IN-STATE COMMUNITY PHARMACIES

Attention Pharmacies and other retailers,
please view the below link for

Information on Methamphetamine Precursor National Precursor Log Exchange (NPLEx) 

 

Community Pharmacy License

Any person or entity intending to establish, operate, or maintain a pharmacy (a facility where drugs and devices are dispensed) in Nebraska, must first obtain a pharmacy license from the Department. 

NOTE:  Hospitals engaged in the compounding and dispensing of drugs and devices, pursuant to chart orders for persons registered as patients and within the confines of the hospital, may dispense under the hospital’s license without the need of a separate pharmacy license.  However, if the hospital is dispensing pursuant to chart orders to persons other than those registered as patients and within the confines of the hospital, they must first obtain a community pharmacy license.

As set forth in Title 175 Chapter 8 of the Regulations Governing Licensure of Pharmacies, a license is issued only for the premises and persons named in the application and is not transferable or assignable. Change of ownership (sale, whether of stock, title, or assets, lease, discontinuance of operations) or change of premises terminates the license. The new owner(s) must apply for a new pharmacy license. If there is a change of premises, the owner(s) must apply for a new pharmacy license.

  Amendments

THERE IS NO CHARGE TO AMEND A COMMUNITY PHARMACY LICENSE.

Change of ownership (sale, whether of stock, title, or assets, lease, discontinuance of operations) or change of premises terminates the license. The community pharmacy license is NOT amendable for these changes.  The owner(s) must apply for a new pharmacy license.

 The following information MAY be amended on a community pharmacy license:

            1)         Change of pharmacist-in-charge
            2)         Continuation of pharmacy license by heirs or estate of deceased licensee
            3)         Pharmacy name change

Once the Department has received the items required to complete the amendment process, the facility will receive an amended pharmacy license.

  CHANGE OF PHARMACIST IN CHARGE

Definition of pharmacist-in-charge (PIC) as found in Title 175 Chapter 8 Regulations Governing Licensure of Pharmacies: a pharmacist who is designated on a pharmacy license or designated by a hospital as being responsible for the practice of pharmacy in the pharmacy for which a pharmacy license is issued and who works within the physical confines of the pharmacy for a majority of the hours per week that the pharmacy is open for business averaged over a 12-month period or 30 hours per week, whichever is less.

A pharmacy needs to have a PIC designated AT ALL TIMES.   There is no grace period. The facility, however, will be allowed 30 days from the actual date of change in PIC to remit the following 4 items to the Department at the address listed on the amendment application in order to complete the PIC amendment process:

1)  pdf iconApplication to Amend a License to Operate a Pharmacy -- keep a copy of the
      completed amendment for the facility's records and send the ORIGINAL to the Department;
2)   PHARMACY PERMIT which shows the current expiration date and name of the outgoing PIC --
      NOTE: the facility should keep a COPY of the license prior to sending the ORIGINAL to the Department;
3) pdf iconAffidavit for Tech Manual due to PIC change -- keep a copy of the completed
      amendment for the facility’s records and send the ORIGINAL to the Department; and
4)   CONTROLLED SUBSTANCE INVENTORY -- keep the original inventory and send a COPY of the
     completed inventory to the Department.  This special inventory is to be done at the time of PIC change. This
     special inventory does not change your normal ANNUAL inventory date (see 8-006.05C2-C5).

  CONTINUATION OF PHARMACY LICENSE BY HEIRS/ESTATE OF DECEASED

 As set forth in Title 175 Chapter 8 Regulations Governing Licensure of Pharmacies (8-004.08), the heirs or executor of the estate must notify the Department within 30 days after the death of the licensee designated on the Nebraska pharmacy license in order to amend the licensee information.

Send the following 2 items to the Department in order to complete the amendment process:

1)      pdf iconApplication to Amend a License to Operate a Pharmacy -- keep a copy of the
         completed amendment for the facility’s records and send the ORIGINAL to the Department; and
2)      PHARMACY PERMIT which shows the current expiration date and name(s) of deceased owner(s) --
         the facility should keep a copy of the license prior to sending the ORIGINAL to the Department.

  PHARMACY NAME CHANGE

As set forth in Title 175 Chapter 8 Regulations Governing Licensure of Pharmacies (8-004.07), the licensee must notify the Department in writing within 5 working days when there is a change in the name of the pharmacy.

