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Part 3, Chapter 7: Manual Appendix G

Forms

STANDARD FORMS USED AT IHS DIRECT CARE FACILITIES

FORM # - AGENCY FORM TITLE FORM DISPOSITION FORM DESCRIPTION
HRSA 17-1 Prescription Blank Non-Permanent (c,d,f,) Destroy after 3 years (m) Completed prescription forms kept by pharmacist

Non-pharmacists cannot fill prescription from other providers.
HRSA 91 Pharmacy Quarterly & Cumulative Report Non-Permanent (b,f) Destroy after 3 years Report is sent to Area Office on a quarterly basis. Report is sent to Area Office on a quarterly basis.

Provides a synopsis of quarterly pharmacy activities.
HRSA 123 Incident Report Non-Permanent (c,e) Used to report risk management problems.
HRSA 168 Pharmacy Operations & Quarterly Report Non-Permanent (c,f) Destroy after 3 years Pharmacy workload data for statistical reporting.
HRSA 173 Audit Report for Narcotics & Other Controlled Substances Non-Permanent (d,g,j) Destroy after 3 years (m) Certifies when narcotics were inventoried against records & describe any discrepancies noted.
HRSA 174 Monthly Report for Narcotics & Other C.S. Pharmacy Non-Permanent (b,f) Destroy after 3 years (m) Certifies when narcotics were inventoried against perpetual records & describes any discrepancies.
HRSA 176 Perpetual Inventory of Narcotics & Other Controlled Substances Pharmacy Non-Permanent (c,f) Destroy after 3 years (m) Tracks receipts and disposition of controlled substance/alcohol to and from Pharmacy inventory.
HRSA 177 Request for Non-Formulary Medication Non-Permanent (c,f) Destroy after 3 years Request to the P&T committee from a provider to add a drug to the formulary.
HRSA 191 Consolidated eight hour Controlled Substance Audit Non-Permanent (c,f,g) Destroy after 3 years Verifies narcotic audit done and audits are correct.  Counts are done by two or more nurses.
HRSA 219 Inventory & Disposition Nursing Unit Narcotics Non-Permanent (c,d,g) Destroy after 3 years Tracks receipts & Disposition of narcotics on Nursing Unit Receipts are signed by receiving nurse & pharmacist (1).
HRSA 245 Transfer of Custody of Controlled Substances & Spirituous Liquors Non-Permanent (c,d,g) Destroy after 3 years (m) Transfers custody of controlled substances & alcohol to new chief pharmacist before old chief leaves.
HRSA 247 Pharmaceutical Formulation Control Record Non-Permanent (c,e) Destroy after 3 years Documents compounded items.  Lists controlled number, person compounding, prechecking & date.
HRSA 248 Pharmacy Requisition Form Non-Permanent (c,f) Destroy after workload recorded Nursing Units use to order drugs from pharmacy.
HRSA 301 Contract Prescription Blank Non-Permanent (c,d,f) Destroy after 3 years (m) Completed prescription forms are to be kept by the pharmacist.  Non-pharmacists cannot fill prescriptions from other providers.
HRSA 331 Pharmaceutical Bulk Compounding Worksheet Non-Permanent (c,e) Destroy after 3 years Documents composition of compounded calculations, lot #'s, expiration & manufacturer of each item.
HRSA 335 Pharmacy Chronological Control Log Non-Permanent (c,e) Destroy after 3 years Documents prepackaged items.  Lists control #, date, item, # of prepackaged, mfg., lot and expiration date.
HRSA 413 Off Schedule Storeroom Issue Report Non-Permanent (f,n) Destroy after 3 years Used by facilities to order drugs/supplies from the Area Supply Depot between regular order times.
HHS 46 Stock Record Card Non-Permanent (c,f) Destroy after 3 years Used to track order quantities, prices & order of drugs purchased directly from manufacturer.
FDA 1571 Investigational New Drug Application (IND) Destroy 10 years after study completion Used to file an investigation drug protocol, change an existing protocol, add or change investigator, or file an IND report.
FDA 1572 Statement of Investigator Destroy 10 years after study completion Used to collect data on all investigations in a study.  Form is forwarded to study sponsor, not FDA.
FDA 1639 Adverse Reaction Report (Drugs & Biologics) Non-Permanent (e,g,i) Destroy after 3 years Use to report drug reactions to the FDA.
FDA 25191 Medical Device & Laboratory Problem Reporting Program Non-Permanent (e,g,i) Destroy after 3 years Used to report medical device or lab products to the USP National Medical Device Problem Program.
FDA 3318 Drug Quality Reporting System (DQRS) Non-Permanent (e,g,i) Destroy after 3 years Used to report drug product problems to the FDA.
DEA 41 Registrants Inventory of Drugs Surrendered Non-Permanent (d,g,j) Destroy after 3 years Document any controlled substances sent to the DEA for surrender or destruction.
