US Law falls under several categories:

1. US Law falls under several categories: • Criminal law: involves a crime against an individual specifically and to society in general. Examples are Murder, rape, sexual assault, burglary, grand larceny. It is brought to trial by a district attorney or prosecutor who seeks an indictment or a conviction of a crime by a jury to the offender. • Civil law (tort law): deals with dispute resolution between individuals and/or organizations. Emphasis is on compensation and not on punishment. Most cases of medical malpractice fall under this category. Medical cases that result in death can be heard here as “wrongful death” cases. • Family Law • Penalties • Misdemeanor is a crime punishable by a jail term of 1 year or less and/or a monetary fine • Felony is a crime punishable by a jail term of greater than 1 year up to life or death.

2. Important Milestones in Pharmacy law • Pure Food and Drug Act of 1906: forbade the manufacture, sale and distribution of adulterated medications as well as meat and poultry products. • Food, Drug, and Cosmetic Act of 1938 established the Food and Drug Administration which oversees the production of drugs, cosmetics and food products in terms of certain standards. Standards are: • Manufacturers of drugs are required to submitted safety data before they can market any drug. • Requirements for label and labeling of drugs • FDA is charged with protecting the public by enforcing FDCA

3. Label and Labeling requirements made by the FDCA. • Labels are on the immediate container of the drug • Must include: • established name of drug and quantity of each active ingredient. • Statement of quantity • Statement of usual dosage • Route of administration • If habit forming, federal disclaimer • Name of all inactive ingredients if not for oral use • Name and address of manufacturer, packer or distributor • Lot number and expiration date • Specific container to be used by the pharmacist to dispense medication (i.e. dispense in an amber vial for light sensitive drugs)

4. Additional label elements added through later amendments • National drug code • FD&C yellow #5 (Tartazine) or yellow #6 if present (human allergens) • If aspartame is present must declare phenylalanine and PKU warning • If sulfites are present, must declare it • If methysalicylate is present in concentration of over 5% must state toxicity warning

5. OTC label requirements • Drug Manufacturer’s name and address • Active ingredient(s) • Inactive ingredients • “Purposes” sections • “Don’t use” section • “Directions” • “Questions” section provides an toll free number of questions • These requirements were added through amendments to the FDCA over the years

6. Labeling requirements by the FDCA • Labeling is the printed material that accompanies the medication container. This is called the Package Insert and is required by the FDA and is intended for use by healthcare clinicians • Description of the chemical nature of the drug including its generic name and chemical properties • Pharmacology • Indications for use • Contraindications-situation where the drug should not be used • Dose • Warnings • Side effect warnings • Adverse reactions • Drug Abuse potential, if applicable • How drug is supplied • Date of most recent revision to labeling

7. FDCA defines a drug • FDCA defined a drug as: “article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animal” • FDCA defines adulteration as: • A product that is combined with an ingredient that reduces its potency or quality, any putrid or decomposing substances • A product that is kept in unsanitary conditions • A product that contains unapproved colorants • Manufactured under conditions that are less than GMP’s • Claims to be a drug of USP standards but is differing in quality • See text for additional information

8. FDCA defines misbranding as “false and misleading labeling” or dispensing or distributing a product in violation of its labeling • Does not include the established name of the drug • The name and/or address of the manufacturer is missing • Failure to include Federal disclaimer or “Rx only” on legend drugs labels (see Durham Humphrey) or dispensing a legend drug without a prescription • Sale of a drug under the name of another • Failure to include “Warning –May be habit forming” if required on its label • See text for other provisions • In general, adulteration involves the composition of the drug products and misbranding involves misleading labeling

9. Amendments to the FDCA • Durham Humphrey Amendment of 1951 • called the prescription drug amendment • Established two classes of drugs: legend drugs that require a prescription and OTC with does not • required that legend drugs must have the federal legend: “Caution: Federal law prohibits dispensing without a prescription”. Later in 1997, legend was shorten to “Rx only” • Legend drugs not label with such are misbranded • Allows prescribers to phone in Rx’s to pharmacies • Kefauver Harris Amendment of 1962: established that drugs be proven safe and effective before they are marketed to the public. • Act came about because of the thalidomide tragedy. • Also called the “Drug efficacy amendment”. Drug needed to be safe and effective. • Established marketing protocols for NDA’s • Also regulate prescription drug advertising

