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What is extra-label drug use (ELDU)? - ✔✔ANSWER✔✔->>ELDU describes
the use of an approved drug in a manner that is not in accordance with the
approved labeling, yet meets the conditions set forth by the Animal Medicinal
Drug Use Clarification Act of 1994 (AMDUCA) and U.S. Food and Drug
Administration (FDA) regulations.
Privacy Act of 1974
,5 U.S.C. § 552a - ✔✔ANSWER✔✔->>The Privacy Act describes the fair
collection, maintenance, use and dissemination by a government agency of
records containing personal identifiers (e.g., name, social security number, date
of birth). Generally, the Act requires that information compiled in a federal record
for a specific individual may not be used for another purpose without consent of
the individual.
Health Insurance Portability and Accountability Act (HIPAA) of 1996: Privacy Rule
Pub. L. No. 104-191 - ✔✔ANSWER✔✔->>The HIPAA Privacy Rule protects
certain patient information (including health insurance and billing information,
medical records, and conversations with providers) from being disclosed by
covered entities (including most health insurance companies, healthcare
providers, and health information clearinghouses) for reasons other than
providing treatment and care, billing and payment, protecting the public's health
(such as through surveillance of specific diseases), or reporting required
information to police (such as gunshot wounds).
Note that CDC is not a covered entity under HIPAA, nor are state or local public
health departments, unless they also treat patients. Regulations are found at 34
C.F.R. Part 160 and Subparts A and E of 164.
Family Educational Rights and Privacy Act (FERPA) of 1973
Pub. L. No. 93- 380, as amended; 20 U.S.C. § 1232g - ✔✔ANSWER✔✔-
>>FERPA applies to all educational agencies and institutions receiving funds under
any program from the United States Department of Education, which
encompasses virtually all public schools and universities, as well as some private
schools.
,The school or agency may not disclose student records without a parent's or
eligible student's written consent (an eligible student is either 18 years or older,
or is attending a post-secondary institution at any age).
FERPA also gives parents and eligible students the right to access and review
records. Parents and eligible students may request explanation of items in the
record, seek amendment to records for information that is "inaccurate,
misleading, or in violation of the student's privacy" and may request a hearing to
challenge the content of the record if the school or agency does not agree to the
amendment.
Disclosure to teachers and other relevant employees of the school or agency
without consent of the parent or eligible child is allowed for legitimate
educational purposes; disclosure without consent is also allowed in several
express purposes, including "in connection with an emergency if knowledge of the
information is necessary to protect the health or safety of the student or other
individuals." For this exception, the school or agency must make a determination
that there is an "articulable and significant threat" to the health and safety of the
student or other individuals, taking into consideration a totality of the
circumstances.
National Response Framework (January 2008; updated May 2013) -
✔✔ANSWER✔✔->>The National Response Framework is a guide to how the
United States conducts all-hazards response, and is intended to capture specific
authorities and best practices for managing incidents that range from the serious
but purely local, to large-scale terrorist attacks or catastrophic natural disasters.
The Framework also contains Incident Annexes that describe the concept of
operations to address specific contingency or hazard situations or an element of
an incident requiring specialized application of the Framework.
, The Biological Incident Annex outlines the actions, roles, and responsibilities
associated with a human disease outbreak of known or unknown origin requiring
federal assistance. HHS is the coordinating agency for this annex.
The Food and Agriculture Incident Annex describes the roles and responsibilities
associated with incidents involving agriculture and food systems that require a
coordinated federal response. Both HHS and the Department of Agriculture are
the coordinating agencies for this annex.
Animal Welfare Act Enforcement Agency - ✔✔ANSWER✔✔->>U.S.
Department of Agriculture - Office of the Inspector General is the USDA's law
enforcement arm after referral by APHIS
What deviations from FDA-approved labeling make it ELDU? -
✔✔ANSWER✔✔->>use in another species
use for a different indication
use at a different dose or frequency
use via a different route of administration.
What is the purpose of the Animal Medicinal Drug Use Clarification Act
(AMDUCA)? - ✔✔ANSWER✔✔->>The Animal Medicinal Drug Use
Clarification Act of 1994 (AMDUCA) made ELDU an FDA-regulated veterinary
medical activity, allowing veterinarians to prescribe extra-label uses of approved
animal and human drugs when the health of an animal is threatened, or when
suffering or death may result from failure to treat animals.
Prior to the passage of the AMDUCA, ELDU of animal drugs was illegal. AMDUCA
amended the Federal Food, Drug, and Cosmetic Act to legalize ELDU under a valid