Guide to Federal Pharmacy Law

Sunscreen Innovation Act (2014)

requires FDA to respond quickly to requests for approval of pending ingredients for OTC sunscreen products

Schedule III, IV, V Prescription Requirements

*A pharmacist may dispense a CIII, IV, or V controlled substance rx drug only pursuant to* -a written rx signed by a practitioner -a fax of a written, signed rx transmitted by the prescriber's agent to the pharmacy, or -an electronic rx that meets CSA requirements -an oral rx made by an individual practioner and promptly reduced to writing by the pharmacist containing all info required except for the signature of the prescriber A prescriber may administer or dispense a CIII, IV, or V substance directly to a consumer in the course of their professional practice without a rx An institutional practitioner-pharmacist may administer or dispense directly (but not prescribe) a CIII, IV, or V substance only pursuant to -a written rx singed by a prescriber -a fax of a written rx or order for medication transmitted by the prescriber or the prescriber's agent to the institutional practitioner-pharmacist -an electronic rx that meets the requirements of the CSA -an oral rx made by a prescriber and promptly reduced to writing by the pharmacist (containing all required info except for the signature of the prescriber) -an order for medication made by a prescriber which is dispensed for immediate administration to the ultimate user

Drug products required to be packaged in child-resistant packaging by the PPPA

*Aspirin* -all oral dosage forms *Methyl Salicylate* -liquid product containing more than 5% by weight unless packaged in pressurized spray conditions *Controlled Substances* -all oral dosage forms *Prescription Drugs* -all oral dosage forms *Iron* -all non-injectable drug products and most iron-containing dietary supplements that contain 350 mg or more of elemental iron per package *Acetaminophen* -oral dosage forms containing more than 1 gram of acetaminophen per single package *Diphenhydramine* -oral dosage forms containing more than the equivalent of 66 mg of diphenhydramine base per package *Ibuprofen* -oral dosage forms that contain 1 gram or more of ibuprofen in a single package *Loperamide* -oral dosage forms containing more than 0.045 mg of loperamide in a single package *Mouthwash* -single packages that contain 3 grams or more of ethanol *Lidocaine* -products that contain more than 5 mg of lidocaine in a single package *Dibucaine* -products that contain more than 0.5 mg of dibucaine in a single package *Naproxen* -oral dosage forms that contain 250 mg or more of naproxen in a single package *Ketoprofen* -oral dosage forms that contain 50 mg or more of ketoprofen in a single package *Fluoride* -products containing more than 50 mg of elemental fluoride and 0.5% fluoride in a single package *Minoxidil* -products that contain more than 14 mg of minoxidil in a single package *Nonprescription drugs* -oral products that contain any active ingredient that was previously available in oral form by prescription only

Pregnancy Warnings

*Category A* -indicates that there have been adequate, well-controlled studies in pregnant women that demonstrate no risk to the fetus during the first trimester of pregnancy or during the last 2 trimesters *Category B* -while adequate, well-controlled studies have not been conducted in pregnant women, animal reproduction studies have failed to demonstrate a risk to the fetus *Category C* -the safety of the drug during human pregnancy has not been determined. Animal studies are either positive for fetal risk or have not been conducted. The drug should not be used in human females unless the potential benefit outweighs the potential risk to the fetus *Category D* -there has been positive evidence of risk to the human fetus mainly based upon adverse reaction date from either investigational or marketing experiences. The drug should be administered only if the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks *Category X* -studies in animals, or reports in pregnant women, indicate that the risk of damage caused by the drug clearly outweighs any possible benefit -CI in pregnant women or, in most instances, for any woman of childbearing age unless appropriate contraceptive methods are being used

Drug Recalls

*Class I* -the drug product may cause serious, adverse health consequences including death -the recall should include stocks located in pharmacies and notification of patients to whom the drug has been dispensed *Class II* -the drug product may cause temporary or reversible effects but the probability of serious adverse effects is remote -the recall will usually include stocks located in pharmacies *Class III* -the drug product is unlikely to cause any adverse health consequences It is the manufacturer's responsibility to send written recall notifies to all wholesalers and pharmacies for recalls in the Class I and II categories It is the pharmacist's responsibility to be aware of all recalls either received in the mail or read in the pharmaceutical literature Occasionally, an ingredient present in either a prescription or nonprescription drug product is determined to be potentially dangerous -the FDA may request that a manufacturer of a certain product DC sales and/or remove the product from the market -this request for a "voluntary" discontinuation or removal is invariably honored

Purchasing or transferring Schedule I or II substances

*DEA Form 222* or its electronic equivalent is required for each sale or transfer of a schedule I or II CS NOTE: DEA form 222 or its electronic equivalent is required for purchases, transfer of schedule I and II products from one pharmacy to another, returns to a suppler, etc. It's use is not required when such drug products are transferred from a central fill pharmacy to a retail pharmacy Each form contains an original, a duplicate, and a triplicate copy (ie Copy 1, Copy 2, Copy 3) Additional forms may be requisitioned on the DEA Form 222a that is mailed to a registrant approximately 30 days after each shipment of order forms to that registrant -registrants may also order additional forms by contacting any Division Office or the Registration Unit of the DEA All requisition forms (DEA Form 222a) must be submitted to the Registration Unit of the DEA

Investigational New Drug Application (IND)

*First application form that a sponsor must submit to the FDA before a drug may be administered to humans* Once submitted, the FDA has 30 days in which to decide whether the investigational drug is suitable for testing In addition, the sponsor must provide complete descriptions of the methodology (clinical protocols) to be used in testing the drugs in humans

Homeopathic Drug Products

*Homeopathic Pharmacopoeia of the United States (HPUS) = official compendium* Basic elements = individualized dosing of patient by homeopathic physicians, based upon a patient's symptoms -the dose of a drug administered is usually extremely low — often dilutions of 1:1000 or 1:100,000 are used with frequent drug administration While any of the drugs were originally labeled by their Latin name, it is now required that their English name be provided Some of the drugs found in homeopathic formulas are also official in the USP/NF -in these situations, the drug must meet the stricter standards found in the USP/NF Manufacturers under GMP however — they do NOT have to have an expiration date on their package

Medicare enrollment

*Initial Enrollment Period* -a 7-month period that begins 3 months before they turn 65, includes the month they turn 65, and ends 3 months after they turn 65 -for those eligible due to disability, this period begins 3 months before their 25th month of disability payments, includes the 25th month, and ends 3 months after *General Enrollment Period* -January 1st through March 31s each year, with coverage starting July 1 A beneficiary's monthly premium is based upon the individual coverage they have chosen and may be paid directly each month or deducted from monthly Social Security checks Anyone enrolling in Medicare may no longer contribute to health savings accounts (HSAs) -this is a medical savings account intended to ease the cost of medical care for working individuals -it is available to taxpayers in the US who are enrolled in a high-deductible health plan (HDHP) -the funds contributed to such an account are not subject to federal income tax at the time of deposit

FDA approved drugs for use in the treatment of opioid addiction

*Methadone* -slow acting, opioid agonist -taken orally so that it reaches the brain slowly, dampening the "high" that occurs with other routes of admin while preventing withdrawal symptoms -only available through approved outpatient treatment programs, where it is dispensed to pts on a daily basis *Buprenorphine HCl (Subutex)* -partial opioid agonist -relieves drug cravings without producing the "high" or dangerous side effects of other opioids *Buprenorphine + Naloxone (Suboxone)* -naloxone is an opioid antagonist -ward off attempt to get high by injecting the med Buprenorphine was the first med eligible to be prescribed by certified physicians through DATA -eliminates the need to visit specialized treatment clinics, expanding treatment access *Naltrexone (Depade, Revia)* -opioid antagonist -poor patient compliance has limited its effectiveness -Vivitrol — long acting injectable formulation of naloxone recently FDA approved for treating opioid addiction — given as a monthly injection — should only be used after a pt has undergone detoxification (to avoid withdrawal) OTPs must maintain current procedures that are adequate to ensure that the following dosage form and initial dosing requirements are met: -methadone must be administered or dispensed only in oral form — practitioners may not prescribe these agents for tx of drug dependence -for each new pt enrolled in a program, the initial dose of methadone must not exceed 30 mg and the total dose for the first day must not exceed 40 mg, unless the program physician documents in the patient's record that 40 mg did not suppress opiate abstinence symptoms -a program physician familiar with the most up-to-date product labeling must make dosing and administration decisions in the use of these drugs

Bioequivalence information

*Orange Book* Several other reference sources available for determining the status of a specific drug product. These include: -United States Pharmacopeia Dispensing Information (USP/DI) Volume III plus supplements -Facts and Comparisons, Inc -FDA's Internet Website Whenever an innovator's new drug product is developed and submitted with a NDA, it becomes the reference standard The bioequivalence of the generic versions of an innovator's drug product must be determined. Based upon such testing, generic products are classified in one of two categories: *-A-rate products*: such products are determined to be bioequivalent to the innovator's drug product and are thus "therapeutically equivalent" to the brand name or reference product -these products may be substituted for one another *-B-rated products*: these are products that are found NOT to be bioequivalent to the innovator's drug product -CANNOT be substituted -FDA does not currently consider to be therapeutically equivalency to other pharmaceutically equivalent products Some drug products identified by the FDA as having actual or potential bioequivalence problems may be acceptable substitutes if the equivalency problems have been shown to be resolved by the results of in vivo and/or in vitro studies -these products are given an "AB" designation — signifies that the product meets "necessary bioequivalence requirements" EXCEPTIONS to bioequivalency regulations: amino acids used in TPN solutions Some drugs and their related drug products marketed before 1983 are not required to be listed in the Orange Book because they have a "Grandfather" exemption. Examples include: -ASA with codeine -codeine -digoxin -ephedrine -epinephrine -levothyroxine -morphine -nitroglycerin -phenobarbital -oral potassium chloride -pseudoephedrine -thyroid -quinine

Refilling of Schedule III, IV, or V Prescriptions

*Schedule III or IV may be refilled not more than 5 times in a 6-month period from the date on which such rx was issued, if authorized by the prescriber* Written CV rx may be refilled in accordance with the prescriber's instructions NOTE: many states limit refills of CV rx to the same maximum of 5 refills within a 6-month period A record of each refilling of a rx must be entered on the back of the rx or on another appropriate document or electronic rx record *The following info must be retrievable by the prescription number:* -name and dosage form of the controlled substance -date filled or refilled -quantity dispensed -initials of the dispensing pharmacist for each refill -the total number of refills for that rx The prescribing practitioner may authorize additional refills of CIII or IV substances on the original rx through an oral refill authorization transmitted to the pharmacist provided the following conditions are met: 1. the total quantity authorized, including the amt of the original rx, does not exceed 5 refills within a 6-month period from the date of issue of the original rx 2. the pharmacist obtaining the oral authorization must record on the reverse of the original paper rx or annotates the electronic record -the date of authorization -the quantity of medication per refill -the number of additional refills authorized -his/her initials on the paper rx or annotates the electronic rx record showing who received the authorization from the prescribing practitioner who issued the original rx 3. The quantity of each additional refill authorized is equal to or less than the quantity authorized for the initial filling of the original prescription 4. The prescriber must issue a new and separate prescription for any additional quantities beyond 5 refills, 6-month limitation As an alternative to the procedures as described above, a computer application may be used for the storage and retrieval of refill info for Rx orders for Schedule III and IV controlled substances, subject to the following conditions: 1. The computerized application must provide on-line retrieval (via computer monitor or hard-copy printout) of original Rx order info. This must include, but is not limited to the: -original rx number -date of issuance of the original rx order by the prescriber -full name and addresss of the pt -name, address, and DEA registration number of the prescriber -name, strength, dosage form and quantity of the controlled substance prescribed -total number of refills authorized by the prescriber 2. The computerized application must provide on-line retrieval (via computer monitor or hard-copy printout) of the current refill history for CII or IV substance rx orders. This refill history must include, but is not limited to the -name of the CS -date of refill -quantity dispensed -identification code, or name or initials of the dispensing pharmacist for each refill -total number of refills dispensed to date for that rx order 3.If such a system provides a hard-copy printout of each day's controlled substance rx order refill DAA, that printout must be verified, dated and signed by the individual pharmacist who refilled such a rx order — this document must be maintained in a separate file at that pharmacy for a period of 2 years from the dispensing date. the printout of the day's controlled substance rx order refill data must be provided to each pharmacy within 72 hours of the date on which the refill was dispensed — must be verified and signed by each pharmacist who is involved with such dispensing NOTE: when filling refill information for original rx orders for Schedule III or IV controlled substances, a pharmacy may use only one of the 2 systems described above (ie putting the info on the back of the original rx or onto a computerized record-keeping system)

2 major laws regarding Unfair Competition

*Sherman Antitrust Act* -prevents restraint of trade or the establishment of monopolies -companies or groups may not have agreements, either formal or informal, among themselves, which would unreasonably restrain trade *Robinson-Patman Act* -intent is to prevent the hindering of competition -a seller is not allowed to practice price discrimination when dealing with similar purchasers -hospitals and similar institutions do have the right to extend their special prices to employees, inpatients, emergency room patients, etc — known as "own use" -while physicians on the hospital staff may be supplied with drugs for personal use, drugs may not be sold to physicians for use in their private practices, especially if the drugs are being sold to patients

Americans with Disabilities Act (ADA)

*The Federal Rehabilitation Act of 1973* prevents an employer from discriminating against a person who is physically or mentally handicapped, but who is otherwise qualified to perform the functions of a job -only applies to those companies receiving federal assistance *Americans with Disabilities Act (ADA)* -expands the original Rehabilitation Act by greatly increasing the number of individuals covered and by covering companies even if they are not receiving federal assistance *-any company employing 15 or more people is covered* In both acts, the term "disabled" is used since it has less of a negative connotation than the term "handicapped" These acts provide civil rights protection to individuals with disabilities similar to those provided to individuals on the basis of race, color, sex, nation origin, age and religion *Among those covered under the ADA* individuals with: *-epilepsy, HIV infections, paralysis, mental retardation, AIDs, alcoholics* *Those NOT protected* individuals who *illegally use drugs* A key concept of both acts is that employers must make a "reasonable effort" to accommodate a disabled employee *The following are additional elements of these laws:* -the employer must make reasonable accommodations for disabled individuals whether those individuals are employees or members of the general public — for the general public, "reasonable accommodations" include providing ramps leading into a building, providing elevator service to all floors of a building, and constructing restroom facilities that are accessible to disable individuals -for an employee, "reasonable accommodations" might include a reduced-height workbench -an employer may not ask about disabilities during an employment interview, but may ask if the prospective employee has the ability to perform the work -an employer may not require a prospective employee to undergo a medical examination before offering a position — however, an employer may require a medical examination as a condition of employment if this is a requirement for all new employees NOTE: tests for illegal use of drugs are not considered to be medical examinations and may be required by an employer

Special Labeling Warning Requirements

-FD&C Yellow No. 5 (tartrazine) — precautions part of the labeling must specify that this agent may cause allergic reactions in some susceptible persons -Aspartame — product precautions must specify the following type of warning: Phenylketonurics: Contains phenylalanine __ mg per __ (dosage units) -Sulfites - prescription drugs and wines contains sulfites (usually as a preservative) must contain an allergy warning in the labeling -Mineral Oil — requires a warning that specifies that it should only be used at bedtime and that it should not be used in infants except if advised by a physician. The labeling should also discourage the use in pregnancy -Wintergreen oil (methyl salicylate) — any product that contains more than 5% of this agent should indicate in the labeling that use other than as directed may be dangerous and that it should be kept out of reach of children -Sodium Phosphate — limits the amount of Sodium Phosphate Oral Solution to not more than 90 ml per OTC container -Isoproterenol Inhalation Products — require a label warning that indicates that user should not exceed the prescribed dose and that the physician must be contacted if breathing difficulty persists Ipecac Syrup — labeling must include: -a boxed stated in red type that states "For emergency use to cause vomiting in poisoning. Before using, call physician, the poison prevention center, or hospital emergency room immediately for advice" -the statement "Warning: Keep out of reach of children. Do not use in unconscious person or for poisoning involving corrosives (lye, strong acids), petroleum distillates such as kerosene, gasoline, cleaning fluids, or for strychnine" -the dosage of the medication. The usual dose is one tablespoonful (15 ml) in individuals over 1 year of age. In addition, Ipecac Syrup may only be sold in 1 oz (30 ml) containers -Acetophenetidin (Phenacetin) — labeling must include a warning about possible kidney damage when the drug is taken in large amounts or for long periods of time -Salicylates (including aspirin) — labeling must include warning regarding Reye's syndrome -Alcohol Warning

Under the REMS program, if a drug product requires the use of a MedGuide, the patient must be provided with the MedGuide under the following circumstances

-When the pt or the pt's agent requests a Medication Guide -When the drug is dispensed in an outpatient setting and the product will then be used by the patient without direct supervision by a health care professional -the first time a drug is dispensed to a healthcare professional for administration to a patient in an outpatient setting, such as in a clinic or dialysis or infusion center -the first time a drug is dispensed in an outpatient setting of any kind -after a MedGuide is materially changed (eg after addition of a new indication or new safety information) -When a drug is subject to a REMS that includes a specific requirement for reviewing or providing a MedGuide as part of an element to assure safe use