10. Thalidomide Scare of 1950’s and 1960’s • First used in Europe as a “wonder” drug for pain, and insomnia. It was reported to be effective for treating nausea and as a result it was used to treat morning sickness in pregnant women. • The US FDA never allowed the drug to be marketed in the US. Pregnant women obtained the drug from other sources like across border trade and their husbands returning from WWII active duty in Europe • Birth defects have been linked to the drug even after only one dose. • This was proven by 1961. • The defect involved an absence/malformation of limbs in the fetus called phocomelia.

11. Thalidomide syndrome

12. Thalidomide Today • Thalidomide was removed from the worldwide market in 1962-1963. • Today however the drug is market in the US under the brand name Thalomid® under very strict conditions and requires registration with the STEPS program (system for thalidomide education and prescribing safety). The program is monitored by the FDA and requires registration by doctors, patients and pharmacists for dispensing. • Drug has approval from the FDA for use in Erythema Nodosum Leprosum and in multiple myeloma.

13. Other lesser known pharmacy laws • 1914: Harrison Narcotic Act : The possession of narcotics and coca became illegal. • 1924: Heroin Act: The manufacture and the possession of heroin became illegal. • 1927: Bureau of Prohibition: enforces the 18th amendment to the US constitution. • 1937: Marijuana Tax Act: requires payment of a tax to buy cannabis. Illegal to do so without payment.

14. The Comprehensive Drug Abuse Prevention and Control Act of 1970 • Established five schedules of drugs that have high potential for abuse. Listed with symbol “C” followed by a number from 1 to 5. 1 having the highest potential for abuse and 5 the lowest. • Established the Drug Enforcement Agency (DEA) under the US Dept of Justice • Standards are set in each class that helps law enforcement prevent diversion and to protect the public. • Schedule I: have no accepted medical use in the US. Includes Heroin (smack), LSD, marijuana (weed), methaqualone (Luddes) • “Crack” cocaine • Crystal Methamphetamine • Hashish • Heroin • Phencyclidine palmitate (PCP) (angel dust) • Rohypnol (Roofies)

15. Schedule II Drugs

16. Schedule III Drugs

17. Schedule IV Drugs

18. Schedule V Drugs

19. Exception to the CSA Drug Schedules • Some drugs are typical narcotics but because they are combined with other less potent dugs with more side effects they are de-scheduled from the CSA • Additive are meant to discouraged abuse • Examples • Pyridium Plus (Butabarbital) • Librax ® (Chlordiazepoxide/Clidinium Bromide) • Donnatal ® (Phenobarbital, atropine, hyoscyamine, scopolamine) • Anaspaz PB (Hyoscyamine/Phenobarbital) • Remember Fiorinal ® (Butalbital/Caffeine/ASA) is a scheduled drug but Fioricet (Butalbital/Caffeine/APAP) is not • Remember: BDZ are CIII federal, in NY they are CII • Remember: Barbiturates are CIV except: Secobarbital (Seconal ®) and Amobarbital (Amytal ®)

20. Schedule II Drugs- General Guidelines • prescriptions may be written for a one month supply maximum with no refills. • Have strong potential for abuse and have a medical purpose • Must use DEA 222 to order • Must use DEA 106 form to report loss or theft • Can be written, or electronic • Can’t be faxed (ok in only limited circumstances) • Can’t be called in (exemption Emergency Verbal)

21. Scheduled III & IV Drugs • Prescriptions can be written, phone in, faxed, or sent electronically • Can be filled for up to 5 refills or up to 6 months • DEA 106 to report loss or theft • Can be transferred to other pharmacy