Send the following 2 items to the Department in order to complete the amendment process:

1)    pdf iconApplication to Amend a License to Operate a Pharmacy -- keep a copy of the
       completed amendment for the facility’s records and send the ORIGINAL to the Department; and
2)    PHARMACY PERMIT which shows the current expiration date -- the facility should keep a copy of the
       license prior to sending the ORIGINAL to the Department.

  Application/Licensure Requirements

A Community Pharmacy applicant must:

1.   Submit a writtenpdf icon application to the Department which includes the information required by Title 175 Chapter 8 Regulations Governing Licensure of Pharmacies.  Please see regulation 175 NAC 8 when completing the application form. The inspection will be based on the information you indicate on the application form in relation to these regulations.

            2.   Submit the required fee of $625 (checks made payable to DHHS Licensure Unit).

 Once the Department receives the completed pdf icon application and the fee, the application will be reviewed by the pharmacy inspector. If there are deficiencies, you will be notified by telephone, e-mail, or US Mail.  If the application is complete, you will be issued a provisional pharmacy license up to 5 weeks prior to your opening date. If you change the anticipated date of opening, it is IMPERATIVE that you contact the Department. The pharmacy inspector will then contact you within 60 days to set up a time for the initial on-site inspection.

In order to prepare for the inspection, a facility may utilize the pdf iconPharmacy Quality Assurance Report (PQAR/self-inspection) to check all items (1 through 34) for compliance, as they will be covered during the initial inspection completed by the pharmacy inspector.  In this case, the self-inspection form should NOT be sent to the Department after completion.   

Upon passage of the inspection, the application file will be reviewed for issuance of a permanent community pharmacy license. Please note that this permanent license number will be different than your provisional pharmacy license number. You will want to advise insurance carriers of the change.  The facility will NOT be required to obtain a new DEA registration based on the change from a provisional status to a permanent status.

Pharmacy statutes and regulations are required to be available for use in the pharmacy.  To ensure that the facility has the most up to date statutes and regulations available, the pharmacy may book mark this web page for quick access to all pharmacy-related statutes and regulations.  The pharmacy may also print the information from the Department’s website.   

The applicant may obtain the Application for Registration for Federal Controlled Substances from the Federal DEA Office by visiting the DEA website at www.deadiversion.usdoj.gov or by calling 888-803-1179.   Effective January 1, 2000, Nebraska no longer requires a state controlled substances registration. Only the federal registration will be required.

If the facility dispenses controlled substances, an opening controlled substances inventory will need to be emailed to dhhs.medicaloffice@nebraska.gov or sent via mail to the Department prior to the initial on-site inspection. Please do NOT fax the initial inventory.  The initial inventory will be logged in and forwarded to your pharmacy inspector.  Please make note of the date  the controlled substances inventory was emailed/sent to the Department, as this date will become the due date of the next year’s ANNUAL controlled substances inventory.

NEW TECHNICIAN MANUALS

In order to use pharmacy technicians, a pharmacy must have in its possession a pharmacy technician manual approved by the Board of Pharmacy. If the facility needs to purchase a new manual, contact the Nebraska Pharmacists Association (NPA) at 402-420-1500. In order to obtain Board of Pharmacy approval, complete the information in the technician manual and submit it to the Department at the address listed in the Contact Us section.

EXISTING TECHNICIAN MANUALS

If the pharmacy will be using a previously approved pharmacy technician manual, the facility will be required to obtain approval from the Board of Pharmacy to use this manual.  Anpdf iconaffidavit to use the same pharmacy technician manual will need to be filled out, submitted to and approved by the Board of Pharmacy. The facility must have, in its possession, a copy of the previously approved pharmacy technician manual.  Send the completed affidavit to the address listed on the top of the form.

NOTE:  If the facility is changing ownership and/or location, and wishes to utilize a pharmacy technician manual previously approved under a different pharmacy license number, that facility must submit an pdf iconaffidavit to use the previously approved manual.

Certification of Licensure

On-line VERIFICATION of a credential for an individual, a business/service, or a facility/service may be completed free of charge at the following link:

            http://www.nebraska.gov/LISSearch/search.cgi

NOTE:  Pharmacy facility licensure is listed under the business/service category at the license lookup link.

Currently, there is NO CHARGE for the CERTIFICATION of a pharmacy FACILITY license; however, if the Pharmacist-In-Charge’s license also needs to be certified, a $25 fee would apply for the CERTIFICATION of that license.  Personal checks are acceptable (if a fee is applicable).  Make checks payable to DHHS Licensure Unit.  Address information available in the Contact Us section.

