Republic of the Philippines

Department of Health

Food and Drug Administration

DRUG - TEAM

6 August 2013 2

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

35 12

11

Registration

Licensing

Clinicals

67 Guidelines/Instructions

REGULATIONS

DEALING with

125 54 28 2

Updated

For deletion

Redundant

33 For revision/outdated

regulations reviewed

7 For further review

FOCUS in

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.

6 August 2013 37

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