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Statute and who makes them? More generalized and made by the government. Rules and who makes them? Very specific and made by the agency that regulates the specific area. (Ex. BOP makes up the rules for the practice of pharmacy) Role of FDA To protect the public by ensuring the safety, effectiveness and security of drugs/medical devices, food, cosmetics, etc. USP/NF Sets standards for the quality, purity, identity, and strength of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. Role of DEA Federal law enforcement agency responsible for enforcement of the controlled substances act, combating drug smuggling and coordinating drug investigations. What department is the DEA under? US Department of Justice Federal Pure Food and Drugs Act Provided federal inspection of meat products and forbade the manufacture sale or transportation of adulterated food production and poisonous medicines. Harrision Narcotic Act Regulated and taxed production, importation and distribution of opiates. Food, Drug and Cosmetic act Gave the FDA authority to ensure drug safety; drugs had to be safe, and new drugs had to be tested. Drug Articles intended to use in the diagnosis, cure, mitigation, treatment and prevention of disease in man or other animals. Articles other than food intended to affect the structure of any function of the body of man. Food Articles used for food or drink Counterfeit Drug A drug which contains false information on the label, isn't what it says it is, or doesn't do what it says it does. Device Instrument recognized by the USP, intended for the diagnosis or treatment of disease, intended to affect the struct or function of the human body. Cosmetic Articles to be applied to the human body to cleanse, beautify, promote attractiveness, or alter appearance. Adulteration Something is wrong with the actual drug entity Misbranding Something is wrong with the label. Durham-Humphrey Amendment All products must be labeled correctly Kefauver-Harris Amendment All products must be safe and effective. Control Substance Act Created the schedules 1-5 controlled substances. Poison Prevention Packaging Act Child-resistant locking caps Tamper Resistant Packaging. Set standards for tamper-resistant packaging. Prescription Drug Marketing Act Cannot sale or trade drugs that were brought by the hospital for discount. Reasons for Prescription Drug Marketing Act designed to discourage the sale of counterfeit, misbranded and expired prescription drugs. Food and Drug Administration Modernization Act Modernized the FDA. Changed the way it would operate in the 21st century. Combat Methamphetamine Epidemic Act Set the strict rules for psuedoephedrine OTC category I Safe and effective OTC category II Isn't safe and effective OTC category III Not enough data Who is DDub? Daniels Wells Ways for Prescription drugs to become OTC Drug company or an interested party requests it then the committee in the FDA can decide. Single Source Available from one place Multisource Available from multiple sources Pharmaceutical Equivalent Same active ingredient, strength, formulation, route. Therapeutic Equivalent Pharmaceutical equivalent and bioequivalent Recall Class I Reasonable potential to cause extreme harm or death to patient. Recall Class II Use of product may cause temporary or reversible consequences. Recall Class III Product is not likely to cause adverse health consequences. What's on the lab of OTC Products? (6) Active ingredient, uses, warnings, directions, other information, inactive ingredients. Who is Cleats? Saul Pandey What is the C1 controlled substance schedule? Highest potential for abuse with NO current therapeutic use in US. ex: Heroin, marijuana. What is the C2 controlled substance schedule? Abuse can lead to severe psychological and physical dependence. ex: opioids, codiene, morphine, amphetamine. oxycodone. What is the C3 controlled substance schedule? Abuse may lead to moderate to low physical dependents but high psychological dependence. Ex. Stimulants and Depressants, Anabolic Steriods What is the C4 controlled substance schedule? Abuse may lead to low to moderate physical and psychological dependence. Ex. Benzodiazepines, phenobarbital. What is the C5 controlled substance schedule? Abuse may lead to limited physical or psychological dependence. Ex. Some cough syrups, buprenorphine, pyrovalerone. Administer The direct application of a drug to the body of a patient or research subject by injection, inhalation, ingestion or other means. Collaborative Pharmacy Practice. The practice of pharmacy where pharmacists and physicians work in conjunction under written protocol where pharmacist may perform certain patient care unctions authorized by the physicians. Collaborative Pharmacy Practice Agreement Written and sign agreement between the pharmacist, physician and patient that provides for collaborative care practice, must be approved by the BOP, BOM. Compounding The preparation, mixing, assembling, packaging, or labeling of a drug or device. Intern Can work in practice under the supervision of a licensed pharmacist and is satisfactorily progressing toward licensure of pharmacist. Pharmacist An individual currently licensed by the state to practice pharmacy or pharmaceutical care. Pharmacist In Charge A pharmacist currently license