Law Midterm

what does adequate directions for use mean?

"Adequate directions for use" in the regulations means "directions under which the layperson can use a drug safely and for the purposes for which it is intended". The regulation continues by stating that the directions for use may be deemed inadequate unless the labeling contains statements of all conditions, purposes, or uses for which the drug is intended and for which the drug is commonly used.

execution of form 222

- 20 numbered lines on each form, only one item per line - Number of last line completed must be noted on each form - The form must contain required information. The NDC number is optional (supplier must enter it). - Must be signed and dated by authorized person - The purchaser, upon receipt of order, must record number of containers received of each item and date received. - Partial order fills by supplier must be completed within 60 days. - Errors, alterations, or erasures not permitted - Complete in pen, indelible pencil or typewritten - Make a copy for your records and send original to the supplier. - When completing the order the supplier will keep the original and sends a copy or email to the DEA. They send the copy at the close of the month.

what must the label contain for cosmetics?

- A cosmetic must be labeled with a list of its ingredients in descending order of predominance. The ingredients must be placed on the outside of the package or container so the consumer can read them at the point of purchase. Some cosmetics must have specified warning statements. - still must meet labeling requirements

what is a prescription under Section (b)(1)?

- A drug intended for use by man which - 1. (A) because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug; or 2. (B) is limited by an approved application under section 505 to use under the professional supervision of a practitioner licensed by law to administer such drug; shall be dispensed only (i) upon a written prescription of a practitioner licensed by law to administer such drug, or (ii) upon an oral prescription of such practitioner which is reduced promptly to writing and filed by the pharmacist, or (iii) by refilling any such written or oral prescription if such refilling is authorized by the prescriber either in the original prescription or by oral order which is reduced promptly to writing and filed by the pharmacist. - Subsection (b)(1) of the amendment provides that the FDA has the authority to categorize as prescription drugs those that are: 1. Unsafe for use except under the supervision of a practitioner because of the toxicity, the method of use, or the collateral measures necessary to use the drug 2. Subject to the new drug application (NDA) approval process

under what situations can protected health information be shared?

- A pharmacy may not use or disclose PHI except for TPO purposes, or to the patient or the patient's personal representative or agent. In addition, the privacy regulations allow the pharmacy to disclose PHI for governmental-type reasons, including: 1. Public health activities (e.g., to authorized health officers) 2. Judicial and administrative proceedings (requests should be made pursuant to a court or administrative order or subpoena) 3. Law enforcement purposes (e.g., to law enforcement officers in certain circumstances) 4. Serious threats to health or safety (e.g., in suspected cases of abuse, neglect, or endangerment) 5. As required by law - In these and related situations, the pharmacist should always contact the privacy officer and an attorney before releasing information.

what must a non-prescription drug labeling include?

- A statement of the identity of the product, including the established name of the drug if any, followed by an accurate statement of the general pharmacological category of the drug or principal intended action(s) (e.g., Suphedrin, pseudoephedrine hydrochloride, nasal decongestant) - The name and address of the manufacturer, packer, or distributor - The net quantity of the contents of the package - Cautions and warnings needed to protect the consumer - Adequate directions for use - A "Drug Facts" panel containing the following information in the following order: 1. Active ingredient(s) (including dosage unit and quantity per dosage unit) 2. Purpose (general pharmacological category or principal intended action) 3. Uses (indications) 4. Warnings (including the following subheadings in bold type): a. "For external use only" (for topical products) or "For rectal (or vaginal) use only" for products intended for these uses b. Do not use (listing of all contraindications) c. Ask a doctor before use if you have (listing of all conditions and situations when the product should not be used) d. Ask a doctor or pharmacist before use if you are (listing of all drug-drug and drug-food interactions) e. When using this product (listing of possible side effects and substances or activities to avoid) f. Stop use and ask a doctor if (listing of signs of toxicity and other reactions requiring immediate discontinuation) g. "If pregnant or breastfeeding" warning h. "Keep out of reach of children" and accidental overdose/ingestion warning - Directions - Other information (as required by the monograph, by regulation, or in the approved labeling) - Inactive ingredients - Questions? or Questions and Comments (followed by a telephone number)

automated dispensing systems (ADS) in LTCFs

- ADS is a mechanical system that stores, packages, counts, labels, and dispenses medications and maintains transaction information. - The purpose is to reduce stocks of excess CSs in LTCFs. - A pharmacy that installs ADS must maintain separate DEA registration at LTCF location. - Distributions that a pharmacy makes to ADSs do not count towards the pharmacy's 5% limit that would require a separate registration as a distributor. - Pharmacy keeps record of CS in the ADS - Transfer CS with 222 form

Records of Dispersal

- Acceptable records of dispersal include Rxs, record books, Form 222, invoices, records of disposal, theft or loss, etc. - Prescriptions may be filed in one of two ways and each Rx must contain all required information. (Schedule II controls, Schedule III, IV, V controls, non-controls)

Records of Receipt

- Acceptable records of receipt include invoices and Form 222. - Pharmacy must record date of receipt on invoice or Form 222. - If invoice contains both CSs & nonCSs, the CSs must be identified in a manner so as to be readily retrievable. - Records of receipt must contain all required information.

State Electronic Drug Rx Monitoring Programs (PDMPs)

- All states have a PDMP. - A state PDMP requires a pharmacy to electronically transmit to the state a record of the CS Rx dispensed. - Enables states to determine possible diversion and abuse situations - Most PMPs allow or mandate practitioners to request patient-specific information. - Many states share data between PDMPs.

methamphetamine production prevention act of 2008

- Although electronic logbooks are not required, it is hoped that they will become the standard and that pharmacies will participate in common electronic logbooks. - Sellers can now capture information by barcode reader. - The seller or purchaser may enter the purchaser's name, address, and date and time of sale. - The seller may collect the purchaser's signature by any of three means. - Sellers must annually engage in self-certification. - log book requirements: must be kept by pharmacy for 2 years, if written must be bound

what was the main effect of the OBRA of 1990?

- Before the passage of OBRA '90, state legislatures, administrative agencies, and courts of law had imposed a variety of requirements on pharmacists. However, none of the efforts that preceded OBRA '90 were as comprehensive as this federal legislation. Although the ideas in OBRA '90 are not new, the uniform application of them throughout the states marks an unprecedented expansion of pharmacy practice standards. Thus, OBRA '90 is perhaps the most important pharmacy-related law of all time, and it merits special attention. The establishment of a federal policy requiring drug use (or utilization) review (DUR) to ensure that drug therapy is as safe and effective as possible is a monumental step in the direction of expanded responsibility for pharmacists. - directly regulated the practice standards of a pharmacist. created a national standard instead of a state-by-state standard

What are the refill allotments for controlled substance prescriptions?

- C-III, C-IV and C-V drugs: limit of 6 months after date of issuances or five times, whichever comes first - must be initially dispensed within 30 days of written (same for C-II). - C-II only for 30 days, no refills, dispensed within 30 days

What are the days' supply limits on controlled substances?

- CII - 30-day supply - CIII, CIV, CV - 30-day supply

How many refills can control substances have?

- CII - No refills - CIII, CIV, CV - up to 5 refills

transferring prescription information

- CS Rx information (except C-II) may be transferred onetime between pharmacies if state law allows and requirements are followed by both transferring pharmacy and receiving pharmacy. - NOT allowed in NYS - Rx information sharing among pharmacies participating in common- electronic record systems is not subject to the transfer Rx requirements (CS Rxs may be transferred up to the maximum number of refills permitted).

what is meant by the closed system for controlled substances?

- Closed system creates national uniformity through a registration system from the start (manufacturing) through the dispensing of controlled substances.

What are the components of a DEA number?

- Composed of 2 letters followed by 7 numbers - Prescriber cannot issue a controlled substance unless they have a valid DEA registration number

describe and define the Poison Prevention Packaging Act.

- Congress enacted the PPPA in 1970 with the intent of protecting children from accidental poisonings with "household substances." The law defines a "household substance" as any substance that is customarily produced for or used in the household and is designated: 1. A hazardous substance in the federal Hazardous Substances Act 2. An economic poison under the federal Insecticide, Fungicide and Rodenticide Act 3. A food, drug, or cosmetic under the FDCA 4. A household fuel when stored in a portable container - The act requires the use of child-resistant containers for packaging most OTC drugs and nearly all prescription drugs that the pharmacist will dispense directly to the consumer. These containers must be manufactured such that 80% of the children less than 5 years of age cannot open them, whereas at least 90% of adults can.

What are the laws around mailing controlled substances?

- Controlled substances and drugs that contain controlled substances are acceptable in the domestic mail only under the following conditions: 1. For mailable controlled substances, generally both the mailer and addressee must meet either of the following conditions: - 1. Be registered with the Drug Enforcement Administration (DEA). - 2. Be exempted from DEA registration, such as military, civil defense, and law enforcement personnel, in performing official duties. 2. For mail-back programs conducted in accordance with 453.7. 3. For prescription medicines containing mailable narcotic drugs (controlled substances), when mailed by drug manufacturers or their registered agents, pharmacies, medical practitioners, or other authorized dispensers as permitted by 21 CFR 1307.11 or in compliance with any regulation of the Food and Drug Administration or other applicable law

how can "dietary supplements" make health claims?