The request should include your facility name, address, licensure type, license number, the state or entity the certification is to be created for, and where the certification is to be sent when completed.  Please note that some state boards will ONLY accept certifications directly from the Department.

Closing Information

THERE IS NO FEE TO COMPLETE THE CLOSURE OF A PHARMACY LICENSE.

As per Section 8-003.04 of the Pharmacy Facility Regulations, which went into effect April 29, 2007, the owner of the pharmacy is required to submit items to the Department for closure of the pharmacy license within 15 days after closing. The pharmacy inspector will NOT be coming to your facility to perform a closing inspection.  A closing controlled substance inventory is NOT required to be sent to the Department.

FOR CHANGE OF OWNERSHIP OR PERMANENT CLOSING OF A PHARMACY

Please complete thepdf iconNebraska Pharmacy Permit Closing Form and return it to the Department along with the following:

            1)         ORIGINAL Pharmacy License
            2)         ORIGINAL Federal Controlled Substances Registration
            3)         Any unused DEA Forms 222, 222a, or 222d
            4)         Information on location of all patient records, including prescription files
            5)         Information on what notification was made to patients of pharmacy regarding the change of ownership or
                        permanent closing of the facility

CLOSING OF A PHARMACY LICENSE DUE TO CHANGE OF LOCATION ONLY

For a change of location ONLY, the facility must:   

            1)         Submit an pdf icon Application for License to Operate a Pharmacy for the new location
                        up to 5 weeks prior to the change of location; and
            2)         Submit a pdf icon Nebraska Pharmacy Permit Closing Form for Change of Location
                        AND the original Pharmacy License within 15 days after closing.

In the section where the DEA information is to be entered on the closing form, please print "Change of Location Only" and indicate the Federal DEA number and the new provisional pharmacy license number.

Complaints

The Department of Health & Human Services, Division of Public Health Investigations is responsible for investigating complaints against health care professions and occupations, welfare fraud, and evaluation reviews.

More details, including contact information, are available by clicking on the following link:

          DHHS Investigations

Contact Us

MAILING ADDRESS:                  DHHS
                                                Division of Public Health
                                                Licensure Unit
                                                PO Box 94986
                                                Lincoln NE 68509-4986

 PHYSICAL ADDRESS:               DHHS
                                                Division of Public Health
                                                Licensure Unit
                                                301 Centennial Mall South
                                                Lincoln NE 68508

LOCATION:                              State Office Building
                                               14th & M Street; 3rd Floor; Lincoln NE

OFFICE HOURS:                      8:00 a.m. to 5:00 p.m. (Central Time) Monday through Friday
                                               Closed holidays

LICENSURE CONTACTS:           Vonda Apking, Health Licensing Coordinator
                                                Phone: (402) 471-2118
                                                Fax: (402) 471-8614
                                                E-mail: vonda.apking@nebraska.gov

                                                Becky Wisell, Program Manager
                                                Phone: (402) 471-4915
                                                Fax (402) 471-8614
                                                E-mail: becky.wisell@nebraska.gov

 PHARMACY INSPECTORS: pdf icon Pharmacy Inspector Listing by County

                                                Gary Cheloha, RP
                                                Phone: (402) 405-7595 (cell)
                                                E-mail: gary.cheloha@nebraska.gov

                                                Mike Rueb, RP
                                                Phone: (402) 416-3534
                                                E-mail: michael.rueb@nebraska.gov

                                                Dean Willson, RP
                                                Phone: (402) 237-9865
                                                E-mail: dean.willson@nebraska.gov                                         

 OTHER CONTACTS:                 DEA
                                                Phone: (888) 803-1179
                                                Web: www.deadiversion.usdoj.gov

                                                National Association of Boards of Pharmacy (NABP)
                                                1600 Feehanville Dr.
                                                Mount Prospect IL 60056
                                                Phone: (847) 391-4406
                                                Fax: (847) 391-4502
                                                Web: www.NABP.net

                                                Nebraska Pharmacists Association (NPA)
                                                6221 S. 58th St., Ste A
                                                Lincoln NE 68516-3679
                                                Phone: (402) 420-1500
                                                Fax: (402) 420-1406
                                                Web: www.npharm.org

                                                Pharmacy Technician Certification Board (PTCB)
                                                2215 Constitution Ave., NW
                                                Washington DC 20037-2985
                                                Phone: (202) 429-7576
                                                Fax: (202) 429-7596
                                                Web: www.PTCB.org

Controlled Substances Information

PLEASE DO NOT FAX YOUR ANNUAL CONTROLLED SUBSTANCES INVENTORYTo submit your ANNUAL controlled substances inventory to the Department, choose ONLY ONE of the following methods:

    1)   Mail a copy to the address listed in Contact Us; OR    
    2)   Submit a scanned copy to dhhs.medicaloffice@nebraska.gov 
           

The ORIGINAL ANNUAL controlled substance inventory must be maintained at the facility. 

