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Philippine College of Pharmaceutical Medicine
Philippine Association of
Pharmacists in the Veterinary Industry
Philippine Association of Pharmacists in the Pharmaceutical Industry
125 regulations reviewed
Total
54 31 21
Administrative Orders
Bureau Circulars
Memorandum Circulars
2 PSD Memos
125 Total
4 3 2
FDA Circulars
FDA Memorandum Circulars
FDA Memorandum
5 Miscellaneous Regulations
regulations reviewed
From 1968 up to 2013
125 54 28 2
Updated
For deletion
Redundant
33 For revision/outdated
regulations reviewed
7 For further review
AO 56 s. 1989 Revised Regulations for the Licensing of Drug Establishments and Outlets
RECOMMENDATION
Definition of Manufacturer To align definition of a manufacturer with the ASEAN definition Specific licensing reqt for Vet manufacturer
Chapter 1
2.1.1.3 - Valid Certificate of Registration of the Establishment’s Filipino Pharmacist from PRC
To consider vet group
2.1.1.4 – Certificate of attendance to FDA Licensing seminar
State validity of seminar attended Clarify accreditation vs. Certificate of Attendance
2.2.1.2 – Books required Add vet books like PNVDF, EP and PVET
AO 56 s. 1989 Revised Regulations for the Licensing of Drug Establishments and Outlets
RECOMMENDATION
3.1.1 Period of validity of Initial and Renewal; 5.2 Validity and Schedule of Fees
Review with 2013-2014 Schedule of fees
4.3 Reapplication after Revocation
Revision of the five years requirement is too long
5.2 Activities engaged by an establishment
For review to allow vet to engage in veterinary drugs and products (cosmetics, food, etc)
AO 56 s. 1989 Revised Regulations for the Licensing of Drug Establishments and Outlets
RECOMMENDATION
Chapter 2
2.2.1.2 – Books required USP – delete Goodman and Gilman - review Prescription books – given more worth Poison books – delet Senior Citizen and Person with Disability Books – to be included Distribution record book for dangerous drugs
2.2.1.5, 2.2.2.4, 4.3.3 Physical presence of pharmacist when establishment is open
To review with pending Pharmacy Law amendment
2.2.1.6.2, 4.2.2 – Filing of prescriptions, recording
Review since most Rx are not left with pharmacist
2.2.1.6.3, 2.2.2.5.2 Dry seal or rubber stamp
Delete
AO 56 s. 1989 Revised Regulations for the Licensing of Drug Establishments and Outlets
RECOMMENDATION
2.2.2.1.1– Signboard To reflect only the name in the signboard
4.1 Temporary closure To review with pending Pharmacy Law amendment
REGULATION RECOMMENDATION AO 54 s. 1999 Change of Manufacturers of Drug Products in Compliance with the CGMP Requirements
To incorporate ACTD adoption
BC 12 s. 2005 BFAD Quality Seal
To consolidate with MC 15 s. 1992, Measures of Compliance with Good Manufacturing Practices
MC 2 S. 1991 Clarification of "packing" and "repacking" in the definition of drug manufacturer
Clarification to secure license to operate for packing and repacking activities only
REGULATION RECOMMENDATION
BFAD Reg 1 s. 1988 Amended general Regulation for the Licensing of Drug Establishment
Should be updated to reflect changing regulatory environment (specify)
MC 2 s. 1990 Compliance with AO 56 s. 1989
update sanctions and penalties for non-compliance to the law
AO 67 s. 1989 Revised Rules & Regulations on Registration of Pharmaceutical Products
RECOMMENDATION
General To accomodate ACTD
2 General Standards Revise annotation re: new registration for new manufacturer; to follow ASEAN Variation
3.3 Pharmacological/therapeutic category
this should not be based on PNDF if it is a new drug since most probably this is not yet included in the PNDF. Include provision for drugs not in PNDF
3.5 Branded/Generic Remove patent protection as this is not under FDA's jurisdiction. Update classification, as per current situation: Branded (innovator) Branded (Generics) Generic (generic)
AO 67 s. 1989 Revised Rules & Regulations on Registration of Pharmaceutical Products
RECOMMENDATION
3.6 Annotation agreement between FDA and PDEA should be revisited
3.6.4 Drugs requiring strict precaution in prescribing and dispensing
Update List B drugs
4.3 Evaluation by testing of submitted sample
Testing of physical attributes against Certificate of Analysis
4,5 Action on Registration Application
deficiency letters (NODs, reapplication) must be included as an action on registration
4.5.4 MR Validity revise to include current practice for MR products FDA Circular No. 2013-004 (validity of 5 years maximum with no extension for MR registration)
4.7 Grounds for limited Approval
