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all personal registration expires 12/31 of each even numbered year Fail to renew within 60 days then may apply to the board but may need to complete additional CE's Fail to renew after 2 years then must retake MPJE and meet all other requirements for renewal What is the number of CE's that must be completed 4 CEUs (40 contact hours per renewal ( 2 year period) what are the amount of CE per area that must be completed 2 hours of law not more than 15 contact hours shall be acquir...

how many compliance officers/inspectors does VA BOP have? 9 - 5 pharmacist inspectors assigned to inspect pharmacies, 4 non-pharmacist inspectors assigned to inspect other facilities licensed by the BOP how many pharmacist members are there on VA BOP? public members? -8 pharmacist -2 public do pharmacist members of the VA BOP have to be actively practicing? is there a minimum numbers of years of practice required? -no -not stated what is the term length of VA BOP members? is there ...

What did the Federal Controlled Substances Act do? Why was it implemented? Legislators very concerned in the 1960s about legal and illegal drugs being abused They were given the opportunity to design an act/law Created the DEA to promulgate and enforce the law Created a closed system between: manufacturer, distributors, prescriber, dispenser, and patient. What did the Pure Food and Drug Act of 1906 do? Prohibited the adulteration and misbranding of foods and drugs in interstate com...

Neither _____ nor _____ are required by an *ANDA*. -pre-clinical animal studies -clinical studies *bioequivalence only Prescription drug advertising is regulated by the _____, while OTC drug advertising is regulated by the _____. -FDA -FTC (Federal Trade Commission) Any false or misleading statements in a drug advertisement could be considered _____. - misbrandingPure Food and Drug Act (1906) description -mandated accurate product labeling and required that the ingredients used...

Codeine Limitation for Schedule III Not more than 18 mg/mL Not more than 90 mg per dosage unit Codeine Limitation for Schedule V Not more than 2 mg/mL and must have additional non- narcotic API Emergency C2 prescription hard copy must be delivered in 72 hours (7 days for federal, PA more strict) May dispense partial fill C2 for LTCF patients for up to 60 days Partial Filling for C3-5 No dispensing beyond 6 months Where and how long inventory records must be maintained 2 years a...

What did the FDCA of 1938 accomplish? Food, Drug, and Cosmetic Act 1) Drugs must be safe prior to marketing 2) Established the FDA - Food, Drug, Cosmetic, Medical device safety Durham-Humphrey Amendment of 1951 • Created a distinction between "OTC" and "Legend Drugs/Prescription". • Authorized verbal prescriptions/refills • Required Legend Drugs to carry the statement: "Caution: Federal law prohibits dispensing without a prescription.". Kefauver-Harris Amendment of 1962 1...

In NJ what are the members of the BOP and how many are there? 11 members that are all citizens 2 public 1 State executive dept member 8 RpH What the the BOP RpH requirements? all must be registered as an RpH in NJ for 5 years or more all must be actively engaged in pharmacy and may continue in pharmacy at least 1 of them must be employed by a chain drug store who owns or operates at least 7 pharmacy sites at least 1 of them must be employed by a health care systemat least one w...

Misbranding Drugs which are sold, dispensed or distributed in violation of labeling requirements of FDCA Adulterated or Misbranded?: False/misleading labeling Misbranded Adulterated or Misbranded?: Packaging fails to identify name & address of manufacturer, packager of distributor, and quantity of drug Misbranded Adulterated or Misbranded?: Any word or statement required on label is not prominent, conspicuous and readable Misbranded Adulterated or Misbranded?:

How many members make up GA Board? 8 Who commissions members of Board? Governor Who approves executive director of Board? Board of Community Health Who serves as Assistant Executive Director if there's no Executive Director of the Board? Director of GA Drugs & Narcotic Agency How many intern hours does an applicant need? 1500 How long is an intern license valid? 5 years What must a school/college submit for the Board's approval for intern hours and how frequently? Summary o...

DEA Form 222 Required for purchase of CI and CII drugs 1 item per line, number of lines noted at the bottom List name and address of supplier Copies 1 and 2 are submitted to supplier, copy 3 kept for record Should record each item received and date received on copy 3 Orders may be partially filled as long as the balance is shipped within 60 days Supplier may substitute 5x100 when 1x500 is requested After order is filled, supplier sends copy 2 to Special Agent in Charge at the DEA Form mu...

