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Questions and Answers
What primary function does the DEA serve concerning pharmaceutical controlled substances?
What primary function does the DEA serve concerning pharmaceutical controlled substances?
- To promote the sale of prescribed medications.
- To prevent diversion and misuse while ensuring an adequate supply. (correct)
- To prevent the illegal export of pharmaceutical drugs.
- To regulate pricing of controlled substances in pharmacies.
In the closed system of distribution established by Congress, which of the following must be registered with the DEA?
In the closed system of distribution established by Congress, which of the following must be registered with the DEA?
- Pharmacies, physicians, and manufacturers but not patients. (correct)
- All individuals in the drug supply chain, including patients.
- Only manufacturers of controlled substances.
- Only federal law enforcement officials.
How does the DEA aim to work with the pharmacy community?
How does the DEA aim to work with the pharmacy community?
- By encouraging the production of illicit drugs.
- By establishing regulations that are difficult to comply with.
- By increasing the complexity of the drug approval process.
- By maintaining a positive working relationship to prevent diversion. (correct)
What type of substances do federal controlled substance laws complement?
What type of substances do federal controlled substance laws complement?
What is one of the DEA's educational responsibilities?
What is one of the DEA's educational responsibilities?
What does the Controlled Substances Act (CSA) help establish?
What does the Controlled Substances Act (CSA) help establish?
What are scheduled listed chemical products (SLCPs)?
What are scheduled listed chemical products (SLCPs)?
What is the legal obligation of handlers of controlled substances within the closed system?
What is the legal obligation of handlers of controlled substances within the closed system?
What is the primary focus of the DEA in its investigations?
What is the primary focus of the DEA in its investigations?
What must a pharmacy do if its license is revoked by a state board?
What must a pharmacy do if its license is revoked by a state board?
Which of the following is a requirement imposed by the CMEA for pharmacies selling SLCPs?
Which of the following is a requirement imposed by the CMEA for pharmacies selling SLCPs?
What is one of the additional administrative remedies the DEA may employ?
What is one of the additional administrative remedies the DEA may employ?
Which substances are identified as immediate precursors in the manufacture of methamphetamine?
Which substances are identified as immediate precursors in the manufacture of methamphetamine?
What happens if a pharmacy refuses to surrender its DEA registration after a state board revocation?
What happens if a pharmacy refuses to surrender its DEA registration after a state board revocation?
What designation did the CMEA create for products containing certain chemicals?
What designation did the CMEA create for products containing certain chemicals?
What actions might the DEA pursue if there is sufficient evidence of controlled substance violations?
What actions might the DEA pursue if there is sufficient evidence of controlled substance violations?
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Study Notes
Drug Enforcement Administration (DEA) Overview
- Established in 1973 as the primary federal agency for drug law enforcement.
- Responsible for enforcing the Controlled Substances Act (CSA) and its regulations.
Responsibilities of DEA
- Prevents diversion and misuse of pharmaceutical controlled substances.
- Ensures an adequate supply of controlled substances for legitimate medical, scientific, and research purposes.
- Works closely with state, local authorities, and other federal agencies for effective enforcement.
Closed System of Distribution
- All legitimate handlers (manufacturers, distributors, physicians, pharmacies) must be registered with DEA and maintain strict records.
- Designed to prevent illegal distribution of controlled substances.
Cooperation with State Authorities
- Federal controlled substance laws complement state laws.
- DEA collaborates with state licensing boards and law enforcement to ensure compliant prescribing and dispensing.
- Majority of investigations into violations are conducted by state authorities.
Investigative Focus
- DEA targets cases involving significant violators with high impact on public health.
- Actions against non-compliant pharmacies include voluntary surrender requests, potential revocation of DEA registration, and administrative hearings.
Chemical Diversion Concern
- DEA monitors the diversion of chemicals like ephedrine and pseudoephedrine, which are used in the illicit manufacture of methamphetamine and amphetamine.
- Products containing these chemicals can be stolen or purchased for use in clandestine drug labs.
Combat Methamphetamine Epidemic Act of 2005 (CMEA)
- Introduced regulations for over-the-counter products containing ephedrine and pseudoephedrine, designating them as Scheduled Listed Chemical Products (SLCPs).
- Effective retail provisions include employee training, self-certification, and restrictions on product access and purchase.
Pharmacy Registration and Compliance
- Pharmacies selling SLCPs must self-certify under CMEA requirements.
- Compliance measures include employee training, maintaining sales logs, and adhering to sales limits to mitigate illegal distribution.
Common Interests with Pharmacy Community
- DEA and pharmacists share interests in managing the appropriate use of controlled substances and SLCPs.
- Promotes a collaborative relationship to enhance public health and safety.
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