- DSHEA allows dietary supplement suppliers to make four types of nutritional support statements without fear that the statements would cause the FDA to consider the product to be a drug. These are: 1. Statements that the product will benefit a classical nutrient deficiency disease as long as it also discloses the prevalence of the disease in the United States. 2. Statements that describe the role of the dietary supplement in affecting the structure or function of the body. 3. Statements that characterize the documented mechanism by which a nutrient or dietary supplement act to maintain structure or function. 4. Statements describing the general well-being from consumption of a nutrient or dietary ingredient (e.g., "energizer," "relaxant," "muscle enhancer"). - To make any of these four nutritional support statements, the seller must have substantiation that they are truthful and not misleading, and the label of the product must contain the disclaimer "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." Also, the manufacturer must notify the FDA within 30 days if it makes one of the permitted statements.

dietary supplements

- DSHEA was passed which classifies dietary supplements as a category of food, not drugs meaning the FDA cannot force pre-market approval - under DSHEA, health claims can be made under specific circumstances - statements about disease preventions can also be made

What are the requirements for dispensing a Schedule V controlled substance OTC?

- Dispensing done only by a pharmacist - No more than 8 oz of an opium-containing product or 4 oz of any other CS may be dispensed to the same purchaser within a 48-hour period (some states have stricter requirements). - The purchaser is at least 18 years of age. - The purchaser furnishes suitable identification. - The sale is recorded in a bound record book with all required information.

how are controlled substances classified?

- Drugs, substances, and certain chemicals used to make drugs are classified into 5 distinct categories of schedules depending upon the drug's acceptable medical use and the drug's abuse of dependency potential. Schedule I drugs have a high potential for abuse and the potential to create severe psychological and/or physical dependence. As the drug schedule changes -- Schedule II, Schedule III, etc., so does the abuse potential. Schedule V drugs represent the least potential for abuse.

emergency phone order

- Emergency 5 day supply CII, CIII, CV - 30 day supply for CIV - Must receive cover within 72 hours or notify BNE - Must write emergency telephone order on the prescription.

define and describe the Prescription Drug Marketing Act of 1987.

- Enacted in 1987, the PDMA amends the FDCA to: 1. Require states to license wholesale distributors of prescription drugs 2. Ban the reimportation of prescription drugs, except by the manufacturer or for emergency use 3. Ban the sale, trade, or purchase of drug samples 4. Mandate storage, handling, and recordkeeping requirements for drug samples 5. Ban the trafficking in or counterfeiting of drug coupons 6. Prohibit the resale of prescription drugs purchased by hospitals or healthcare facilities, with certain exceptions - The PDMA was passed after 2 years of congressional hearings, during which it was established that many prescription drug products were being misbranded and adulterated because they were being diverted from the normal stream of distribution. Congress concluded that the U.S. public could no longer purchase prescription drugs with the certainty that the products were safe and effective unless legislation was enacted. The FDA issued final regulations, implementing the PDMA in 1999.

legitimate medical purpose and usual course of professional practice

- Examples of invalid prescriptions include: 1. Narcotic Rxs written for the purpose of maintaining or detoxifying an addict 2. Rxs written for fictitious patients 3. Rxs written without a good-faith medical examination 4. Rxs written when there is no medical reason - A facially valid Rx is not necessarily a valid Rx. - Pharmacists will more likely face enforcement action in situations where there is blatant or glaring misconduct as opposed to isolated prescriptions. - DEA has published examples of situations that might be suspicious

What is the Validation Method for DEA numbers?

- First letter identifies type practitioner or registrant o A, B, F = physicians, dentists, vets, hospitals, or pharmacies o M = midlevel practitioner o P,R = manufacturer, distributor, researcher, narcotic treatment program - Second letter match the first letter of the prescribers last name or first name of the business - When letter verified do the following formula o Add the 1st, 3rd, and 5th digits of the DEA # o Add 2nd, 4th, and 6th digits of the DEA # and multiply by 2 o Add the two numbers together o Sum with a two-digit number, the second digit will match the 7th digit of the DEA#

correcting errors and omissions

- For C-III, C-IV & C-V Rxs, the pharmacist may add or change any information after consultation with practitioner and documentation, except, patient's name, name of CS (except for generic substitution), or prescriber's signature. - For C-II Rxs, the DEA had tradionally maintained that additions or changes could be made the same as with other CS Rxs. that position has flip-flopped in recent years, but it appears corrections can be made if state law or policy permits

What is the prescription drug monitoring program in NYS?

- ISTOP (Internet System for Tracking Over Prescribing): o Provider must check ISTOP before sending CS o Must document that they checked the PMP. They may designate that someone checks for them o Pharmacists may check or designate an employee o Must report dispensed medication with 24 hours

How do you record refilling a controlled substance if you have an electronic system?

- If automated system, must provide online retrieval either by display or hard copy printout of the original Rx information and up-to-date refill history o Hard copy printout requirements o In lieu of printout, may maintain bound logbook or separate refill file o Records must be maintained for 2 years o Pharmacies must have an auxiliary system for documenting refills is computerized system suffers downtime

What is DEA Form 41?

- If you need to dispose or destroy CSs, this form needs to be filled out and completes - Does not apply to CSs collected from ultimate users or LTCFs

differentiating treatment of pain from treatment of addiciton

- Important to determine whether the purpose of opioid treatment is legally for pain or illegally for addiction - Important to ascertain whether taper-down dosages are for detoxification of addiction or withdrawal due to physical dependence - Important to distinguish addiction from dependence - Exceptions allowing for treatment of addicts outside of licensed addiction programs or DATA

those allowed to prescribe CSs

- Individual practitioners (IPs) authorized to prescribe (or issue medication orders) in their state and registered by DEA or exempt from registration - Employees or agents of IP may communicate prescriptions to a pharmacist or prepare the Rx for signature of IP - Delegation of prescriptive authority not legal unless agent also has prescriptive authority - When suspicious, might check the validity of a DEA number by performing the calculations or searching national database

long-term care pharmacy

- LTC facilities not registered with DEA - DEA concerned about excess supplies of CS and this permits automated dispensing systems, partial filing, and voluntary collection receptacles by registered "collectors"

dispensing from LTCF emergency kits

- LTCF Emergency kits permitted. - Pharmacy is responsible for kits - DEA does not consider nurse an agent of prescriber for this purpose. - Prescriber must issue prescription to pharmacy and pharmacist must authorize nurse to dispense from kit.

What are the specific labeling requirements for controlled substances?

- Label must include date of filling if a C-II drug and date of initial filling if in another schedule - refills should be labeled with both date and of initial filling and date of dispensing - labels must include all required information plus a cautionary statement prohibiting the ultimate user from transferring the drug - labeling requirements are not applicable if prescribed for administration to an institutionalized patient, provided that restrictions and requirements are met

What are the limits for pseudoephedrine related products under the CMEA? Both daily, monthly and mail order limits?

- Law limits sale to no more than 3.6g of ephedrine, PSE, or PPA baser to a single purchaser per day. - NO consumer may purchase more than 9g within a 30-day period or 7.5g within a 30-day period by mail order.

Who takes care of an automated dispensing machine? Is it registered with the DEA?

- Long term care facilities. The pharmacy installs ADS and must maintain separate DEA registration at LTCF location - LTCFs are not registered with DEA

Dispensing C-III, C-IV and C-V Drugs

- May be dispensed pursuant to written, faxed, electronic, or oral order - Oral orders must be promptly reduced to writing - Written and faxed Rx must contain prescriber's signature - C-III and C-IV may not be filled more than 6 months after the date the prescription was issued

when is someone Medicaid eligible and what can it cover?

- Medicaid provides for the healthcare costs of certain categories of indigents, including the blind, the disabled, the aged, and members of families with dependent children. Eligibility is determined by an individual's income and assets. - Medicaid can be used to cover the cost of (1) inpatient and outpatient hospitalizations, (2) laboratory and x-ray studies, (3) physician care, (4) home healthcare, (5) dental care, (6) nursing care, etc.

What is the logbook requirements? What information must the logbook contain?

- Must be kept back in the pharmacy, must keep all recorders for 2 years, if written in must be bound. - Must contain name of product, quantity of product, name and address of purchaser, date and time of sale, patient signature, license number

administrative inspection warrant (AIW)

- No consent required - Probable cause is required - 'Valid public interest' - Completed in a reasonable manner - Contrast to probable cause for search warrant (SW) - AIW created by Supreme Court as alternative to SW - AIW may only be served during regular business hours - Several exceptions exist at to when a warrant is not required

What are the rules when partial filling a controlled substance?

