S Register 1-14 Page No.PDEA (Records required of a ... Name / Dosage Strength and Form OUT Date...
Transcript of S Register 1-14 Page No.PDEA (Records required of a ... Name / Dosage Strength and Form OUT Date...
Brand Name / Dosage Strength and Form
Date Received
Supplier Information: Name, address, PDEA license no / Local Permit No and date
issued
Quantity Received
Date Dispensed
Patient Information: Name, age, address
SPFDD SN
S2 license
No Practitioner Information: Name, address
Quantity Dispensed
Balance Remarks
Ex. Name
of buyer or
sent
through
courier,etc.
Transfer of drugs other than through Rx
Returns by patient shall be covered by an appropriate permit
to be entered in the (ex. Return stocks to supplier,
IN columns Surrender to PDEA)
Page No. PDEA S Register 1-14 (Records required of a drugstore)
IN OUT Initial Stock / Balance Forwarded _____
Brand Name / Dosage Strength and Form
Date Received
Supplier Information: Name, address, PDEA license no / Local Permit No and date
issued
Quantity Received
Date Dispensed
Patient Information: Name, age, ward or
Ward Information: Name of Ward, Receiving nurse
Rx/Order No or
Requisition No.
S2 license
No
Practitioner Information: Name, Department
Quantity Dispensed
Balance Remarks
Ex.Out-
Px / In-Px
/ Ward
Stock,etc.
Transfer of drugs other than through
Rx/Order and ward requisitions shall be
Returns by patient covered by an appropriate permit
to be entered in the (ex. Return stocks to supplier,
IN columns Medical Missions, Surrender to PDEA)
Page No.
Initial Stock / Balance Forwarded _____
Page No. PDEA S Register 2-14 (Records required of a hospital pharmacy)
Initial Stock / Balance Forwarded _____ IN OUT
Brand Name / Dosage Strength and Form
Date Received
Supplier Information: Name, address, PDEA license no / Local Permit No and date
issued
Quantity Received
Date Sold or
Delivered Name of Purchaser Address
S4 / S3 license No
Local Permit No.
Name of Trucker /Carrier
Quantity sold or
delivered Balance
All transfer of drugs
shall be covered by
an appropriate permit
Returns by clients including return stocks
to be entered in the to supplier, surrender to
IN columns PDEA
Note: If distributor has an agreement with another licensed company (ex. Principal Company), the imported DD directly delivered to distributor company shall be reflected as follows. If importer
shall retain samples, it shall be duly recorded.
02Jan2012
Exporter: ABC Company,Japan Importer: Principal Company, Mkti S5-I No: 00123001-N001 IP#123, AC#321dtd 11July2012
1000 tablets
1000tabs
03Jan2012 Principal Company ... ... n/a Pick-up by principal
5tablets 995tablets
Page No. PDEA S Register 3-14 (records required of a distributor)
IN OUT Initial Stock / Balance Forwarded _____
Name of Raw Material
(Arrival at Port of Entry)
and Date Received
Supplier Information: Exporter name, country of
origin, IP No. and date issued
Quantity Received
(as verified by PDEA Officer)
Date Sold or
Delivered Name of Purchaser Address
S5C license No
Local Permit No.
Name of Trucker /Carrier
Quantity sold or
delivered Balance
All transfers shall be
covered by an
Returns by clients appropriate permit
to be entered in the including surrender to
IN columns PDEA
PDEA S Register 4-14 (Records required of an importer/distributor of raw material/s)
Initial Stock / Balance Forwarded _____ IN OUT
Page No.
Brand Name / Dosage Strength and Form
(Arrival at Port of Entry)
and Date Received
Supplier Information: Exporter name, country of
origin, IP No. and date issued
Quantity Received
(as verified by PDEA Officer)
Date Sold or
Delivered Name of Purchaser Address
S4 / S3 license No
Local Permit No.
Name of Trucker /Carrier
Quantity sold or
delivered Balance
All transfers shall be
covered by an
Returns by clients appropriate permit
to be entered in the including surrender to
IN columns PDEA
Note: If importer has a storage/distribution agreement with another licensed company (ex. Company X), the imported DD may be delivered directly to Company X upon arrival, if importer secured
own S5-D license for Company X address. If retention stocks are to be retained by importer, it shall be duly reflected in the records, ex:
1Jan2012
ABC Company,Japan IP#123, AC#321dtd 11July2012
1000 tablets
1000tabs
2Jan 2012 Company X Canlubang, Laguna S4-234005-R012
Direct delivery upon importation to importer’s S5-D whse(Co X)
GHI Delivery Services
1000tabs 0
3jan2012
Company X S5D license#... re. IP#123... as retention Sx
5tablets 5tablets (retention Sx)
PDEA S Register 5-14 (Records required of an importer/distributor of finished products)
Initial Stock / Balance Forwarded _____ IN OUT
Page No.
