pharmacy law chapter 3 slides---for quiz 2 Flashcards
Durham-Humphrey Amendment
Establishes criteria for distinguishing _______ drugs from _______ drugs
what does it Legally establish
Although the amendment did not contemplate electronic prescriptions, what do other federal and state laws do
what does it exempt on a dispersed drug except for certain provisions?
what does it specify for a dispensed Rx to contain
what date must be on the dispensed Rx drug?
Establishes criteria for distinguishing prescription drugs from OTC drugs
*Legally establishes oral prescriptions and refills
*Although the amendment did not contemplate electronic prescriptions, other federal and state laws permit them.
Exempts the pharmacy label on dispensed drugs from Section 502, except for certain provisions
*Specifies the minimum information that a dispensed Rx label must contain
- Expiration or beyond-use dating on dispensed Rx label required pursuant to state laws
what are the three methods of Switching Prescription Drugs to OTC?
– ________: _____-specific switch
– Petition: product-______
– Adding or _________ an OTC drug monograph: affects all ______ in the ______
Three methods:
– SNDA: product-specific switch
– Petition: product-specific switch
– Adding or amending an OTC drug monograph: affects all products in the class
Third Class of Drugs/Behind-the-Counter/Nonprescription Under Conditions of Safe Use
what do the behind-the-counter drugs refer to
what was the rationale behind the third class of drugs
how does the FDA feel about it?
Refers to creating a class of drugs that can only be sold from the pharmacy department
*Rationale based on the fact that more dangerous drugs are being switched and would allow even more to be switched
*Historic opposition of the FDA appears to be shifting
Professional Practice Considerations Related to D-H
what does the federal law leave up to the state?
who determines the scope of authority?
Prescription refill authorization issues
– Distinguish authorization of refill from
transmittal authority
*Prescriptive authority issues
– Federal law leaves it up to the states to determine who may prescribe independently or in collaborative practice.
– Scope of authority as determined by the state for prescribers who are not MDs or DOs is important for pharmacists to know.
Emergency Contraception:
Historical Journey of Plan B
what was Plan B approved in 1999
what did the citizen petition request
After the initial rejection of Barr’s SNDA, what did the FDA approve of this drug in 2006 for who at what age, and where can it be sold?
what happened in the Tummino lawsuit
what did the judge petition for the FDA to do
in 2011, what did Teva submit SNDA for
what did the FDA commissioner do to the SNDA for drugs as OTC; who overturned it
what did the FDA do again leading to another Tummino decision in 2013, and what did the court order the FDA to do for Plan B
Finally, what did the FDA do for Plan B as an OTC
Plan B was approved in 1999 as Rx only
- Citizen Petition in 2001 requesting a switch to OTC status without age restriction followed by SNDA requesting the same in 2003
- After initial rejection of Barr’s SNDA, the FDA finally approved the drug in 2006 as OTC in women 18 and older and only sold behind the counter of pharmacies.
- FDA denied Citizen Petition in 2006 prompting Tummino lawsuit, where the judge found FDA abused its discretion
- Judge ordered age reduced to 17 and FDA to reconsider the petition
In 2011, Teva submitted SNDA for the drug as OTC without age or point-of-sale restriction.
*FDA Commissioner approved SNDA to eliminate age restriction in 2011; overturned by secretary of DHHS
*The FDA again denied the Citizen Petition leading to another Tummino decision in 2013 where the court reversed the FDA’s decision and ordered the FDA to make Plan B OTC without restrictions.
*The FDA ultimately declined to appeal and approved Plan B One-Step as an OTC drug without restriction.
Conscientious Objection
Can pharmacists obstruct a patient’s legal right to receive meds?
what did the state regulations require pharmacists to do
Refers to whether a pharmacist has a right to refuse to dispense prescriptions when a moral or religious objection exists
*States have passed laws or regulations addressing this issue.
*Courts have held that a pharmacist cannot obstruct a patient’s legal right to receive medications.
State regulations requiring pharmacists to dispense except in certain situations have been upheld.
Other D-H Related Practice Considerations
Collaborative practice agreements
– Authority granted to pharmacists in most states
* Authority to dispense
– Depends on state law
– The FDA does not believe D-H dispensing standards apply to prescribers; however, most states regulate prescriber dispensing in some manner.
Prescription Drug Labeling
Information for the Patient
Patient package inserts (PPIs)
*Although the FDA originally had wanted PPIs required for most drugs, it applies to very few, including estrogen-containing drugs, DES, and oral contraceptives.