- Pharmacists are able to partial fill a Schedule II if they are not able to dispense the full quantity. The remainder must be filled within 72 hours. If not filled within72 hours the remainder is void and you contact the provider to inform them. - C-III, C-IV, and C-V drugs: permitted provided it is recorded in the same manner as refill, the total quantity dispensed dose not exceed total prescribed, and no dispensing after 6 months from date of issuance, and would still have to fill/dispense remainder within 72 hours

What is the Combat Methamphetamine Epidemic Act?

- Places restriction on OTC drugs used to manufacture methamphetamine including pseudoephedrine.

is pre-market approval required for cosmetics?

- Premarket approval from the FDA is not necessary for a cosmetic (except for color additives), although manufacturers must substantiate the safety of their cosmetic product and each of its ingredients. Moreover, the manufacturer of a cosmetic does not have to conform to CGMP or even register with the FDA; registration is voluntary - cosmetics require very little proof of safety before hitting the market

what is Medicare Part D?

- Prescription drug coverage program available to all Medicare beneficiaries. Private companies approved by Medicare provide the coverage. - Enacted in 2003 and allows Medicare eligible patients to use a standalone drug benefit plan or Plan D to cover prescription drug costs. Medicare Part D only covers prescription drugs which are prescribed for their medically accepted indications. A participating pharmacy will receive a reimbursement form the provider for the cost of the drug plus a small dispensing fee.

inventory records

- Prior to beginning business and subsequently every two years, an inventory must be conducted containing a complete and accurate record of all CSs "on hand." - May be taken on any date within 2 years. - "On hand" means in possession of or under the control of the registrant. - Inventory may be taken at the beginning or end of the business day; records must be written, typed, or printed. - Newly scheduled drugs must be inventoried on date of scheduling. - The exact count must be made of C-I or C-II drugs. - The estimated count is permissible for other schedules unless container holds more than 1,000 units. - Keep Record for 5 years

What are the inventory record requirements for controlled substances?

- Prior to beginning business and subsequently every two years, an inventory must be conducted containing a complete and accurate record of al CSs on hand - Keep record for 5 years

DEA Form 222

- Required for any distribution of C-I or C-II drugs - Forms obtained by requesting in writing from nearest DEA office - Forms issued in mailing envelopes containing 7 or 14 forms - Forms are now a single part form. - Forms are serially numbered and issued with name, address and registration number of registrant, authorized activity, and schedules registrant is authorized to handle. - A registrant may not correct or change any information or errors on the forms.

Power of Attorney (POA)

- Required to allow person other than one who signed registration to execute Form 222 - If using CSOS everyone will receive their own unique certificate and password from the DEA.

when is adequate information for use needed?

- Some drugs cannot be labeled adequately to protect the consumer and meet the "adequate directions for use" requirement of § 502(f). The FDA classifies these drugs as prescription drugs, which makes them exempt from the requirements of § 502(f). Prescription drugs must contain "adequate information for use" rather than adequate directions for use (21 C.F.R. § 201.100(c)(1)). Thus, the labeling must include such information as: 1. The drug's indications 2. Side effects 3. Dosages 4. Routes, methods, frequency, and duration of administration 5. Contraindications 6. Other warnings and precautions that enable a practitioner to administer, prescribe, or dispense the drug safely - Prescription drug labeling is directed to the practitioner, not the patient.

state vs. federal authority

- State law must be stricter than federal law to not conflict. - Pharmacists should follow stricter law - DEA generally has a close relationship with state pharmacy boards - Presumption of interstate commerce in the federal regulation of controlled substances

what are the labeling requirements under Section (b)(2)?

- Subsection (b)(2) exempts the dispensing pharmacist from the labeling requirements of § 502 except for: 1. The label must not be false or misleading. 2. The drug dispensed must not be an imitation drug. 3. The drug must not be sold under the name of another drug 4. The packaging and labeling must conform to official compendia standards. 5. If it is a drug liable to deterioration, it must be packaged and labeled appropriately. 6. It must be packaged in conformance with the PPPA - Subsection (b)(2) also specifies the minimum information that the pharmacist must include on the label of a dispensed drug. The law was provided earlier in this section with (b)(2) stating, in part: "the name and address of the dispenser, the serial number and date of the prescription or its filling, the name of the prescriber, and, if stated in the prescription, the name of the patient, and the directions for use and cautionary statements, if any, contained in such prescription." However, most state laws require additional information on the label: the name, initials, or license number of the dispensing pharmacist, the expiration date or beyond-use date of the drug, the drug's name, strength, and quantity dispensed, the address of the patient, the name of the manufacturer or distributor, and the lot or control number - patient package inserts are now required for prescriptions (med guide can also be required for the prescription)

DEA inspections

- The DEA has the authority to inspect any place where CS records are kept or persons are registered. - Allowed to examine and copy all records and reports, inspect within reasonable limits, and take an inventory of CSs - Without consent of owner or PIC, inspector not allowed to inspect financial, sales (other than shipping), or pricing data - The audit procedure involves inspecting records of drugs received less drugs dispersed and comparing with inventory. - Prior to inspection, the inspector is required to state the purpose of inspection and present the owner or PIC with credentials and written notice of inspection.

does the FDA allow off-label use? why?

- The FDA has taken the position that a drug may be legally prescribed and dispensed for an off-label indication or dosage. In a 1972 proposal statement, the FDA announced: 1. If an approved new drug is shipped in interstate commerce with the approved package insert and neither the shipper nor the recipient intends that it be used for an unapproved purpose, the requirements of § 505 of the Act are satisfied. Once the new drug is in a local pharmacy after interstate shipment, the physician may, as part of the practice of medicine, lawfully prescribe a different dosage for his patient, or may otherwise vary the conditions of use from those approved in the package insert, without informing or obtaining the approval of the Food and Drug Administration - Why? In certain circumstances, off label uses of approved products are appropriate, rational, and accepted medical practice

how does the federal government regulate pharmacies?

- The federal government regulates drug products that are distributed and monitored by state-licensed pharmacists in state-licensed pharmacies. - Indirectly, however, the federal regulation of drugs also regulates pharmacists and pharmacies because the drug product is so significantly interwoven into pharmacy practice

what must a prescription drug labeling include?

- The name and address of the manufacturer, packer, or distributor - The established name of the drug product - Ingredient information, including the quantity and proportion of each active ingredient - Names of inactive ingredients (with certain exceptions) if not for oral use - A statement of identity (generic and proprietary names) - The quantity in terms of weight or measure (e.g., 100 mg) - The net quantity of the container (e.g., 100 tablets) - A statement of the recommended or usual dosage or reference to the package insert - The symbol "Rx only" or the legend (e.g., "Caution: Federal law prohibits dispensing without prescription") - The route of administration if it is not for oral use - An identifying lot or control number - A statement directed to the pharmacist specifying the type of container to be used in dispensing the drug (e.g., "Dispense in tight, light-resistant container as defined in the National Formulary") - The expiration date, unless exempted (when an expiration date is stated only in month and year, the expiration date is the last day of the month.)

controlled substance registrant protection act

- The purpose of the law is to make it a federal crime if robbery results in $500 or greater replacement cost of CSs, or person suffers "significant" injury, or interstate commerce is involved in the planning or execution of the crime. - Penalties can result in up to 20 years of imprisonment, $25,000 fine, or both. If a weapon is used, the penalties are higher. If death results, the penalty is higher yet.

how is "cosmetic" defined under Section 201 of the FDCA?

- The term "cosmetic" means (1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap. - a cosmetic will only fall into the drug definition if the claims made either imply or state that the cosmetic (1) will treat or prevent disease, or (2) will affect a function or structure of the body

exercise of clinical judgement and pain treatment

- Treatment of pain is a legitimate medical purpose. - Drug tolerance and physical dependence as a consequence of opioid use is normal and natural. - The quantity of drugs prescribed and frequency of Rxs alone are not indicators of improper prescribing. - The pharmacists' role under CSA is determining the legitimacy of Rx for pain rather than therapeutic appropriateness of using opioids.

what are the three mechanism the FDA can use to enforce the FDCA?

- Under § 302, the FDA can bring an injunctive action against the violator to cause it to cease its illegal activity. - Under § 303, the FDA can institute criminal proceedings against violators, resulting in fines, imprisonment, or both. Section 304 allows the FDA to seize any adulterated or misbranded food, drug, or cosmetic in interstate commerce. Because of the strict liability nature of § 302 and the realization that minor violations of the act should not be subject to criminal prosecution or seizure actions - Congress added § 309, which allows the FDA to send a warning letter to the violator as a first step when such an action would adequately serve the public interest.

What are the indications for methadone?

- Used for both pain and addiction - We, as pharmacists, can only dispense for pain

what to watch out for

- Watch out for suspicious patterns. - Non-Local Prescribers - Non-Local Patients, or multiple non-local patients from the same address. - Patients that only fill controls and not maintenance meds with your pharmacy. - Prescription not written by the prescribers specialty - Dangerous combos (Narcotic, Benzo, Muscle Relaxant) - Patients requesting cash payments when they have insurance

when can a medication guide be required?