Rosiglitazone REMS Program

-a Med Guide must be dispensed with each Rx -providers must be certified by the manufacturers -may be dispensed only by specially certified pharmacies -may only be dispensed to patients who are enrolled in the Program -manufacturer (GlaxoSmitKline) must submit REMS assessments to the FDA 6 months, 12 months, and annually from the date of initial approval of the Program

REMS program for Lotronex (alosetron hydrochloride)

-a Medication guide must be dispensed with each Rx -providers must be certified in the Prescribing Program and submit a Prescriber Enrollment Form (PEF) in which they attest they understand the proper use of the drug and the appropriate treatment of patients with LOTRONEX -each pt must sign a Patient Acknowledgement Form -pharmacist may only fill LOTRONEX prescriptions if they have a PPL sticker on them -manufacturer must file reports with the FDA every 6 months during the 1st year in the program and then annually in the following years Telephone, faxed,or electronic Rx for LOTRONEx are not permitted under this program -drug must be dispensed in its original package Similar REMS programs are available for: -Bosentan (Tracleer) -Clozapine (Clozaril) -Dofetilide (Tikosyn) -Alendronate (Fosamax)

The term "labeling" refers to either:

-the info printed on the label and outside package of a drug product. Refers to all labels and other written, printed, or graphic matter either on the product, its container, its wrapper, or accompanying the product. Thus, the prescription drug product insert is considered part of the labeling -the info printed by the pharmacist on the prescription label for a drug product being dispensed Now must read "Rx only"

A distinctive generic name, proprietary name, or USAN is assigned to each new drug based on the following criteria

-the name should be short, distinctive, and not likely to be confused with other existing names -the name should provide some indication of the therapeutic or chemical class to which the drug belongs

Purchaser requirements for CSOS

-to be a valid order, the purchaser must sign an electronic order for a Schedule I or II controlled substances with a digital signature issued to the purchaser, or the purchaser's agent, by the DEA The following data fields must be included on an electronic order for Schedule I and II controlled substances: -a unique number the purchaser assigns to track the order. The number must in the following 9-character format: the last two digits of the year X, and 6 characters selected by the purchaser (eg 10X123456) -the purchaser's DEA registration number -the name of the supplier -the complete address of the supplier (may be completed by either the purchaser or the supplier) -the date the order is signed -the name (including strength where appropriate) of the controlled substance product or the NCD number (the NCD number may be completed by either the purchaser or the supplier) -the quantity in a single package or container -the number of packages or containers of each item ordered *an electronic order may include controlled substances that are not in schedules I and II and may also include non-controlled substances*

Every location where controlled substances are manufactured, distributed, or dispensed must have its own DEA registration EXCEPT for the following:

-warehouses used by registrants to store controlled substances -a practitioner's office where drugs are prescribed, but not administered or dispensed -common carriers (eg freight delivery companies) -an office where sales of controlled substances are solicited, made or supervised, but the location does not contain controlled substances

Opioid agonist treatment medications dispensed to patients for unsupervised use are to be subject to the following requirements:

1. Any pt may receive a single take-home dose for a day that the clinic is closed for business, including Sundays and state and federal holidays 2. Dispensing opioid tx meds to pts for unsupervised use must be determined by the Medical Director The medical director must consider the following: -absence of recent abuse of drugs, including alcohol -regularity of clinic attendance -absence of serious behavioral problems at the clinic -absence fo known recent criminal activity -stability of the pt's home environment and social relationships -length of time in comprehensive maintenance treatment -assurance that take-home meds can be safely stored within the pt's home -whether the rehab benefit the patient derived from decreasing the frequency of clinic attendance outweighs the potential risks fo diversion If it is determined that a pt is responsible in handling opioid drugs, the following restrictions apply: -during the first 90 days of tx, the take-home supply is 1 dose/week -in the second 90 days of tx, the take-home supply is 2 doses/week -in the third 90 days of tx, the take-home supply is 3 doses/week -in the remaining months of the first year, a pt may be given a max of 6-day supply of take-home med -after 1 year of continuous tx, a pt may be given a max 2-week supply of take-home med -after 2 years of continuous tx, a pt may be given a max 1-month supply of take-home med, but must make monthly visits

Patient Protection and Affordable Care Act (Health Care Reform Act) of 2010

1. Requires that all individuals have health insurance. 2. Require standards for financial and administrative transactions including timely and transparent claims using standard electronic transactions. 3. Stop agreements between brand name and generic drug manufactures that limit or dley competition from generic drugs. 4. Phase elimination of the "donut hole" or "coverage gap" during which the patient pays all costs of prescription drugs. *children are able to stay on their parent's health insurance policies until they turn 26 years old (ie through the age of 25) *Women's Preventive Health Care Amendment (2012)* began providing services to women including: well woman visits, gestational diabetes screening, HPV screening, STD counseling, HIV counseling and screening, contraceptive counseling

Drugs exempted by the PPA

1. Sublingual dosage forms of nitroglycerin 2. Sublingual and chewable forms of Isosorbide dinitrate in dosage strengths of 10 mg or less 3. Erythromycin ethylsuccinate granules for oral suspension and oral suspensions in packages containing not more than 8 grams or the equivalent of erythromycin 4. Erythromycin ethylsuccinate tablets in packages containing no more than the equivalent of 16 grams erythromycin 5. Anhydrous cholestyramine in powder form 6. Potassium supplements in unit dose forms, including individually wrapped effervescent tablets, unit dose vials of liquid potassium and powdered potassium in unit dose packets, containing not more than 50 mEq per unit dose 7. Sodium fluoride drug preparations, including liquid and tablet forms, containing no more than 264 mg of sodium fluoride per package 8. Betamethasone tabs packaged in manufacturers' dispenser packages containing no more than 12.6 mg of betamethasone 9. Mebendazole in tablet form in packages containing not more than 600 mg of the drug 10. Methylprednisolone in tablet form in packages containing not more than 84 mg of the drug 11. Colestipol in powder form in packages containing not more than 5 grams of the drug 12. Pancrelipase preparations in tablet, capsule or powder form 13. Cyclically administered oral contraceptives in mnemonic (memory-aid) dispenser packages which rely solely upon the activity of one or more progestogen or estrogen substances 14. Prednisone in tablet form when dispended in packages containing no more than 105 mg of the drug 15. Conjugated estrogen tablets when dispensed in mnemonic dispenser packages containing not more than 32.0 mg of the drug 16. Norethindrone acetate tabs in pneumonic dispenser packages containing not more than 50 mg of the drug 17. Medroxyprogesterone acetate tabs 18. Sacrosidase (sucrase) preparations in a solution of glycerol and water 19. Hormone Replacement Therapy products that rely solely upon the activity of one or more progestogen or estrogen substances

Medigap

= health insurance *sold by private insurance companies* to fill the "gaps" in the original Medicare Plan coverage -covers some out-of-pocket expenses not paid by original Medicare Sometimes referred to as a Medicare Supplemental Insurance Health insurance companies are not permitted to sell new Medigap policies that cover drugs — however, people who already have such policies may keep them Medigap plans without drug coverage may still be sold There are about 12 different types of Medigap policies available — these policies must follow federal and state laws A Medigap policy must be clearly identified on the cover as "Medicare Supplement Insurance" -each policy has a different set of basic and extra benefits

Orphan Drugs

= one that would be difficult for a company to develop into a profitable product because the cost of the NDA process would exceed the anticipated market sales -usually these drugs are marketed for the treatment of diseases that affect a relatively small patient population Rare diseases or conditions are considered to be those that affect fewer than 200,000 persons in the US The Orphan Drug Act of 1983 encourages companies to develop orphan drugs by giving them incentives such as tax relief, exclusive marketing rights, and faster NDA approval

How does HIPAA affect pharmacies?

A "Notice of Privacy Practices" must be given to each pt when first provided service in the pharmacy -also must be posted in a prominent location and on its web site if on exists Other requirements include the following: 1. If the pt refuses to sign an acknowledgement, the pharmacy can still provide the service (pharmacist should document this) 2. The acknowledgement is needed only the first time service is provided. Also, only one acknowledgement is needed within a pharmacy chain 3. A 3rd party, such as parent or guardian, may sign the acknowledgment. Friends or relatives may not signs but may still pick up prescriptions Patients may report predicted violations of the HIPAA to the Department of Health and Human Services Office for Civil Rights (HHS/OCR) All family members do not have to receive the notice — instead just the person named in an insurance policy -thus, children under the age of 18 do not have to sign the privacy notice A record of required signatures must be maintained for 6 years from date obtained or from the last date a prescription is dispensed (whichever is later)

Dispensing Schedule V controlled substances without a rx

A CV that is not a rx drug pursuant to any federal, state or local law may be dispensed by a pharmacist without a rx to a retail purchaser provided that: -such dispensing is made only by a pharmacist and NOT by a non-pharmacist employee even if under the supervision of a pharmacist -not more than -240 ml (8 oz) of any such controlled substance containing opium, or -120 ml (4 oz) of any other such controlled substance, or -48 dosage units of any such controlled substance contains opium, or -24 dosage units of any other such controlled substance *May be dispensed at retail to the same purchaser in any given 48-hr period -the purchaser is at least 18 yo -every purchaser of a controlled substance not know to him/her to furnish suitable identification -record book for dispensing CS without a rx must be maintained by a pharmacist. The book must contain: (must be maintained for 2 years) -name and address of each purchaser -name and quantity of controlled substance purchased -date of each purchase -name or initials of the pharmacist who dispensed teh substance to the purchaser NOTE: only a pharmacist may dispense an OTC CV although a non-pharmacist can complete the sale Central fill pharmacist may not dispense controlled substances to a purchaser at retail

Persons Entitle to Issue Controlled Substance Prescriptions

A Rx for a controlled substance may be issued only by an individual practitioner who is: -authorized to prescribe controlled substances by the jurisdiction in which he/she is licensed to practice his profession, and -either registered or exempted from registration pursuant to the CSA An employee or agent of the individual practitioner (eg a nurse, secretary) may communicate a Rx issued by an individual practitioner or to a pharmacist

Schedule II Prescription Requirements: Written Prescriptions and Orders

A pharmacist may normally dispense a Schedule II controlled substance prescription drug pursuant to a written Rx signed by the practitioner -may also dispense an electronic order *An individual practitioner may administer or dispense directly a Schedule II controlled substance in the course of his/her professional practice without a prescription to a narcotic dependent person for the purpose of maintenance or detoxification treatment if the practitioner meets both of the following conditions:* 1. The practitioner is separately registered with DEA as a narcotic treatment program 2. The practitioner is in compliance with DEA regulations regarding treatment qualifications, security, records, and unsupervised use of the drugs pursuant to the CSA A physician who is not specifically registered to conduct a narcotic treatment program may administer, but not prescribe, narcotic drugs to a person for the purpose of relieving acute withdrawal symptoms when necessary while arrangements are being made for referral for treatment *-Not more than 1 day's medication may be administered to the person or for the person's use at one time* *-such emergency treatment may be carried out for not more than 3 days and may not be renewed or extended* An institutional practitioner may administer or dispense directly (but not prescribe): -a CII controlled substance pursuant to a written prescription signed by the prescribing practitioner; or -an order for Schedule II medication that is to be dispensed for immediate administration to the ultimate user

Regulations regarding prescriptions for multiple patients

A practitioner is NOT permitted to issue prescriptions for multiple patients with a single signature *However, a practitioner is allowed to sign multiple prescriptions for a single patient at one time* Once an electronic controlled substance prescription is signed, it does not need to be transmitted to the pharmacy immediately. Signing and transmitting an electronic controlled substance Rx are 2 distinct actions Electronic prescriptions for controlled substances should be transmitted as soon as possible after signing. However, it is understood that practitioners may prefer o sign prescriptions before office staff add pharmacy or insurance info -therefore, DEA does not require that transmission of the prescription occur simultaneously with signing the prescription

Prescription copies of electronic controlled substance prescripitons

A practitioner may print copies of any electronic prescriptions for controlled substances if they are clearly labeled: "Copy only — not valid for dispensing" -the copies must be printed *after* transmission

Cancelling and voiding of order forms (DEA form 222)

A purchaser may cancel part or all of an order on an order form by notifying the supplier in writing of such cancellation The supplier must indicate the cancellation on copies 1 and 2 of the order form by drawing a line through the cancelled items and printing "canceled" in the space provided for number of items shipped A supplier may void part or all of an order form by notifying the purchaser in writing of such voiding -the supplier must indicate the voiding in the manner prescribed for cancellation in the previous paragraph

Required records pharmacies must maintain for controlled substances

A registrant must maintain the following records: -Official order forms (DEA Form 222) -Power of Attorney authorization to sign order forms -Receipts and invoices for CIII, IV and V controlled substances -all inventory records of controlled substances including the initial and biennial inventories -records of controlled substances distributed or dispensed -Report of Theft or Loss (DEA Form 106) -Inventory of Drugs Surrendered for Disposal (DEA Form 41) -Records of transfers of controlled substances between pharmacies -DEA registration certificate

Canceling and Voiding Electronic CSOS orders

A supplier may void all or part of an electronic order by notifying the purchaser of the voiding. -if the entire order is voided, the supplier must make an electronic copy of the order, indicated on the copy "Void" and return it to the purchaser -the supplier is not required to retain a record of orders that are not filled The purchaser must retain an electronic copy of the voided order To partially void an order, the supplier must indicate in the linked record that nothing was shipped for each item voided

Drug-free Workplace

According to the Federal Anti-Drug Abuse Act of 1988: -the unlawful possession of controlled substances by employees is prohibited in the workplace -if an employee is convicted of criminal possession of drugs, he/she must inform the employer of the conviction within 5 days -employers may take appropriate action

Kefauver-Harris Amendment of 1962

Adopted as the result of a public concern about thalidomide -caused serious birth defects in the offspring of many women in Europe who used the drug Also referred to as the *Drug Efficacy Amendment* -Required that all new drugs marketed in the US had to be shown to be not only safe, but also effective -Place authority for regulating prescription drug advertising into the hands of the FDA -Required informed consent for individuals who were research subjects in clinical investigations, reporting of adverse drug reactions, creation of Good Manufacturing Practice (GMP) requirement that clearly defined the conditions under which drugs could be manufactured in the US STUDY TIP: -remember that prescription drug advertising is regulated by the FDA -OTC (nonprescription) advertising is regulated by the Federal Trade Commission (FTC)

Adulteration vs Misbranding

Adulteration refers to the composition of a product while misbranding refers to the labeling A product is considered to be adulterated if: -it contains in whole or in part any flighty, putrid, or decomposed substance -it has been prepared, packaged or held under unsanitary conditions where it may have been contaminated -it has been manufactured under conditions that do not meet the standards of GMPs -it contains an unapproved color additive -it contains a drug recognized in official compendium, but its strength, purity or quality is lower than the official standards -its container is composed of a deleterious substance that may enter (leach) into the product contents -it contains a drug not recognized in official compendium, but its strength, quality or purity is lower than that listed on the label -it contains any ingredient as a substitute for the active drug A drug is considered to be misbranded if the labeling: -is false or misleading -is missing either the name or location of the manufacturer, packer, or distributor -does not contain a word, statement or other info required by law to be displayed in a prominent, readable manner -does not include the established name of the active drug -does not have each active drug ingredient identified -does not state "Rx only" if the drug is available only by prescription (however, when dispensing to a consumer, the prescription label does not have to state "Rx only") -does not contain a precautionary statement for a drug product that is subject to deterioration -is missing the quantity of the container contents (eg a numerical count of 100, net weight of 50 g, or a net volume of 4 fluid oz) -has inadequate directions for use of nonprescription drugs or does not include appropriate warnings required to protect those using the medication or packaging -is not in accordance with USP/NF specifications -offers the sale of a drug under the name of the other drug NOTE: it is considered misbranding if a pharmacy dispenses a prescription-only drug without a legal prescription or an authorized refill

Veterinary product problems reporting

Adverse events and product problems that occur with the use of medical products (drugs and devices) in animals should be reported to the FDA's Center for Veterinary Medicine at 1-888-FDA-VETS

Clinical Trials

After FDA approves an IND, the sponsor may initiate clinical (human) trials 3 phases: -Phase 1: a small group of health individuals is given the drug. Primary purpose = evaluate the drug's toxicological, pharmacokinetic, and Pharmacologic properties, as well as to assess safety of the drug in humans -Phase 2: a larger group (100 or more) of patients that have the disease or symptoms of the condition to be treated by the drug is given the new drug. Purpose = to determine the effectiveness of the drug and to obtain info about adequate dosage, relative safety, and adverse effects -Phase 3: large groups of patients (sometimes 1000s) in several geological locations. Purpose = to obtain data concerning the drug's effectiveness as compared to a control group that receives a placebo Phase 4: post-marketing surveillance

Supplemental New Drug Application (SNDA)

After marketing a drug product, the manufacturer may desire to make some changes in the drug's synthesis, production procedures or manufacturing locations, packaging, labeling, etc Rather than submit an NDA, the company may submit a Supplemental New Drug Application (SNDA) This abbreviated application permits desired changes to be implemented