What are the requirements for graduates from a US pharmacy program for internship hour reporting? After July 1, 2020 they do not need to document completion of internship hours with the Commission Can interns change sites for recording intern hours? If so, what must be done? - Yes they can without Commission approval, but must notify them of the new site prior to earning hours - must be submitted within 30 days after intern has left the site with no intention of obtaining future experien...

How many members serve in the state board of pharmacy? 8 members (7 pharmacist and 1 consumer) How long does each member of the board of pharmacy serve? 5 years Who issues pharmacist licenses? The GA BOP Is the GA BOP a separate entity or under another department? Separate Entity How are board members selected? Appointed by the governor How often does the board convene? At least annually to organize and elect a president and vice president What is the minimum age to become a ...

Waiting period for MPJE after failing 30 days Adjusting drug regimen shall not... include substuting or selecting a different drug which differs from that initially prescribed by pt's physician unless substitution is authorized in order or protocol. RPH can make changes to pt's drug therapy IF authorized in protocol Ordering or performing route patient monitoring fxns may be necessary in drug therapy management. If MD disagrees with professional judgment of RPH Judgment of the M...

Massachusetts State Board of Pharmacy consists of how many members? A) 7 B) 13 C) 9 D) 5 (b) 13, [M.G.L Chapter 13: Section 22]. The governor shall appoint 13 members to the board. Members shall be residents of the commonwealth. No person who has been convicted of a felony or other crime involving embezzlement, theft, fraud or perjury shall serve as a member of the board. The board shall be comprised of: 8 registered pharmacists; 1 pharmacy technician; 1 representative of the p...

Change of Address/Employment/Legal Name Notify Board within 10 days. Must notify with change in employment listing old employer and new employer. Change of name must include a copy of document that created name change (marriage certificate) + wallet card Loss of Controlled Substances - PIC must report loss/theft directly to board immediately - *Complete inventory of CS with in 48 hours and send copy to BOP within 15 days with report* Change of PIC - Return pharmacy permit to BOP with wr...

Sherman Antitrust Act This act: Outlaws agreements that restrain trade. Prevent monopolies and mergers that lessen competition Federal Food Drug and Cosmetic Act This act states: No adulterated or misbranded drugs in interstate commerce Adulteration Gross - Think inside the capsule Misbranded Improperly labeled - think outside the bottle FDCA This act requires: ingredients are disclosed on bottle drug must be proven safe before marketing authorizes FDA inspection of manufactur...

DEA 224 Registration for: - Retail pharmacies - Hospitals/clinics - Practitioners - Teaching Institution - Mid-Level Practitioners Retail pharmacy registration 224 Hospital registration 224 Clinic registration 224 Practitioner registration 224Teaching institution registration 224 Mid-Level practitioner registration 224 DEA 225 Registration for: - Manufacturers - Distributors - Researchers - Analytical laboratories - Importers - Exporters Manufacturer registrat...

How many time may a candidate repeat the NAPLEX or MPJE No more than 5 consecutive times without passing How many days do you have to wait in between NAPLEX attempts 45 days How many days do you have to wait in between MPJE attempts 30 days What must be completed by a pharmacist wanting license reinstatement that has been out of practice for 1 year but less than 6 years -submit renewal -pay past renewal fees and reinstatements fees -submit proof of continuing education for each in...

Pharmacists can prescribe nicotine replacement therapy, including Zyban and Chantix False; pharmacists can prescribe NRT but Zyban and Chantix do not contain nicotine so it does not constitute NRT Pharmacists can dispense naloxone without prescription: 1. by protocol with physician 2. pursuant to statewide standing order/approved by DHSS 3. to a qualified first responder agency Sales records must be maintained for ____ years and prescription records maintained for ____ years sales rec...

Pure Food and Drug Act of 1906 (Wiley Act) Prevents adulteration and misbranding Drugs met standard of strength/quality/purity according to USP/NF Food, Drug, and Cosmetic Act of 1938 Required manufacturer to prove drug safety prior to marketing it Also defined/regulated: adulteration, misbranding, interstate commerce Durham Humphrey Amendment of 1951 Divided medications into OTC and prescription (legend) drugs Kefauver-Harris Amendment of 1962 Manufacturer's must prove that a dr...