- When the patient or patient's agent requests a MedGuide - When the drug is dispensed in an outpatient setting and the patient will use the drug without direct supervision of a healthcare professional (e.g., community or hospital ambulatory care pharmacy) - 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 infusion center - The first time a drug is dispensed in an outpatient setting of any kind after a MedGuide is materially changed - When a drug is subject to a REMS that includes specific requirements for reviewing or providing a MedGuide

prescription drug user free act of 1992

- allowed FDA to pull in fees for reviewing clinical studies and approving new drug applications - sunset provision - law will expire in a certain year unless reauthorized

dietary supplement health and education act of 1994

- allowed dietary supplement manufacturers to have wider latitude in labeling and marketing - dietary supplements have a lot of regulations

what distinction did the Durham-Humphrey Amendment of 1951 make?

- also known as the Prescription Drug Amendment, the Durham-Humphrey Amendment, made distinctions between what determines if a drug is a prescription drug, as well as why there happens to be two classes of drugs instead or one or three. - a drug can be changed from OTC to prescription and vice versa

safe medical devices act of 1990

- amended the medical device amendment of 1976 allowing for further post market regulation and improving the efficiency of premarket approval for devices

medical device user free and modernization act of 2002

- another law that was passed to allow FDA to collect a fee for doing their job

modification, transfer, or termination or registration

- any modifications must be approved by the DEA - if registrant dies or ceases legal existence, the DEA must be notified and the registration terminated - registrations cannot be assigned or terminated without DEA approval

practical considerations during an inspection

- be cordial and cooperative - if inspection is not routine, PIC should contact owner and perhaps attorney if necessary - if DEA agents have a warrant, cannot refuse inspection - if state inspectors do not have a warrant, whether consent is required depends upon state law - never lie and generally best to say as little as possible - document what is said and done and do not sign anything not understood

conducting research with CS

- coincidental activity of dispenser to conduct research with schedule II-V CS if authorized - research with C-1 drugs requires submission of protocols with application

how does the process by which a new drug is approved by the FDA differ if the drug is intended to treat serious and life-threatening diseases?

- criticism that the NDA process is too slow in this respect - FDA can allow the dissemination of investigational drugs under FDAMA - Only allowed if: (1) the drug is to be used for serious or life-threatening diseases, (2) there is no comparable or satisfactory alternative, (3) the drug is under investigation to treat the disease or condition is question, (4) the sponsor is actively seeking NDA approval, (5) there is sufficient evidence of safety and efficacy in the case of serious disease; or there is a reasonable basis to conclude that the drug may be effective and no unreasonable risk to patients in the case of life-threatening diseases

What information must be on a controlled substance?

- date of issuance (no predating or postdating) - full name and address of patient, drug name, strength, dosage form, and quantity prescribed. Must also include directions for use and name, address, and registration number of practitioner, and refills. - before filling, must contain written or typed name or initials of dispensing pharmacist, the date dispensed, and the units or volume dispensed.

controlled substance prescriptions

- defined as an order for medication dispensed to or for an ultimate user - the Rx does not include orders for medications dispensed for immediate administration (ex: hospital chart orders) - prohibition against prescriptions for office use - no samples

dispensing C-II drugs

- general rule: C-II prescriptions must be written and signed by a prescriber (written = electronic) - some states have stricter laws (ex: quantity limits, time limits, security Rx forms) - NYS = 30 day limit unless there are codes

the generic drug enforcement act of 1992

- imposed criminal and civil penalties for various drug approval violations including false statements, bribes, and failure to disclose material facts in premarket approval phase - for manufacturers and developers

why was the pure food and drug act of 1906 passed?

- in response to investigative journalism and public outcry - to correct adulteration and poor labeling - law affected any food and drugs in interstate commerce

how and why did the pure food and drug act of 1906 fail?

- law fell short of its purposes - court held that false claims of efficacy were allowed; the law only prohibited labeling and misidentified the food or drug - court narrowed scope of the law, in response, some manufacturers just omitted information off labels - law was too narrow and it didn't create any affirmative duty for manufacturers to identify of label their products, so they didn't - Congress amended the law in 1912 to prohbit any false claims of efficacy

what is the purpose of the the food, drug and cosmetics act of 1938?

- law provided that no new drugs could be marketed or put on the market until proven safe for use under the conditions described on the label and approved by the FDA - drug has to be proven safe for its intended use - law expanded labeling requirements - label had to include directions and contain warnings about habit forming qualities - law also covers cosmetics and devices - proactive, any new drugs from this point forward had to comply with the FDCA

how is the the food, drug and cosmetics act of 1938 interpreted by the court?

- law was very broad, court held that because the act fell within interstate commerce the act controlled many transactions - USV Sullivan was broadly interpreting the FDCA therefore it can be applied to many transactions

federal controlled substances act

- located in Title 21 of the Code of Federal Regulations, Part 1300-1321 - creates a closed system via registration - establishes national uniformity - enforced by the DEA

nutrition labeling and education act of 1990

- mandate nutrition labeling on food products and allowed claims of nutritional value as long as they were within FDA regulations

what is a Narcotic?

- natural or synthetic opium or opiates or derivatives including cocaine, which is not an opiate derivative

medical device amendments of 1976

- passed to allow the FDA to regulate medical devices - requires the classification of devices according to their function and premarket approval by the FDA and created/established performance standard for devices and required conformance to the good manufacturing practices and required adherence to record and reporting requirements

orphan drug act of 1983

- passed to fix a market failure - passed to incentivize manufactures and developers to develop orphan drugs

food and drug administration amendments act of 2007

- passed to reauthorize an expiring law - law gave FDA more power - power to require post-market clinical studies to assess risk

central filling of Rxs

- pharmacies that fill rxs for other retail pharmacies pursuant to contractual arrangement. must be a common owner - may fill both new and refill rxs - any rx dispensed for another pharmacy must be transported to that pharmacy for furnishing to patient - label of dispensed drug must indicate at which pharmacy the drug was dispensed - cannot accept rxs directly from patient or practitioner or deliver rx directly to patient or practitioner - corresponding responsibility doctrine applies to pharmacists at both facilities

off-label drug use

- physicians often prescribe drugs for off-label use and the FDA allows this - the pharmacist can dispense a drug for off-label use - if you think the prescription is risky, document that you contacted to physician

maufacturing

- production, preparation, compounding, or processing of a drug; also, packaging, repackaging, labeling or relabeling - excludes activities of practitioners incidental to dispensing

what is the intent of the federal food, drug, and cosmetics act?

- protect consumers from adulterated or misbranded foods, drugs, cosmetics, or devices - the main purpose of FDCA is adulteration and misbranding - under the act, no new drug may be marketed or sold unless it has been proven safe and effective for its intended used and approved by the FDA

food and drug administration modernization act of 1997

- purpose of the act was to clean up some the red tape associated with the premarket approval phase for drugs and make the process of drug approval more efficient - allowed for fast-track approval system for drugs intend to treat serious or life-threatening illnesses/conditions - created a data bank of clinical trials - authorized scientific panels to review clinical investigations - streamline initial premarket approval phase - gave FDA greater control over OTC drugs and established label requirements for inactive ingredients in drugs

FDA safety and innovation act of 2012

- reauthorized a previous law - added powers to FDA - ability to inspect foreign manufacturers

drug advertising

- regulated by both the FDA and FTC - commercial speech is permissible if: (1) the speech must not be false or misleading, (2) the government must have a substantial interest, (3) the government must be advancing an interest through the regulation, and (4) it must be narrowly tailored - FDA requires a "true statement" - FTC oversees OTCs - they can stop "deceptive" advertising

prescription drug marketing act of 1987

- required sales restrictions and record keeping requirements for prescription drug samples

color additives amendment of 1960

- required that any color additive be approved for safety before hitting the market - included similar provision, cancer causing provision

internet prescriptions

- rogue internet pharmacy businesses are those that sell Rx medications to customers either without requiring Rxs or by issuing Rxs pursuant to online surveys - ryan haight act law defines a valid rx as one that has been issued for a legitimate medical purpose by a practitioner who has conducted at least one in-person medical evaluation of the patient - the act establishes several requirements with which online pharmacies must comply - although the act only applies to CS Rxs, most states consider any Rx not dispensed pursuant to a legitimate physician-patient relationship as invalid

misbranding

- section 502 of the FDCA - this sections focuses on the label and labeling - both must be approved as part of the pre-market approval phase - section (f) requires "adequate directions for use" or "adequate information for use" - the info needed for an OTC and prescription differ

State Pharmacy Board Inspections

- some states allow warrantless searches of pharmacies - state warrantless search statutes may be constitutional provided certain requirements are met

drug price competition and patent term restoration act of 1984

- streamlined the generic drug approval process while allowing patent extensions over innovator drugs

what are the five core offices of the Commissioner's Office

- the Office of Foods and Veterinary Medicine - the Office of Global Regulatory Operations and Policy - the Office of Medical Products and Tobacco - the Office of Operations, and - the Office of Policy, Planning, Legislation, and Analysis.

food additives amendment of 1958

- the amendment required that any food additives receive premarket approval for safety - included that any cancer causing additives be prohibited

distributing

- to DELIVER a controlled substance - WHOLESALERS need to register as distributors TO THE DEA - practitioners registered to dispense are exempt, provided they comply with all conditions - stocking of automated dispensing system in long term care facility and return of controlled substances to suppliers by practitioners are exempt, provided recordkeeping requirements are met - distributors required to designs and operate a system able to detect suspicious orders of CS and inform the DEA upon discovery

institutional medication records

-Medication or chart orders are distinguished from prescriptions and need only contain minimum information necessary to provide an acceptable dispersal record -Must be readily retrievable -Discharge medication orders may only be dispensed pursuant to Rx

IPs exempt from registration

-Must include registration number of institution and special internal code number -Must include name of prescriber stamped, typed, or hand printed, as well as signature of prescriber -IPs in armed services or public health must include on the Rx the service ID number in place of the registration number.

purpose of CS prescription

-legitimate medical purpose (not amphetamines to keep a truck driver awake) -practitioner must be working in usual course of professional practice (not dentist for tennis elbow) - corresponding responsibility upon the pharmacist - knowingly prescribing or dispensing a CS Rx not for a legitimate medical purpose violates the law

what are three components of prospective drug use review? define the three components.