Issuing of Controlled Substance Prescriptions

All Rx for controlled substances must be dated and signed on the day when written and must bear the: -full name and address of the pt -drug name, strength, and dosage form -quantity prescribed -directions for use -name, address, and registration number (ie DEA number) of the practitioner A Rx for a CIII, IV, or V approved by the FDA specifically for "detoxification treatment" or "maintenance treatment" must include the identification number issued to the practitioner by the DEA Administrator A computer-generated Rx that is printed out or faxed by the practitioner must be manually signed An agent of the practitioner (eg secretary or nurse) may prepare Rx for the practitioner's signature, but the prescribing practitioner is still responsible for assuring that the Rx conforms in all essential respects to the law and regulations. A corresponding liability rests upon the pharmacist who fills a Rx that is prepared in proper form An individual practitioner exempted from a registration under the CSA must instead include on all prescriptions issued by him or her, the registration number of the hospital or other institution and the special internal code number assigned to him or her by the hospital or other institution NOTE: many states permit institutions such as hospitals to provide institutional prescribers who do not have their own registration number with the hospital DEA number plus a numerical suffix that specifically identifies the prescriber Each written Rx must have the name of the physician stamped, typed or hand-printed on it, as well as the signature of the physician -an official exempted from registration under the CSA (eg a military or Public Health Service physician) must include his/her branch of service or agency and service identification number on all prescriptions issued, instead of the DEA number usually required -the service identification number for a Public Health Service employee is his/her SSN

Formulary requirements under Medicare

All standard plans must include drugs within all therapeutic categories and classes developed by the USP Insurers do NOT have to include ALL drugs within each category. However, there are 6 drug classes that do require that most drug products be included: -anticonvulsants -antidepressants -antineoplastics -antipsychotics -antiretrovirals -immunosuppressants Drugs for any category must be for a medically accepted indication -therefore, research drugs are not covered but "off-label" use drugs may be acceptable Plans may alter their therapeutic categories and classes of drugs only at the beginning of each play year unless a change is needed to accommodate newly approved drugs or new uses of an existing drug -maintenance changes to formularies such as removing a branded drug and replacing it with a newly available generic is allowed at any time -if a specific drug is not covered by a plan, the patients may appeal for exceptions if his/her doctor can show that the non-formulary drug is medically necessary Also, under the standard Part D plans, the following groups of drugs are generally not covered: -barbiturates -benzodiazepines -weight loss or weight gain drugs -hair growth drugs -drugs that increase fertility -prescription vitamins except prenatal and fluoride products -outpatient drug for which the manufacturer requires monitoring Formulary changes by plans, such as drug removal or reduction to a less favorable tier must be done with CMS approval -a 60-day notice must be given to CMS, state prescription plans, pharmacies, and plan enrollees -EXCEPTION: formulary drug that has a new BBW, which may be removed at any time -if an enrollee is taking the drug being "switched", he or she must be allowed to obtain the drug without penalty for the rest of the plan year

Treatment investigational new drugs

Allow the administration of an investigational new drug to patients that have not been enrolled in the new drug's clinical trials program These patients must be in an imminent life-threatening stage of an illness for which there is presently no cure or where the presently used drugs do not appear to be effective The company developing the drug must have presented data outlining the drug's safety and efficacy, and the drug must be in either *Phase 2 or Phase 3 of clinical trials* If a drug is being considered as a Treatment IND candidate, a "treatment protocol" must be submitted to the FDA, which describes its proposed use in the designated patients

Durham-Humphrey Amendment of 1951

Amendment to the FDCA that established 2 classes of drugs: -Those that req'd medical supervision to be used safely *These drugs did not have to list 'adequate directions for use' — this was satisfied by the pharmacist placing directions provided by teh prescriber on the label of the dispensed product *Were required to include: 'Caution: Federal law prohibits dispensing w/o a rx" on the manufacturer's label *These drugs were called 'Legend' drugs (prescription drugs) -Those that did NOT req medical supervision had to have adequate directions for use on their labels *OTC drugs (nonprescription medications) This amendment also provided oral prescription and prescription refill legislation

Prescribing by Hospital Employees

An individual practitioner (eg intern, resident, staff physician, mid-level practitioner) who is an agent or employee of a hospital or other institution may, when acting in the usual course of business or employment, administer, dispense, or prescribe controlled substances under the registration of the hospital or other institution in which the practitioner is employed, provided that: -the dispensing, administering or prescribing is in the usual course of the practitioner's professional practice -the practitioner is authorized to do so by the state -the hospital or institution has verified that the practitioner is permitted to dispense, administer or prescribe controlled substance within the state -the practitioner acts only within the scope of their employment -the hospital or institution authorizes the practitioner to dispense or prescribe under its registration and assigns a specified internal code number for each practitioner so authorized EXAMPLE: AB1234567-012 AB1234567: Hospital DEA number 012: physician's hospital code number

Endorsing an Order form (DEA Form 222)

An order form made out to any supplier who cannot fill all or a part of the order within the specified time limitation may be endorsed to another supplier for filling The endorsement must be made only by the supplier to whom the order form was first made and must include (in the spaces provided on the reverse sides of Copies 1 and 2 of the order form) -the name and address of the second supplier -the signature of a person authorized to obtain and execute order forms on behalf of the first supplier The first supplier may not fill any part of an order on an endorsed form. The second supplier must fill the order, if possible, and ship all substances directly to the purchaser Distributions made on endorsed order forms must be reported by the second supplier in the same manner as all other distributions except that where the name of the supplier is requested on the reporting form, the second supplier must record the name, address and registration number of the first supplier

I accepted or Defective order forms (DEA form 222)

An order form must not be filled if it: -is not complete, legible, or properly prepared, expected or endorsed; or -who's any alteration, erasure, or change of any description If an order cannot be filled for any reason, the supplier must return Copies 1 and 2 to the purchaser with a statement as to the reason (eg illegible, altered, etc) A supplier may for any reason refuse to accept any order -a statement that the order is not accepted is sufficient -when received by the purchaser, Copies 1 and 2 of the order form and the statement indicating why it was not filled must be attached to Copy 3 and retained in the files of the purchaser An order form that is incorrect may not be corrected. In order for the order to be filled, a new order form must replace it

Purpose for Issuing of Controlled Substances Prescriptions

An order/Rx that is not issued in the usual course of professional treatment or as part of legitimate and authorized research is not a Rx. A person knowingly filling such an order or Rx, as well as the person issuing it, is in violation of the CSA A prescription may not be issued for an individual practitioner to obtain controlled substances for the purpose of general dispensing to patients NOTE: if a practitioner wishes to dispense controlled substances to patients, he/she must order them directly from a supplier (ie wholesaler or manufacturer) *In other words, prescribing controlled substances for "office use" is not permissible* A Rx may not be issued for "detoxification treatment" or "maintenance treatment" unless the Rx is for a Schedule III, IV, or V narcotic drug approved by the FDA specifically for use in maintenance or detoxification treatment and the practitioner is in compliance with requirements specified in the CSA

Definition of an anabolic steroid

Any drug or hormonal substance, chemically and pharmacologically related to testosterone (other than estrogens, progestins, and corticosteroids) that promotes muscle growth, and includes: -Boldenone -Chlorotestosterone -Dihydrotestosterone -Drostanolone -Ethylestrenol -Formebulone -Mesterolone -Methandienone -Methandranone -Methandriol -Methandrostenolone -Methenolone -Methyltestosterone -Mibolerone -Nandrolone -Norethandrolone -Oxandrolone -Oxymesterone -Oxymetholone -Stanolone -Stanozolol -Testolactone -Testosterone -Trenbolone -any salt, ester, or isomer of a drug or substance described or listed above, if that salt, ester, or somber promotes muscle growth STUDY TIP: most drugs that have anabolic steroid activity have the suffix "androlone" in them

Combat Methamphetamine Epidemic Act (CMEA) of 2005

Applies to all cough and cold products that contain the methamphetamine precursor chemical ephedrine, pseudoephedrine, or phenylpropanolamine 1. Retail sales may not exceed 3.6 grams PSE per day per purchaser, regardless of the number of transactions 2. Individuals are prohibited from purchasing more than 9 grams of PSE per 30-day period 3. All non-liquid forms (including gel caps) of PSE products must be sold in blister packs with no more than 2 dosages or in unit-dose packets or pouches 4. Mail-order companies may not sell more than 7.5 grams of PSE to a customer within a 30-day period 5. All PSE products must be placed behind a counter that is not accessible to customers 6. A retailer without a pharmacy may still sell the combination PSE products from behind a counter or locked display case 7. Retailers must maintain a logbook of info on transactions involving PSE products — may be either written or electronic 8. The purchaser must enter onto the log their signature, their name and address, and the date and time of the sale 9. Logbooks must provide notice to purchasers that entering false statements or misrepresentation in the logbook may subject them to criminal penalties 10. Logbook requirements do not apply to purchase of single sale packages that contain no more than 60 mg of PSE — each entry must be maintained for 2 years from the date of entry 11. Retailers must train sales personnel

Out-of-State and Foreign Prescriptions

As a rule, the FDA prohibits the interstate shipment (which includes importation) of unapproved new drugs Individuals who obtain Rx drugs from outside the US via the mail or by visiting another country. The FDA does not sanction such actions but appears to be somewhat flexible provided that: 1. The intended use of the drug is unapproved and is for a serious condition for which effective treatment may not be available domestically either through commercial or clinical means 2. The drug product will not be distributed to others 3. The product is considered not to represent an unreasonable risk 4. The individual seeking to import the product affirms in writing that it is for the patient's own use (generally not more than a 3 month supply) and provides the name and address of the doctor licensed in the US responsible for his or her treatment with the product, or provides evidence that the product is for the continuation of a treatment begun in a foreign country/area 5. The drug supply may be shipped directly to the patient or to either their physician or pharmacy

The DEA is under the supervision of the

Attorney General of the United States

Supplier requirements for CSOS

Before filling an electronic order, the supplier must: -verify the integrity of the signature and the order by using software that complies with CSOS regulations -verify that the digital certificate has not expired -check the validity of the certificate holder's certificate by checking the Certificate Revocation List The supplier must retain an electronic record of every order, and, linked to each order, a record of the number of commercial or bulk containers furnished on each item and the date on which the supplier shipped the containers to the purchaser. The linked record must also include any data on the original order that the supplier completes If an order cannot be filled in its entirety, a supplier may fill it in part and supply the balance by additional shipments within 60 days following the date of the order No order is valid more than 60 days after its execution by the purchaser A supplier must ship the controlled substances to the registered location associated with the digital certificate used to sign the order When a purchaser receives a shipment, the purchaser must create a record of the quantity of each item received and the date received. The record must be electronically linked to the original order and archived -a supplier may not endorse an electronic order to another supplier to fill -a supplier must, for each electronic order filled, forward either a copy of the electronic order or an electronic report of the order, in a format that DEA specifies, to DEA within 2 business days

Generic substitution of Biosimilars

Biologics Price Competition and Innovation Act (BPCIA) of 2009 As part of the Patient Protection and Affordable Care Act, Congress passed the BPCIA This act includes an approval process modeled after the process for generic small-molecular drugs under the Hatch-Waxman Act However, the approval of new molecular biological entities are approved by one of two pathways: *351(a)* -A Biological License Application (BLA) which involves a full evaluation of purity, safety and potency *351(k)* -a Biosimilar Application which invokes an abbreviated evaluation of purity, safety and potency The designation of "biosimilars" refer to unique biologic drugs derived from living organisms by recombinant technology The FDA defines a biosimilar as a biologic product that is "highly similar" to the reference product -reference product may be a vaccine, blood or blood component, gene therapy, tissues or proteins (except those that are chemically synthesized polypeptides) The biosimilar product must have the same mechanism of action, route of administration, dosage form and strength as the reference product -thus no clinically meaningful difference should exist between the biosimilar and the reference product in respect to safety, purity and potency

Use of Buprenorphine Products

Both Subutex (buprenorphine HCl) and Suboxone (buprenorphine + naloxone) sublingual tablets are FDA approved for the treatment of opioid dependence Buprenorphine = CIII Qualified office-based practitioners may prescribe it under the DATA 2000 regulations It is recommended that Subutex be given during the first few days of treatment, while Suboxone be given during the maintenance phase of treatment

Controlled Substance Ordering System (CSOS)

CSOS provides an electronic equivalent to the DEA official order form (Form 222) CSOS regulations permit, but does not require, registrants to order Schedule I or II substances electronically and maintain the records of these orders electronically The advantages of electronic ordering include -Greater Ordering Freedom: CSOS transactions are the only allowance for electronic ordering of Schedule I and II controlled substances, but may also be used for III-V substances. Additionally, unlike the paper Form 222, which is limited to ordering a maximum of 10 items per form, CSOS has no line item limit for a single order -Faster Transactions: CSOS certificates contain the same identification information as DEA Form 222, which allows for timely and accurate validation by the supplier. Faster transactions allow for rapid ordering and smaller inventories -Accurate Orders: CSOS reduces the number of ordering errors -Decreased Cost: order accuracy and decreased paper work result in a lower transaction cost

OTC ingredients are generally classified into what categories

Category 1 -generally recognized as safe and effective (GRASE) for the claimed therapeutic indication Category II -not generally recognized as safe and effective or having unacceptable indications Category III -insufficient data available to permit final classification Example -in 2002 the FDA banned the use of aloe and cascara sag Rada as laxative ingredients in OTC use — deemed as not being GRASE -placed these ingredients into cat II -any products containing these are now considered to be misbranded

Schedule II Controlled Substances

Characteristics: -have a high potential for abuse -have currently accepted medical use in treatment in the US or a currently accepted medical use with severe restrictions -abuse of the drug may lead to severe physical or psychological dependence Examples: Straight opiates and opioids: -Alfentanil (Alfenta) -Cocaine -Codeine -Diphenoxylate -Fentanyl (Sublimaze, Duragesic) -Hydrocodone and hydrocodone combination products (Vicodin, Lorcet, Lortab) -Levomethadyl Acetate -Levorphanol -Meperidine (Demerol) -Methadone -Morphine (MS Contin) -Nabilone (Cesamet) -Oxycodone (OxyContin, Percocet, Percodan) -Sufentanyl (Sufenta) -Tincture of Opium Stimulants -Amphetamine (Adderall, Vyvanse) -Methylphenidate (Ritalin, Concerta) -Methamphetamine (Desoxyn) Depressants -Pentobarbital -Secobarbital (Seconal) Hallucinogens -Phencyclidine (PCP)

Schedule I Controlled Substances

Characteristics: -have a high potential for abuse -have no currently accepted medical use in treatment in the US -lack accepted information on the safety of their use, even under medical supervision Common Examples: -Bufotenine -Diethylamide -Heroin -Lysergic acid (LSD) -Marijuana (cannabis) -Mescaline -Methaqualone -Peyote STUDY TIP: do not attempt to memorize the exhaustive list of the hundreds of CI drugs — the drugs given as examples above are the drugs that you will most likely be questioned about

Schedule IV Controlled Substances

Characteristics: -have a low potential for abuse relative to the drugs or other substances in schedule III -have a currently accepted medical use in treatment in the United States -abuse may lead to limited physical or psychological dependence relative to the drugs or other substances in Schedule III Examples: -Alprazolam (Xanax) -Butorphanol (Stadol) -Carisoprodol (Soma) -Chloral Hydrate -Chlordiazepoxide (Librium) -Clonazepam (Klonopin) -Diazepam (Valium) -Diethylpropion (Tenuate) -Eszopiclone (Lunesta) -Fenfluramine -Flurazepam -Mazindol -Meprobamate -Midazolam -Modafinil -Oxazepam -Pemoline -Pentazocine (Talwin) -Phenobarbital -Phentermine -Propoxyphene -Sibutramine -Temazepam (Restoril) -Tramadol (Ultram) -Triazolam (Halcion) -Zaleplon (Sonata) -Zolpidem (Ambien)

Schedule V Controlled Substances

Characteristics: -have a low potential for abuse relative to the drugs or other substances in schedule IV -have a currently accepted medical use in treatment in the US -abuse of the drug or other substance may lead to limited physical or psychological dependence relative to the drugs or other substances in schedule IV Examples: -Narcotic drugs containing non-narcotic active medicinal ingredients. Any compound, mixture, or preparation containing any of the following narcotic drugs, or their salts calculated as the free anhydrous base or alkaloid, in limited quantities as set forth below, which must include one or more non-narcotic active medicinal ingredients in sufficient proportion to confer upon the compound, mixture, or preparation valuable medicinal qualities than those possessed by narcotic drugs alone: 1. Not more than 200 mg of codeine per 100 ml or per 100 grams 2. Not more than 100 mg of dihydrocodeine per 100 ml or per 100 grams 3. Not more than 100 mg of ethylmorphine per 100 ml or per 100 grams 4. Not more than 2.5 mg of diphenoxylate and not less than 25 mcg of atropine sulfate per dosage unit 5. Not more than 100 mg of opium per 100 mls or per 100 grams 6. Not more than 0.5 mg of difenoxin and not less than 25 mcg of atropine sulfate per dosage unit -Acetaminophen w/codeine elixir -Promethazine w/codeine -Diphenoxylate w/atropine (Lomotil) -Ezogabine -Lacosamide -Pregabalin (Lyrica) STUDY TIP: note that all of the quantities listed above are evenly divisible by 5. This is a clue that they are classified in Schedule V