revise to include current practice for MR products FDA Circular No. 2013-004 (risk management plan instead of PMS Protocol)
AO 67 s. 1989 Revised Rules & Regulations on Registration of Pharmaceutical Products
RECOMMENDATION
5 Renewal to align with current regulation on renewal i.e. Automatic renewal, regular renewal
Schedule of Fees update fees
ANNEX 1 General Requirements
align with ACTR
ANNEX 1, General Requirements ,5 Number of Label
number of labeling materials required must be aligned with checklist
ANNEX 1, Specific Requirement, 2 New Drug
revise to include current practice for MR products FDA Circular No. 2013-004
Annex 1, Add'l Reqt 3 Branded Drug, 5 Investigational Drug, 6 New Drug
delete these parts; not current practice
Annex 1, Add'l Reqt 4 Imported Finished Product
change to include CPP and Export Certificate/Free Sale (if product is not marketed in country of origin)
REGULATION RECOMMENDATION BC 05 s. 1997 Revised Checklist of Requirements and the 1997 Guidelines for the Registration of Pharmaceutical Products
To accomodate ACTD To provide separate checklist for Vet Products To adopt ACTD glossary and reclassify existing terms vis a vis (i.e. NDA vs NCE)
AO 2006-0021 Supplemental Guidelines to AO 67 s.1987: Revised Rules & Regulations on Reg. of Pharmac'l Products & BC 5 s.1997 in evaluating NDA
To incorporate FDA Circular 2013-004 – PMS To provide separate checklist for Vet Products
AO 2005-0031 Guidelines & Procedures for the Issuance of the PCPR & the Listing of Identical Drug Products based on the Identity of Manufacturer & Pharmac'l Formulation
To address labeling concerns for LTO To provide separate checklist for Vet Products
BC 12 s. 1991 Clarification of New Registration when there is a Change of Manufacturer
To delete in alignment with ACTD
MC 16 s. 1991 Conditional Registration for Improvement of Immediate Container of Packaging of Registered Drug Products
To incorporate ASEAN Variation Guideline
AO 4 s. 1992 Policy & Requirements for Availing of Compassionate Special Permit (CSP) for Restricted Use of Unregistered Drug & Device
To provide implementation details (i.e., manner of importation) Consider one time issuance for total therapy regimen
BC 4 s. 1995 Period within which an Initial Conditional Registration shall be Processed and Issued
Delete following latest issuance of schedule of fees
AO 169 s. 2004 Implementing guidelines for the exclusive use of generic names or generic terminology in all prescriptions and orders in all DOH facilities
To incorporate the concept of biosimilars of WHO/EMEA
FDA Memorandum Circular No. 2013-001-A Amendment- Memorandum Circular No. 2013-001 Re: Submission of Application for License to Operate (LTO) and Certificate of Product Registration (CPR) With Electronic Copy
Clarification for the types of submission covered, i.e. Clinical reports, protocol, etc. Review application of new issuance FDA MC 2013-023
AO 103 s 2002 Batch Certification of Antibiotics
To consolidate with other “Batch Certification” Regulations
BC 7 S.2004 Registration of veterinary products
BET; Date of stability studies data being submitted; monitored released To provide separate checklist for Vet Products
AO 111-A s. 1991 Rules and regulations on registration of veterinary drug products
For review pending issuance of JAO/MOA between FDA and BAI (Separate Checklist For Veterinary Registration)
AO 55 s. 1988 Requirements for labeling materials of pharmaceutical products
RECOMMENDATION
2.1 Minimum mandatory information
to allow the option of putting "see package insert for full prescribing information" or "see package insert for indication, contraindication, precaution and warning"
2.4 Label of the primary container outside of the PDP
there should be a provision for small labels i.e. ampules or vials on what minimum mandatory information should be seen
4 Biological Products there should be more detailed labeling requirements for biologicals
AO 55 s. 1988 Requirements for labeling materials of pharmaceutical products
RECOMMENDATION
9 Small Containers revisit minimum mandatory requirements stated in 9.2; amount of info vs size of labels and weigh risk-benefit of making the important info readable than overcrowding the small label Consider other means for indicating important drug information on immediate container label
11 Exemption put a clear guideline on criteria for exemption and align with FDA circular 2013-012 RE: Validity of GLE for Pharma Products
FOR CONSOLIDATION AO 85 s. 1990 Requirements for labeling materials of certain categories of products containing two or more active ingredients