1. A screen of prescriptions before dispensing 2. Patient counseling by the pharmacist 3. Pharmacist documentation of relevant information

what are the three main parts of the OBRA of 1990?

1. Rebates 2. Demonstration projects 3. DUR

what are the three main parts of drug use review (DUR)

1. retrospective review 2. educational programs 3. prospective view

How long do records need to be kept for the DEA?

2 years

when is a cosmetic adulterated?

A cosmetic is considered adulterated if: 1. It contains any poisonous or deleterious substances that may injure users. 2. It contains any filthy, putrid, or decomposed substance. 3. It was prepared under unsanitary conditions. 4. The container contains a substance that may contaminate the contents. 5. It contains an unsafe color additive but is not a hair dye.

how is a "drug" different than a "cosmetic?"

A cosmetic may become a drug if its intended use fits under the drug definition. Some products are both cosmetics and drugs. For example, shampoo is a cosmetic because its intended use is to clean the hair. However, antidandruff shampoo is both a cosmetic and a drug since its intended purpose is to treat dandruff

CODE B

ADHD - 90-day supply permitted

What is the Drug Addiction Treatment Act of 2000?

Allows physicians to prescribe medications for opioid addiction - Buprenorphine (C-III)

what is an unnecessary drug?

An unnecessary drug is any drug when used: 1. In excessive dose (including duplicative therapy) 2. For excessive duration 3. Without adequate monitoring 4. Without adequate indications for its use 5. In the presence of adverse consequences that indicate the dose should be reduced or discontinued 6. Any combination of these reasons

what is the definition of an "article" under the FDCA?

Articles can include chemical and non-chemical entities, and in fact most anything. Part B of the drug definition addresses products intended for use with diseases, whereas part C recognizes that even products not intended for use with diseases may still be drugs if they make a structure or function claim. Establishing that an article is a drug, as opposed to a food, dietary supplement, or cosmetic, provides the agency with considerably more authority over the article. If therapeutic or structure/function claims are made, an article is a drug, no matter what disclaimers may be included in the labeling.

what is Good Manufacturing Practices?

CGMP is a set of regulations that establishes minimum requirements for the methods, facilities, or controls used in the manufacture, processing, packaging, or holding of a drug product. The intent of the CGMP regulations is to ensure that the drug is safe and meets the quality and purity requirements. The CGMP applies to manufacturers, not pharmacies, unless the pharmacies engage in activities in which they may be deemed manufacturers, or the pharmacy is also registered as an outsourcing facility.

How long are refills good for on controlled substances?

CIII, CIV and CV - 6 months

CODE C

Chronic debilitating neurologic conditions (seizures, movement disorder, spasm activity) - 90-day supply permitted

CODE D

Chronic pain - 90-day supply permitted

pharmacy inspections

Constitutional issues - The Fourth Amendment protects individuals from unreasonable searches and seizures. - Requires the issuance of a search warrant based on probable cause - The exclusionary rule provides that any evidence obtained in violations of the Fourth Amendment will not be admissible.

what is a consultant pharmacist?

Consultant pharmacist must review each resident's drug regimen at least once a month to promote positive outcomes and minimize adverse consequences and potential risks associated with medications. With recent CMS rule revisions, when pharmacists are performing required DRRs, they must not include a review of the resident's medical chart. DRR includes a review of the medical record to prevent, identify, report, and resolve medication-related problems, medication errors, or other irregularities.

What form do you use to register with the DEA?

DEA Form 224 - retail pharmacy, hospital/clinic, practitioner, teaching institution

how are "dietary supplements" different than "drugs"?

DSHEA mandates that the FDA regulate dietary supplements more as a special type of food than as drugs. For this reason, the FDA cannot require premarket approval of dietary supplements as it does for drugs. Thus, the manufacturer is responsible for determining if its product is safe and that its claims about the product are substantiated by adequate evidence. Moreover, except for new dietary supplements, the manufacturer does not have to provide the FDA with the evidence upon which it relies to substantiate the product's safety and efficacy.

retrospective review

DUR board that comprises physicians and pharmacists. The DUR board performs many activities, bit its most important function is to review data concerning the use of medications over a particular period of time and compare these data with criteria for medication use previously developed by the DUR board. DUR board recognizes "ideal" drug therapy and determines whether actual medication use conforms to the ideal.

What APIs are included under the CMEA?

Ephedrine, pseudoephedrine (PSE), and phenylpropanolamine (PPA)

How are benzodiazepines treated differently in NYS?

Federal C-IV but are treated like a C-II in NYS, meaning no refills, verbal 5-day emergency supply rule, max of 30-day supply

How is testosterone treated differently in NYS?

Federally classified as Schedule III, but are NYS classified Schedule II. Therefore, no refills, same 5 days emergency rules as a C-II, and only 30 days supplies unless CODE F

CODE F

Hormone deficiency in males, gynecologic conditions that respond to treatment with anabolic steroids, metastatic breast cancer, anemia, and angioedema - 180-day supply permitted

How do you record refilling a controlled substance if you do not have an electronic system that can track refills?

If non-automated system, must record required information on back of Rx or other readily retrievable document

What is DEA Form 106?

If pharmacy loses or thinks that CSs are stolen - must inform DEA within one day and fill out this form

what is the difference between a mandatory and permissive substitution State?

In "mandatory" substitution states, pharmacists must substitute a less expensive generic drug for the brand name drug, unless the prescriber writes "dispense as written," "brand necessary," or a similar notation on the prescription. In "permissive" substitution states, a pharmacist may choose to substitute if the prescriber issues the prescription in a way that permits substitution. Without the prescriber's permission, either express or tacit, substitution is not allowed in most states, even if the consumer wishes a substitute. - the orange book helps guide what is a permissible substitution

what are the two elements to determine if an article is a prescription under US v. Article of Drug-Decholin?

In Decholin, the court established that the FDA must prove two issues to change the status of a drug from OTC to prescription: 1. that the toxicity and method of use require practitioner supervision and 2. that the collateral measures necessary to use the drug require supervision

why is it important compounding was left outside the definition of a drug under the FDAMA?

It meant that under § 503A, a pharmacy is exempt from adequate directions for use, CGMP, and new drug requirements, if the compounded drug product meets the following conditions: 1. It is for an individual patient based on the receipt of a valid prescription and compounded by a licensed pharmacist or physician. 2. It is for a 'limited quantity" if prepared in anticipation of receiving a prescription. The amount anticipated must be legitimately based on the established practice history between the prescriber, pharmacy, and patients. 3. It is not essentially a copy of a commercially available product, unless compounded only occasionally and not in inordinate amounts. 4. It is compounded in compliance with the USP chapters on compounding, using bulk substances that comply with monograph standards, if one exists. If no monograph exists, the drug must be a component of an FDA-approved human drug product. If neither of the previous conditions exists, then it must appear on a list of bulk drug substances developed by the FDA by regulation. 5. It is compounded with bulk drugs that are manufactured by an entity registered with the FDA. 6. It is compounded with ingredients (other than bulk substances) that comply with USP standards. 7. It does not include drugs from an FDA list of items that have been withdrawn or removed from the market because of safety or efficacy.It does not include drug products identified by the FDA by regulation as presenting difficulties for compounding because of adversely affecting safety or efficacy. 8. The compounder does not distribute more than 5% of the total prescriptions dispensed or distributed by the pharmacy absent a memorandum of understanding (MOU) between the pharmacy's state and the FDA.

What is legitimate medical purpose?

Legitimate medical purpose is the usual course of professional practice generally means acting in accordance with accepted standards of medical practice.

electronic order system (CSOS)

May be used instead of Form 222 Purchaser can order any drug Registrant must obtain a digital certificate for each DEA registered location

other requirements of written CS Rxs

Must be signed on day of issuance Written in ink, indelible pencil, or typed and manually signed Corresponding responsibility of pharmacist and prescriber that a CS Rx complies with all requirements

Records Required of Individual Practitioners

Must keep records of CSs they dispense, but not of those they prescribe. Need not keep records of CSs they administer unless the IP regularly engages in dispensing or administering and charges patients. Record must be kept of CSs administered in the course of maintenance or detoxification of treatment of addiction. May administer or dispense CS without a Rx

can C-V product be sold without Rx (i.e., OTC) in NYS?