Schedule III Controlled Substances

Characteristics: -have a potential for abuse less than that of the drugs or other substances in schedules I and II -have a currently accepted medical use in treatment in the US -abuse of the drug or other substance may lead to moderate or low physical dependence or high psychological dependence Examples: -Acetaminophen w/Codeine -Anabolic Steroids -Benzphetamine (Didrex) -Buprenorphine (Buprenex) -Buprenorphine/Naloxone (Suboxone) -Butalbital (Butisol) -Butalbital (Fiorinal) — (NOT Fioricet) -Dronabinol (Marinol) -Nalorphine -Phendimetrazine (Bontril) -any compound, mixture or preparation containing amobarbital, Secobarbital, pentobarbital or their salts combined with one or more other active medicinal ingredients that are not listed in any schedule -any suppository dosage form containing amobarbital, Secobarbital or pentobarbital or their salts -Gamma hydroxybutyrate (GHB, sodium oxybutynin, Xyrem) -Narcotic Drugs. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation containing any of the following narcotic drugs, or their salts calculated as the free anhydrous base or alkaloid, in limited quantities as set forth below: 1. Not more than 1.8 mg of codeine per 100 ml or not more than 90 mg per dosage unit, with an equal or greater quantity of an isoquinolone alkaloid of opium 2. Not more than 1.8 grams of codeine per 100 ml or not more than 90 mg per dosage unit, with one or more active, non-narcotic ingredients in recognized therapeutic amounts (eg Tylenol w/codeine, Empirin w/Codeine) 3. Not more than 300 mg of dihydrocodeinone (hydrocodone) per 100 ml of not more than 15 mg per dosage unit, with a 4-fold or greater quantity of an isoquinoline alkaloid of opium (eg Tussionex, Lortab, Vicodin) 4. Not more than 300 mg of dihydrocodeinone (hydrocodone) per 100 ml or not more than 15 mg per dosage unit, with one or more active non-narcotic ingredients in recognized therapeutic amounts 5. Not more than 1.8 grams of dihydrocodeine per 100 mls or not more than 90 mg per dosage unit, with one or more active non-narcotic ingredients in recognized therapeutic amounts (eg Synalgos-DC) 6. Not more than 300 mg of ethylmorphine per 100 mls or not more than 15 mg per dosage unit, with one or more active, non-narcotic ingredients in recognized therapeutic amounts 7. Not more than 500 mg of opium per 100 ml or per 100 grams or not more than 25 mg per dosage unit, with one or more active, non-narcotic ingredients in recognized therapeutic amounts NOTE: anabolic steroids are classified in Schedule III by the federal government. Some states may classify them or other Schedule III substances in Schedule II STUDY TIP: remember that hydrocodone products that are combinations with acetaminophen (eg Vicodin, Lortab, etc), aspirin (eg Lortab ASA), chlorpheniramine (eg Tussionex), or any other combinations have been reclassified to Schedule II to reduce the abuse of such products NOTE: notice that schedule II barbiturates such as amobarbital, Secobarbital, and pentobarbital become Schedule III substances if they are combined with non controlled drugs (eg aspirin) or if they are in a suppository dosage form STUDY TIP: note that with the exception of opium and morphine, quantities of drugs listed in the above section as Schedule III substances are all evenly divisible by THREE. This may be helpful if you are asked to determine the schedule of a compounded product

Inactive ingredients on labels

Considered to be good manufacturing practice The additives should be listed alphabetically by name but separate from the last of the therapeutically active ingredients. The names should be those used in the official compendia. If not included in these references, the names may be obtained from other sources. The order of preference for these secondary sources is: -USP Dictionary of USAN and International Drug Names -CTFA International Cosmetic Ingredient Dictionary and Handbook -Food Chemicals Codex

Storing of Prescription Information

Controlled substance prescriptions must be filed in one of the following ways: *Option 1 (3 separate files)* -a file for CII drugs dispensed -a file for CIII, IV and V drugs dispensed -a file for prescription orders for all noncontrolled drugs dispensed *Option 2 (2 separate files)* -a file for all CII drugs dispensed -a file for all other drugs dispensed (non-controlled and those in CIII, IV, and V) *if this method is used, a rx for a CIII, IV or V drug must be made readily identifiable and retrievable by use a red "C" stamp not less than 1 inch high* *Option 3 (2 separate files)* -a file for all CII-V — if this method is used, a rx for a CIII, IV and V must be made readily retrievable by use of a red "C" not less than 1 inch high -a file for rx orders for all non-controlled drugs dispensed NOTE: -if a pharmacy has an electronic recordkeeping system for rx, which permits identification by rx number and retrieval of original documents by prescriber's name, patient's name, drug dispensed and date filled, then the requirements to mark the hard copy prescription with a red "C" is waived

Drug Addiction Treatment Act of 2000

DATA 2000 Provides a waiver from The Narcotic Addict Treatment Act (NATA) requirements and permits qualified office-based physicians to prescribe and pharmacists to dispense CIII, IV and V narcotic drugs, or combinations of these drugs, approved by the FDA for the treatment of opioid addiction In order to qualify for a waiver under DATA 2000, physicians must hold a current state medical license, a valid DEA registration number, and must meet a variety of special conditions In additions, physicians must attest that they have the capacity to refer addiction treatment patients for appropriate counseling and other non-pharmacological therapies, and that they will not have more than 30 patients on such addiction treatment at any one time

Schedule II Prescription Requirements: Missing Information

DEA instructs pharmacists to adhere to state regulations or policy regarding the changes that a pharmacist may make to a CII Rx after oral consultation with a prescriber *A pharmacist is never permitted to make changes in:* -the pts name -controlled substance prescribed (except generic substitution permitted by state law) -prescriber's signature

FDA Adverse Event Reporting System (FAERS)

Database that contains info on adverse event and medication error reports submitted to the FDA -designed to support the FDA's post-marketing safety surveillance program for drug and therapeutic biologic products Reporting of adverse events and med errors by health care professionals and consumers is voluntary If a manufacturer receives an adverse event report, it is required to send the report to the FDA The reports in FAERS are evaluated by clinical reviewers in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER)

MedMarx

Developed by the USP to allow hospitals to anonymously report, track and benchmark medication error data

The iPLEDGE Program for Isotretinoin

Developed due to the danger of severe birth defects from the use of isotretinoin Requires both female and male patients to enroll in a computerized registry in order to receive an isotretinoin product -prescribers and pharmacies are also required to register in order for the drug manufacturers to ship them the drug Program requires patients to sign a Patient Information Informed Consent form -must also agree to monthly doctor visits for refills and agree not to share the medication with others -the doctor then registers each patient into the iPLEDGE database and gives them a special identifying code number Risk continues for 30 days after DCing the drug A female patient must have the isotretinoin prescription filled within 7 days of a pregnancy test that has confirmed that she is not pregnant

Type E

Indicates a drug for a life-threading or severely debilitating disease, these drugs are also given a priority review and may be used in patients in imminent danger of death

Type F

Indicates a drug that has been placed on hold until submitted data has been further validated

Type V

Indicates a drug that is being considered for "orphan drug" status

Cosmetics

Do NOT require pre-marketing approval from the FDA Do not have to meet GMP program however they are obligated to manufacture these products under sanitary conditions — otherwise products could be considered to be adulterated While the Federal Food, Drug and Cosmetic Act of 1938 does not specifically state that cosmetics have to be tested for safety, any cosmetic that poses a safety problem to the general public will be considered as being misbranded If an unapproved color additive is used in the formulation, the product will be classified as being adulterated *Regulation of advertising and labeling cosmetics falls under the jurisdiction of the Federal Trade Commission (FTC)* -the labels of cosmetic products must contain the names of ingredients listed in descending order of prominence -ingredients present in quantities of 1% or less may be listed at the bottom, in random order The ingredient names listed on labels must be the generic names listed in the USP/NF -if not listed here , other relevant sources such as CTFA Cosmetic Ingredient Dictionary may be used — compiled by the Cosmetic Toiletry and Fragrance Association (CTFA) — contains many ingredients commonly used in cosmetics Many cosmetic products, especially those intended for use in body cavities (eg mouthwashes and vaginal products) must be packaged in tamper-resistant packaging

Patient Package Inserts (PPIs)

Document, written in lay language, which is intended to educate the client about the proper use and potential dangers inherent in the use of the product accompanying the PPI These rules apply to all physicians, community pharmacists, and hospital pharmacists who dispense drugs. It also means that hospital pharmacies must provide PPIs to hospitalized patients who are receiving estrogen and progestin-containing products such as Premarin, oral contraceptive products, and intrauterine contraceptive devices containing these drugs -this can be done by providing patients with the PPI prior to administering the first dose of such drug products -subsequent PPIs may be provided to the patient every 30 days thereafter -this PPI requirement also applies to patients in long term care facilities such as nursing hoes Prescribers who dispense prescriptions from their offices are NOT exempt from the requirement of providing PPIs -in Jan 2006 the FDA released a major revision to the PPI guidelines. The revision included a section called Highlights and required that the PPI have a Table of Contents and the date of initial product approval. It also requires that the PPI contain a toll-free phone number and Internet address

Type N

Indicates a drug that is being considered for non-prescription status

Requirements for commercial containers containing controlled substances

Each commercial container containing a controlled substance must have printed on the label the symbol designating the product's assigned controlled substance schedule (ie CII, CIII, etc) -the word "Schedule" need not be used -the symbol must be large enough to be easily seen without taking the container off the shelf

Pharmaceutically equivalent

Each drug product must have the same active ingredient, same dosage form, same route of administration, and must be identical in dosage strength or concentration -may however contain different excipients

Type AA

Indicates a drug with potential use for AIDS or HIV — related disease, such drugs are often given fast-track status for potential approval

Federal Anti-Tampering Act (1982)

Enacted after several incidents of deliberate contamination of OTC products with poisonous substances Requires that tamper-evidence packaging be used for select OTC products and cosmetics, particularly those taken orally

Prescription Drug Marketing Act of 1987

Enacted in order to place more stringent controls on the distribution of prescription drug products and samples Elements of this legislation include: -requiring that prescription drug wholesalers be licensed by states under federal guidelines -banning re-importation of prescription drugs produced in the US -banning the sale, trade, or purchase of prescription drug samples -specifying precise storage, handling and record-keeping requirements for drug samples -prohibiting, with certain exceptions, the resale of prescription drugs purchased by hospitals or health care facilities

Inventory requirements

Every required inventory and other records must be kept by the registrant and be *available for at least 2 years from the date of such inventory and records*, for inspection and copying Financial and shipping records may be kept at a central location rather than at the registered location, if the registrant has notified the DEA of his/her intention to keep central records Must take an inventory of all stocks and controlled substances on the date he/she first engages in the manufacture, distribution, or dispensing of controlled substances After the initial inventory is taken must take a new inventory at least every 2 years (may be taken on any date that is within 2 years of the previous biennial inventory) — person conducting should sign the inventory When the status of a non-controlled substance is changed to a controlled substance or when moved from one schedule to another, must taken an inventory the date the change is make. Thereafter, thesubstance must be included in each inventory made by the registrant When conducting a controlled substance inventory, the registrant must make an exact count of substances in sealed, unopened containers. For opened containers the following should be performed: -if in CI or II make an exact count of the contents -if CIII, IV or V make an estimated count unless that container holds more than 1000 tabs or caps in which case an exact count of the contents must be made Each person registered or authorized to maintain and/or detoxify users of CS as part of a narcotic treatment program, must maintain records with the following info for each narcotic CS: -name of substance -strength of substance -dosage form -date dispensed -adequate identification of patient (consumer) -amount consumed -amount and dosage form taken home by pt -dispenser's initials

Type 1

Indicates a new molecular structure, different from existing drugs, that may be used for the same therapeutic purpose The drug must not be presently marketed in the US -chemical classification

Expiration dating vs Beyond-use dating

Expiration date = originated with the dating required on manufacturer's containers Beyond-use date = used to describe the dating of drug products that are dispensed by pharmacists In all cases, the BUD may not be greater than the expiration date on the manufacturer's original package *Expiration dating for a commercial drug product as established by the manufacturer* -the manufacturer has established this dating for a specific package and a specific product -homeopathic products are exempted from the requirement of an expiration dating *Expiration dating for a unit dose package that has been prepared from a bulk container of a commercial drug product* -the repackager, usually a pharmacist, will determine this dating -the current guideline provided in the USP/NF is for repackaged drug products to have the shorter of 2 potential dates: -12 months MAX Or -25% of the time remaining on the original package of bulk drug product *Expiration dating for individual prescriptions being dispensed by a pharmacist* -there is no federal law concerning this type of dating. Instead, some states have established their own guidelines, usually a max of 1 year *Manufacturer's expiration dating* -most manufacturers indicate the expiration date on the container labeling in terms of months and year -pharmacists may not continue to dispense a drug product once its expiration date has passed

T/F: a pharmacist that compounds a prescription as part of their professional practice is considered to be manufacturing

FALSE

Unit-dose Packaging and Labeling

FDA has issued guidelines as to what information should be on each unit-dose package. This info includes: -generic name and trade name, if appropriate -quantity of active drug or drugs present (and the number of dosage units, if more than one) -name of the manufacturer, packer or distributor -the repackager's lot number -the expiration date -any other appropriate info concerning the specific drug Many institutions repackage drug products into single dose units -a new expiration date must be provided for the repackaged product -USP/NF states: in the absence of stability data to the contrary, the expiration date should not exceed 25% of the remaining time between the date of repackaging and the original expiration date OR a 12 month dating from the date the drug was repackaged, whichever of these 2 is the LEAST

Faxing of Schedule II Prescriptions

Faxing of a CII to the dispensing pharmacy by the prescriber or the prescriber's agent is permitted for: -*home infusion pharmacies* receiving Rx intended for Parenteral administration -*a resident of a long term care facility* -schedule II controlled substance prescriptions, written for a *pt enrolled in hospice*, certified by or licensed by the state may be faxed to a pharmacy for dispensing. The hospice pt may reside in a personal residence or hospice facility. The practitioner or the practitioner's agent *must note on the prescription that the pt is a hospice p*t In each case, the fax serves as the original written Rx and must be filed accordingly In all other cases, a Rx order for a CII may only be faxed for information purposes and may not serve as the original Rx order. The Rx may only be dispensed once the original is presented NOTE: many states have their own regulations pertaining to faxing of controlled substances — be sure to check on these

Labeling requirements for Manufacturer's Containers

Federal law requires that the following information appear on manufacturer's containers of drug products: -name and address of the manufacturer, packer, or distributor -established name of the drug or drug product -the net quantity (weight, quantity or dosage units) in the package -the weight of each active ingredient contained in each dosage unit. An additional requirement for electrolyte replacement therapy is inclusion of the electrolyte concentration in terms of mEq -the federal legend "Caution: Federal law prohibits dispensing without a prescription" or the more recent version, "Rx only" -if dosage units are not taken orally, the specific route or routes of administration must be stated -special storage directions, if appropriate -manufacturer's control or lot number -the expiration date established by the manufacturer

OTC Labeling of Sodium Content

Federal regulations require that the labeling for OTC products intended for oral administration must indicate the sodium content per dosage unit if the *amount exceed 5 mg/single dose* -this total refers to all sources of sodium whether present in active or inactive ingredients -applies to rectal OTC products containing di basic sodium phosphate and/or monobasic sodium phosphate If the amount of sodium present in the labeled maximum daily dose of the product is *more than 140 mg, a warning on the label must state: "Ask a doctor before use if you have a sodium-restricted diet"* *Sodium Free*: contains 5 mg or less of sodium in the labeled maximum daily dose *Very Low Sodium*: Contains 35 mg or less of sodium in the labeled maximum daily dose *Low Sodium*: Contains 140 mg or less of sodium in the labeled maximum daily dose NOTE: all of the above quantities refer to the content of sodium NOT sodium chloride

Vaccines for Children Program (VCP)

Federally dunked program Provides for administration of 16 vaccines at no cost to children who might not otherwise be vaccinated because of inability to pay CDC buys vaccines at a discount and distributes them to state health departments and certain local and territorial public health agencies -these agencies then distribute them at no charge to those private physicians' offices and public health clinics registered as VFC providers

Transfer of Prescription Information Between Pharmacies

For CIII, IV or V may be transferred on a 1-time basis only for the purpose of refill dispensing All transfers of CIII, IV or V are subject to the following requirements: *The transfer is communicated directly between 2 licensed pharmacist and the transferring pharmacist completes the following:* -writes "VOID" on the face of the invalidated rx -on the reverse side of the invalidated rx the name, address and DEA number of the pharmacy to which it was transferred and the name of the pharmacist receiving the rx -records the date of the transfer and the name of the pharmacist transferring the info *The pharmacist receiving the transferred rx must write the word "transfer" on the face of the transferred rx and reduce to writing all info required by CSA to be on a rx, including:* -writing the word "TRANSFER' of the face of the transferred rx -entering all info required by CSA on the rx including the: -date of issuance of the original rx -original number of refills authorized -date of original dispensing -number of valid refills remaining -date(s) and locations of previous refill(s) -pharmacy's name, address, and DEA number and rx number from which the rx was transferred -name of pharmacist transferring -pharmacy's name, address, DEA number and rx number from which the rx was originally filled *The original and transferred prescription(s) must be maintained for a period of 2 years from the date of last refill*

Type 6

Indicates a new therapeutic indicated for a drug already approved -chemical classification

Type 5

Indicates that a drug is being manufactured by a new company -chemical classification

What is an emergency?

