Pharmacy Inspections

what factors trigger pharmacy inspection

1. fear of imminent danger to the public

2. formal complaint

3. belief that violation has occurred

exclusionary rule

no evidence obtained pursuant to an illegal search can be used in court against a defendant

DEA preregistration inspections

conducted prior to an applicant receiving DEA registration and help ensure that applicants are legitimate entities able to comply with the CSA and DEA rules

DEA cyclic inspection purpose

assess a registrants' ongoing compliance with CSA and DEA rules

______________ provided that DEA may enter and inspect any place where controlled substance records are kept or persons are regulated under the ______________

CSA; CSA

what is provided within the scope of a DEA inspector per the CSA

DEA inspector is allowed to examine and copy wall records and reports, to inspect the premises within reasonable limits, and to take an inventory of the controlled substances

what is NOT provided within the scope of a DEA inspector per the CSA unless written consent is provided by the owner/pharmacist

DEA inspector cannot inspect financial data, sales data other than shipment data, or pricing data (without written consent)

DEA inspector must obtain a _________________________________________ to search signed by the owner or pharmacist in charge

written statement of informed consent

the written statement of informed consent informs the owner/pharmacist that...

there is a constitutional right to refuse the inspection until warrant is obtained, any incriminating evidence found may be seized and used against the owner/pharmacist in a criminal prosecution, notice of inspection has been presented, consent is voluntary and not coerced, consent may be withdrawn at any point during inspection

________________ keeps original written statement of informed consent for DEA inspection and ______________ keeps the copy

inspector; person who consented

probable cause for administrative inspection warrant (AIW) under CSA is defined as:

valid public interest

what must be contained in an AIW

- name and address of the premises inspected

- statement of statutory authority for the warrant

- statement as to the nature and extent of the inspection, including when necessary a request to seize specified items

- statement that the premises either have not been previously inspected or were last inspected on a particular date

T/F an AIW can be served day or night and must be completed in a reasonable manner

F; must be served during regular business hours (opposed to a search warrant that can be served day or night)

T/F according to the constitution an owner/pharmacist can refuse consent when presented with an AIW

F; CANNOT refuse consent

result of refusal to consent to AIW

unlawful; carries maximum penalty of $25,000 fine, up to 1 year imprisonment, or both

T/F inspector does not need an AIW if it is an initial inspection of a new pharmacy for licensure purposes

T

T/F AIW is required even if records are ordered pursuant to an administrative subpoena

F; not required

T/F AIW is still required in an emergency situation to protect the owner/pharmacist under the 4th amendment of the Constitution

F; NOT required if there is an exceptional or emergency situation where obtaining a warrant would be impractical because of lack of time or opportunity to obtain one

an AIW is not required when a warrant is not constitutionally required for situations such as:

- when a search is made incident to a lawful arrest

- when the inspection is limited to areas of the commercial premises open to the public

- when the evidence is in plain view, providing the officer is legally in a place the officer should be and inadvertently sees the evidence

T/F requirements of the CSA applicable to DEA inspectors also apply to state board inspectors since federal requirements trump state requirements

F; state law dictates the procedures that state boards must follow

warrantless searches of licensed premises may be constitutional if:

- the industry is one that is pervasively regulated

- licensee's expectation of privacy is outweighed by the government interests of protecting the public health, safety, and welfare

- the statute carefully limits the time, place, and scope of the inspection

T/F the pervasively regulated industry exception will not permit a warrantless search if an applicable statute specifies the necessity of a warrant

T

Congress stance on CSA warrantless search

warrant remains the necessary standard procedure, since there is no statute defining specific standards for warrantless inspections in terms of time, place, and scope unless and until Congress sees fit to change the statute

Fourth Amendment of the Constitution

Prohibits unreasonable search and seizure

what generally satisfies valid public interest

large purchases of controlled substances or a substantial period since the last inspection