NO

CODE E

Narcolepsy - 90-day supply permitted

does a pharmacy have to meet the manufacturing requirements under the FDCA? What is the exception and where does it come from?

No, section 510(g) of the FDCA provides in part that pharmacies are exempt from registering as manufacturers if they do not manufacture, prepare, propagate, compound or process drugs or devices for sale other than in the regular course of their business of dispensing or selling drugs or devices at retail. Section 510(g) recognizes that the traditional compounding by pharmacists, which is regulated by state law, is not manufacturing. The pharmacy exception provided by this section is important because a pharmacy that is deemed a manufacturer must obtain a license from the FDA, most likely obtain an approved Investigational New Drug (IND) application, and conform to the regulations regarding current good manufacturing practice (CGMP)

CODE A

Panic Disorder - 90-day supply permitted

What can a pharmacist add to a controlled substance prescription without practitioner authorization?

Patient address, patient sex, patient age

What can a pharmacist change on a controlled substance prescription without practitioner authorization?

Patient address, patient sex, patient age

What can a pharmacist never change on a controlled substance prescription?

Patient name, practitioner signature, date written, drug name

What is never allowed to be added to a controlled substance prescription?

Patient name, practitioner signature, date written, drug name, quantity

What can a pharmacist add to a controlled substance prescription with practitioner authorization?

Practitioner DEA#, institutional DEA#/suffix, directions, code, MDD, and strength

What can a pharmacist change to a controlled substance prescription with practitioner authorization?

Practitioner DEA#, institutional DEA#/suffix, directions, code, MDD, and strength, and dosage form

electronic transmission Rxs

Prescribers must: Undergo identity proofing, Digitally sign using two of three possible factors for authentication, and Agent can enter Rx information but cannot have access to authentication factors and sign. Pharmacy requirements: The pharmacy or ASP must digitally sign, and the pharmacy must archive the Rx, If Rx transmission fails, regulation establishes that certain requirements must be followed, May make changes to Rx after receipt, Must back up daily and keep records for two years

what is a "new drug" and what must a manufacturer show to have the drug approved by the FDA?

Section 201(p) of the FDCA defines a "new drug" as a drug that is not generally recognized by qualified experts as safe and effective for use under the conditions recommended in the drug's labeling. The definition also provides that, even if the drug is so recognized, it must also have been used to a "material extent or for a material time under the conditions recommended in the labeling".

what section permits an inspection under the FDCA and when is it allowed?

Section 704 of the FDCA states that FDA inspectors may inspect facilities where drugs are held at reasonable times, within reasonable limits, and in a reasonable manner. However, § 704 exempts from FDA inspection authority pharmacies that regularly dispense prescriptions and that do not manufacture, prepare, or compound drugs or devices for sale other than in the regular course of their retail business. Nonetheless, the agency has always assumed it has the authority to inspect pharmacies, especially when it has reason to believe that the pharmacy may be engaging in manufacturing or repackaging activities and has often done so.

What information is a pharmacy required to collect for pseudoephedrine sales?

Seller or purchaser may enter the purchaser's name, address, and date and time of sale.

how do states regulate pharmacies?

State governments regulate pharmacists and pharmacies by licensing them. State governments ensure that pharmacists are competent and that pharmacies are appropriately managed to protect the public health

can a drug be switched from prescription to OTC? What needs to be shown?

Subsection 503(b)(3) of the Durham-Humphrey Amendment authorizes the FDA to switch prescription drugs to OTC status by regulation when the conditions warrant. these conditions would include proof that the product can be adequately labeled such that the consumer can self-diagnose, self-treat and self-manage the condition being treated, and that the supervision of a practitioner is not required. Proof would also be required that the drug has a low potential for misuse and abuse and that the benefits of OTC availability outweigh the risks.

how is a drug defined under the FDAMA?

The FDA held the position that compounded drugs are "new drugs," thus giving the agency the authority to regulate the products if it chose to do so, regardless that the pharmacy was not manufacturing. § 503A took this authority away from the agency. The law defines compounding as "... combining, admixing, mixing, diluting, pooling, reconstituting, or otherwise altering a drug or bulk drug substance to create a drug." Excluded, however, are such acts as mixing and reconstitution performed in accordance with the manufacturer's directions when performed on receipt of a prescription for a patient.

when are patient information and medical guides currently required by the FDA?

The FDA in 1995 published a proposed rule that would have implemented a new patient information program. The program consisted of two parts. One part would require that manufacturers provide Medication Guides (Med Guides) for a few specifically designated drugs that pose a "serious and significant" concern to public health. The second part mandated that "useful" written patient information (now called consumer medication information (CMI)) be given to the patient for every drug each time a new prescription is dispensed.

describe the food, drug and cosmetics act of 1938

The FDCA of 1938, with amendments, forms the nucleus of today's law. It provided that no new drug could be marketed until proven safe for use under the conditions described on the label and approved by the FDA. The law also expanded the definitions of misbranding and adulteration used in the earlier act, requiring that labels must contain adequate directions for use and warnings about the habit-forming properties of certain drugs. The 1938 law applies to cosmetics and devices as well. Significantly, however, the act exempted drugs marketed before 1938 from the requirement that new drugs be proven safe before being marketed.

how is a "drug" different than a "device?"

The MDA differentiates devices from drugs by stating that a device does not achieve any of its principal intended purposes through chemical action and is not dependent on being metabolized for the achievement of any of its principal intended purposes. The term "device" does include in vitro diagnostic products used to aid in the diagnosis of disease or verification of pregnancy.

define and explain what the Medical Devices Amendment of 1976 accomplished.

The Medical Device Act of 1976 amended the FDCA to establish a comprehensive system of device regulation that includes device classification, premarket testing, and standards of performance. The FDA will not regulate a product as a medical device if it is intended for general wellness, is of low risk, and makes no references to diseases or conditions. Pursuant to the device amendments, the FDA must classify all devices marketed after 1976 into one of three classes: 1. Class I devices require the least regulation because they pose the least potential harm to users; therefore, "general controls" are adequate to ensure safety and effectiveness. 2. Class II devices are those for which general controls alone are insufficient to ensure safety and effectiveness. These products must meet specific performance standards established by the FDA before the FDA will permit marketing. 3. Class III devices must have premarket approval because they are life supporting or life sustaining, or they present a potential unreasonable risk of illness or injury.

notice of inspection (NOI)

The NOI must contain the name of the owner or PIC, name and address of the business, date and time of inspection, and a statement that the NOI was given. The inspector must obtain a written statement of informed consent signed by the PIC or owner. Consent must be voluntary and not coerced and may be withdrawn at any time during the inspection. The PIC or owner can grant the inspector limited consent.

what is the process for a prescription to be classified as an OTC?

The OTC drug review process was initially the primary mechanism by which drugs were switched from prescription to OTC status. Under the review process, the advisory review panels may recommend such a switch to the FDA. If the agency agrees, it publishes a final OTC drug monograph to this effect, which becomes binding on manufacturers of that active ingredient. Today, most switches occur through a NDA or SNDA. Using this manner, generally allows the manufacturer to obtain market exclusivity for the product. Approval for one NDA holder to switch does not automatically apply to other manufacturers of products containing the same ingredients. Each manufacturer must submit an NDA or SNDA for approval. Therefore, switches for identical products can occur at different times.

what information does the Orange Book contain? why is the useful?

The Orange book lists thousands of currently marketed drug products that the FDA has approved as safe and effective. Note that the Orange Book only includes approved drug products; marketed unapproved drug products are not included. The Orange Book is a great resource for healthcare professionals to find out when a drug was approved, when a patent or exclusivity will expire (so as to determine when a generic might be available), and whether generic equivalents exist. Approved drug products that are "pharmaceutical equivalents" (defined by the FDA as products that contain the same active ingredients and are identical in strength and are of the same dosage form) are rated in the publication for "therapeutic equivalence." Physicians and pharmacists were initially reluctant to substitute because of bioequivalence concerns. To assist healthcare professionals, healthcare entities, and others with this problem, the FDA published Approved Drug Products with Therapeutic Equivalence Evaluations, which became known as the Orange Book

what is the difference between an expiration date and beyond use date?

The expiration date identifies the time during which the drug may be expected to meet the requirements of the USP monograph for the drug. Beyond use date (BUD), is defined as the date after which the drug should not be used, and it must not exceed the manufacturer's expiration date. The BUD may or may not be the same at the manufacturers expiration date. Once the manufacturer's container is opened and the drug is transferred to another container for dispending/repackaging, the manufacturer's expirations date is technically no longer valid and thus a suitable beyond use date should be placed on the label of the prescription container.

how is "counterfeit drug" defined under Section 201 of the FDCA?

