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Pharmacy 151 Board of Pharmacy Rules/Regulations.

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Presentation on theme: "Pharmacy 151 Board of Pharmacy Rules/Regulations."— Presentation transcript:

1 Pharmacy 151 Board of Pharmacy Rules/Regulations

2 2.010-Operational Standards Supervision Supervision No Pharmacist on Duty No Pharmacist on Duty Facility Requirements Facility Requirements Warehouses Warehouses Owner Responsibility Owner Responsibility Rx Files (Manual vs. EDP); Refills; Three File System……. Rx Files (Manual vs. EDP); Refills; Three File System…….

3 2.018-Prescription Requirements Conformance with Two-line Blank or Originate form Out of State Conformance with Two-line Blank or Originate form Out of State Date, Assigned Unique Readily Retrievable Identifier** Date, Assigned Unique Readily Retrievable Identifier** Patient(s) Patient(s) Prescriber Prescriber Prescriber Indication of Drug Name, Dosage, Directions for Use, Actual Name and Dosage……. Prescriber Indication of Drug Name, Dosage, Directions for Use, Actual Name and Dosage…….

4 2.018-Prescription Requirements Refills Refills Quantity Dispensed and Pharmacist Initials Quantity Dispensed and Pharmacist Initials Alterations to a Rx. Based on Prescriber Contact Alterations to a Rx. Based on Prescriber Contact Controlled Substance Information as Required by Law Controlled Substance Information as Required by Law Required on All Rx.---->Handwritten; Telephone; Oral; Fax; Electronic Required on All Rx.---->Handwritten; Telephone; Oral; Fax; Electronic

5 2.120-Transfer of Prescription Information Controlled Substances: 1 Transfer and Must be Between Two Licensed Pharmacists Controlled Substances: 1 Transfer and Must be Between Two Licensed Pharmacists Pharmacies Sharing E.D.P. Database May Transfer as long as Refills Available Pharmacies Sharing E.D.P. Database May Transfer as long as Refills Available Records of Transferred Controlled Substances Must Include Dates and Locations of all Previous Refills……. Records of Transferred Controlled Substances Must Include Dates and Locations of all Previous Refills…….

6 2.130-Drug Repackaging Standards for Pre-packs Standards for Pre-packs –Minimum USP Requirements –Expiration Date: Manufacturers Expiration or 12 Months, Whichever is Less.** –Labeling: Name and Strength of Drug, Name of Manufacturer or Distributor, Expiration Date and Assigned Lot Number –Containers: Class “B” Minimum 37/75

7 2.190-Patient Counseling Maintain and Review of Patient Information Maintain and Review of Patient Information Minimum Requirement--->Offer Minimum Requirement--->Offer –Any Pharmacy Employee –Written Offer When Patient or Caregiver Not Available –“Offer” Required on All New and Refill Rx. –Inpatients are Exempt

8 2.300-Record Confidentiality Patient Care Records-->CONFIDENTIAL Patient Care Records-->CONFIDENTIAL –Rx., Rx. Orders, Patient Profiles, –Must Maintain Adequate Security –Records Released to: Patient, Prescriber or Current Practitioner, Requests or Subpoenas from a Lawful Court, Person Authorized by Court Order, Patient Authorized Access, Pharmacist/Pharmacist, As Authorized Under HIPPA – Board Rep.: Authority to Inspect and Copy

9 3.011-Generic Formulary For___________________Date_______Address___________________________Rx ______________ _______________ Substitution PermittedDispense As Written

10 3.011-Generic Formulary Albuterol Aerosol, Metered; Inhalation ABArmstrong0.09mg./INH ABGenPharm0.09mg./INH ABGlaxo Smith Kline (Ventolin) 0.09mg./INH BNSchering 0.09mg./INH ABIvax0.09mg./INH ABPliva0.09mg./INH 12/02

11 3.011-Generic Formulary State of Missouri Negative Formulary State of Missouri Negative Formulary Albuterol AerosolArmstrong Pharm. Albuterol AerosolArmstrong Pharm.GenPharm Glaxo Smith Kline IvaxSidmak Chlorpromazine HCL; Tablet 12/02

12 3.040-Return and Reuse of Drugs Accepted from Institutions Only Accepted from Institutions Only –Hospitals –LTC Facilities –Hospice Facilities Assurance of Storage Requirements Assurance of Storage Requirements –Manufacturer/USP –Pharmacy Originally Dispensed Drug Lot Number and Expiration Date Traceable Lot Number and Expiration Date Traceable

13 3.040 Return and Re-Use of Drugs Returns for Re-use Must: Returns for Re-use Must: –Original Manufacturer’s Packaging with T- ES –Federal Registered Repackagers with T-ES* –Licensed Pharmacy Products that are Un- used with T-ES* –Licensed Pharmacy Products where Un- used Portion can be separated and Re- used* NO PRODUCTS CAN BE REPACKAGED* AND RE-USED MORE THAN ONE TIME


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