For the purposes of authorizing an oral Rx of a controlled substance listed in Schedule II, the term "emergency situation" means those situations in which the prescriber determines that: -immediate administration of the controlled substance is necessary for proper treatment of the intended ultimate user; and -no appropriate alternative treatment is available, including administration of a drug which is not a schedule II controlled substance; and -it is not reasonably possible for the prescriber to provide a written Rx to be presented to the person dispensing the substance, prior to the dispensing

Type 2

Indicates that the drug is a new derivative of a molecular structure already approved in the US, for example a new salt or ester of an existing drug -chemical classification

Type 3

Indicates that the drug is a new formulation of a drug already marketed in the US -chemical classification

Thalomid REMS Program

Has been associated with causing serious teratogenic malformations — has been reintroduced to the market Prescriber Requirements -must enroll and become certified with Celgene -must counsel patients as to the benefits and risks -must provide contraception and emergency contraception counseling -must verify a negative pregnancy test for all female patients or reproductive potential -must complete a THALOMID Patient-Physiican Agreement Form -prescriber and patient must complete an applicable mandatory confidential survey -must obtain an authorization number from Celgene and write it on every Rx -must not prescribe more than a 4-week supply with no refills -must send the Rx to a certified pharmacy Pharmacy Requirements -must be certified by Celgene for the program -must obtain a confirmation number from Celgene before dispensing -must dispense Thalomid to the patient along with a Medication Guide

Type S

Indicates that the drug is similar to other drugs on the market Such drugs will generally undergo a standard review -therapeutic classification

Type P

Indicates that the drug represents a major therapeutic gain because there are no other effective drugs available for treating a particular illness or because it has significant advantages compared to currently marketed drugs Often given a priority review -therapeutic classification

HIPAA

Health Insurance Portability and Accountability Act Assure the security and privacy of patients' medical records while allowing the flow of health info needed to provide high quality health care -every healthcare provider who *electronically* transmits health info is a covered entity Medical groups such as clinics, hospitals, physician offices, etc must provide a written policy notice to each patient that describes how medical info concerning the patient may be used and disclosed -*signed form must be kept for a minimum of 6 years*, but there is no requirement for future signatures

Medical Device Problems reporting

Health care facilities (eg hospitals, nursing homes, etc) first under the Safe Medical Device Act of 1990 (SMDA) and then by the FDA Modernization Act of 1997, are legally required to report suspected medical device related deaths to both the FDA and manufacturer, if known Serious injuries must be reported to the manufacturer, or to the FDA if the manufacturer is unknown

Type 4

Indicates that the product is a new combination of 2 or more drugs -chemical classification

Lost CSOS orders

If a purchaser determines that an infilled electronic order has been lost before or after receipt, the purchaser must provide, to the supplier, a signed statement containing the unique tracking number and date of the lost order and stating that the goods covered by the first order were not received through loss of that order If the purchaser executes an order to replace the lost order, the purchaser must electronically link an electronic record of the second order and a copy of the statement with the record of the first order and retain them If the supplier to whom the order was directed subsequently receives the first order, the supplier must indicate that it is "Not Accepted" and return it to the purchaser. The purchaser must link the returned order to the record of that order and the statement A purchaser must, for each order filled, retain the original signed order and all linked records for that order for 2 years. The purchaser must also retain all copies of each unaccepted or defective order and each linked statement A supplier must retain each original order filled and the linked records for 2 years If electronic order records are maintained on a central server, the records must be readily retrievable at the registered location

Lost or stolen order forms (DEA form 222)

If a purchaser determines that an infilled order form has been lost, he/she must prepare another form in triplicate -purchaser must also prepare a statement containing the serial number and date of the lost form -the statement should indicate that the goods covered by the first order form were not received because that order form was lost Copy 3 of the second form and a copy of the statement must be retained with Copy 3 of the order form first executed. A copy of the statement must be attached to Copies 1 and 2 of the second order form sent to the supplier A copy of the statement must be attached to Copies 1 and 2 of the second order form sent to the supplier. If the supplier to whom the order was directed subsequently receives the first order form, the supplier must write "Not accepted" on the face of the form and return Copes 1 and 2 to the purchaser, who must attach it to Copy 3 and the statement Whenever any used or unused order forms are stolen or lost by any purchaser or supplier, he/she must immediately report the loss to the Special Agent in Charge of the DEA in the Divisional Office responsible for the area in which the registrant is located If any unused order form reported stolen or lost is subsequently recovered or found, the Special Agent in Charge of the DEA in the Divisional Office responsible for the area in which the registrant is located must immediately be notified

Compounding or Repackaging of Controlled Substances

If a registrant purchases a controlled substance for the purpose of repackaging them for sale within a pharmacy or to other registratns, the registrant must register *as a manufacturer* A pharmacist may compound controlled substances for "office use" as long as the product: -is compounded as an aqueous, oleaginous or solid dosage form -does not contain more than 20% controlled substance -is only distributed to a practitioner who is authorized to dispense

Regulations regarding transmission failure of electronic prescriptions

If it failed, electronic prescriptions may not be converted by an intermediary to another form for transmission An electronic prescription must be transmitted from the practitioner to the pharmacy in its electronic form If the Rx is a CIII, IV or V controlled substance, the practitioner can print the prescription, manually sign it, and fax the prescription directly to the pharmacy -the Rx must indicate that it was originally transmitted to, and provide the name of, a specific pharmacy, the date and time of transmission, and the fact that the electronic transmission failed

Return of an unused order form (DEA form 222)

If the registration of any purchaser terminates (because the purchaser dies, ceases legal experience, discontinues business or professional practice), or changes the name or address as shown on his registration, or if his/her registration is suspended or revoked, all unused order forms must be returned to the nearest office of the DEA

Theft of controlled substances

Immediately upon discovery of a theft or significant loss of CS, a pharmacy must contact the nearest DEA by telephone, facsimile or by a brief written message explaining the circumstances -a pharmacy should also notify the local police as may be required by state law -the DEA must be notified directly A pharmacy must also complete a *DEA form 106 (report of theft or loss of controlled substances)* -this will formally document the actual circumstances of the theft or significant loss and the quantities of the controlled substances involved, once the info has been determined -the pharmacy should send the original DEA Form 106 and a copy to the DEA Diversion Field Office and keep a copy for its records If, after an investigation it is determined that no such theft or significant loss occurred, no DEA form 106 need to be filed -however, the registration should notify DEA in writing of this fact in order to resolve the initial report and explain why no DEA form 106 was filed *Breakage, damage or spillage does not constitute a "loss of controlled substance"* -in such situations, any recoverable controlled substances must be disposed of according to DEA requirements and a DEA Form 41 should be filed

Importation

Implies that a drug product is being brought into the US from another country for distribution Theoretically the drug product must meet all of the standards established by the FDA for that drug including the FDA's GMP and labeling standards

Food, Drug and Cosmetic Act of 1938

In 1937, 107 deaths caused by the mistaken use of diethylene glycol (automobile anti-freeze) as a vehicle in a sulfanilamide elixir resulted in the passage of this law This law required, for the first time in the US, that any new drug could not be marketed unless it had first been proven to be safe when used according to directions on the label Also required that labels include adequate directions for use and warnings about habit-forming drugs that were contained in the product Also the first law that applied to cosmetic products and medical devices as well as to food and drug products Drug products marketed prior to 1938 were exempted or "grand-fathered" and did not, therefore, have to be labeled or proven safe under this law NOTE -several drug products sold in pharmacies (eg levothyroxine, digoxin, nitroglycerin, and phenobarbital) were on the market prior to 1938 and are, therefore, still "grandfathered" from this law

Ban on sales of ephedra and ephedrine alkaloids

In 2004, the FDA banned the sales of dietary supplements containing this drug, citing that its use posed unreasonable risk of illness or injury to consumers FDA claimed it to be adulterated Ban does not apply to rx or nonprescription drug products or to conventional foods such as herbal teas -also does not apply to products that are prepared or used for "Traditional Chinese Medicine" since this practice uses ephedra for temporary respiratory conditions and not chronically

Exportation of controlled substances

In 2005 the Controlled Substances Export Reform Act was passed. This law authorizes the Attorney General (or his designee, the DEA) to permit re-export of controlled substances in categories I-IV to other countries as long as: -they are being shipped to DEA permit or license holders in those countries -DEA is notified of the re-export within 30 days

Medicaid Tamper-Resistant Prescription Requirement

In 2008, CMC issued a requirement that specified that all written, non-electronic prescriptions for Medicaid outpatient drugs that were to be reimbursable by the federal government must contain at least 3 tamper-resistant features They must be designed to: -prevent unauthorized copying of a completed or blank Rx form -prevent the erasure or modification of info written on the rx by the prescriber -prevent the use of counterfeit rx forms Does not apply to: -durable medical equipment, prosthetics, orthotics, and supplies such as diabetic testing strips *Each state Medicaid Agency has issued its own guidance on this requirement*

Schedule II prescription requirements: oral prescriptions or orders

In an emergency situation, a pharmacy may dispense a CII controlled substance upon receiving the oral authorization of a prescribing practitioner, provided that: *-the quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period* -the Rx must be *immediately reduced to writing by the pharmacist* and must contain all required info except for the signature of the prescriber -if the pharmacist does not know the prescriber, he/she must make reasonable effort to *determine that the oral order is legitimate* -*within 7 days after authorizing an emergency oral prescription, the prescriber must have delivered to the dispensing pharmacist a written prescription for the emergency quantity prescribed — this "cover" Rx must have written on its Face "Authorization for Emergency Dispensing" and the date of the oral order.*The "cover" Rx may be delivered to the pharmacist in person or by mail (if delivered by mail, it must be postmarked within the 7-day period). Upon receipt of the "cover" Rx, the dispensing pharmacist is required to attach this Rx to the oral emergency Rx that had earlier been reduced to writing The pharmacist is required to notify the nearest DEA office if the prescriber fails to deliver a written "cover" prescription to him/her in a timely basis Central fill pharmacies are not permitted to prepare Rxs for a controlled substance listed in CII upon receiving an oral authorization from a retail pharmacist or an individual practitioner

Regulations regarding Rx for Detoxification and Maintenance Treatment

In order to administer or dispense (but not prescribe) narcotic drugs listed in any schedule to a narcotic drug-dependent person for "detoxification treatment" or "maintenance treatment" a practitioner must be separately registered with the DEA and must comply with the special regulatory standards imposed relative to treatment qualification, security, records and unsupervised use of drugs A physician who is not specifically registered to conduct a narcotic treatment program may administer (but not prescribe) narcotic drugs to a person for the purpose of relieving acute withdrawal symptoms, when necessary, while arrangements are being made for referral for treatment -not more than 1 day's medication may be administered to the person or for the person's use at one time -such emergency treatment may be carried out for not more than 3 days and may not be renewed or extended

Expiration Dating for Compounded Prescriptions

In the absence of stability info, the following guidelines are appropriate for beyond-use dating: -for nonaqueous liquids and solids made using commercially manufactured products: not more than 25% of the time remaining on the commercial product or a max of 6 months, whichever is less -for aqueous solutions made from solids obtained from commercially manufacturers drugs products: 14 days when stored at a cold temp -for all others: for the duration of therapy, but not more than 30 days

FDA Modernization Act of 1997

Included in this legislation are the following: -provisions for the fast-track review of some New Drug Application submissions (intent is to expedite the approval of new drugs used to treat serious or life-threatening conditions -clarification of the conditions under which pharmacies may perform extemporaneous compounding of prescriptions -the Rx drug legend "Caution: Federal law prohibits dispensing without a prescription" is replaced by "Rx only" -the provision that required certain substances to be labeled "Warning—May be habit forming" has been eliminated -encouragement for manufacturers to conduct research for new uses of drugs and to submit supplemental NDAs for these uses -encouragement for drug manufacturers to perform pediatric studies of drugs by providing them with an additional 6 months of marketing exclusivity

Package insert requirements

Information in package insert must be approved by the FDA Requirements: 1. description of the drug (solubility, chemical characteristics, etc) 2. clinical pharmacology 3. Indications and usage 4. Contraindications 5. Warnings 6. Precautions 7. Adverse reactions 8. Potential for abuse or patient dependence 9. Symptoms and treatment of overdose 10. Dosage and administration 11. Available dosage forms of the product 12. Date of the most recent revision of the labeling 13. Recommended or usual dosage In 2006 the FDA initiated a new prescription drug information format to improve patient safety. The following are some of the major features of the new product insert requirements: -a new section called Highlights provides immediate access to the most important prescribing info about the drug benefits and risks -a table of contents that facilitates easy access to detailed safety and efficacy information -inclusion of the date of initial product approval -a toll-free number and Internet reporting options are provides to encourage reporting of suspected side effects The Highlights include a concise summary of information including: -boxed warnings -indications and usage -dosage and administration

Tamper Resistant Packaging Act

Intent = to prevent the intentional contamination of OTC products Exemptions: -aerosol products -nonprescription products not accessible to the general public -lozenges, and drugs in first-aid kits

Controlled Substance Records: Pharmacists/Pharmacies

Inventories and records of all controlled substances listed in CI and CII must be maintained separately from all other records of the pharmacy -prescriptions must be maintained in a separate rx file Inventories and records of CIII, IV and V must be maintained either separately from all other records or in such for that the info required is readily retrievable from other records of the pharmacy -prescriptions must be maintained either separately or in such form that they are readily retrievable Prescriptions will be deemed readily retrievable if, at the time they are initially filed, the face of the rx is stamped in red ink in the lower right corner with the letter "C" no less than 1 inch high and filed either in the rx file for controlled substances listed in CI and II or in the customary consecutively numbered rx file for non-controlled substance — this requirement is waived if the pharmacy has a computer system that permits identification by rx number

Labeling CII Prescriptions

Label must show: -date of filling -pharmacy name and address -serial number of the Rx -name of pt -name of the prescribing practitioner -directions for use -following warning: "Caution: Federal law prohibits the transfer of this drug to any person other than the pt for whom it was prescribed" -other cautionary statements, if any, contained in such prescription or required by law NOTE: this "caution" statement is not required to appear on the label of a CII controlled substance dispensed for use in clinical investigations which are "blinded" NOTE: if the rx is filled at a central fill pharmacy, the central fill pharmacy must affix to the package a label showing the retail pharmacy name and address and a unique identifier indicating that the prescription to was filled at the central fill pharmacy, in addition to the info listed above These requirements do not apply when a controlled substance listed in CII is prescribed for administration to a pt in an institution, provided that: -not more than 7-day supply of the CII substance is dispensed at one time -the controlled substance listed in CII is not in the possession of the ultimate user prior to the administration -the institution maintains appropriate safeguards and records regarding the proper administration, control, dispensing and storage of the controlled substance listed in CII, and -the system employed by the pharmacist in filling a rx is adequate to identify the supplier, the product, and the pt, and to set forth the directions for use and cautionary statements, if any, contained in the rx or required by law

Regulations regarding prescription alterations of electronic prescriptions

May NOT be altered as it is transmitted from a practitioner to a pharmacy -does NOT apply to changes that occur after receipt at the pharmacy

Re-registration for a DEA registration

May apply to be re-registered not more than 60 days before the expiration date of their registration Bulk manufacturers of Schedule I or II controlled substances or importers of Schedule I or II controlled substances may apply to be re-registered not more than 120 days before the expiration date of their registration

Breakthrough therapy expedited review program

May be requested as early as IND application and preferably prior to end-of-Phase II meeting Similar to Fast Track, but breakthrough drugs must show early clinical evidence of substantial improvement over exhibiting therapies Same benefits as Fast Track, with an even greater emphasis on early meetings and coordination with experiences and senior FDA personnel Breakthrough drugs can sometimes skip portions of the standard FDA review process without compromising safety and efficacy standards

Fast Track program

May be requested for IND applications and prior to BLA or NDA submission Intended for drugs that address unmet medical need by either treating a conditions for which no other treatment exists or drugs that offer substantial benefit over existing treatment Sponsors get extra opportunities to meet with FDA to discuss study design and how to best expedite the drug development Sponsors may have early reviews of their product marketing before the complete application has been submitted

Communicating rx information between retail pharmacies and central fill pharmacies for initial and refill prescriptions of CIII, IV or V substances