Duty of manufacturers and pharmacists to distribute to patients
*Law applies to institutional pharmacy as well as community.
Consumer medication information (CMI)
*Originally,the FDA wanted to require MedGuides for drugs posing a serious and significant concern to public health and CMI for all other drugs.
* Congress intervened to prevent the FDAfrom implementing CMI rules and allowed private sector to develop standards for CMI.
* A 2008 study shows private sector has not yet met the 95% “useful information” standard required by Congress.
* Responsibility of manufacturer and dispenser to dispense MedGuides to patients for drugs requiring MedGuides
Prescription Drug Labeling
Information for the Patient (3 of 3)
Medication guides (MedGuides)
- Required for drugs FDA has determined as posing“ serious and significant concerns”
- Required for new and refill prescriptions
*Generally required for outpatients not under direct
supervision of healthcare professional with some exceptions
- Content of MedGuide. must be approved by FDA
- Every new. MedGuide approved since 2007 has been in conjunction with a REMS.
*FDAproposingasinglepageinformationdocument
Prescribing and Dispensing Approved Drugs for Off-Label Indications
Drug products commonly prescribed for off-label uses
- Off-label prescribing and dispensing is legal under FDCA.
- Off-label prescribing and dispensing requires professional evaluation of risk vs. benefit.
- Courts generally regard labeling as evidence toward the standard of care and not as prima facie establishing the standard of care.
Pharmacy Compounding
1 of 2
Pharmacies compounding for their patients pursuant to prescription are exempt from FDCA manufacturing provisions.
*FDA1992complianceguide
– Published by FDA over concern that some pharmacies
were crossing the line from compounding to
manufacturing and were not compounding properly
* FDAMA(Section503A)1997
– Defined compounding and delineated nine activities that might cross the line from compounding to manufacturing; added other requirements regarding compounding
– Stripped FDA of authority to consider compounded drugs as “new drugs”Pharmacies compounding for their patients pursuant to prescription are exempt from FDCA manufacturing provisions.
FDA 1992 compliance guide
Published by FDA over concern that some pharmacies were crossing the line from compounding to manufacturing and were not compounding properly
FDAMA (Section503A) 1997
Defined compounding and delineated nine activities that might cross the line from compounding to manufacturing; added other requirements regarding compounding
Stripped FDA of authority to consider compounded drugs as “new drugs”
Pharmacy Compounding (2 of 2)
The U.S. Supreme Court ruled that advertising restrictions in Section503A were unconstitutional, but failed to consider if all of the compounding law was invalid as ruled by the Ninth Circuit or whether the unconstitutional provisions were severable.
FDA 2002 compliance guide
The FDA adopted the Ninth Circuit’s position that Section503A was not valid, but reinstituted most of its requirements in the 2002 compliance guide.
Reestablished position that pharmacy-compounded drugs are new drugs
Pharmacy Compounding: New Drug Issue
The Fifth Circuit disagreed with the Ninth Circuit and found that the unconstitutional advertising provisions of Section503A are severable. It further found that compounded drugs are thus exempt from the new drug provisions, provided the pharmacy meets all the conditions established in Section503A.
Franck’s Lab decision regarding compounding for animals
Compounding Quality Act of 2013(1 of 2)
Passed as part of Drug Quality and Security Act in response to New England Compounding Center tragedy
Reinstated Section503A, minus unconstitutional provisions, thus stripped FDA of its perceived new drug authority
It allows compounders of sterile products to voluntarily register as “outsourcing facilities.” Products are exempt from misbranding provisions but must meet certain CGMP requirements.
Compounding Quality Act of 2013 (2 of 2)
Outsourcing facilities:
May compound non-sterile drugs
May dispense to individual patients
Cannot have a separate area functioning as a Section503A pharmacy
State Compounding Laws
The NECC event and DQSA prompted many states to enhance compounding laws and regulations.
Many state laws and regulations follow USP standards.
Repackaging Rx Drugs
Section503A and Section503B do not exempt repackaged drugs from the act.
Compliance guidance, however, provides conditions under which the FDA will not take enforcement action.
Compounding Essentially Copies
Compounding “regularly or in inordinate amounts” products that are “essentially copies” of “commercially available products” prohibited unless change for an identified patient produces a significant difference
Guidance provides definitions of terms for Section503A pharmacy and Section503B outsourcing facility.