BC 5 s. 2005 Black box warning for all anti-depressant drugs
AO 99 s. 1990 Requirements for labeling materials of categories of pharmaceutical products containing four or more active ingredients outside the coverage of AO 85 s 1990
PSD Memo 2-2005 Black box warning for all erythromycin products
AO 23C s. 2000 Policies & Guidelines on OTC Drug Products
BC No. 3 s. 2003 Mandatory printing of boxed warning on all phenylpropanolamine (PPA) containing products (OTC and Rx)
BO 67-B s. 1996 Requiring the inclusion of warning statement for products containing sodium metabisulfite and other derivatives of this sodium salt
PSD Memo 06-2005 Standard indication and black-box warning for all COX-2 inhibitors
MC 6 s. 1991 Implementation details of AO 99 s. 1990
BC No. 18 s. 2005 New advisory on labelling selective cycloxygenase-2 (COX-2) inhibitors and non-steroidal anti-inflammatory drugs (NSAID)
FDA Circular No. 2011-002 Application for Revisions/Updates in the Package Insert, Patient Leaflet Information, Prescribing Information, Core Data Sheet and Basic Succinct Statement
BC No. 8, s. 2005 (selective COX-2 inhibitors)
AO 61 s. 1968 General regulations for the enforcement of the food, drug & cosmetic act (C-3 Misbranding-Drugs & Devices)
BC No. 11 s. 2005 Revised labelling of selective COX-2 inhibitor drugs and NSAIDS
6 August 2013 25
Bam Aquino and C. Villar expressed interest
Cong Datu & Gloria Arroyo, Cong Defensor
Draft reviewed in June 2013
Already submitted to PRC legal office for their comment
6 August 2013 26
"Pharmacy Assistants" are persons who assist pharmacists in compounding
and dispensing of medicines in community, hospital, industrial settings
and in other activities, such as, but not limited to medical missions,
under the supervision of the pharmacist and as described in Section 41 of
this Act. Pharmacy aides/clerks are those who assist in other aspects of
pharmacy operation.
SEC. 41. -Handling of Drugs by Persons Other than a Pharmacist, - For the
purpose of this section, persons handling drugs other than the pharmacist
are: professional medical ,representatives, pharmacy assistants,
pharmacy aides/clerks, and other persons who assist pharmacists in
dispensing medicines or any other person performing functions involving
the handling of drugs and drug products, It is preferred that these
positions are occupied by those who finished pharmacy degree, not
necessarily licensed as pharmacists and who have undergone the
prescribed training from a Commission-accredited provider.
No person, except pharmacy graduates, shall be allowed to render such
services without undergoing comprehensive standardized training
programs approved and accredited by the Board, A reasonable fee shall be
assessed by the accreditation board for the examination and
accreditation.
6 August 2013 27
"Non-traditional outlets" ~ other retail outlets licensed by FDA other than
drugstores and pharmacies where drugs are made available in conjunction
with the provisions of R.A.9502.
"Online pharmacy" refers to any activity of taking orders for medicines
online or thru the internet
"
"Pharmaceutical marketing" means any activity undertaken, organized or
sponsored by a drug establishment which is directed at promoting the
prescription, recommendation, supply, administration or consumption of its
pharmaceutical product(s) through direct personal contact and all media,
including the internet;
"Telepharmacy" is the provision of pharmacy services utilizing
electronic information and communication technology under the
supervision of a pharmacist;
6 August 2013 28
SEC. 23. Non payment of the Registration Fees. –
The Board shall suspend a registered pharmacist from the practice of
his/her profession for non-payment of the PRC registration fees for more
than three (3) consecutive years from its last or previous year of
payment. The resumption of his/her practice shall take place only upon
payment of delinquency fees plus surcharges and interest and in
accordance with the rules of the Commission. The ruling of the three-
year period may be interrupted upon written notice about the
discontinuance of his/her practice and surrender of his/her certificate of
registration with professional identification card to the Board and/or the
Commission.
SEC. 20. Affixing R.Ph. after a Registered Pharmacist's Name - Only
pharmacists who are duly registered and licensed by the Board and the
Commission has the light to affix the title, "Registered Pharmacist" or
"R.Ph." after his/her name.