As of January 1, 2009, each registrant manufacturing, distributing, storing, or dispensing controlled substances in Schedules I, II, III, IV, or V of section 28-405 of the Statutes Relating to Pharmacy shall prepare an ANNUAL inventory of each controlled substance in his or her possession.  Such inventory shall:

  • be taken within two years after the previous biennial inventory date, but in no event later than December 31, 2009, and each year thereafter be taken within one year after the previous annual inventory date;
  • contain such information as shall be required by the Board of Pharmacy;
  • be copied and such copy forwarded to the Department within thirty days after completion;
  • be maintained at the location listed on the registration for a period of five years;
  • contain the name, address, and Drug Enforcement Administration number of the registrant, the date and time of day the inventory was completed, and the signature of the person responsible for taking the inventory;
  • list the exact count or measure of all controlled substances listed in Schedules I, II, III, IV, and V of section 28-405; and
  • be maintained in permanent, read-only format separating the inventory for controlled substances listed in Schedules I and II of section 28-405 from the inventory for controlled substances listed in Schedules III, IV, and V of section 28-405.

NOTE:  Although it is not required, it is EXTREMELY helpful to include the pharmacy’s Nebraska community pharmacy license number on the inventory.  

A registrant whose inventory fails to comply with these requirements shall be guilty of a Class IV misdemeanor. 

This information does not apply to practitioners who prescribe or administer, as a part of their practice, controlled substances listed in Schedules II, III, IV, or V of section 28-405 of the Statutes Relating to Pharmacy, unless the practitioner regularly engages in dispensing a prescription drug or device to his/her patients. 

For community pharmacies completing change of pharmacist-in-charge (PIC), please review the information listed under Amendments.  The same requirements for the ANNUAL inventory apply to an inventory taken for change of PIC.  

If you have questions regarding your inventory, please contact your pharmacy inspector.

DEA Registrant Information

DEA registrant information can be accessed by credentialing organizations, hospitals, and pharmacies after obtaining a USER ID and PASSWORD. To obtain a USER ID and PASSWORD, contact Joyce Novak by e-mail at joyce.novak@nebraska.gov.

Link to DEA registrant information:  Federal Controlled Substance (DEA) Registrant

The data contains Federal Controlled Substances Registration numbers and expiration dates for health care providers that hold a Nebraska license and have submitted proof of holding such Federal Registration. Federal Controlled Substances (DEA) Registrant information is validated on licenses at the time of issuance and updated on a quarterly basis. 

DEA Theft/Loss Information

            DO NOT use the DEA 106 form if the theft/loss is not a controlled substance.

 The DEA 106 theft/loss report form is available at the following DEA web site (there is a link on the right side of the page): www.deadiversion.usdoj.gov.

Before you begin, make sure that you have the following information available for your reference while filling out the DEA 106 theft/loss form:

            1)         Your facility DEA #
            2)         The EXACT name of the facility as it appears on your DEA registration
            3)         The police report
            4)         The National Drug Code (NDC) & quantity of CS being reported as theft/loss
            5)         Background information related to the theft/loss (ie: date, place, type, estimated
                        value, etc)

DEA regulations state that you need to keep a copy of the report form you are submitting for your records for 2 years.

Once you have submitted the 106 Report Form to the DEA, one copy of the form should be sent to each of the following:

            1)         Diversion Captain
                        Nebraska State Patrol Headquarters
                        PO BOX 94907
                        Lincoln NE 68509-4907

             2)        Division of Investigation
                        Nebraska Department of Health & Human Services
                        1033 O Street Suite 500
                        Lincoln NE 68508

             3)        DHHS
                        Division of Public Health
                        Licensure Unit ATTN: Pharmacy
                        PO BOX 94986
                        Lincoln NE 68509-4986

             4)       Your pharmacy inspector (addresses available in the Contact Us section)

If you have questions, please contact the DEA via e-mail at www.deadiversion.usdoj.gov or by phone at (888) 803-1179, the Division of Investigation at (402) 471-0175, or your pharmacy inspector (e-mails and phone numbers available in the Contact Us section).

Duplicate License

A duplicate/reissued license is available for a fee of $10.00.   Please complete and submit the followingwpe2.jpg (723 bytes)form.