May be transmitted electronically from a retail pharmacy to a central fill pharmacy including via facsimile. The retail pharmacy transmitting the rx must: 1. Write the word "CENTRAL FILL" on the face of the original rx and record teh name, address and DEA number of the central fill pharmacy and the name of the retail pharmacy pharmacist transmitting the rx and the date of the transmittal 2. Ensure all info required is transferred 3. Indicate in the number of refills already dispensed and the number of refills remaining 4. Maintain the original rx for a period of 2 years from the date the rx was last refilled 5. Keep a record of receipt of the filled rx, including the date of receipt, the method of delivery and the name of the retail pharmacy employee accepting delivery The central fill pharmacy receiving the transmitted rx must: 1. Keep a copy of the rx or an electronic record of all info transmitted including the name, address an dDEA number of the retail pharmacy 2. Keep a record of the date of receipt, the name of the licensed pharmacist filling the rx and the dates of filling or refilling of the rx 3. Keep a record of the date the fillling rx was delivered to the retail pharmacy and the method of delivery

Controlled substance prescribing by mid-level practitioners

May receive an individual DEA registration granting controlled substance privileges HOWEVER — such a registration is contingent upon authority granted by the state in which they are licensed

Tall man lettering

Means of reducing medication errors Based upon the use of larger (taller) letters in a drug name to make the drug name more easily distinguishable from drugs that have a similar spelling In 2012, the FDA and ISMP published a list of recommended Tall Man letters for look-alike drugs including, but not limited to: -acetaZOLAMIDE vs acetoHEXAMIDE -buPROPion vs busPIRone -chlorproMAZINE vs chlorproPAMIDE -clomiPHENE vs clomiPRAMINE -cycloSERINE vs cycloSPORINE -DAUNOrubicin vs DOXOrubicin -DOBUTamine vs DOPamine -hydrALAZINE vs hydrOXYzine -TOLAZamide vs TOLBUTamide -vinLBAStine vs vinCRIStine

MedWatch Program

MedWatch, the FDA Medical Products Reporting Program, is an initiative designed to: -educate all health professionals about the critical importance of being aware of, monitoring for, and reporting adverse events and problems to the FDA and/or the manufacturer -ensure that new safety info is rapidly communicated to the medical community, thereby improving patient care *4 Goals* -to increase awareness of drug and device-induced disease -to clarify what should (and should not) be reported to the agency -to simplify problem reporting by operating a single system for health professionals to report adverse events and product problems to the agency -to provide regular feedback to the health care community about safety issues involving medical products Form FDA 3500B is a consumer friendly version of Form 3500 and Form FDA 3500A is a mandatory reporting form for IND reporters, manufacturers, distributors, importers and user facility personnel

Medicare Part C

Medicare managed care (Medicare Advantage)

Medicare Part D

Medicare prescription drug program (PDP) Medicare contracts with private insurance companies to provide drug-only coverage OR coverage through Medicare Advantage local and regional managed care plans, the MA-PD The cost to the beneficiary depends on the beneficiary's income. If the beneficiary is not in a low-income category, they will pay a monthly premium, have an annual deductible, and have co-payment responsibilities The PDP benefits include the cost of any prescription drug, biological product, and insulin if it is presently covered by Medicaid and is intended for a medically accepted indication The premiums, deductibles and percentages are based upon an individual — therefore, a husband and wife must each have their own plans Co-payments may be based on a 3 or 4 level tier system by each health con insurance company. The tiers often consist of: -Tier 1: least expensive generic drug -Tier 2: preferred brand name drug -Tier 3: non-preferred brand name drug -Tier 4: rarer, high cost drugs Once the beneficiary has enrolled, the premium and deductible cannot change between January 1 and December 31 -the co-pay amount may change if the drug is moved to another tier -the beneficiary may change plans only once a year unless he/she moves out of the plan's area, into a nursing home, or the plan stops service in the area The Medicare Part D coverage gap, often coined the "Medicare donut hole" describes the financial gap between the Part D Rx initial coverage limit and the catastrophic-coverage threshold -this gap is when the patient pays the largest amount for prescriptions until reaching the catastrophic-coverage level -patients may choose plans that either reduce or eliminate the donut hole — by 2020 the donut hole is planned to be completely phased out Other provisions of Medicare programs include the following: -all Rx benefits programs must accept participation from any pharmacy that agrees to the terms and conditions of their drug plan — referred to as the "any willing provider clause" -the sponsors cannot require beneficiaries to obtain their Rx through mail-order pharmacies -larger quantities, including 90-day supplies of long-term drugs, may be obtained at the participating local pharmacy -if brand-name product is dispensed, the patient must be informed of the availability of lower-cost generic versions of the drug -pharmacists are eligible to receive payment from Medicare for providing MTM, if the patient is enrolled in Medicare Part D -each drug plan sponsor must establish MTM programs for enrolled individuals having high drug costs resulting from multiple chronic conditions -importation from Canada and some other countries may be permitted if the HHS certifies that the importation poses no additional risk to the public health -explicitly blocking the use of Medicare's purchasing power to negotiate prices with pharmaceutical manufacturers to obtain lower cost drugs for the elderly and disabled -bringing higher reimbursement prices paid by Medicare into a lower range — the manufacturer-reported AWP will be phased out in favor of an "ASP" — average sales price — this value will be between the actual acquisition cost (AAP) paid and the present AWP -preventing a drug company from filing multiple 30-month stays to prevent competing companies from marketing a generic version of a drug product -allowing multiple manufacturers of a generic product to obtain a 180 day exclusitiivty period if they file their applications on the first day of eligibility In 2008 Medicare Part D began to cover the cost of vaccines and their administration, which formerly was covered by Part B

Prescription File Storage Period

Most states require Rx records to be kept for 2-5 years As of Jan 1st, 2005 the Medicare Modernization Act of 2003 requires prescription records to be kept for 10 years

Persons entitled to fill controlled substance prescriptions

Only a pharmacist, acting in the usual course of his/her professional practice, may fill a prescription for controlled substances.

Labeling and filling of Schedule III, IV and V Prescriptions

Must affix to the package a label showing the: -pharmacy name and address -serial number -date of initial filling -name of patient -name of practitioner issuing the rx -directions for use -cautionary statements, if any, contained in the rx, as required by law NOTE: remember that the warning: "Caution: Federal law prohibits the transfer of this drug to any person other than the pt for whom it was prescribed" must also be applied to the rx container of CII, III, and IV rx except those that are for use in clinical investigations, which are "blinded" *if the rx is filled at a central fill pharmacy, the central fill pharmacy must affix to the package a label showing the retail pharmacy name and address and a unique identifier (ie the central fill pharmacy's DEA registration number) indicating that the rx was filled at the central fill pharmacy, in addition to the info required above These labeling requirements do not apply when a CIII, IV or V substance is prescribed for administration to an ultimate user who is institutionalized, provided that: -not more than a 34-day supply or 100 dosage units, whichever is less, of the controlled substance listed in CIII, IV or V is dispensed at one time -the CS listed in CIII, IV, or V is not in the possession of the ultimate user prior to administration -the institution maintains appropriate safeguards and records the proper administration, control, dispensing and storage of the CIII, IV or V controlled substances -the system employed by the pharmacist in filling a rx is adequate to identify the supplier, the product and the pt, and to include the directions for use and cautionary statements, if any, contained in the rx or required by law

Regulations regarding prescription back-up of electronic prescriptions

Must back-up files daily It is not required, however, DEA recommends as a best practice that pharmacies store their back-up copies at another location to prevent loss of records in the event of natural disasters, fires or system failures Once a Rx is created electronically, all records of the Rx must be retained electronically *Electronic controlled substance prescription records must be kept for a minimum period of 2 years* (as is the case with paper prescription records)

Registration of Manufacturers, Distributors and Dispensers of controlled substances

Must be registered by the DEA to engage in activities with controlled substances Hospital registrations are issued to the entire hospital as an "institutional practitioner" NOTE: pharmacists do not generally need to register with the DEA if they are working in a registered establishment -at the time a retail pharmacy, hospital/clinic, practitioner or teaching institution is first registered, that business activity shall be assigned to a specific month of the year. The expiration date of the registrant will be the last day of the month designated. -after the initial registration period, the registration expires 36 months from the initial expiration date

Labels for Herbals and Dietary Supplements

Must contain the standard common names as listed in the reference source, Herbs of Commerce, published by the AHPA (American herbal products association) The standardized common herbal names must be used, but inclusion of the Latin names is optional If an herb is not listed in the Herbs of Commerce, the manufacturer must include the herb's Latin name on the label Manufacturers are permitted to make structure or function claims on labels if the statements do not indicate that the product will diagnose, cure, treat or prevent a disease While the manufacturer must substantiate the product claims, they do NOT have to be reviewed or approved by the FDA — this fact MUST be stated on the product label

is soap considered a cosmetic?

NO

Examples of mid-level practitioners

NP, nurse midwives, nurse anesthetists, clinical nurse specialists, PA who are authorized to dispense controlled substances by the state in which they practice

Invalid CSOS orders

No electronic order may be filled if: 1. The required data fields have not been completed 2. The order is not signed using a digital certificate issued by the DEA 3. The digital certificate used has expired or has been revoked prior to signature 4. The purchaser's public key will not validate the digital signature 5. The validation of the order shows that the order is invalid for any reason If an order cannot be filled for any reason, the supplier must notify the purchaser and provide a statement as to the reason. A supplier may, for any reason, refuse to accept any order and, if a supplier refuses to accept the order, a statement that the order is not accepted is sufficient notification When a purchaser receives an unaccepted electronic order from the supplier, the purchaser must electronically link the statement of non acceptance to the original order. The original order and the statement must be retained Neither a purchaser or a supplier may correct a defective order — the purchaser must issue a new order for the order to be filled

National Drug Code (NDC)

Numbering system that aids in identifying a drug product. 3rd party payers also employ NDC numbers to identify products for reimbursement Contains 10 or 11 digits Example: 1074 (manufacturer) 0128 (ID of specific drug) 04 (ID of package) Each manufacturer has its own number which has been assigned to them by the FDA — known as the "labeler's code" Newer drug products have either 10 or 11 digit NCD numbers, of which the first 5 represent the manufacturer and the remaining digits represent the drug and package The NCD Directory is a publication that contains listings of NCD numbers and their identity -other books, such as the Red Book and the Blue Book, as well as the National Drug Code Directory, available at the FDA website, have NDC numbers and their equivalents listed All Rx drugs marketed in the US must have NCD numbers. While placing the NCD number on the package labeling is not mandatory, most companies do so. The NDC number also does not have to appear on individual dosage units nor is there any federal law requiring that NDC numbers appear on prescription labels

NonRx drugs: General labeling requirements

OTC status is granted to drugs and drug products that have bee shown to be: -safe for use without a physician's supervision -conditions suitable for self-diagnosis -have adequate written directions for self-use The FDA requires that all nonprescription, OTC medicine labels have a "Drug Facts" section Below is an example of what elements an OTC "Drug Facts" section must have, in the order in which the info must appear on the label: -Active Ingredient -Uses -Warnings -inactive ingredients -Purpose -Directions -Other Information *If any of the above info is missing, the nonprescription product is considered misbranded*

Bad Advertising

Office of Prescription Drug Promotion ("OPDP") started the Bad Ad Program -Bad advertising about Rx drugs may be reported to the OPDP by emailing a summary of an incident to [email protected] or by calling 301-796-1200 Purpose = educate health care providers about misleading or inaccurate promotion of prescription drugs by companies -also solicits help from health care providers in identifying and reporting such activities

Prescription Ownership

Once a Rx has been filled and dispensed, the prescription is legally owned by the pharmacy -it should not be removed from the files except by court order If the prescriber or patient requests the actual prescription, the pharmacist should refuse but offer a copy of the prescription

New Drug Application (NDA) Process

Once sufficient data has been obtained, a new drug application must be submitted to the FDA for review If the FDA is satisfied, the NDA is approved and teh NDA will be "on file" at the FDA. At this point, the manufacturer may market the new drug product Once submitted, the FDA generally reviews the application for at least 6 months and provides expertise and other interested parties the opportunity to comment on the submission After the drug is marketed, Phase 4 studies are conducted -the drug manufacturer must also submit yearly reports concerning new info and field reports concerning the drug product

Abbreviated New Drug Application (ANDA)

Once the patent expires, other companies may wish to introduce the drug under the drug's generic name only or as a brand name product. Rather than requiring the secondary companies to submit a complete NDA, the FDA will permit an ANDA -these submissions require less data, but do require proof that the new drug product's pharmacokinetic properties, its bioavailability, and clinical activity are similar to that of the innovator's drug product The first applicant to complete a formal review showing that its generic product is biologically equivalent to the brand name product will be rewarded 6 months of exclusive rights to sell the generic

Completing DEA Form 222

Only 1 item may be entered on each numbered line of the order form -the number of lines completed must be noted on that form at the bottom of the form, in the space provided The name and address of the supplier from whom the controlled substances are being ordered must be entered on the form. Only one supplier may be listed on any form Each order form must be signed and dated by a person authorized to sign an application for registration. The name of the purchaser, if different from the individual signing the order form, must also be inserted in the signature space Any purchaser may authorize one or more individuals to obtain and execute order forms on his/her behalf by creating a Power of Attorney for each such individual NOTE: remember that when ordering controlled substances on a DEA form 222, a registrant is not permitted to order different drug products on the SAME LINE. For example, 3 x 100 Percodan tablets may be ordered on one line but NOT 1 x 100 Percodan and 1 x 100 codeine sulfate 30 mg tablets. Each different product must be ordered on a separate line

Filling orders written on DEA form 222

Only a person registered as a manufacturer or distributor of controlled substances listed in Schedule I or II may fill an order form, except for the following: -a pharmacist who is discontinuing a pharmacy -if a registrant's registration is expiring without re-registration -if a registrant is returning a Schedule I or II substance to the supplier (ie wholesaler or manufacturer) from which it was obtained -a person registered or authorized to conduct chemical analysis or research with controlled substances may distribute a controlled substance listed in Schedule I or II to another person registered or authorized to do the same -a person registered as a compounder of narcotic substances for use at off-site locations in conjunction with a narcotic program at the compounding location. Such persons may fill orders for narcotic drugs for off-site narcotic treatment programs only NOTE: -in summary: any transfer of CI or II drugs from one registrant to another (eg pharmacy to pharmacy, pharmacy to wholesaler or manufacturer, etc) requires the use of a DEA Form 222. It's use is not required when such drug products are transferred from a central fill pharmacy to a retail pharmacy

Partial filling of Schedule II Prescriptions

Permissible if the pharmacist is unable to supply the full quantity for in a written or emergency oral prescription — must make a notation of the quantity supplied on the face of the written Rx -*remaining portion of the Rx may be filled within 72 hours of the first partial filling* -if the remaining portion is not or cannot be filled within the 72-hr period, the pharmacist must notify the prescribing practitioner -no further quantities may be supplied beyond 72 hours without a new Rx NOTE: partial filling of a CII is not permitted if it is being done on the request of the pt — only permitted if the pharmacist is unable to supply the full quantity prescribed *A Rx for a CII written for a pt in a LTCF or for a pt with a medical diagnosis documenting a terminal illness may be filled in partial quantities* -the pharmacist must record on the Rx whether the pt is "terminally ill" or an "LTCF patient" For each partial filling, the dispensing pharmacist must record on the BACK of the Rx (or on another appropriate record, uniformly maintained, and readily retrievable) the -date of the partial filling -quantity dispensed -remaining quantity authorized to be dispensed -identification of the dispensing pharmacist *the total quantity of CII substances dispensed in all partial fillings is not permitted to exceed the total quantity prescribed* *Schedule II Rx for pts in a LTCF or pts with a medical diagnosis documenting a terminal illness are valid for a period not to exceed 60 days from the issue date* Info related to current CII Rx for pts in a LTCF or for pts with a medical diagnosis documenting a terminal illness may be maintained in a computerized system if this system has the capability to permit: -output (display or printout) of the original Rx number, date of issue, identificatio of prescribing individual practitioner, identification of pt, identification of med authorized, listing of the partial fillings that have been dispensed under each Rx and other info required by the CSA -immediate (real time) updating of the Rx record each time a partial filling of the Rx is conducted

Partial filling of Schedule III, IV and V Prescriptions

Permissible, provided that: -each partial filling is recorded in the same manner as a refill -the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed -no dispensing occurs beyond 6 months after the date on which the prescription was issued

2013 Drug Quality and Security Act

Permits compounding pharmacies to register with the FDA as "outsourcing facilities" and to be subject to rules dealing with quality control and oversight that are similar to rules that apply to large drug manufacturers However, there is no requirement for compounding pharmacies to register with the FDA nor any FDA-specified procedures that must be followed to ensure safety

Dietary Supplement Health and Education Act (DSHEA)

Places health foods, food supplements, and herbal products into a class different from prescription and nonprescription drugs Included in the class are: -herbals, amino acids, vitamins, minerals, and related supplements Among the major provisions of the original act and later additions are: -products may be marketed without their efficacy proven — FDA or FTC would have to challenge products after they had been introduced onto the market if evidence surfaced that they are ineffective -products currently on the market do not have to be proven safe — responsibility of the FDA to prove that a product is unsafe -the USP has published the "Manufacturing Practices for Dietary Supplements" in USP General Chapter 2750. The FDA regulations for Good Manufacturing Practices (GMPs) for dietary supplements were published. These regulations make distinctions between: -Dietary Supplement (DS) — ie the final product -Dietary Ingredient (DI) — ie a vitamin, mineral, herb or other botanical, an aa, or a dietary substance to supplement the diet -non-DI — ie an excipient or substance used in the manufacture of DS The GMP rules do not provide specific guidelines or requirements for tests that a company needs to conduct to verify identity, purity, strength, and composition of ingredients and finished products — company may establish its own testing procedures Manufacture must keep written records for 1 year past the expiration date or 2 years beyond the date of distribution of the last batch of supplements Violations of the GMP rules will result in the product being considered "adulterated"

Medicare Part A

Provides hospitalization insurance to eligible individuals.