6 August 2013 29
SEC. 29. Indication of Numbers: Certificate of Registration, Professional
Tax Receipt , ad Accredited Integrated National Organization (AIPO)
membership. - The pharmacist shall be required to indicate on any
document he/she signs, uses or issues in connection with the practice of
pharmacy the following information:
(a) his/her registration number and date of issuance,
(b) the expiration dale of his/her professional identification card,
(c) the Professional Tax Receipt (PTR) Number and date of issuance, and
(d) the certificate of AIPO membership (annual/lifetime) number and the
official receipt of payment, number and date.
Concerns from the Industry was raised
6 August 2013 30
SEC. 30. Registry of Pharmacists. –
The Board shall prepare and maintain a registry of the names, residences
and/or office addresses of all registered pharmacists which shall be updated
annually in cooperation with the Accredited Integrated Professional
Organization (AIPO), indicating therein the status of the certificate of
registration, professional identification card and Accredited Integrated
Professional Organization (AIPO) membership, whether valid or inactive due
to death, or other reasons, delinquent, suspended or with revoked
certificate of registration. The said registry of pharmacists shall be
conspicuously posted within the premises of the Commission and the
information therein made available to the public upon inquiry or
request.
6 August 2013 31
SEC. 31. Display of Certificate of Registration. -It shall be the duly of
every pharmacist engaged in the practice of pharmacy either on his/her
own account or under the employ of another to display his/her original
certificate of registration in a prominent and conspicuous place
in a retail drug outlet or drug establishment which he operates or in
which he/she is employed in his/her professional capacity as
pharmacist. No pharmacist shall, with his/her knowledge, allow
his/her certificate of registration to be displayed in such establishment
when he/she is notactually employed or operating therein in his/her
professional capacity.
A photocopy of the registration certificate duly certified by the Board
shall be displayed in Category B establishments as described in Section
33 of this Act.
6 August 2013 32
SEC. 33. Pharmacist Requirement and Compensation. -
Category A. Establishments where the direct and immediate control,
supervision and responsibility of a registered and licensed pharmacist
is required at all times when open for business include:
1. Every drug establishment/outlet selling prescription drugs and
medicines, ethical products, pharmacists-only over-the-
counter drugs and medicines and medicated cosmetics
whether owned by the government or a private person or
firm, whether sold at wholesale or retail
2. Each operation of pharmaceutical laboratories, pharmaceutical
manufacturing laboratories or other establishments with
processes involving the preparation, manufacture, quality
control, repacking, importation, exportation, distribution,
sale or transfer of pharmaceutical products and medicated
cosmetics in quantities greatly in excess of single therapeutic
doses
6 August 2013 33
SEC. 33. Pharmacist Requirement and Compensation. –
Category B. Establishments where supervision and oversight of a
registered and licensed pharmacist is required pursuant to the
provision of pertinent laws include:
1. Retail outlets selling over-the-counter drugs only
2. Establishments involved in the manufacture, importation,
exportation, distribution and sale of medical devices
3. Institutional pharmacies providing medicines to employees and their
relatives
4. Government agencies including local government units, city
and municipal health units, and, private establishments
involved in the procurement, distribution, dispensing and
storage of drugs and medicines
5. Institutions providing telepharmacy services
6. Other non-traditional outlets of drugs and medicines provided no
prescription or ethical products are sold
6 August 2013 34
SEC. 33. Pharmacist Requirement and Compensation. –
A pharmacist working in a Category A establishment may be
allowed to simultaneously work or render pharmacy services in not
more than two Category B establishments, provided that the
Category B establishments are within a ten (l0) kilometer radius
from the Category B
6 August 2013 35
SEC. 33. Pharmacist Requirement and Compensation. –
Pharmacists in government service shall receive a starting salary
equivalent to Salary Grade 15 as provided in R.A. 6758 (Compensation
and Position Classification Act of 1989) and its amendments.
Pharmacists in the private sector shall receive an entry-level salary in
peso equivalent of at least 35% above the prevailing minimum wage.
6 August 2013 36
SEC. 43. Membership in the Accredited Integrated Professional
Organization of Pharmacists. –
All registered pharmacists and pharmacy assistants must be members of
the AIPO and must maintain membership throughout the duration of the
practice of the profession. Professional identification card shall not be
renewed if the requirements for membership with AIPO are not met
including credit units for attendance at duly accredited continuing
professional development (CPD) education activities.