Mixing, Diluting, Repackaging Biologicals
The FDCA does not permit this under Section 503A or Section503B.
Compliance guidance, however, provides conditions under which the FDA will not take enforcement action.
Compounding by Hospitals and Health Systems
Unless an outsourcing facility must comply with Section503A
Compliance guidance, however, permits hospital pharmacy to compound without receiving prescriptions or orders, provided certain conditions are met.
Insanitary Conditions
Both Sections503A and 503B facilities subject to Section501(a)(2)(A) adulteration provisions
Compliance guidance describes insanitary conditions, procedures and actions facilities should employ, and potential regulatory actions.
Compounding Using Bulk Drug Substances
Section503A requires that bulk drug substances used in compounding must appear on a list as developed by the FDA pursuant to regulation.
Section503B requires that bulk drug substances used in compounding must appear on a list established by the FDA based upon clinical need or an FDA list of drug shortages.
Radiopharmaceuticals
Compounding of radiopharmaceuticals specifically excluded from the exemptions of Section503A
The guidance document, however, provides conditions under which the FDA will not take action when nuclear pharmacies compound or repackage to meet patient needs.
Section503B applies to the compounding of radiopharmaceuticals.
MOU
MOU required between state and FDA in order to allow a compounder to distribute more than 5% of total prescriptions dispensed or distributed
Draft MOU guidance requires states to determine if compounder’s interstate distributions are “inordinate” and defines “inordinate.”
Rx Requirement for Section503A Pharmacies
Guidance prohibits supplying compounded drugs for “office use;” the drug product being compounded must be for an identified individual patient based on the receipt of a valid prescription order.
Guidance interprets “limited quantity” as applied to anticipatory compounding.
Other Compounding Issues
Dietary supplements
OTC drugs
Manufacturer patent issues
USP 800
Establishes standards for all healthcare entities that handle hazardous drugs (HDs)
Compliance required by December 1, 2019
HDs are defined and identified by the National Institute for Occupational Safety and Health (NIOSH); the Institute maintains a list of these drugs (to be updated in 2018).
Allows entities to make assessment of risk and to determine alternative strategies
Orange Book and Generic Substitution
State generic substitution laws
Every state permits pharmacists to substitute generically in some manner.
State laws differ considerably.
Labeling must accurately differentiate generic product from brand.
Orange Book
Evaluates pharmaceutically equivalent products on the basis of bioequivalence
Pharmaceutical equivalence—products contain same active ingredients and are identical in strength and dosage form
Bioequivalent pharmaceutical equivalents are generally presumed therapeutically equivalent—having the same clinical safety and efficacy.
The Orange Book uses a two-letter rating system; some products use two letters and a number.
Pharmacists must comply with state law when substituting and exercise professional judgment substituting B-rated products.
Narrow Therapeutic Index (NTI) Drugs
Drugs with less than a two-fold difference between median lethal dose and median effective dose or two-fold difference between minimum toxic concentrations and minimum effective concentrations
Controversy exists as to whether the FDA’s statistical parameters for bioequivalence are accurate enough for certain NTI drugs; the FDA drafted new guidelines.
Pharmacists should exercise particular professional judgment when called upon to substitute B-rated NTI drugs.
Substitution of Biosimilar Biologics
can the biosimilar be highly similar to the reference product?
should the biosimilar produce the same clinical result as the reference product
what should a biosimilar do both of
what does the purple book provide
what can interchangeable biosimilars be substituted without
Under the BPCIA, to be “interchangeable” a biosimilar must not only be “highly similar” but also produce the same clinical result as the reference product without greater risk.
The Purple Book provides a guide to health care professionals.
Interchangeable biosimilars may be substituted without intervention of a prescriber (state law allowing).
Drug Supply Chain Security
what is the risk of it?
what efforts were put in place to protect the security of the drug supply chain
Numerous opportunities for diversion and introduction of counterfeit drug products
Federal efforts to protect the security of the drug supply chain include the Prescription Drug Marketing Act of 1987 and the Drug Supply Chain Security Act of 2013.
Prescription Drug Marketing Act(1 of 4)
what does it require from wholesalers?
what does it ban except by a manufacturer?
what does it further ban for RX drugs?
what does it mandate for RX
What does it prohibit by the hospital or healthcare facilities
Requires state licensing of wholesalers
Bans reimportation of Rx drugs except by manufacturer
Bans sale, trade, or purchase of Rx drug samples
Mandates requirements for Rx drug samples
Prohibits resale of Rx drugs purchased by hospitals or healthcare facilities
Prescription Drug Marketing Act (2 of 4)
why does it establish restrictions?
