MPJE (Michigan Law) Latest Update Graded A

MPJE (Michigan Law) Latest Update Graded A Hatch-Waxman Act In 1984 this allowed greater access for companies to dispense generic drugs. Drugs companies must submit this for a generic drug: Abbreviated New Drug Application (ANDA) ANDA process Does not require companies to repeat animal and clinical research on ingredients. ANDA Process applies to drugs made after: 1962 Generic drug has to match with the following: Identity, Strength, Purity and Quality (ISPQ) If a drug has an NDC does it guarantee drug approval? NO Use of an unapproved drug such as Domperidone is: Misbranding Side effects statement: States to call doctor for medical advice about SE. Alway may report SE to FDA. Included with new fills and refills Does the side effect statement apply to inpatients and health care facility under the order of a licensed practitioner? NO OTC Side Effect Statement: If not statement, must have number to report it to Font requirements for statements: There isn't a specific requirement for meds but for OTC must be a minimum of 6 point bold letter. Anything topical is exempt from Poison Prevention Packaging Act except: Nasal and lidocaine What is exempt from the Poison Prevention Packaging Act? Samples and Starter Packs Any nose drop with this substance needs a PPPA: Oxymetazolone Market Withdrawal: A firm removes the product from the market to correct a violation Michigan Samples Under article 17 a physician may delegate to a pharmacist in writing the receipt of a complimentary starter dose of drugs other than CS CS to Foreign Countries Has to be registered as an exporter to ship CS out of country. US resident can bring up to how many CS units from overseas: 50 but they have to declare it PI (Package Insert) vs PPI (Patient Package Insert) Package insert is just professional information where patient package insert is required with all fills if medication requires it Michigan Counseling MUST offer counseling with each new drug patient is on Are pharmacies able to compound and manufacture drugs at the same location? NO If a pharmacy ships more than 5% of compounded drugs they must: Sign a memorandum of understanding with the FA Outsourcing Facility Has to be licensed by the state of Michigan as a pharmacy but the FDA registration is "voluntary" An outsourcing facility can compound copies of a medication when: It is on a shortage list An outsourcing facility has how many days to report an adverse event? 10 days Is there a limit on the ratio of technicians and support staff to pharmacists NO Pharmacy intern to RPH ratio 2:1 Pharmacy Board Composition 6 pharmacists, 4 public members and 1 technician Term length Two terms of four-years along with one partial term Disciplinary Subcommittee Has to include 3 professional members (tech/RPH) and 2 public members Disciplinary Subcommittee Requirement One public person has to vote with the majority otherwise the bill does not pass. Full license no limitation in time and restriction to whom a person can work for Limited License Restricted to one employer who they can work for Temporary License Has an expiration of one year