Medicare Part B

Provides medical insurance for physician services

Storage of controlled sbustances

Practitioners and non-practitioners authorized to conduct research or chemical analysis must store CS listed in CII, III, IV and V in a securely locked, substantially constructed cabinet Pharmacies and institutional practitioners may store controlled substances by -keeping them in a locked secure cabinet -dispersing them throughout the stock of non-controlled substances in such a manner as to obstruct the theft or diversion *an electronic alarm system is also recommended Carfentanil, etorphine hydrochloride and diprenorphine must be stored in a safe or steel cabinet equivalent to a US Government Class V security container

Verification of DEA numbers

Prior to Oct 1, 1985 — *begin with A* All numbers issued after *begin with B* -when registration numbers beginning with letter B are exhausted, the DEA will issue numbers to begin with F *Registration numbers issued to mid-level practioner's begin with the letter M* *The first letter of the registrant's last name or business name follows the first letter of the registration number (eg J for Jones) and then a computer generated sequence of 7 numbers (eg MJ3614511) A pharmacist may verify a prescriber's DEA number by performing the following calculation: Assuming that the DEA number to verify is BR2398238 *Add the 1st, 3rd, and 5th digits of the number* 2 + 9 + 3 = 14 *Add the 2nd, 4th, and 6th digits of the number and multiply this sum by 2* 3 + 8 + 2 = 13 13 x 2 = 26 *Add the results of the first 2 calculations* 14 + 26 = 40 *the last digit of this final sum (in this case "0") should be the same as the last digit (ie the 7th and final digit) of the DEA number being tested* -since the last digit of the DEA number provided is "8" it is not a valid DEA number. The final number should be "0" to make it a valid number

FDA Expedited Review Programs

Priority Review Fast Track Breakthrough Therapy Accelerated Approval

Pure Food and Drug Act of 1906

Prohibited foods and drugs that were distributed through interstate commerce to be adulterated or misbranded -the law fell short of protecting the public since it did not require manufacturers to list on the label the ingredients or directions for use of a product -this law also did not regulate cosmetic products or medical devices

Orphan Drug Act of 1983

Provided various tax and licensing incentives to manufacturers, thereby making development of such drugs more appealing. -a rare disease is usually considered one that affects less than 200,000 persons in the US

Medical Device Amendment of 1976

Provides for better classification of medical devices according to their specific function, establishment of performance standards for these devices, pre-market approval requirements, conformance with GMP standards, and requirements for adherence to record and reporting requirements

Reimportation

Refers to a drug product that is manufacturer in the US with FDA-approved labeling, shipped to a foreign country, and then shipped back into the US According to the FDA, this procedure is legal only if performed by the original manufacturer

Pharmaceutical alternatives

Refers to drug products that contain the same therapeutic moiety BUT may consist of different: -salts -esters or complexes -dosage forms -strengths *most states do not allow substitution Amon pharmaceutical alternatives

Refilling schedule II prescriptions

Refilling of a CII is PROHIBITED

Rx to OTC Reclassificatio

Requests for the reclassification of a rx-only drug to OTC status are accomplished by one of the following 4 mechanisms: -if the drug is now a rx drug, a full NDA requesting OTC status may be submitted to the FDA for its evaluation -the FDA may grant an exemption if it deems that rx-only status is unnecessary -a supplement to the NDA may be filed which the FDA will review -the Nonprescription Drug Advisory Commitee may recommend that a particular ingredient be converted to nonrx status

Identity Proofing for electronic prescriptions for controlled substances

Required in order to utilize electronic prescribing of controlled substances — authorization to prescribe will not be granted to a practitioner until their identity has been confirmed Individual practitioners must obtain 2-factor authentication credential or digital certificates from federally approved credential service providers (CSPs) or certification authorities (CAs) For 2-factor authorization, DEA will permit the use of 2 of the following: -something you know (a knowledge factor) -something you have (a hard token stored separately from the computer being accessed), and -something you are (biometric information) *the hard token, if used, must be a cryptographic device or a one-time password device that meets Federal Information Processing standards The practitioner must use the 2-factor credential to sign the prescription — constitutes the legal signature of the DEA-registered prescribing practitioner An agent of the practitioner may enter information at the practitioner's direction prior to the practitioner reviewing and approving the information as long as the practitioner signs and authorizes the transmission of the prescription

Controlled Substance Records: Prescribers

Required to keep records of controlled substances in CII, III, IV and V that are dispensed, other than by prescribing or administering, in their practice — NOT required to keep records of CS that are prescribed in the lawful course of their practice (unless prescribed as part of a maintenance or detoxification treatment) NOT required to keep records of CII, III, IV, V that are administered in their practice unless the practitioner regularly engages in the dispensing or administering of controlled substances and charges patients, either separately or together, with charges for other professional services, for substances so dispensed or administered

Poison Prevention Packaging Act (PPPA)

Requires child-resistant closures that prevent access to almost all prescription drugs, nonprescription drugs, and hazardous household products in order to protect young children from serious injury or illness caused by their accidental ingestion -if an OTC product is marketed in several sizes, one package size is not required to have a safety closure. Such products must include on their label the statement, "This package for households without young children" -all new and refilled prescriptions must be dispensed in a child-resistant closure unless: -the prescriber specifies that none is to be used -the patient indicates that they do not want such a closure -the container is being used in a hospital or similar institution in which the drugs are maintained and administered by health professionals. However, child-resistant containers should be used by pharmacies providing drug products to nursing homes *prescriber may only provide a waiver for the use of a child-resistant container for a single prescription at a time. Patients, however, may provide a blanket waiver for the use of child-resistant containers for one or more of their prescriptions -when preparing Rx refills for patients, both parts of plastic container units must be replaced. If the container body is constructed by glass, it may be reused but the plastic closure must be replaced. This is a safety precaution since many plastic closures may lose their child-resistant features after repeated use. The pharmacy may employ reversible closures (those designed to be used as either safety or regular tops) although this practice is discouraged by the CPSC

Trade Name or Brand Name

Selected by a pharmaceutical company for its own brand of a generic drug Purpose = to encourage prescribers to prescribe a specific company's product exclusively

Good Manufacturing Practice (GMP)

Set a regulations that specify the minimum standards required to manufacture pharmaceutical products in the US — designed to assure safety and quality of pharmaceuticals Manufacturers must be registered with the FDA and they must describe their manufacturing and production processes as part of the NDA process -the FDA inspects the drug manufacturer's facilities approximately once every 2 years to determine compliance with GMPs

Exportation

Shipment of drug products to a foreign country This action is generally acceptable if performed by the original manufacturer or a duly licensed wholesaler, and if there is no intention to bring the product back into the US

Vaccine problem reporting

Should NOT be reported to the MedWatch program or on the Med Watch form, but should be sent to the joint FDA/CDC Vaccine Adverse Event Reporting System (VAERS)

Medicare Prescription Drug Improvement and Modernization Act of 2003

Signed into law December 2003 Currently encompasses 4 programs: -Medicare Part A -Medicare Part B -Medicare Part C -Medicare Part D

Generic Name

Single specific name assigned to a drug by the USAN -in the US, each specific drug structure is given only one generic name

Email use in pharmacy practice

Sometimes called the CAN-SPAM act — affects all unsolicited commercial emailing -intent is to reduce unsolicited emailing (ie spam) from all sources All companies that issue email messages must identify themselves within the message and provide physical address contact information. In addition, the subject line of the email must be truthful and not deceptive Other requirements of this law specify that each commercial email message must: -identify itself as an advertisement or solicitation -originate from a legitimate email address to which a recipient may reply -be sent from a legitimate domain name and have correct header information that allows tracing to its origin -have a mechanism by which a recipient may choose not to receive future messages An added incentive for complying with the CAN-SPAM act is that the federal government is empowered to levy a fine up to $16,000 for each separate email violation of this law

Drug Price Competition and Patent-Term Restoration Act

Sometimes called the Hatch-Waxman Amdendment -attempted to resolve a dispute between generic drug and brand name drug manufacturers Congress streamlined the drug approval process for generic products by requiring submission of a only an abbreviated new drug application (ANDA) -*does not require costly clinical testing for approval of a generic product, it only requires proof of bioequivalence with its brand-name counterpart* Brand name drug manufacturers were provided with incentives to develop new drug products by being *awarded up to 5 additional years of patent protection* to compensate them for the lengthy time it takes to go through the FDA approval process

Applications for Registration for controlled substances

Specific DEA registration forms must be used by different types of entities to register with the DEA Pharmacies: Form 224 Manufacturers, Distributors, Importers, Exporters, Researchers: Form 225 Narcotic Treatment Programs: Form 363 *registration renewal forms for these entities generally have the same number, but with an "a" suffix — 224a, 225a, 363a -these forms are mailed to each registered entity approximately 60 days before the expiration date of the registration -if a registered entity does not receive registration renewal forms within 45 days before the expiration date of his/her registration, he/she must promptly notify DEA and request such forms in writing Each application, attachment, or other document filed as part of an application, must be signed by the -applicant, if an individual, or -by a partner of the applicant, if a partnership, or -by an officer of the applicant, if a corporation, corporate division, association, trust or other entity NOTE: federal law does not require the applicant for DEA registration to be a pharmacist -an applicant may authorize one or more individuals, who would not otherwise be authorized to do so, to sign applications for the applicant by filing with the Registration Unit of the DEA a Power of Attorney for each such individual -a person who is authorized to sign registration applications must sign the Power of Arrontey -it must also contain the signature of the individual being authorized to sign applications -the Power of Attorney is valid until revoked by the applicant NOTE: remember these important time periods: -*a DEA registration is valid for 36 months* -*registration renewal forms are sent to the registrant 60 days before the expiration date of the registration* -*registrants must notify DEA in writing if they have not received their renewal forms within 45 days of their expiration date* The DEA may deny registration if the Applicant has -materially falsified the information on the application -been convicted of a drug-related felony -committed acts which would make registration inconsistent with the public interest -had its state license suspended, removed or denied -in addition, the DEA may revoke a registration for the above reasons as well in cases where the applicant has been subject to mandatory exclusion from participation in the Medicare or state health care program

Prescriptions access at "out-of-network" pharmacies under Medicare Part D

Sponsors of Part D plans must ensure that the beneficiary will be able to obtain prescription drugs when traveling outside of the geographic area of their pharmacy or when the pharmacy they normally use is either closed or the drug is out of stock When it is necessary to patronize an "out-of-network pharmacy" the beneficiary must pay the new pharmacy's usual and customary price when purchasing the prescription. The beneficiary will then submit a claim to their plan for reimbursement. The beneficiary is responsible for any difference in the new pharmacy's charge and that allowed by the plan sponsor

Accelerated Approval review programs

Sponsors should discuss Accelerated Approval with FDA drug development Intend for drugs with long-term endpoints, such as increased survival or decreased morbidity, that are difficult to measure efficiently in trials Allows approval based on easily measured outcomes that are reasonably likely to predict clinical benefit Sponsors are required to confirm a drug's efficacy in post-market clinical trials Priority Review, Fast Track, and Breakthrough drugs can also be eligible for Accelerated Approval

Customized Patient Med Paks

The usual information for unit dose packages is required, plus a serial number for the patient Med Pak in addition to the prescription serial numbers for each drug product The expiration dating for the Med Pak is based upon the "beyond-use" dating principle but should not exceed 60 days from the date that the Med Pak was prepared

Therapeutic substitution

Terms used when a pharmacy has the right to substitute a different drug for the one designated on the prescription or medical order, without contacting the prescriber (eg one cephalosporin drug for another) -this practice is generally limited to institutions that utilize a drug formulary

Alcohol Regulations

The Bureau of Alcohol, Tobacco and Firearms controls the sale of alcohol *Pharmacies may purchase 95% ethanol (190 proof grain alcohol) for routine compounding by using Form ATF-11* -if a pharmacy is selling alcohol in the form of a beverage, it must obtain a retail liquor dealer's stamp Institutions that have a need for greater volumes of alcohol may choose to purchase tax-free alcohol, since it is must lower in cost -such pharmacies must purchase alcohol using Form ATF-1447 The following are federal statutes that relate to the use of tax-free alcohol -its use is limited to medicinal or scientific use, or in pt tx -the alcohol may not be sold or loaned to other pharmacies or physician's offices -the alcohol, either by itself or as a component of other products, may not be sold to outpatients. Exception: permits nonprofits clinics to dispense medicines made with tax-free alcohol provided the client is not charged for the med -containers of alcohol, usually supplied in 10 or 55-gallon drums, must be stored in a securely locked, fire-resistant store-room -a running, accurate inventory must be kept for all alcohol in stock How may a prescriber's order for an alcohol-containing beverage (eg brandy at bedtime) for an institutionalized client be handled? Either the -institution may buy the alcohol-containing beverage, furnish it to the client, and then bill the pt, or -the hospital pharmacy may give the pt's relatives permission to bring in alcohol for the pt Another available form of tax-exempt alcohol is Specially Denatured Alcohol (SDA) -SDAs refer to specific formulas of grain (ethyl) alcohol that have been rendered unsuitable for use as a beverage by the addition of denaturants such as sucrose octaacetate, brucine, or butyl alcohol -SDAs are often used for pharmaceutical processing and in commercial products such as mouthwashes

Identification of Commercial Solid Dosage Forms

The Code of Federal Regulations (CFR) requires manufacturers to imprint solid oral dosage forms, whether they are prescription or nonprescription products (there are some exemptions to this — example: nitroglycerin sublingual tablets) The imprint code must permit the identification of both the manufacturer and the specific drug product

Testing protocols for child-resistant packaging (CRP)

The Consumer Product Safety Commission (CPSC) which has jurisdiction of the PPPA, has established testing protocols for child-resistant packaging (CRP) Test panels used to assess such packaging generally consist of 2 groups: -children under 5 years of age -adults 50-70 years of age A package will fail the child-resistant test if more than 20% of the children can open the package in a total of 10 minutes. However, to meet adult-friendly requirements, 90% of a 100 person adult panel must be able to open and close the package in 5 minutes, and then do so a second time within 1 minutes

Federal Investigation of Pharmaceutical Theft or Robbery

The Controlled Substances Registrant Protection Act of 1984 (CSRPA) provides for the federal investigation of pharmaceutical thefts and robberies if any of the following conditions are met: -replacement cost of the controlled substances taken is $500 or more -a registrant or other person is killed or suffers "significant" bodily injury during the commission of the robbery or theft of a controlled substance -interstate or foreign commerce is involved in planning or executing the crime

Electronic prescriptions for controlled substances

The DEA provides practitioners with the option of writing prescriptions for controlled substances electronically -it also permits pharmacies to receive, dispense and archive these electronic prescriptions These regulations to do mandate that practitioners prescribe controlled substances using only electronic means. Nor do they require pharmacies to accept electronic prescriptions for controlled substances for dispensing — VOLUNTARY

Prescription Compounding vs Manufacturing

The FDA Compliance Policy Guide of 1992 states that pharmacies may compound drugs extemporaneously if: -the quantity prepared is reasonable for filling either existing prescriptions or those anticipated based upon prescribing habits of local prescribers and/or prescriptions already on file -the dosage forms prepared are not being compounded, provided or sold to other pharmacies or 3rd parties such as physician's offices -the drug products compounded are not ones already available from commercial sources. That is, they are not compounded versions of FDA-approved drug products -the ingredients included in a compounded dosage form meet official standards, usually those found in the USP/NF. If an ingredient does not have an official monograph, it may be used to compound a prescription if it is a component of or an approved drug product, or it is on a list of approved substances developed by the Secretary of the US Department of Health and Human Services -the pharmacy does not actively solicit business for specific compounded drug products by advertising or by otherwise promoting their compounding capabilities. However, the pharmacy may advertise to both the public and health professionals that it specializes in prescription compounding -the pharmacy does not attempt to compound a drug product which is on the list of products that have been withdrawn or removed from the market because they were unsafe or ineffective -the pharmacy limits its interstate distribution of compounded products to not more than 5% of the total prescriptions filled by that pharmacy

Counterfeit Drugs

The FDA and other agencies oppose the purchase of prescription drugs from abroad They also warn against the purchase of such drug products from domestic web sites unless they display the VIPPS (Verified Internet Pharmacy Practice Sites) seal -developed by NABP -hyperlink seal that allows the visitor to link to the NABP VIPPS site where verified info about the pharmacy is available