The term "counterfeit drug" means a drug which, or the container or labeling of which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, or device, or any likeness thereof, of a drug manufacturer, processor, packer, or distributor other than the person or persons who in fact manufactured, processed, packed, or distributed such drug and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by, such other drug manufacturer, processor, packer, or distributor.

how is "device" defined under Section 201 of the FDCA?

The term "device" means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is: 1. recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, 2. intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or 3. intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes - a device is defined under the MDA - it stated a device does not achieve any of its principal intended purposed through chemical actions and is not dependent of being metabolized for the achievement of any of its principal intended purposes

how is "drug" defined under Section 201 of the FDCA?

The term "drug" means (A) articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any articles specified in clause (A), (B), or (C).

how is "food" defined under Section 201 of the FDCA?

The term "food" means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article - food is currently excluded under section (c) of the definition of drugs

how is "label" defined under the FDCA?

The term "label" means a display of written, printed, or graphic matter upon the immediate container of any article; and a requirement made by or under authority of this Act that any word, statement, or other information appearing on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper. The term "label" refers to information required on the container or wrapper.

how is "labeling" defined under FDCA?

The term "labeling" means all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article. The term "labeling" has a far broader application. Although the term labeling includes the label, it also applies to the information "accompanying" the drug such as the package insert.

in what two situations does off-label use occur?

These off- label uses may even constitute the medically accepted standard of care for treatment. This is especially true in the treatment of cancer and human immunodeficiency virus infection

kefauver-harris amendment of 1962

This amendment, also called the Drug Efficacy Amendment, strengthened the new drug approval process by requiring that drugs be proved not only safe, but also effective. The efficacy requirement was made retroactive to all drugs marketed between 1938 and 1962. The amendment also: 1. Transferred jurisdiction of prescription drug advertising from the Federal Trade Commission (FTC) to the FDA 2. Established the Good Manufacturing Practices (GMP) requirements 3. Added more extensive controls for clinical investigations by requiring the informed consent of research subjects and reporting of adverse drug reactions

define 340B drugs.

This is section 340B of the Public Health Service Act. The upshot is that under the act certain entities—those serving indigent or underserved patients—can register as 340B entities which allows them to acquire certain drugs at a reduced price and sell those drugs to eligible patients

drug quality and security act of 2013

Title 1 of the Act = The Drug Quality and Security Act - Increased regulation over compounding when the pharmacy then ships those drugs to another party Title 2 of the Act = The Drug Supply Security Chain - Requires a record to be kept as a drug moves through the chain of production

what new provision was added to the FDAMA and how was it significant?

Title I of the DQSA, the Compounding Quality Act, reinstated § 503A, striking out the unconstitutional provisions, thus making the law applicable nationwide. The reinstatement of the law also stripped the FDA of its perceived authority to regard any drug product compounded by a pharmacy as a new drug. The FDA issued a compliance guidance in June 2016 explaining its policies regarding the resurrected § 503A and noting that the 2002 CPG was no longer relevant. The agency reemphasized that pharmacies that follow § 503A requirements fall under state regulatory authority and are exempt from federal CGMP, labeling with adequate directions for use, and new drug requirements. It further stated that it expects state boards of pharmacy to continue their oversight and regulation of pharmacy compounding and will cooperate with state authorities when pharmacies violate § 503A.

what is USP 800 and what does it require?

USP 800 established standards intended to protect the healthcare worker, the environment, and the patient from the exposure of HDs. USP 800 requires entities that handle HDs to maintain at a minimum the following: 1. A list of HDs to be kept 2. Proper facility and engineering controls 3. Competent personnel 4. Safe work practices 5. Proper use of appropriate Personal Protective Equipment (PPE) 6. Policies for HD waste segregation and disposal

what occurs as soon as a patient is admitted due to federal regulation of LTCFs?

a baseline care plan is made when the patient is admitted, and a comprehensive plan is developed shortly after.

what is a breach of protected health information?

a breach is "the acquisition, access, use or disclosure" of PHI in an unpermitted manner that "compromises the security or privacy of the PHI" meaning that is poses a significant risk of financial, reputational, or other harm to the individual. - There are three exceptions; (1) when the acquisition, access, use or disclosure is unintentional and in good faith and does not result in further use or disclosure, (2) when the unauthorized person to whom the PHI has been disclosed would not reasonably have been able to retain it, or (3) when the disclosure is inadvertent between two authorized individuals at the same facility if the info is not further used or disclosed.

four main ways a drug can be "adulterated"

a drug is considered adulterated in (1) it is not pure, (2) it may have been contaminated, (3) it may have been exposed to a contaminated container, or (4) it is manufactured under conditions not confirming to the GMP

what is the minimum necessary requirement?

a pharmacy may disclose only the minimum amount of PHI necessary to accomplish the objective. For example, if a claims processor needs more information in order to process a claim, the pharmacy may provide only that information and no more. There are exception to the minimum necessary requirement: including communication to the patient, communications regarding the treatment of the patient with other providers involved in the treatment, when authorized by the patient, when required by DHHS for compliance and enforcement purposes, and when required by law.

prohibited acts under the FDCA

adulteration and misbranding - there is not intentionality ("mens rea") required; and this only applied to drugs and devices

What is the Narcotic Addiction Treatment Act of 1974?

allows dispensing of methadone at clinics by physician, PN or LPN under supervision

how is "food" different than a "drug?"

almost any food might be considered a drug if a therapeutic or health claim is made for it under part B of the drug definition. Part C of the drug definition, however, specifically excludes foods. This, then, raises the question: How is food defined for the purpose of part C? Stated another way, is it the intent of part C to exclude all substances normally defined as foods, regardless of their intended use?

How often must sellers self-certify?

annually

Who needs to register with the DEA?

anyone who manufacturers, distributes, or dispenses controlled substances (among others) must register with the DEA. Individual practitioners also must register with the DEA.

What is an automated dispensing machine?

automated dispensing systems (ADS) is a mechanical system that stores, packages, counts, labels, and dispensed medications and maintains transaction information.

define and describe the Drug Supply Chain Act of 2013.

because of the lack of a federal pedigree program, some states enacted their own pedigree laws and other states planned to follow. Needless to say, a patchwork of state pedigree laws was hardly desirable. Congress preempted these state laws by passing the DSCSA in 2013, which is Title II of the DQSA. DSCSA applies to "trading partners" within the prescription drug supply chain. Trading partners include five types of entities: manufacturers, wholesalers, repackagers, third-party logistics providers (3PLs), and dispensers (pharmacies). Trading partners must have systems in place to quarantine, investigate, and notify the FDA and certain other partners of "suspect" and "illegitimate" prescription drug products (e.g., counterfeit, diverted, stolen, and adulterated or unfit so as to cause serious adverse health consequences) not later than 24 hours after making the determination

What is corresponding responsibility?

both pharmacist and provider are responsible for complying with all the things that need to be on the prescription. Also, to make sure the CS is being prescribed for a legitimate medical purpose.

who must comply with HIPAA?

called "covered entities" under the privacy rule, health plans, healthcare clearinghouses, and healthcare providers that conduct financial or administrative transactions electronically must comply. With the 2013 rule modifications to HIPAA, business associates of covered entities are also directly liable for compliance.

describe the pure food and drug act of 1906

concern for the risks to public health and safety associated with unsanitary and poorly labeled foods and drugs prompted Congress in 1906 to pass the Pure Food and Drug Act. the law prohibited the adulteration and misbranding of foods and drugs in interstate commerce

the 21st century cures act of 2016

created to add further efficiency to drug approval process

dispensing

definition includes to deliver a controlled substance pursuant to the lawful order of a practitioner; includes prescribing, administering, and dispensing

what are Flexible Spending and Health Savings Debit Cards?

essentially, this allows an employer to deduct a certain amount of pre-tax income every year and deposit it into a flexible spending account or health savings account for which that person can then use for qualifying medical purchases (e.g., copays, etc.).

penalties - section 841

establishes penalties for drug traffickers and is applicable to practitioners who prescribe and/or dispense outside of the ordinary course of professional practice

penalties - section 842

establishes penalties for practitioners for not conforming to the requirements of the CSA, such as recordkeeping. The standard was changed from strict liability to negligence.

special dietary foods definition

foods which meet special dietary needs by reason of physical, physiological, or pathological reasons (ex: baby formula)

medical foods definition

foods which must be used under physician supervision and that are intended for specific dietary management of a disease or condition

what is the process for a recall to be implemented?

for any type of recall, the FDA has the authority to prescribe the procedures to which the recall must conform. The manufacturer is responsible for notifying sellers of the recall. In turn, sellers are responsible for contacting consumers, if necessary. Guidelines issued by the FDA require that written notices for class I, class II, and some class III recalls be sent by first- class mail with the envelope and letterhead conspicuously marked, preferably in red, URGENT: DRUG RECALL. The FDA posts information about drug product recalls on its Enforcement Reports website.

