What is not true of cgmps - Study guides, Class notes & Summaries

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A drug...shall be deemed adulterated...if...the methods used in, or the facilities or controls used for its manufacture, processing, packing, or holding, do not conform to, or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this Act as to safety and has the identity and _____________ and meets the quality and ______________ characteristics, which it purports or is represented to possess." solution:palata...

BACE EXAM VERSION B QUESTIONS AND ANSWERS What event occurred in the 1950's that contributed to the growth of biotechnology? Structure of DNA described, as well as its method of replication The advent of recombinant DNA technology began with which of the following events? Isolation of restriction enzymes Which of the following statements is FALSE regarding vaccines? They signal the immune system to make antigens against the microorganism for which the vaccine was developed. ...

Biotechnician Assistant Credentialing Practice Exam Latest Update Graded A After performing the PCR reaction with the primers she designed to amplify lanA, the same technician found that her PCR reaction contained two distinct bands, one at the expected size of 1200 kilobase pairs, and another unexpected band at 2000 kilobase pairs. What is the most likely reason there is an unexpected band in her PCR reaction? She used an annealing temperature that was too low In a biotechnology lab, tap wate...

RAC Chapter 18N (15)- OTC Drug Products Questions And Answers In 1951 the Durham-Humphrey Amendment to the Federal Food, Drug,and Cosmetic Act (FD&C Act) established what three criteria that would limit a drug to prescription status: - ANS-• habit forming drugs • not safe for use unless supervised by a healthcare professional • limited to prescription use under a New Drug Application (NDA) What are the typical characteristics for OTC drugs? - ANS-• benefits clearly outweigh pos...

Texas pharmacist can administer all vaccines - ANSWER True requires written protocol with MD What age can pharmacist administer influenza - ANSWER 7 Can C2 prescriptions be refilled? - ANSWER no therefore no emergency refills What is the min age for vaccines other than the flu? except? - ANSWER 14 unless the child is referred by a physician can only be given at pharmacy or location provided in protocol (LTCF) How many hours for nuclear training - ANSWER 700 hours State board ...

RAC Chapter 18N (15)- OTC Drug Products Questions and Answers In 1951 the Durham-Humphrey Amendment to the Federal Food, Drug,and Cosmetic Act (FD&C Act) established what three criteria that would limit a drug to prescription status: ANSWER • habit forming drugs • not safe for use unless supervised by a healthcare professional • limited to prescription use under a New Drug Application (NDA) What are the typical characteristics for OTC drugs? ANSWER • benefits clearly outweigh p...

In 1951 the Durham-Humphrey Amendment to the Federal Food, Drug,and Cosmetic Act (FD&C Act) established what three criteria that would limit a drug to prescription status: - Answer-• habit forming drugs • not safe for use unless supervised by a healthcare professional • limited to prescription use under a New Drug Application (NDA) What are the typical characteristics for OTC drugs? - Answer-• benefits clearly outweigh possible risks • potential for misuse and abuse is low •...

Laws vs. Regulations - Answer laws - enacted through a federal or state legislative process regulations - (or rules) provide specific details to help implement the law, and are issued by state regulatory agencies (e.g. state board of pharmacy) FDA Drug Approval Process - Answer 1) pre-clinical testing (animals) 2) manufacturer files an investigational new drug (INDA) application with the FDA 3) INDA approval --> begin Phase 1 study, Phase 2, then Phase 3 4) file a new drug application...

Texas MPJE Exam 2022 Questions and Answers A Grade Texas pharmacist can administer all vaccines - True requires written protocol with MD What age can pharmacist administer influenza - 7 Can C2 prescriptions be refilled? - no therefore no emergency refills What is the min age for vaccines other than the flu? except? - 14 unless the child is referred by a physician can only be given at pharmacy or location provided in protocol (LTCF) How many hours for nuclear training - 700 ho...