22. Schedule drugs continued • Schedule V: includes cough preparation with codeine. Example is Tussin C® (Guaifenesin with Codeine). Up to 11 refills are allowed like a regular prescription and is valid for one year. • Can be phone in, written, faxed or electronically sent to a pharmacy • DEA 106 is filed for theft or loss • Can be filled with out a prescription only under the following conditions: • Sold by a pharmacist • Log book must be keep • No more than 4 ounces or 24 solid dose forms in a 48 hour period to a single patient

23. Other provision of the CSA • All individuals handling controlled substance are required to register with the DEA (Drug Enforcement Agency which is a branch of the US Dept. of Justice). This includes MD’s, drug companies, distributors, pharmacies (not individual pharmacists). • A prescription for a controlled substance must have the following to be dispensed: • The full name and address of both prescriber and patient. • DEA of the prescriber • Date prescription was written • Signature of the prescriber. • Drug name, dose, directions for use • Quantity • Refills (if any) • A pharmacist can’t alter the name of the patient, drug, or the prescriber’s signature. Under Federal law, other information can be altered with prescriber’s permission

24. Security Requirements • As per Federal Law, prescriptions for CII-CV can be either locked up or dispersed. • If CII are grouped together, they must be locked up in a cabinet • If CIII-CV are grouped together, they must be locked up in a cabinet • If controlled substances are not locked up, they must be scattered among the pharmacy’s entire inventory • Either group and Lock or Separate and scatter

25. Record Keeping of Controlled Substances • All invoices of controlled substances must be kept for two years • DEA 222 must be attached to the corresponding invoice • CII invoice must separate from other pharmacy invoices • Biennial Inventory • All scheduled controlled substances in house must be inventoried every two years • Exact physically count of CII is required • Estimated count of CIII-CV is ok if products are container s with less than 1,000 count • Controlled Substance Prescriptions • Maintained on file for 2 years • Options for filing • 1. Three files- CII, CIII-CV, other legend drugs • 2. Two files- CII, CIII-CV + other drugs (CIII-CV must have red “C” in corner) • 3. Two files- CII-CV and other legend drugs (CIII-CV must have red “C” in corner)

26. To destroy controlled substances • Must notify DEA office and state narcotic office (NYS DOH Bureau of Narcotic Enforcement) of Day and time of destruction • DEA 41 is used to surrender drugs to the DEA directly • To report theft of controlled substances • Notify local police • Notify DEA office • State narcotic office • Fill out DEA 106 form • To order c2 drugs complete • DEA 222 form • To apply for a DEA registration • DEA 224

27. DEA numbers • DEA numbers are issued by the US Dept of Justice to entities that prescriber, dispense, manufacturer, distribute or export scheduled controlled substances • Contains 2 letters with a 7 digit number • 1 st letter signifies the type of DEA registrant • A/B/F are doctors, dentists, hospitals, clinics, pharmacies • M are midlevel practitioners (PA, NP, etc) • P/R are manufacturers, exporters, wholesalers, etc • 2 nd letter is part of the entity’s name (most often the first initial of the last name) • Six digits are the serial number • Seventh digit is a checksum digit

28. DEA Number • To verify if a DEA number is valid perform the checksum algorithm • First Add the 1st,3rd,5th digits together • Second add 2nd,4th and 6th digits together and multiply by two • Third add the results of the two together and if it match the check digit the DEA is valid. If not, the DEA number is fraudulent

29. Penalties involving violations of the CSA of 1970

30. Penalties for Violations of CSA of 1970

31. The above table contains that maximum penalty for jail time or amounts that are less than the one above the fine and penalties are less. These listed offenses are for first time offenses Flunitrazepam (Rohypnol® or street name of “Roofies” is a benzodiazepine that produces powerful sedation and anterograde amnesia. It is a “date rape drug” and has been used in committing sexual assault in the US and other countries. GHB (gamma hydroxybutyrate) is similar to flunitrazepam and is a date rape drug also known as “Georgia Home Boy","Lollipops"