Drug samples
Establishes restrictions to limit misbranding and adulteration situations
Defined as a unit of drug not intended to be sold and intended to promote the sale of the drug
Establishes requirements for distribution to prescribers
Prohibits community pharmacies from receiving samples
Prescription Drug Marketing Act (3 of 4)
Purchase and resale:
Enacted to prevent hospitals and similar entities from reselling, purchasing, trading, or offering to do any of these activities; differentially priced drugs to community pharmacies and others so as to prevent adulteration and misbranding opportunities
Important exceptions exist, most notably selling or dispensing Rx drugs pursuant to prescription.
Prescription Drug Marketing Act (4 of 4)
Product returns permitted
Wholesaler regulation intensified
Pedigrees Under PDMA
The FDA granted authority to require secondary wholesalers to maintain pedigrees of drugs.
The 1999 regulation to implement was enjoined on the grounds it would likely cause irreparable harm to secondary wholesalers and violate the equal protection clause.
The FDAAA in 2007 mandated that the FDA develop track and trace standards and SNIs, but fell short of developing a true federal pedigree program until the DSCSA of 2013.
Drug Supply Chain Security Act(DSCSA 2013)
Established timeline for trading partners toward implementation of a track and trace system
A full system electronic track and trace system
must be in place by November 2023.
Applies to transactions where prescription drugs change ownership with some important exceptions
Establishes uniform national licensing standards for wholesalers and 3PL providers
Trading Partners
Trading partners include:
–Manufacturers
–Wholesalers
–Repackagers
–3PLs
–Pharmacies
Suspect and Illegitimate Products
Trading partners must have a system to quarantine, investigate, and notify the FDA and other partners of “suspect” and “illegitimate” prescription drug products
Product Tracing Information
Includes transaction information, history, and statement
Must be passed, received, and maintained for six years by each trading partner
Any method (paper or electronic) of passing the information is permissible until November 2023, at which time only electronic is permissible.
Important exceptions for pharmacies
Unique Product Identifier (UPI)
Manufacturers are required to affix UPI to each individual package and homogenous case by November 2018.
Importation for Personal Use
PDMA generally prohibits reimportation of Rx drugs
Many stakeholders wish to obtain Rx drugs from Canada and other countries because of lower costs.
The FDA has instituted a “compassionate use policy.”
The CSA also allows for limited personal importation.
The MMA allows wholesale importation of Rx medications from Canada, provided the secretary of DHHS would approve.
The Homeland Security Act permits limited personal importation from Canada.
The FDA will enforce the no importation law against businesses (Rx Depot case).
FDA Inspection of Pharmacies
The FDA can inspect a pharmacy to determine if the pharmacy is compounding or manufacturing.
It can extend the search if probable cause exists that the pharmacy is manufacturing.
The FDA may search without a warrant.
Use of Alcohol in Pharmacy Practice
Tax-paid alcohol
–Used in compounding in community pharmacies
–Obtainable from outlets that sell liquor at retail
Tax-free alcohol (190 proof ethyl alcohol)
–Available to hospitals for medicinal, mechanical, and scientific purposes and in treatment of patients. May be used only for inpatients.
–Charity clinics may use for medicines for outpatients if they do not charge.
Poison Prevention Packaging Act(1 of 2)
Intent of act to protect children from accidental poisonings due to “household substances”
Administered by the Consumer Product Safety Commission
The law establishes the standards for child-resistant containers.
Container may not be reused unless glass or threaded plastic and then only with new closure
Poison Prevention Packaging Act (2 of 2)
Exemptions
–Prescriber requests
–Patient requests
–Institutionalized patients
–Certain drug products such as SL nitroglycerin and SL and chewable isosorbide dinitrate
–For manufacturer: may market one size in noncompliant package with appropriate statement
Drug Advertising by Pharmacies
Price advertising
–Considered reminder advertising and thus exempt from Section502(n), provided that certain conditions are met
Product advertising
–Subject to strict liability standard
Constitutionality of State Pharmacy Advertising Laws
Challenges to state laws that prevented advertising based on the reasonableness of the laws had failed
–The Virginia decision established that the First Amendment applies to commercial speech and to recipients of the speech.
–The Virginia decision does not bar states from prohibiting false or misleading advertising, advertising professional superiority, or from making it illegal for pharmacies to offer discounts or rebates.