5 levels of risk mitigation

The Food and Drug Administration Amendments Act (FDAAA) of 2007 gave the FDA authority to require an Evaluation and Mitigation Strategy (REMS) from manufacturers to ensure that the benefits of a drug or biological product outweigh its risk *1. Professional Label and Package Insert* *2. REMS — Medication guide (MedGuide)* *3. REMS — Communication Plan* (may include training videos, protocols, informed consent agreements, etc) *4. Elements to Assure Safe use (ETASU)* — these elements may include restrictions on accessing a drug based on the following: -the training or experience of a prescriber -the type of setting that dispenses the drug must demonstrate sufficient training The site of care may be specified (eg the patient must be admitted to a hospital before receiving the medication) -the patient must show evidence or documentation of safe-use conditions -the patient must agree to be properly monitored. In some cases, the patient must be enrolled in registry *Implementation System* — most often used for drugs with severe adverse event profiles. Typical limited distribution systems include the following: -*Open Distribution* — generally for oral drugs -*Managed Distribution* — usually for drugs that are used in specialized care sites -*Controlled Distribution* — usually for drugs that are used by specific types of physicians (eg oncologists) in a specific practice site -*Restricted Access* — usually for drugs that require patient registry or are being utilized for treating rare diseases

OBRA 90 and Patient Counseling

The Medicaid Prudent Pharmaceutical Purchasing Provisions of this Act establish conditions for the federal government to reimburse states for outpatient Medicaid services In order for a state to receive money for its Medicaid program, it must have a drug use or drug utilization review (DUR) program -the DUR program must include a *prospective component and a retrospective component* *Prospective DUR* Review of a patient's written medical record and/or his medication profile before dispensing a Rx to a patient. Minimally the following info is required in the profile" -pt's name, address, phone number -age and DOB -sex of the patient -disease state(s) info, if known or provided by provider or patient -any known allergies -a list of meds previously dispensed -pharmacist comments, when appropriate When a Rx is presented to the pharmacist, he or she must perform a prospective DUR. This consists of: -a review of the Rx and pt records for over or under utilization of drugs -checking for therapeutic duplication -checking for incorrect doses or dosing regimens -extending a verbal offer to the client or to their representative to personally discuss matters that will enhance or optimize their drug therapy A critical component of OBRA 90 is the requirement that an offer to counsel the patient must be provided -since Medicaid is under the jurisdiction of the individual states, each state has the right to establish whether patient counseling will be required for all pts What type of info must the pharmacist provide if counseling is required? Federal law does not state how much or what specific info is to be provided by the pharmacist When does the pharmacist NOT have to counsel a patient? Only if the pt refuses to be counseled May a pharmacy intern counsel a patient? Up to state BOP *Retrospective DUR* -requirement for individual states — NOT for pharmacies -expected that each state will establish a committee OBRA 90 also established and funded demonstration projects with the intent of evaluating outcomes of patient care and the cost efficiency of pharmacist interventions Another objective of OBRA 90 legislation is to reduce the cost of state Medicaid programs -pharmaceutical manufacturers are required to offer Medicaid programs the lowest price ("best price") for drug products

Storage of order forms (DEA form 222)

The PURCHASER must retain Copy 3 of each order form that has been filled -must also retain files of all copies of each unaccepted or defective order form and each statement attached thereto Order forms must be maintained separately from all other records of the Registrant The SUPPLIER must retain Copy 1 of each order form that he/she has filled Order forms and other related documents must be kept available for inspection for a period of 2 years *a supplier of carfentanil, etorphine hydrochloride and diprenorphine must maintain order forms for these substances separately from all other order forms and records NOTE -carfentanil and etorphine hydrochloride are potent narcotics that are used exclusively in veterinary practice. They are often used to immobilize large animals -diprenorphine is an opioid antagonist used to reverse the effects of these 2 narcotic agents

Official status of herbals

The USP/NF has developed monographs for some botanicals that appear to have therapeutic efficiency The monographs describe the portion of plant used, its botanical characteristics, and appropriate assay procedure for ingredients -do NOT describe the therapeutic use of the herbs Herbs with monographs: -chamomile, cranberry liquid preparations, feverfew, garlic, ginger, ginkgo, milk thistle, St. John's wort, saw palmetto, valerian

Excluded (Exempt) Controlled Substances

The following non-narcotic substances are some examples of drug products that contain controlled substances but are excluded or exempt from all schedules: Isuprel Elixir — Controlled substance ingredient: phenobarbital Pyridium Plus Tablets — controlled substance ingredient: butabarbital Lufyllin-EPG Elixir — controlled substance ingredient: phenobarbital Butibel Tablets — controlled substance ingredient: butabarbital sodium Librax Caps — controlled substance ingredient: chlordiazepoxide HCl Donnatal Tabs and Elixir — controlled substance ingredient: phenobarbital Anaspaz PB — controlled substance ingredient: phenobarbital NOTES: manufacturers may apply to the DEA for exemption of a product from controlled substance status. The exemption may be granted if it appears unlikely that the product can be abused. Because most of these brand name excluded products are of little therapeutic value, just about all of them have been removed from the market. The DEA always provides a current list of products that contain controlled substances but are exempt from all controlled substance schedules. The list may be found online by the name Exempt Prescription Products List

OTC labeling for electrolytes besides sodium

The label must indicate the presence of each of the following minerals if the level of the mineral in each dose is equal to or exceeds the threshold amount indicated: *Calcium: 20 mg* *Magnesium: 8 mg* *Potassium: 5 mg* In addition, label warning intended for individuals on electrolyte-restricted diets are required if the maximum daily intake of a mineral will exceed the threshold amounts indicated below: *Sodium: 140 mg* *Calcium: 3.2 g* *Magnesium: 600 mg* *Potassium: 975 mg*

Refilling prescriptions for written nonprescription drugs

The pharmacist may refill prescriptions written for nonprescription drugs without prescriber authorization unless: 1. The dose requested is greater than the recommended dose on the label of the commercial OTC product 2. The prescriber has limited the number of refills on the original rx 3. The drug is a CV controlled substance where the number of refills must be designated by the prescriber 4. The individual state has set a time period limit for refills

How does the FDA and other inspection bodies classify a unit-dose product that does not have an expiration date?

The product is misbranded

FDA Classification System for New Drugs

Therapeutic Classification -Type P -Type S Chemical Classification -Type 1 -Type 2 -Type 3 -Type 4 -Type 5 -Type 6 Type AA Type E Type F Type N Type V

Narrow Therapeutic Index Drugs (NTIs)

These are drugs which have narrow therapeutic ratios: -less than a 2-fold difference between the median lethal dose (LD50) and the median effective dose (ED50) -less than a 2-fold difference between the minimum toxic concentration (MTC) and the minimum effective concentration (MEC) in the blood The FDA has identified the following drugs as NTIs: -carbamazepine -cyclosporine -digoxin -ethosuximide -levothyroxine -lithium -phenytoin -procainamide -tacrolimus -theophylline -warfarin Variability limits for most NTIs are 95-105% (FDA allows most drugs to have a variability limit of 90-110%)

Compounding of Sterile Products for Use in the Home

These products are designated as "home-use sterile drug products" or "HSDs" Techniques required to prepare such products are classified as "low risk" or "high risk" *Low Risk*: these are techniques involving commercially available sterile products that are manufacturers in a "closed system." Examples include: -transfer of a solution from a commercial vial or ampule with a needle and syringe -compounding TPN solutions using commercially available sterile solutions -transfer of sterile solutions into elastomeric devices *High Risk*: these are techniques involving more complex skills to assure sterility and safety of the final product. They are further classified into: -*Category 1* activities include the following techniques -pooling sterile drug products for subsequent transfers -complex compounding involving numerous aseptic processes -preparing an infusion intended for multi-day use in a portable pump or reservoir system Example Cat 1: preparation of TPN's using automated compounding devices -*Category 2* activities involve ingredients, products, and techniques which pose the greatest risk of contamination. In most instances, the final product will have to be sterilized by the compounder. Examples include: -using non-sterile drug substances in preparing a product -using "open systems" such as the compounding of morphine solutions for injection or infusion using morphine powder -compounding sterile nutritional solutions using non-sterile ingredients during which the initial mixing is performed in an unsealed or nonsterile reservoir

Medication Guides

This program provides standards for the distribution and quality of written prescription information material or MedGuides to be dispensed to patients The FDA requires MedGuides for products when: -patient labeling could prevent serious adverse effects -the product has serious risks relative to benefits -patient adherence to directions is crucial The MedGuide paper sheets or the means to produce them are distributed by drug product manufacturers to dispensers, who are then required to provide them to patients Manufacturers must obtain FDA approval before distributing their MedGuides. There are currently several hundred drug products that must be dispensed with MedGuides. Some of these include: -advair diskus (salmeterol and Fluticasone) -anaprox (naproxen sodium) -Avonex (interferon beta-1a) -Concerta (methylphenidate) -Cordarone (Amiodarone) -Coumadin (warfarin) -duragesic (fentanyl) -Elidel cream (pimecrolimus) -Emsam (selegiline transdermal system) -epzicom (abacavir and lamivudine) -Forteo (Teriparatide) -Infergen (interferon alfacon-1) -isotretinoin -lariam (mefloquine) -lexapro (escitalopram) -lindane shampoo and lotion -Lotronex (alosetron) -mifeprex (mifepristone) -nolvadex (tamoxifen) -NSAIDs -Palladone (hydromorphone) -Pegasys (peginterferon alfa-2a) -PEG-Intron (pegylated interferon alfa-2b) -Protopic ointment (tacrolimus) -Rebetol (ribavirin) -Rebif (interferon beta-1a) -Remicade (infliximab) -Revlimid (lenlidomide) -Ritalin (methylphenidate) -Roferon-A (interferon alpha-2A) -Serevent Diskus (salmeterol) -Soltamox (tamoxifen oral solution) -Soriatane (Acitretin) -Strattera (atomoxetine) -Symlin (Pramlintide) -Tracleer (bosentan) -Trizivir (abacavir, lamivudine, and zidovudine) -Viramune (nevirapine) -Xolair (omalizumab) -Ziagen (abacavir) -Zyban (bupropion HCl)

Enrollment in CSOS

To enroll — the individual purchaser is required to acquire a CSOS digital certificate The holder of the digital certificate has a private key, which is available to anyone. What one key encrypts, only the other key can decrypt. Only one public key will validate signatures made using its corresponding private key. Because only one person holds the private key, it is that person's responsibility to ensure that it is not divulged or compromised

Ordering controlled substances using DEA form 222

To order a controlled substance in CI or II, the purchaser must complete DEA Form 222, submit Copy 1 and Copy 2 form to the supplier, and retain Copy 3 in his/her own files. -the supplier fills the order, and records on Copies 1 and 2 the number of commercial or bulk containers furnished on each item and the date on which such containers are shipped to the purchaser If an order cannot be completely filled, ti may be partially filled and the balance supplied by additional shipments within 60 days following the date of the order form. The order form is no longer valid after 60 days from the time it was executed by the purchaser. The controlled substances may only be shipped to the purchaser and to the location printed by the DEA on the order form The supplier must retain Copy 1 of the order form for his/her own files and forward Copy 2, at the close of the month during which the order is filled, to the Special Agent in Charge of the DEA office in the ARA in which the supplier is located If a single order is filled by partial shipments, Copy 2 must be forwarded to the regional DEA office at the close of the month during which the final shipment is made or during which the 60-day validity period expires The purchaser (ie the pharmacist, physician, etc) must record on Copy 3 of the order form the number of commercial or bulk containers received on each item and the dates on which such containers are received STUDY TIPS: -the supplier who fills a controlled substance order always keeps the original portion of the order. In this case, the supplier is "filling" the order for the purchaser. When a prescription is filled, the pharmacist is the supplier and, therefore, keeps the original prescription -it is important to remember the colors and the final destination of each portion of DEA Form 222 Copy 1 (Brown) — goes to the supplier Copy 2 (Green) — first goes to the supplier and is then forwarded to the DEA Copy 3 (Blue) — retained by the purchaser

Prescription Container Labeling

USP 36-NF 31 1. The top of the Rx label should specify the patient name, prescription (serial) number, the drug name (full generic and brand name), the strength, and clear directions for use provided in simple language 2. Other less critical, but important content, should not supercede critical patient info 3. The readability of the label should be improved by the use of familiar large fonts such as 12 point Times Roman or 11 point Arial 4. Drug names should be spelled out rather than using an abbreviation or acronym 5. Explicit instructions must be clarified -should use numbers instead of alphabetic characters (eg 2 instead of two) -implicit directions such as "take 2 tabs twice daily" should be avoided — use take 2 tabs in morning and 2 tabs in evening -specific hour designations such as 8 am and 10 pm or every 12 hours should be avoided — use "in the morning or after breakfast" 6. Unless the patient prefers that it not appear, the prescription label should include the purpose for use if it is included on the prescription 7. The pharmacist should address limited English proficiency 8. The pharmacy name, address, telephone number, etc should not supercede the above critical info and should be placed away from dosing instructions 9. The Rx label should also include the prescriber's name 10. The date on the Rx label should indicate when the Rx was either written or dispensed 11. Inclusion of expiration dating, lot number of the drug product, and/or name of the drug manufacturer is left to the discretion of individual states

Practitioner Self-prescribing

Under federal law, a controlled substance prescription is valid only if it is "issued for a legitimate medical purpose by a practitioner acting in the usual course of sound professional practice" While federal law is not specific with regard to self-prescribing, Policy E-8.19 of the American Medical Association (AMA) states: "Physicians should generally not treatment themselves or members of their immediate family" and makes an exception only for certain emergency situations *it is the responsibility of the prescribers to use good professional judgement an dit is the legal responsibility of pharmacists to adhere to sound professional practice in filling prescriptions. What constitutes "sound professional practice" is left to state laws

Responsibility for designating a nonproprietary or generic name for a new drug belongs to

United States Adopted Names Council (USAN) However, the Secretary of Human Health Services (HHS0 must grant final approval for any drug name

Official Compendia of the United States

United States Pharmacopoeia/National Formulary (USP/NF) -NOT published by the US government -published by a private organization known as the US Pharmacopoeia Convention (USPC) Homeopathic Pharmacopoeia of the United States (HPUS) NOTE: if a drug is listed by its official name in the USP/NF or HPUS, it must meet the requirements specified in either book, otherwise it must have the designation "not USP/NF" (without this, its considered to be misbranded or adulterated) -if a drug is official in both the USP/NF and HPUS, it must meet the standards established in the USP/NF monograph unless it is distinctly marketed and labeled as a homeopathic drug

Patent Protection

Up to 1984, innovator companies has a 17-year period of exclusive patient rights, including the time that elapsed during the development period and the FDA review process The Drug Price Competition and Patent-Term Restoration Act of 1984, aka Waxman-Hatch Amendment: granted longer patent protection (up to an extra 5 years) while the manufacturers of generic drugs were provided with easier access to approval of their drug applications In June 2005, the Supreme Court rules that drug makers do not have to wait until a patent expires before conducting basic research -thus, a company could conduct studies on a drug projected by another company's patent

Priority Review program

Used for Biologics License Application (BLA) or New Drug Application (NDA) submission Reduces a drug's FDA review period from 10 months to 6 Drugs qualifying for Fast Track, Breakthrough Therapy, and Accelerated Approval can also be eligible for Priority Review

Therapeutic equivalence

Used to denote drug products that are: -pharmaceutical equivalents AND -bioequivalent Drug products that are considered to be bioequivalent have been clinically evaluated and have been shown to have similar pharmacokinetic properties (ADME) Most critical in claiming bioequivalence is that 2 products each produce similar: -time to peak -peak concentrations -AUC

Mailing of Prescription Drugs

Virtually no restrictions on mailing Rx products via USPS -controlled substances allowed -prohibits mailing of poisons or alcohol-containing products that could be considered beverages USPS regulations permit the mailing of controlled substances by drug manufacturers or their agents, pharmacies or other authorized handlers when distribution is lawful under DEA regulations and if the mailer or the addressee meets one of the following conditions: -the mailer or addressee is registered with the DEA -the mailer or the addressee is exempt from DEA registration as permissible by law USPS regulations permit mailing of any controlled substance provided it is not outwardly dangerous and will not cause injury to a person's life or health, and if the following preparations and packaging standards are met: -the inner container of any parcel containing controlled substances is packaged and labeled as required by the provisions of the Controlled Substances Act -the controlled substance is placed in a plain outer container or is securely wrapped in plain paper -if the cs consists of prescription medicines, the inner container is also labeled to show the name and address of the pharmacy, practitioner, or other person dispensing the prescriptions -the outside wrapper or container is free of markings that would indicate the nature of the contents *USPS regulations do not apply to commercial shippers such as UPS and FedEx

Drugs@FDA

Website produced by the FDA, Center for Drug Evaluation and Research -searchable website that contains info about approved and tentatively approved Rx, nonprescription, and discontinued drug Primary uses of Drugs@FDA are to: -find labels for approved drug products -find generic drug products for a brand name provider -find all drug products with a specific active ingredient -view the regulatory history of an approved drug -find consumer information for drugs approved after 1998 -find therapeutic equivalent drug products for a brand name or generic drug product