32. Rockefeller Drug Laws • In 1973, NYS governor Nelson Rockefeller signed in law one of the most draconian state drug laws in the US. • Anyone with illegal possession with intent to sell 57 grams or more of heroin, cocaine, marihuana, morphine would sentenced to a minimum of 15 years • Anyone with illegal possession of 113 grams or more of the above drugs would serve 15 years to life. • Due to political pressures, governors George Pataki and David Patterson greatly reduced these minimum sentences to class D felonies and for marihuana a misdemeanor • Criminal possession of prescription narcotics is still a felony in most cases in NY

33. The Orphan Drug Act of 1983 • Passed by congress to provide incentives for drug companies to create drugs for rare diseases in which the profit motivation is not there. • 50% tax credit in the cost of conducting clinical trials. • Research grants • Waive the costs of submitting fees to the FDA. • Example is a drug called Aldurazyme® made by BioMarin Pharmaceuticals (California based company with the ticker symbol: Nasdaq: BMRN). It is an enzyme that is lacking in a genetic disease called Hurler’s syndrome. People with Hurler’s are often disfigured with gargoyle like features. They are often mentally retarded with other neurological features. They also have failing organs in particular the liver. They often will die by about 10 years of age because of liver disease.

34. The Drug Price Competition and Patent Term Restoration Act of 1984 • Result of a decade long dispute between generic drug manufacturers and brand drug manufacturers • Allowed manufacturers of generic drugs to file an Abbreviated New Drug Applications (ANDA) with the FDA. • Allowed these companies to show that their generic drugs where therapeutically equivalent to their brand competitors without the necessity of going through extensive efficacy and safety testing. • Did not sit well with large brand drug companies. To help these drug manufacturers recoup their costs the term of brand drug patents were extended by an additional five years • Called “generic drug act” • Also called the Hatch Waxman act

35. Anabolic Steroid Control Act of 1990 • Placed anabolic steroids in the CIII category. • Hormones that are pharmacological similar to testosterone • Responded to high rate of steroid abuse in young teens and athletes (Mark McGuire and Barry Bonds). • Example of such drugs: Anadrol® (oxymetholone) and Winstrol ® (stanozolol).

36. Omnibus Budget Reconciliation act of 1990 (OBRA 90) • Passed by congress to address the rising cost of the medicaid and medicare programs • Required pharmacist to counsel all medicaid patients. This requirement later extended to all patients depending on the state of residency. • Required the pharmacist to perform a DUR, drug utilization review to screen for: • Drug interactions • Therapeutic duplicates • Drug disease interactions • Wrong dosing • Abuse of medications (earlier refills) • Created a need for pharmacy technicians to assist pharmacists in the technical aspects of pharmacy to allow them to devoted more time to the clinical aspects of pharmacy practice.

37. The Health Insurance Portability and Accountability Act of 1996 • Known as “HIPAA” • Requires that protected health information (PHI)be safeguarded by the healthcare industry. • Medical records need to be safeguarded electronically which may involve encryption coding and password protection. • Patient’s rights under HIPAA include: • Access to their own health information • Ability to amended information • Ability to control to whom PHI is disclosed • Receive written notification of how PHI may be used by the health provider also know as “notice of privacy practices” • When PHI is used by a provider for any reason other than treatment or payment, explicit authorization must be obtained from the patient. • Portability refers to the ability to transfer insurance provision from one employer to another • Requires pharmacy to appoint a HIPAA compliance officer

38. Penalties for HIPAA violations • Civil Penalties: up to $25,000 fine • Criminal Penalties are incurred if the entity knowingly using PHI unlawfully • $50,000 and 1 year in prison • $100,000 and 5 years in prison if entity obtains PHI under false pretenses • $250,000 and 10 years in prison if entity sells PHI for personal gain or for malicious harm to patient’s reputation

