pharmacy law chapter 3 slides---for quiz 2 Flashcards
(49 cards)
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.”