Name of Raw Material
Date Received
Supplier Information: Name, address, PDEA license no / Local Permit No and date
issued. ------------
If imported, Exporter name, country of origin, IP No. and
date issued
Quantity Received
Date Used Purpose:
Name, dosage strength and form of finished product to be manufactured
Theoretical Yield (and Actual Yeld, if it differs with the T Yield)
Lot/Batch Number
Local Permit No.
Quantity used
Balance Remarks
Expired RMs to be surrendered
to PDEA through use of local
Permit
PDEA S Register 6A-14 (Records required of a manufacturer of finished products)
Initial Stock / Balance Forwarded _____ IN OUT
Page No.
Brand Name / Dosage Strength and Form
Date Manufactured
Manufacturing Local Permit No and date issued
Quantity manufactured (Actual Yield)
Date Sold or
Delivered or
exported
Name of Purchaser Address S4 / S3
license No
Local Permit No. or Export
Permit No.
Name of Trucker /Carrier
Quantity sold or
delivered Balance
All transfer of drugs
shall be covered by
an appropriate permit
Returns by clients including return stocks
to be entered in the by clients, surrender to
IN columns PDEA
Note: If retention stocks are to be retained by manufacturer, it shall be duly reflected in the records, as follows:
5000tabs
... Retention sample for batch #... (Please see separate register for retention stocks)
n/a n/a n/a 100 tablets retained
4900tabs
PDEA S Register 6B-14 (Records required of a manufacturer on distribution of its manufactured finished products)
Initial Stock / Balance Forwarded _____ IN OUT
Page No.
Raw Material (name, form, concentration or purity)
or Finished Product (Brand Name / Dosage Strength and Form)
Date Received
Supplier Information: Name, address, PDEA license no / Local Permit No and date
issued. ------------
If imported, Exporter name, country of origin, IP No. and
date issued
Quantity Received
Date Used or
Dispensed
Details of Usage / Dispensation
Quantity Used or
Dispensed Balance
Research Subject (Person or animal), if any: Name, age, address
SPFDD SN
S2 license
No
Practitioner Information: Name, address
Remarks on usage to subject
PDEA S Register 7-14 (Records required of a n S6 holder-for use in Research / Laboratory)
Initial Stock / Balance Forwarded _____ IN OUT
Page No.
DD (name, form, concentration or purity, training aid/container no, if any, and type of container)
Date Received
Supplier Information: Name, address, PDEA
license no / Local Permit No and date issued.
------------ If imported, Exporter name, country of origin, IP No. and
date issued
Quantity Received Received
By (Custodian’s Signature)
Date used for
training
Time Weight Location of
training
Received by (Handler’s Signature)
Date Returned
Time Weight Received by (Custodian’s
signature) Balance Remarks
Net wt
Gross wt
Note: A controlled substances accountability register or folder shall be kept for each separate controlled substance training aid shipment or issue from the supplier. A new folder is started
whenever procurement of controlled substance is initiated
PDEA S Register 8-14 (Records required of an S6 holder -for use in Training school conducting programme for K-9)
Initial Stock / Balance Forwarded _____ IN OUT
Page No.
Raw Material (name, form, concentration or purity)
or Finished Product (Brand Name / Dosage Strength and Form)
Date Manufactured/
Imported
Manufacturing Local Permit No or Import Permit No.
------------ and Batch No. or any other
identifying info
Quantity Retained
Date Disposed
Details of Disposal Local Permit
No. Quantity disposed
Balance Remarks
PDEA S Register 9-14 (Records required of a licensee keeping Retention Samples)
Initial Stock / Balance Forwarded _____ IN OUT
Page No.
Brand Name / Dosage Strength and Form
Date Received
Supplier Information: Name, address, PDEA license no / Local Permit No and date
issued
Quantity Received
Date Prescribed
and Dispensed
Patient Information:
SPFDD No. Quantity
Dispensed Balance Remarks
Name of Patient Age Address
Transfer of drugs other than
through Rx shall be covered by
an appropriate permit, including
surrender to PDEA
Page No. PDEA S Register 10A-14 (Records required of an S2 licensed physician or dentist acquiring dangerous drug stocks in accordance with Section 30(1)(c)(ii) or other special case/s
IN OUT Initial Stock / Balance Forwarded _____
Brand Name / Dosage Strength and Form
Date Received
Supplier Information: Name, address, PDEA license no / Local Permit No and date
issued
Quantity Received
Date Prescribed
and Dispensed
Patient and Owner Information:
SPFDD No. Quantity
Dispensed Balance Remarks Name of
Animal Patient Identifying marks Owner’s Name Address
Transfer of
drugs other than
through Rx
shall be covered
by local permit
Ex. Surrender to
PDEA
PDEA S Register 10B-14 (Records required of a S2 licensed veterinarian acquiring dangerous drug stocks in accordance with Section 30(1)(c)(ii)
Initial Stock / Balance Forwarded _____
Page No.