DEA 106 Notification of Theft or Loss of Controlled Substance Non-Permanent (d,g,j) Destroy after 3 years (m) Report drug loss or theft to DEA, IHS, and State Board of Pharmacy.
DEA 222 Controlled Substances Order Form Non-Permanent (d,g,o) Destroy after 3 years DEA required order form for all controlled substances.
DEA 224 Application for Registration & DEA 224-A Registration Application Non-Permanent (d,h,k) Destroy upon registration Provider and Institutional registration required by the Controlled Substance Act.
ERC Vaccine Adverse Event Non-Permanent (e,g,i) Destroy after 3 years Used to report Vaccine Adverse Events & Reporting System (VAERS) reactions to ERC Bioservices Corporation Information goes to CDC & FDA.
GSA Federal Supply Schedule Non-Permanent (c,g) Destroy 3 months after contract expiration Contains copies of drug contracts with each company, prices, terms, etc.  This is an informational copy of the original contract.
DEA Controlled Substance Biennial Inventory List Non-Permanent (b,h,j) Destroy after 3 years DEA required biennial inventory of all controlled substances in the facility as of inventory date.
JCAHO Medication Area Inspection Record Non-Permanent (e,g) Destroy after 3 years This form verifies that all nursing units are checked for outdated drugs, proper storage of drugs, etc. monthly.
DEA BOP Schedule II Order File Non-Permanent (d,g) Destroy after 3 years Copies of all controlled substance orders must be kept for DEA/BOP/Area inspection.
DEA BOP Controlled Substance Prescription Files Non-Permanent (d) Destroy after 3 years (m) Prescription file for schedule II and III-V prescriptions must be readily retrievable for DEA/BOP/Area inspection.
DEA BOP Controlled Substance and Alcohol Certificate File Non-Permanent (d,g) Destroy after 3 years This file contains completed HRSA 191 and 219 forms filed on a readily retrievable fashion for DEA Area inspection.
DEA BOP Pharmacy Perpetual Inventory of Controlled Substance and Alcohol Non-Permanent (d) Destroy after 3 years (m) Contains completed HRSA 174 and 176 forms on a readily retrievable fashion for inspection.
Pharmacy Pharmacy Requisition File Non-Permanent (c) Destroy after workload recorded Includes all requisitions received by the pharmacy from other departments
FDA Ineffective Drug List (DESI List) Non-Permanent (d) Destroy after update is received Describes drugs that are deemed less than effective by the FDA.  Federal funds cannot be expanded on less than effective drugs.
Pharmacy Drug Information File Non-Permanent (c) Destroy after update is generated File of formal drug information searches conducted by the pharmacy.
IHS Pharmacy Module Manuals Non-Permanent (f) Destroy after update us received Technical manuals for the RPMS Pharmacy Module.
Pharmacy Pharmacy Profiles Non-Permanent (c) Destroy after update is generated Patient profiles are maintained by the pharmacist.  The outpatient record functions as the outpatient pharmacy profile.
Pharmacy Purchase Order File Non-Permanent (c,d,f,g) Destroy after 3 years (m) Includes all purchase orders (PO's) for drugs generated by the manufacturer/distributor PO's are the drug audit trail.
Pharmacy Inpatient Order Copies Non-Permanent (c) Destroy after order checked and work load recorded. No carbon required (NCR) copies of physician's orders includes all other order facsimiles.
Pharmacy Investigational Drug File Non-Permanent (c,f) Destroy 10 years after study completion. Includes all records pertaining to the purchase, handling, dispensing, administration, and disposal of investigational drugs.

(Footnotes)

  1. Minimum time each record should be retained by the facility.
  2. Original is kept at the facility, one copy is forwarded to the Area Pharmacy Officer.
  3. Records are stored at the originating facility.
  4. Required by Federal Law.
  5. Required by JCAHO and PHS/IHS regulations.
  6. Required by PHS and HRSA regulations.
  7. Required at facilities with and without a pharmacist.
  8. Required at facilities that dispense or administer controlled substances.
  9. One copy is kept at the facility, one copy is sent to the appropriate agency.
  10. One copy is kept at the facility, one copy is sent to the DEA, and one copy is sent to the Area Pharmacy Officer.  The State Board of Pharmacy (BOP) may also require a copy.
  11. One copy is kept at the facility, one copy is sent to the DEA.
  12. Or equivalent form.
  13. May be longer by State Law. i.e., CA 7 years in clinics without a pharmacist.
  14. Original sent to supply depot, copy kept at originating facility.
  15. Original kept at facility two copies sent to distributor.