power. The new approach of the CSA depends on record keeping and registration requirements of sufficient detail to be able to track transactions between manufacturers, suppliers, practitioners, and consumers. The concept of the DEA number originated with the CSA.
What is The Poison Prevention Packaging Act (PPPA) (1970)?
- The Poison Prevention Packaging Act was intended to decrease accidental poisonings from prescription medications.
- It requires locking caps on all prescriptions dispensed from the pharmacy with only three exceptions. First, when a patient asks for a non-safety lid. Second, when a prescriber asks for a non-safety lid. And third, when the drug dispensed is an exempted drug.
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