1.5 Facility Inspections, Ownership & Location Changes, Closing & Facility Discipline

1.5 Facility Inspections, Ownership & Location Changes, Closing & Facility Discipline

The MPJE blueprint covers the full life cycle of a licensed practice setting: licensure, renewal and reinstatement, inspection, and discipline. Section 1.3 covered the license classes. This section covers what happens after a pharmacy is licensed.

Administrative inspections (§ 58-17b-103)

DOPL may, to check compliance, require a self-audit or enter and inspect the business premises of a licensee (or of a person doing work that requires a license).

Before inspecting, DOPL must identify the person in charge and then:

1. give proper identification;
2. ask to see the applicable license;
3. describe the nature and purpose of the inspection; and
4. on request, state its authority to inspect and the penalty for refusing.

During the inspection DOPL may examine any record, prescription, order, drug, device, equipment, or electronic media; copy records at its own cost; take a drug or device for analysis; temporarily seize a drug or device suspected to be adulterated, misbranded, outdated, or otherwise in violation, pending an adjudicative proceeding; box and seal suspect drugs; and dispose of or return seized items under division rule (R156-17b-103).

• Inspections must be conducted during regular business hours (§ 58-17b-103(4)).
• If DOPL concludes that a violation occurred and discipline is appropriate, the director or designee promptly issues a fine or citation (§ 58-17b-103(5)).
• Knowingly refusing to permit an inspection is unlawful conduct (§ 58-17b-501(1)). Failing to comply with an inspection, and failing to correct operating-standard violations within the time DOPL sets, are unprofessional conduct (R156-17b-502(7), (10)).
• Controlled substance licensees must make CS stock, records, and facilities available for inspection during regular business hours and at other reasonable times (R156-37-601).

Required notices (§ 58-17b-614)

A pharmacy must report to DOPL in writing at least 10 business days before:

• a permanent closure;
• a change of business name or ownership;
• a change of location;
• a sale or transfer of controlled substances because of a closure or ownership change; or
• any other event DOPL requires by rule.

A Class D pharmacy must also report, within 10 business days after it is issued, any final disciplinary order against the pharmacy or its PIC by its home state. A pharmacy must report immediately any disaster, accident, or emergency that may affect the purity or labeling of drugs. Copies of these notices must be kept for two years.

Ownership, name, and address changes (R156-17b-618)

A qualifying change of ownership also requires an inventory of legend drugs and controlled substances on the date of the change. That inventory is the seller's closing inventory and the buyer's initial inventory, and any Schedule I or II transfer uses a DEA Form 222 (R156-17b-605(5)).

Closing a pharmacy (R156-17b-604)

1. Follow the DEA rules for discontinuing or transferring a business (21 CFR 1301.52) and for Form 222 handling.
2. If the pharmacy dispenses prescriptions, post a closing notice at the prescription department and the public entrances, giving the closing date and the name, address, and phone number of the pharmacy that will hold the prescription files.
3. On the closing date, remove all prescription drugs by returning them to the manufacturer or supplier, or by transferring, selling, or giving them to a person legally entitled to possess them.
4. Transfer prescription files, refill information, and patient profiles to a licensed pharmacy within a reasonable distance. Remove "pharmacy" signs, or notify the landlord that using the word at that address is unlawful.
5. Within 10 days after closing, send DOPL a surrender notice giving the closing date, surrendering the license, attesting that a closing inventory was taken and how drugs were disposed of or transferred, and naming the pharmacy that received the files.

If the pharmacy closes suddenly (fire, natural disaster, death, seizure, eviction, bankruptcy), these steps are done as far in advance as circumstances allow. If the PIC is unavailable, the owner or legal representative is responsible.

Renewal and reinstatement of the facility license

Pharmacy licenses run on a two-year cycle that ends September 30 of odd-numbered years (R156-1-308a). DOPL sends a renewal notice at least 60 days before expiration, and a license not renewed by its expiration date expires automatically (R156-1-308c). A Class D pharmacy that compounds must submit an inspection report conducted within the prior two years to renew (§ 58-17b-308(4)).

Discipline of a pharmacy

A pharmacy license can be denied, refused renewal, revoked, suspended, restricted, placed on probation, or reprimanded under § 58-17b-401 and § 58-1-401. DOPL can also act through citations under § 58-17b-504(5):

• A citation may assess a fine of up to $10,000 per single violation or up to $2,000 per day of ongoing violation, whichever is greater, following the fine schedule in R156-17b-402, and may include a cease and desist order.
• Other license sanctions (suspension, revocation, probation) cannot be imposed through a citation.
• The recipient must notify DOPL in writing within 20 calendar days of service to contest it. Otherwise the citation becomes the final order and is not subject to further agency review.
• No citation may be issued more than one year after the violation is reported to DOPL.
• More generally, DOPL must start discipline within four years after conduct is reported, and not more than 10 years after it occurred, except for proceedings responding to a civil or criminal judgment or settlement (§ 58-1-401(6)).

Fines fund pharmacy licensee education and enforcement (§ 58-17b-505). Examples from R156-17b-402: a pharmacy that fails to offer counseling faces $2,000 per occurrence; buying or selling drug samples carries $1,000–$5,000 for a first offense and $10,000 for a subsequent one.