Fees

Initial licensure fee - $625.00
Renewal licensure fee - $625.00
Duplicate/reissue license fee - $10.00
Administrative fee - $25.00 (for a denied credential or a withdrawn application)
Certification fee for facility - $0
Certification fee for Pharmacist-In-Charge - $25

License Lookup

On-line verification of a credential for an individual, a business/service, or a facility/service may be completed free of charge at the following link: http://www.nebraska.gov/LISSearch/search.cgi

NOTE:  Pharmacy facility licensure is listed under the business/service category at the license lookup link.

Lists/Labels

You may purchase lists on-line for health related occupations and professions, early childhood programs, and health care facilities and services.

To begin, click on the following link:   Lists and Labels

Long Term Care

A Long-Term Care Automated Pharmacy means a designated area in a long-term care facility where an automated medication system is located that stores medication for dispensing pursuant to a medical order to residents in such long-term care facility, that is installed and operated by a pharmacy licensed under the Health Care Facility Licensure Act and located in Nebraska, and is licensed as a Long-Term Care Automated Pharmacy.

The Pharmacist-in-Charge shall submit an application for initial licensure and/or a renewal application and the required fee of $625.00 to the Department. The expiration date of a Long-Term Care Automated Pharmacy is July 1st annually.

Application for License to Operate a Long-Term Care Automated Pharmacy  NEW!

 

Pharmacy Professions

Click here to be routed to the pharmacy professions page for applications, name/address change, duplicate/re-issuance of credential, etc for pharmacists, pharmacist interns and pharmacy technicians.

NOTE:   All PHARMACIST licenses expire January 1 of each EVEN year.
              All PHARMACY TECHNICIAN registrations expire January 1 of each ODD year. 
              All PHARMACIST INTERN registrations are NOT renewable.

Please check the registration/licensure status of all personnel at your facility to ensure that you are in compliance by employing only properly registered/licensed persons.  You may check the status of your licensed/registered personnel by asking them to supply you with a current copy of their credential card or by checking their credential on-line at the following site:  http://www.nebraska.gov/LISSearch/search.cgi

Pharmacists and pharmacist interns must have their credential issued PRIOR to working in the pharmacy as a pharmacist or a pharmacist intern.

Pharmacy technicians must submit an application for registration to the Department within  30 days from the date of hire in order to continue working in the pharmacy as a pharmacy technician.  Once the technicians have submitted the application for registration, they must complete the registration requirements within a maximum of 150 days or they are no longer eligible to continue employment in a pharmacy as a pharmacy technician. If the pharmacy technician has an EXPIRED technician registration, they may not work as a technician until such time that the registration has been made ACTIVE.

If your technicians cannot supply you with a copy of their current registration card, and/or you have been unsuccessful at finding registration information through our on-line verification web site, or if your technicians state that they have sent in an application more than 150 days ago, please Contact Us in order to check the status of the application before allowing them to continue to work as technicians in the pharmacy.

Renewals

All community pharmacy licenses expire July 1st of each year.

At least 30 days before July 1 of each year, the Department will send a renewal notice by means of US Mail to each licensee at the licensee’s current mailing address as noted in the records of the Department.

Self-Inspection Form

All community pharmacies are required to complete an annual self-inspection known as the wpe2.jpg (723 bytes)Pharmacy Quality Assurance Report (PQAR). This self-inspection will be due ANNUALY on the anniversary date of the facility's initial on-site inspection. 

The facility may complete the PQAR up to 30 days prior to the due date and forward it to their pharmacy inspector (addresses available in the wpe2.jpg (723 bytes) Pharmacy Inspector Listing by County information).

Please click here to review information regarding use of technicians and the reporting of your pharmacy personnel on your PQAR.

Please print the PQAR from this on-line source.  If you have additional questions, or you are unable to print the form from this link, please E-MAILdhhs.medicaloffice@nebraska.gov.

Statutes/Regulations for Pharmacy

The following links are in pdf format:

     Regulations:

             Cancer Drug Repository Program – 181 NAC 6
                                Cancer Drug Repository participants list: http://www.dhhs.ne.gov/cancerdrugs/participants.pdf
              Pharmacies - 175 NAC 8
             Practice of Pharmacy - 172 NAC 128
             Wholesale Drug Distributors - 172 NAC 131
             Mandatory Reporting - 172 NAC 5
                       Mandatory Reporting Forms

    Statutes:

            Statutes Relating to Pharmacy
   

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