Regulatory Open Forum

Morning all,

In Canada, pharmacists very often remove tablets from their original bottles and place them in generic bottles with their own labels on them. Mostly this is where there is no child resistant cap on the bottle. Even if they do keep the tablets in the original bottle they put their own label over the manufacturer label. They also do not hand over the package insert but throw it and any secondary packaging straight in the recycling and issue their own information leaflet. I was wondering if this is standard practice in the US?? Given the amount of time and effort we put into negotiating the position and size and content of text on packaging with Health Canada, this pharmacy practice is frustrating.

Patricia R. Smith PhD RAC US

Directrice Principale, Affaires réglementaires, Assurance qualité, Pharmacovigilance et Information médicale/ Senior Director, Regulatory Affairs, Quality Assurance, Pharmacovigilance and Medical Information

Otsuka Canada Pharmaceutique

2250, boul. Alfred-Nobel, bureau 301

Saint-Laurent (Québec)

H4S 2C9

Bureau : 514-332-3057

Cellulaire : 514-945-3996

Télécopieur : 514-332-3107

ÉNONCÉ DE CONFIDENTIALITÉ Les renseignements contenus dans le présent courriel et toute pièce qui y est jointe peuvent être confidentiels et ils sont destinés uniquement au(x) destinataire(s) prévu(s).

Si vous n'êtes pas le destinataire prévu, veuillez (1) m'en informer immédiatement en répondant au présent message, (2) vous abstenir d'utiliser, de diffuser, de distribuer ou de reproduire une quelconque partie

du message et, s'il y a lieu, les pièces jointes, et (3) détruire toutes les copies du présent message et, s'il y a lieu, les pièces jointes.

STATEMENT OF CONFIDENTIALITY The information contained in this email message and any attachments may be confidential and is intended for the use of the addressee(s) only. If you are not an intended recipient, please: (1) notify me immediately by replying to this message; (2) do not use, disseminate, distribute or reproduce any part of the message or any attachment; and (3) destroy all copies of this message and any attachments.

Morning all,

In Canada, pharmacists very often remove tablets from their original bottles and place them in generic bottles with their own labels on them. Mostly this is where there is no child resistant cap on the bottle. Even if they do keep the tablets in the original bottle they put their own label over the manufacturer label. They also do not hand over the package insert but throw it and any secondary packaging straight in the recycling and issue their own information leaflet. I was wondering if this is standard practice in the US?? Given the amount of time and effort we put into negotiating the position and size and content of text on packaging with Health Canada, this pharmacy practice is frustrating.

Patricia R. Smith PhD RAC US

Directrice Principale, Affaires réglementaires, Assurance qualité, Pharmacovigilance et Information médicale/ Senior Director, Regulatory Affairs, Quality Assurance, Pharmacovigilance and Medical Information

Otsuka Canada Pharmaceutique

2250, boul. Alfred-Nobel, bureau 301

Saint-Laurent (Québec)

H4S 2C9

Bureau : 514-332-3057

Cellulaire : 514-945-3996

Télécopieur : 514-332-3107

ÉNONCÉ DE CONFIDENTIALITÉ Les renseignements contenus dans le présent courriel et toute pièce qui y est jointe peuvent être confidentiels et ils sont destinés uniquement au(x) destinataire(s) prévu(s).

Si vous n'êtes pas le destinataire prévu, veuillez (1) m'en informer immédiatement en répondant au présent message, (2) vous abstenir d'utiliser, de diffuser, de distribuer ou de reproduire une quelconque partie

du message et, s'il y a lieu, les pièces jointes, et (3) détruire toutes les copies du présent message et, s'il y a lieu, les pièces jointes.

STATEMENT OF CONFIDENTIALITY The information contained in this email message and any attachments may be confidential and is intended for the use of the addressee(s) only. If you are not an intended recipient, please: (1) notify me immediately by replying to this message; (2) do not use, disseminate, distribute or reproduce any part of the message or any attachment; and (3) destroy all copies of this message and any attachments.

Morning all,

In Canada, pharmacists very often remove tablets from their original bottles and place them in generic bottles with their own labels on them. Mostly this is where there is no child resistant cap on the bottle. Even if they do keep the tablets in the original bottle they put their own label over the manufacturer label. They also do not hand over the package insert but throw it and any secondary packaging straight in the recycling and issue their own information leaflet. I was wondering if this is standard practice in the US?? Given the amount of time and effort we put into negotiating the position and size and content of text on packaging with Health Canada, this pharmacy practice is frustrating.

