DEA Pharmacist's Manual Questions with complete solutions

Who enforces the Controlled Substances Act (CSA)? - Drug Enforcement Administration (DEA) What are the main responsibilities of the DEA? - 1. prevent diversion and abuse of controlled substances 2. ensure there is an adequate and uninterrupted supply of controlled substances to meet the country's needs Which 3 nonprescriptio products require ID, log of sales, purchase/sale limits, and must be placed out of customer reach? Under what law? - Ephedrine Pseudoephedrine Phenylpropanolamine Combat Methamphetamine Epidemic Act of 2005 (CMEA) Describe the 5 schedules of controlled substances - I - high potential for abuse + no currently accepted medical use in the US II - high potential for abuse which may lead to severe psychological or physical dependence but have has accepted medical use III - potential for abuse is less than schedule I/II and abuse may lead to moderate or low physical dependence or high psychological dependence IV - low potential for abuse relative to schedule III V - low potential for abuse relative to schedule IV and consist of preps containing limited quantities of certain narcotics (generally for antitussive, antidiarrheal and analgesic purposes) What form must be completed in order for a pharmacy to register with the DEA? - DEA form 224 Which statement is correct? I. If a person owns and operates more than one pharmacy, each place of business must be registered with the DEA II. If a person owns and operates more than one pharmacy, only one business needs to be registered with the DEA while all other owned pharmacies will be blanketed - I - each must be registered with the DEA through form 224 What form is used to request a duplicate certificate of registration with the DEA? - DEA Form 223 According to federal law, a pharmacy registration must be renewed with the DEA every _____ years utilizing DEA Form ______ - 3 years 224a When is the earliest a registrant can renew a pharmacy's existing registration with the DEA? - no more than 60 days prior to the current expiration date True or false. A corporation that owns/operates a chain of pharmacies may submit a single DEA form for renewal. - True - DEA form 224b; along with the affidavit, a list of the corporation's registrations must be provided in lieu of a separate registration application for each pharmacy registration A pharmacy is moving to a new location. What is your responsibility in regards to the DEA? - contact the DEA registration specialist in your area in writing or request modification of registration online -if moving to a different state, must obtain a controlled substances registration prior to approval of modification of the federal registration. once modified, DEA will issue new schedule II forms After termination of DEA registration, how long must controlled substance records be kept/stored? - 2 years What must be returned if terminating DEA registration for pharmacy? - -certificate of registration -DEA forms unwanted controls should be disposed of in accordance with DEA regulations A pharmacy registrant wants to transfer his business operations to another pharmacy registrant. What must be submitted to the DEA agent in the area and what is the latest they can be done? - , address, registration number and authorized business activity of both the registrant d/c'ing the business and the person acquiring the business 2. indicate whether location of the business will continue or move to another location 3. date which transfer of controlled substances will occur (complete inventory must be taken/recorded and given to person acquiring) Must be submitted at least 14 days prior to the date of propose