39. Ancillary Laws • Poison Prevention Packaging Act of 1970 • Required childproof dispensing containers for all Rx drugs • Elderly people who desire non child resistant container must sign a waiver. • A prescriber can waive the requirement by only for one prescription at a time (no blanket authorization) • Drug exceptions to the PPPA are sublingual nitroglycerin, oral contraceptives in the memory package dial, erythromycin ethylsuccinate tablets, Mebendazole Tablets, Pancrelipase preparations, among others see text on page 52 • Conditional Exceptions • patients in hospitals • For OTC products with more than one strength, one strength can be marketed with out this package if the following is on the package: “Not for households with young children” • Upon dispensing a refill, the pharmacist must used a new plastic vial and cap to refill the prescription due to the high wear and tear of Rx vials

40. Prescription Drug Marketing Act of 1987 • Passed to stop the passage of counterfeit drugs into the marketplace and to stop unfair monetary gain from illegally procured drugs • Made it illegal for retail pharmacies to have in its possession Rx drug samples from the manufacturer • Hospital Pharmacies were not allowed to resale drug obtained through discounted pricing. • Prevents the reimportation of drug into the US except by the drug manufacturer • Think of it has the “prescription drug samples act”

41. Medical Device Amendment of 1976 • Life saving medical devices were required to have premarket approval by the FDA • Example is a cardiac pacemaker and defibrillators • The Drug Listing Act of 1972 • Amendment to FDCA • Required all drugs to have an NDC code • NDC’s have three parts • First set of five numbers-Manufacturer • Second set of four numbers-drug product • Third set of two numbers-package size

42. Medicare Prescription Drug, Improvement, and Modernization act of 2003 • Provides prescription drug coverage for medicare participants • Provides for medication therapy management (MTM) where pharmacist can receive compensation for this • Also called the Medicare Modernization act (MMA) • Medicaid Tamper Resistant Prescription Act of 2007 • Due to high federal cost of funding medicare and medicaid, the government mandated that doctors implement counterfeit proofing strategies of their prescription pads • Does not apply if an Rx is faxed, phoned or electronically sent directly to the pharmacy

43. Online Pharmacy Consumer Protection Act of 2007 • Also called the Ryan Haight Act • Ryan Haight was a 17 year old teen who died from an overdose of vicodin ® obtained from an internet based pharmacy. Ryan posed as a adult male with severe back pain • Established guidelines for online pharmacies • Must display compliance with this law on the site’s homepage • Defined that a Rx for a controlled substance must be for a legit medical reason AND involves at least one in person medical evaluation

44. Occupational Safety and Health Act of 1970 • Created OSHA agency • Addresses workplace safety from hazardous substances • Addresses air quality, flammable and explosive chemicals, and hazardous drugs • Requires a reporting system for job related injuries • Requires the use of SDS-Safety Data Sheets (also called MSDS M=Material) • SDS are required to be distributed by manufacturers of hazardous chemicals or drugs to the purchaser • SDS provides users of such with data on Hazards, fire aid measures of exposed, fire fighting methods, handling and storage, Physical and chemical properties, stability and reactivity

45. Resource Conservation and Recovery Act of 1976 • Known as the RCRA • Established different classes of hazardous waste materials • F listed (industrial solvents) • K listed (specific industrial wastes) • P listed (finished commercial drug products that are acutely toxic) includes warfarin, nicotine, physostigmine, epinephrine (Adrenalin) • U listed (finished commercial drug products that are subacutely toxic). Most chemotherapy drugs • Most Pharmacies use a vendor that handles and disposes hazardous drugs for them in compliance with the RCRA

46. FDA Modernization act of 1997 • Changed the disclaimer of “caution-Federal law prohibits dispensing without a prescription” first established with the Durham Humphrey Act to simply “Rx only” • Drug Addiction Treatment Act of 2000 • Referred to as DATA2000 • Before this law, only MDs licensed to prescribe methadone for opiate/Heroin addiction can write for methadone for this purpose and only in setting of a clinic licensed by the state and federal government as a detoxification maintenance provider • With this law, MD’s can be licensed to prescribe Buprenorphine based products for office based treatment of addiction • Suboxone (Buprenorphine) and Subutex (Buprenorphine/Naloxone) • This MD have the DEA number of X+ 7 digits