who accepts responsibility for the operation of a pharmacy in conformance with all laws and rules and who is in full charge of the pharmacy and personnel. Who makes up the BOP? 5 practicing pharmacists and 2 members of the public. Qualifications for licensure of a pharmacist (5) 18 or older graduate of recognized school completed at least 1500 hours of internship pass examination approved by BOP present to the BOP that he or she is a person of good moral character, has not been convicted of felony and is not addicted to alcohol or controlled substances. Who is JJ Han? Sheldon Wolfson AKA Shelly, Shewold, Sdub, Kosher Boy Requirements for pharmacy technician(4) 18 or older. High school graduate or equivalent present to the BOP that he or she is a person of good moral character, has not been convicted of felony and is not addicted to alcohol or controlled substances. Must complete BOP approved technician training program. Max # of Techs per pharmacist 4 Indirect supervision of technicians Pharmacist may take a break for 30 minutes but not leave the building. While on break, techs may continue filling but they cannot be delivered until the pharmacist is verified. Protocols must be in place that allow tech to interrupt the break if emergency arises. Requirements for generic substitutions A pharmacist who receives a prescriptions for a brand name drug shall substitute a less expensive equivalent generic name drug unless with professional judgement the pharmacist or physician believes that the less expensive drug is not suitable for the particular patient. Pharmacist in Charge requirements Pharmacy must be under the direction and supervision of licensed pharmacist who shall be designated by the owner of the pharmacy as the PIC. Must be filled within 30 days of designation. An interim PIC may be designated for no more than 60 days. PIC is responsible for the pharmacy's compliance within the State and federal pharmacy laws and regulations and for maintaining records and inventory. Can you fill a prescription more than one year after written date? No. Unless approved by the physician. Partial filling of prescriptions of Schedule II Permissible if the pharmacist is unable to supply the full quantity. The remaining must be filled within 72 hours. Partial filling LTFC Schedule II can be valid for a period of 60 days unless discontinued by the physician. Must note "terminal ill" or "LTCF patient". Collaborative pharmacy practice agreement requirements Be a licensed pharmacist. Have at least $1,000,000 insurance coverage. And one of the following: Certificate from BOPS, ASHP residency program (2 year experience), holds PharmD and 3 years clinical experience and ACPE approved program for area collaborative practice, bachelor degrees require 5 years. Administration of immunizations Pharmacists may give influenza or pneumonia vaccines to anyone 18 years or older. Prior to administrations, must have completed a board approved immunization course and completed American Red Cross or AHA basic life support training and maintain certification in the same. Rx requirements for controlled substances (II) In emergency, pharmacist may take oral rx from dr for schedule II. No schedule II may be refilled. Patient must present photo ID reflecting DOB. Who is Zeus? Alex Wells AKA Adub Nobody can possess a controlled substance unless obtained by a valid prescription. Exactly. Controlled substance monitoring system Must contain: Name, address, phone # and DEA # of dispensing pharmacy Name, address, DOB for patient. Name, address and DEA # of practitioner. Name and national drug code # of schedule II, III, and IV, quantity and dosage, date the script was filled, and number of refills. Purpose of internship? for the intern to acquire practical experience under the direct supervision and instruction of licensed pharmacist preceptor. Intern certificate expires and must be renewed? Expires on June 30th of each year. Can be renewed annually and up to 4 years from date of issue. Must be displayed at the place of internship. Intern must notify the BOP within how many days of employment? 10. Intern must notify the BOP within how many days of termination? 10 When must you submit "Certification by Preceptor as to Internship?' Immediately after termination of internship. To be certified as an intern, do you have to be enrolled in school? Yes, or a graduate of a SOP. How many hours will the BOP accept from school intern hours? 800 hours. Can you get intern hours from outside the state? Yes. Or up to 1/3 from another country. Returning drugs Drugs cannot returned to pharmacy unless to be destroyed unless they are EXACTLY as they were and sealed; NO controlled substances. Drug Substitution (bioequivalance) Must start with an A in the orange book. Example AB. Emergency Dispensing by Pharmacist Cannot dispense more than 10 days worth of medicine. Must contact Dr. after. How long do we keep records? 5 years. Schedule II controlled substances are valid for? 90 days. Schedule III and IV are valid for? 6 months. Schedule III and IV may not be refilled more than? 5 times. Schedule III and IV partial fills? May be more than 5 times as long as long as the total quantity is not exceeded. Prescription monitoring program information must be transmitted how often? Weekly. Who looks like a taxi driver? Peter Relvas.