Patricia R. Smith PhD RAC US

Directrice Principale, Affaires réglementaires, Assurance qualité, Pharmacovigilance et Information médicale/ Senior Director, Regulatory Affairs, Quality Assurance, Pharmacovigilance and Medical Information

Otsuka Canada Pharmaceutique

2250, boul. Alfred-Nobel, bureau 301

Saint-Laurent (Québec)

H4S 2C9

Bureau : 514-332-3057

Cellulaire : 514-945-3996

Télécopieur : 514-332-3107

ÉNONCÉ DE CONFIDENTIALITÉ Les renseignements contenus dans le présent courriel et toute pièce qui y est jointe peuvent être confidentiels et ils sont destinés uniquement au(x) destinataire(s) prévu(s).

Si vous n'êtes pas le destinataire prévu, veuillez (1) m'en informer immédiatement en répondant au présent message, (2) vous abstenir d'utiliser, de diffuser, de distribuer ou de reproduire une quelconque partie

du message et, s'il y a lieu, les pièces jointes, et (3) détruire toutes les copies du présent message et, s'il y a lieu, les pièces jointes.

STATEMENT OF CONFIDENTIALITY The information contained in this email message and any attachments may be confidential and is intended for the use of the addressee(s) only. If you are not an intended recipient, please: (1) notify me immediately by replying to this message; (2) do not use, disseminate, distribute or reproduce any part of the message or any attachment; and (3) destroy all copies of this message and any attachments.

Morning all,

In Canada, pharmacists very often remove tablets from their original bottles and place them in generic bottles with their own labels on them. Mostly this is where there is no child resistant cap on the bottle. Even if they do keep the tablets in the original bottle they put their own label over the manufacturer label. They also do not hand over the package insert but throw it and any secondary packaging straight in the recycling and issue their own information leaflet. I was wondering if this is standard practice in the US?? Given the amount of time and effort we put into negotiating the position and size and content of text on packaging with Health Canada, this pharmacy practice is frustrating.

Patricia R. Smith PhD RAC US

Directrice Principale, Affaires réglementaires, Assurance qualité, Pharmacovigilance et Information médicale/ Senior Director, Regulatory Affairs, Quality Assurance, Pharmacovigilance and Medical Information

Otsuka Canada Pharmaceutique

2250, boul. Alfred-Nobel, bureau 301

Saint-Laurent (Québec)

H4S 2C9

Bureau : 514-332-3057

Cellulaire : 514-945-3996

Télécopieur : 514-332-3107

ÉNONCÉ DE CONFIDENTIALITÉ Les renseignements contenus dans le présent courriel et toute pièce qui y est jointe peuvent être confidentiels et ils sont destinés uniquement au(x) destinataire(s) prévu(s).

Si vous n'êtes pas le destinataire prévu, veuillez (1) m'en informer immédiatement en répondant au présent message, (2) vous abstenir d'utiliser, de diffuser, de distribuer ou de reproduire une quelconque partie

du message et, s'il y a lieu, les pièces jointes, et (3) détruire toutes les copies du présent message et, s'il y a lieu, les pièces jointes.

STATEMENT OF CONFIDENTIALITY The information contained in this email message and any attachments may be confidential and is intended for the use of the addressee(s) only. If you are not an intended recipient, please: (1) notify me immediately by replying to this message; (2) do not use, disseminate, distribute or reproduce any part of the message or any attachment; and (3) destroy all copies of this message and any attachments.

Morning all,

In Canada, pharmacists very often remove tablets from their original bottles and place them in generic bottles with their own labels on them. Mostly this is where there is no child resistant cap on the bottle. Even if they do keep the tablets in the original bottle they put their own label over the manufacturer label. They also do not hand over the package insert but throw it and any secondary packaging straight in the recycling and issue their own information leaflet. I was wondering if this is standard practice in the US?? Given the amount of time and effort we put into negotiating the position and size and content of text on packaging with Health Canada, this pharmacy practice is frustrating.

