Week 4 - Chapter 4 (MAX) Flashcards

Question

Give example of distributing, distributors, dispensers and stocking

Answer 1

Distributing: to deliver a CS Wholesalers must register as distributors. Practitioners registered to dispense are exempt, provided they comply with all conditions. Stocking of ADS in LTCF and return of CSs to suppliers by practitioners are exempt, provided recordkeeping requirements are met.

Answer 2

Distributing

Answer 3

Coincidental activity of dispensers to conduct research with schedule II–V CSs if authorized Research with C-I drugs requires submission of protocols with application.

Answer 4

When Each principal place of business where CSs are administered, dispensed, or stored requires separate registration.

Answer 5

The dispenser registration form is DEA Form 224, which is online, and renewed online

Answer 6

Any modifications must be approved by the DEA. If registrant dies or ceases legal existence, the DEA must be notified, and the registration terminated. Registrations cannot be assigned or terminated without DEA approval.

Answer 7

On discontinuance of business without transfer of business, the registrant must return a certificate of registration to the DEA for cancellation together with any unexecuted Form 222s. Controlled substances must be disposed of pursuant to regulations.

Answer 8

A proposal must be submitted to the DEA at least 14 days prior to the transfer with required information. The transfer may occur, unless DEA notifies otherwise. A complete inventory of CSs must be taken on the date of transfer. C-II products must be recorded via Form 222.

Answer 9

The attorney general may deny a practitioner applicant a registration if it is determined not to be in the public interest, which requires the consideration of five factors. The AG may suspend or revoke a registration to manufacture, distribute, or dispense upon finding that the applicant materially falsified an application; has been convicted of a felony; or has had a state license or registration suspended, revoked, or denied

Answer 10

All applicants and registrants must provide effective controls and procedures to guard against theft and diversion. The DEA considers several factors when evaluating the overall security system of a registrant or applicant. Individual practitioners must securely lock CSs in a substantially constructed cabinet. Pharmacies and institutional practitioners may do the same or disperse them throughout the stock of noncontrolled substances. May not employ any person whose application for registration has been denied or revoked -Presence of Alarms

Answer 11

Section 841 establishes penalties for drug traffickers and is applicable to practitioners who prescribe and/or dispense outside of the ordinary course of professional practice. Section 842 establishes penalties for practitioners for not conforming to the requirements of the CSA, such as recordkeeping. The standard was changed from strict liability to negligence

Answer 12

Constitutional issues: The Fourth Amendment protects individuals from unreasonable searches and seizures. Requires the issuance of a search warrant based on probable cause The exclusionary rule provides that any evidence obtained in violations of the Fourth Amendment will not be admissible.

Answer 13

The DEA has the authority to inspect any place where CS records are kept or persons who are registered. Allowed to examine and copy all records and reports, inspect within reasonable limits, and take an inventory of CSs Without consent of owner or person in charge (PIC), inspector not allowed to inspect financial, sales (other than shipping), or pricing data The audit procedure involves inspecting records of drugs received less drugs dispersed and comparing with inventory. Prior to inspection, the inspector is required to state the purpose of inspection and present the owner or PIC with credentials and written notice of inspection.

Answer 14

The NOI must contain the name of the owner or PIC, name and address of the business, date and time of inspection, and a statement that the NOI was given. The inspector must obtain a written statement of informed consent signed by the PIC or owner. Consent must be voluntary and not coerced and may be withdrawn at any time during the inspection. The PIC or owner can grant the inspector limited consent.

Answer 15

No consent required Probable cause requirement Valid public interest Contrast to probable cause for search warrant (SW) AIW created by Supreme Court as alternative to SW AIW may only be served during regular business hours. Several exceptions exist as to when a warrant is not required.

Answer 16

Some states allow warrantless searches of pharmacies. State warrantless search statutes may be constitutional, provided certain requirements are met.

Answer 17

Be cordial and cooperative. If inspection is not routine, the PIC should contact the owner and perhaps attorney if necessary. If DEA agents have a warrant, cannot refuse inspection If state inspectors do not have a warrant, whether consent is required depends upon state law. Never lie and generally best to say as little as possible Document what is said and done and do not sign anything not understood.

Answer 18

Congress first authorized narcotic treatment programs (now OTPs) in 1974. Only LAAM, methadone, buprenorphine, and buprenorphine containing products are authorized drugs for treatment of opioid addiction. Practitioners wanting to conduct maintenance or detox treatment must be registered by the DEA.

Answer 19

Used for severe pain outside of narcotic treatment programs Not legal to prescribe or dispense as an antitussive The American Pharmacists Association (APhA) lawsuit established that the FDA could not restrict the distribution of methadone. Manufacturers voluntarily restricted 40 mg methadone tablets to OTPs.

Answer 20

-Enacted in 2000 with intent of allowing addicts to be treated for addiction in office-based settings (outside of OTPs) -Currently, only permitted drugs are buprenorphine products -Treatment must be by a “qualifying practitioner” DEA number and state authorized to prescribe As of 2023 — NO DEA X NUMBER NEEDED As of 2023 — NO PATIENT LIMITS Goal: Increase in practitioners that can treat OUD patients, even pharmacists if states allow

Answer 21

The purpose of the law is to make it a federal crime if robbery results in $500 or greater replacement cost of CSs, or person suffers “significant” injury, or interstate commerce is involved in the planning or execution of the crime. Penalties can result in up to 20 years of imprisonment, $25,000 fine, or both. If a weapon is used, the penalties are higher. If death results, the penalty is higher yet.

Answer 22

Purpose: Curb illicit manufacture of controlled substances. - Places 20 chemicals + tableting/encapsulating machines under federal control. - Government authority: DEA can add or delete chemicals through rulemaking. -Requirements for manufacturers/suppliers: 1) Verify legitimacy of customers before transactions. 2)Maintain records of transactions. 3) Report certain transactions to the DEA.

Answer 23

Amends prior anabolic steroid legislation enacted to prevent misuse in order to enhance athletic performance Maintains anabolic steroids as schedule III Adds several steroids to the act Provides for automatic scheduling of certain salts, esters, and ethers of anabolic steroids without need to prove muscle growth

Answer 24

Places restrictions on OTC drugs used to manufacture methamphetamine including pseudoephedrine The law limits sale to no more than 3.6 g of ephedrine, PSE, or PPA base to a single purchaser per day. No consumer may purchase more than 9 g within a 30-day period or 7.5 g within a 30-day period by mail order. Check Pharmacist Manual) The products must be stored behind the counter or in a locked cabinet where customers do not have direct access. Sales must be recorded with required information. Many states have stricter laws.

Answer 25

CSs may be mailed, provided they meet the packaging standards established by the U.S. Postal Service.

Week 4 - Chapter 4 (MAX) Flashcards

(52 cards)