schedule II

high potential for abuse and abuse may lead to severe physical or psychological dependence, have accepted medical use in NYS, no refills allowed (ex: hydrocodone, cocaine, stimulants, depressants, phenobarbital, methadone, hydromorphone, meperidine, oxycodone, fentanyl, Adderall, Ritalin)

describe the durham-humphrey amendment

i. Also referred to as the Prescription Drug Amendment, the Durham-Humphrey Amendment was enacted in 1951. The amendment established two classes of drugs—prescription and OTC—and provided that the labels of prescription drugs need not contain "adequate directions for use" so long as they contain the legend, "Caution: Federal law prohibits dispensing without prescription." When dispensed by a pharmacist, inclusion on the label of directions from the prescriber satisfies the "adequate directions for use" requirement. In addition to establishing the two classes of drugs, the amendment also authorizes oral prescriptions and refills of prescription drugs. - this allowed the prescription drugs to be properly labeled once dispensed by the pharmacist - OTC drugs would have to comply with the labeling requirements under the 1938 act giving greater leeway to prescription drugs allowing labeling to occur as they were dispensed

when is price advertising permissible?

i. The FDA considers the advertising of prescription prices by pharmacists to be reminder advertising. Under 21 C.F.R. § 200.200, prescription drug reminder advertisements, intended to provide price information to consumers, are exempt from the requirements of the advertising regulations (21 C.F.R. § 202.1), provided certain conditions are met: 1. The only purpose of the advertising is to provide information on price, not information on the drug's safety, efficacy, or indications for use. 2. The advertising contains the proprietary name of the drug, if any; the established name (generic), if any; the drug's strength; the dosage form; and the price charged for a specific quantity of the drug. 3. The advertising may include other information such as the availability of professional or other types of services, as long as it is not misleading. The price stated in the advertising shall include all charges to the consumer; mailing fees and delivery fees, if any, may be stated separately. Any reminder advertising that is not in compliance with the regulations may be the subject of regulatory action

what is the Patient Safety and Quality Improvement Act of 2005?

in response to a study showing there a many adverse health effects every year from medical and pharmaceutical treatment, this law was passed. In essence this law allows pharmacists to report adverse events in a confidential manner with an outside organization then offer ways to eliminate the risk

What are the storage requirements for CS for Individual Practitioners?

individual practitioners must securely lock CS's in a substantially constructed cabinet.

what information is protected under HIPAA?

information covered under HIPAA is called protected health information (PHI). It includes all forms of health information thar relate to the past, present or future physical or mental health; the provision of care; or payment for care; and identify the patient of could reasonably be expected to identify the patient.

what are patient packaging inserts?

information for the patient included with prescribed drugs that explains the drugs' uses, risks, and precautions.

Are there any specific labeling requirements for controlled substances?

labeled with identification symbols designating the schedule in which the drug has been placed. Symbols are generally C-I, C-II, C-III, C-IV, and C-V, but the symbol may be a "C" with the schedule designation inside it. Symbol must be prominently located on the label of the commercial container. Symbol or label must be clear and large enough to provide easy identification.

schedule III

lesser potential for abuse than C-II drugs, and abuse may lead to moderate or low physical dependence of high psychological dependence, includes many C-II drugs in combinations with a noncontrolled ingredients or in smaller dosages or in a less abusable dosage form (ex: products containing less than 90mg of codeine per dosage unit (Tylenol with codeine), ketamine, anabolic steroids, testosterone, stimulants, dronabinol, paregoric, GHB) - strength limits of 1.8g of codeine per 100mL - also strength limits for dihydrocodeinone, opium, morphine, and other drugs

schedule V

low potential for abuse relative to C-IV drugs, and abuse may lead to limited physical or psychological dependence relative to C-IV drugs, strength limits of 200mg of codeine per 100mL, 100mg of dihydrocodeine or opium per 100mL, 1.5mg of diphenoxylate and no more than 25mcg atropine per dosage unit (ex: cough preparations with <200mg of codeine per 100mL, Lomotil, Motofen, Lyrica, Parepectolin)

schedule IV

lower potential for abuse than C-III drugs, and abuse potential may lead to limited physical or psychological dependence (ex: Xanax, Soma, Darvon, Darvocet, Valium, Ativan, Ambien, tramadol)

How often must you register or re-register with the DEA?

manufacturers and distributors must register annually, dispensers must register every 3 years. Current registrant should receive a registration form approximately 65 days before expiration.

schedule I

no accepted medical use, high potential for abuse and lack accepted information on safety of use (ex: heroin, LSD, marijuana, ecstasy, methaqualone, and peyote)

Those Allowed to Dispense Controlled Substances

only a pharmacist acting in usual course of professional practice and who is registered individually or employed by a registered pharmacy or institutional practitioner

What is a DEA 222 form?

ordering form required for any distribution of C-I or C-II drugs

Multiple C-II Rxs for Same Drug and Patient on Same Day

permitted provided: - each RX must be on a separate blank - The total quantity prescribed does not exceed 90-day supply. - The practitioner determines a legitimate medical purpose to do this. - The practitioner writes instructions on each Rx (other than first) as to earliest date each Rx may be dispensed. - Multiple Rxs do not create undue risk of diversion. - Permissible under state law

What are the storage requirements for CS for pharmacies?

pharmacies may lock them in a cabinet or disperse them through the stock of noncontrolled substances.

prospective view

pharmacists have an opportunity to consider prescribed drug therapy and apply what they know about proper medication use. Prospective DUR generates new data concerning the dispensing of medications, and these data represent the most up to date patterns of actual medication use. The DUR board can examine these new data and determine which old problems with drug therapy have been eliminated or diminished and whether new problems have become evident.

what does the federal food, drug, and cosmetics act establish?

provides comprehensive regulation of all drugs introduced into interstate (power federal legislature has under Article 1 of the Constitution)

What is a prescription drug monitoring program?

requires a pharmacy to electronically transmit to the state a record of the CS Rx dispensed, enables states to determine possible diversion and abuse situations

What is meant by an ultimate user for controlled substances.

someone that lawfully obtains and possesses the controlled substance (ex: patient that receives CS from a prescription). Can also be defined as that patients representative.

What must a seller do to register to sell pseudoephedrine products?

submit to the Attorney General a statement regarding self-certification and training on the law

the FDA is headed by

the Commissioner - appointed by Congress

can "foods" make health claims?

the confusion over what health claims would be appropriate for food products and whether they could escape being branded as drugs by sliding into the special dietary food category prompted Congress to enact the NLEA of 1990 (P.L. 101-535) that amends § 403 of the FDCA. In part, the amendment for the first time allowed food labeling to contain a health or disease-prevention claim, but only if the FDA had promulgated a regulation approving the claim and establishing the conditions under which the claim can be used. FDAMA modified the NLEA to permit health claims without the requirement that the FDA must issue a regulation, as long as there is "significant scientific agreement," as determined by the FDA.

the FDA is part of...

the department of health and human services (DHHS)

what is the drug chain?

the drug supply chain refers to the system, beginning with the manufacturing process of a drug product with bulk ingredients; to the distribution process incorporating wholesalers, repackagers, warehouses, transportation, and pharmacies; and to the dispensing of the drug product by the pharmacy to the patient. This complex drug supply chain offers the opportunity at numerous stages for drug product diversion and to introduce counterfeit drug products as well as adulterated and/or misbranded drug products with potentially devastating results.

educational programs

these programs can be face-to-face visits by an expert who calls on a physician or pharmacist; they can be symposia attended by professionals involved with medication use; or they can be written materials delivered to the healthcare professional. The goal of the educational programs is to improve the way that medications are used. These programs should be more effective than continuing education programs because they address solutions to real problems.

what is the Purple Book?

to guide healthcare professionals in evaluating biologics, the FDA electronically publishes the "Purple Book". The Purple Book includes the date a biological product was licensed and whether the product has been determined to be biosimilar to (noted with a "B") or interchangeable with (noted with an "I") a reference biological product.

true or false: a food can make health claims if, under the FDAMA, the claim has significant scientific agreement. otherwise, the claim can pull the food into a drug or special dietary food category (which means more regulation)

true

true or false: each principal place of business where CS are administered, dispensed, or stored requires separate registration

true

true or false: in Nutrilab, the court stated that a food substance which is intended to affect the structure/function of the body will be treated as a drug

true

why was the DQSA of 2013 implemented?

uncertainty existed regarding the scope of the FDA's authority over pharmacy compounding, but it did not draw public or Congressional attention until 2012 when a Massachusetts pharmacy (New England Compounding Center [NECC]) compounded and shipped large batches of contaminated sterile injectables to hospital pharmacies, physicians' offices, and other licensed entities. The products killed 64 people and injured more than 700 others and highlighted the lack of clarity in the law regarding the FDA's authority over large batch compounders. Congress responded by enacting the DQSA of 2013

Controlled substances cannot be pre or postdated. What does this mean?

when doctor signs and dates the prescription, they have to put the date that they actually signed it, they can't put a date that in the future.

If there is a difference is schedule of a controlled substance on a federal vs state level which would you follow?

you would follow the stricter of the two, usually being the state level