Patricia R. Smith PhD RAC US

Directrice Principale, Affaires réglementaires, Assurance qualité, Pharmacovigilance et Information médicale/ Senior Director, Regulatory Affairs, Quality Assurance, Pharmacovigilance and Medical Information

Otsuka Canada Pharmaceutique

2250, boul. Alfred-Nobel, bureau 301

Saint-Laurent (Québec)

H4S 2C9

Bureau : 514-332-3057

Cellulaire : 514-945-3996

Télécopieur : 514-332-3107

ÉNONCÉ DE CONFIDENTIALITÉ Les renseignements contenus dans le présent courriel et toute pièce qui y est jointe peuvent être confidentiels et ils sont destinés uniquement au(x) destinataire(s) prévu(s).

Si vous n'êtes pas le destinataire prévu, veuillez (1) m'en informer immédiatement en répondant au présent message, (2) vous abstenir d'utiliser, de diffuser, de distribuer ou de reproduire une quelconque partie

du message et, s'il y a lieu, les pièces jointes, et (3) détruire toutes les copies du présent message et, s'il y a lieu, les pièces jointes.

STATEMENT OF CONFIDENTIALITY The information contained in this email message and any attachments may be confidential and is intended for the use of the addressee(s) only. If you are not an intended recipient, please: (1) notify me immediately by replying to this message; (2) do not use, disseminate, distribute or reproduce any part of the message or any attachment; and (3) destroy all copies of this message and any attachments.

Morning all,

In Canada, pharmacists very often remove tablets from their original bottles and place them in generic bottles with their own labels on them. Mostly this is where there is no child resistant cap on the bottle. Even if they do keep the tablets in the original bottle they put their own label over the manufacturer label. They also do not hand over the package insert but throw it and any secondary packaging straight in the recycling and issue their own information leaflet. I was wondering if this is standard practice in the US?? Given the amount of time and effort we put into negotiating the position and size and content of text on packaging with Health Canada, this pharmacy practice is frustrating.

Patricia R. Smith PhD RAC US

Directrice Principale, Affaires réglementaires, Assurance qualité, Pharmacovigilance et Information médicale/ Senior Director, Regulatory Affairs, Quality Assurance, Pharmacovigilance and Medical Information

Otsuka Canada Pharmaceutique

2250, boul. Alfred-Nobel, bureau 301

Saint-Laurent (Québec)

H4S 2C9

Bureau : 514-332-3057

Cellulaire : 514-945-3996

Télécopieur : 514-332-3107

ÉNONCÉ DE CONFIDENTIALITÉ Les renseignements contenus dans le présent courriel et toute pièce qui y est jointe peuvent être confidentiels et ils sont destinés uniquement au(x) destinataire(s) prévu(s).

Si vous n'êtes pas le destinataire prévu, veuillez (1) m'en informer immédiatement en répondant au présent message, (2) vous abstenir d'utiliser, de diffuser, de distribuer ou de reproduire une quelconque partie

du message et, s'il y a lieu, les pièces jointes, et (3) détruire toutes les copies du présent message et, s'il y a lieu, les pièces jointes.

STATEMENT OF CONFIDENTIALITY The information contained in this email message and any attachments may be confidential and is intended for the use of the addressee(s) only. If you are not an intended recipient, please: (1) notify me immediately by replying to this message; (2) do not use, disseminate, distribute or reproduce any part of the message or any attachment; and (3) destroy all copies of this message and any attachments.

Morning all,

In Canada, pharmacists very often remove tablets from their original bottles and place them in generic bottles with their own labels on them. Mostly this is where there is no child resistant cap on the bottle. Even if they do keep the tablets in the original bottle they put their own label over the manufacturer label. They also do not hand over the package insert but throw it and any secondary packaging straight in the recycling and issue their own information leaflet. I was wondering if this is standard practice in the US?? Given the amount of time and effort we put into negotiating the position and size and content of text on packaging with Health Canada, this pharmacy practice is frustrating.

Patricia R. Smith PhD RAC US

Directrice Principale, Affaires réglementaires, Assurance qualité, Pharmacovigilance et Information médicale/ Senior Director, Regulatory Affairs, Quality Assurance, Pharmacovigilance and Medical Information

Otsuka Canada Pharmaceutique

2250, boul. Alfred-Nobel, bureau 301

Saint-Laurent (Québec)

H4S 2C9

Bureau : 514-332-3057

Cellulaire : 514-945-3996

Télécopieur : 514-332-3107

ÉNONCÉ DE CONFIDENTIALITÉ Les renseignements contenus dans le présent courriel et toute pièce qui y est jointe peuvent être confidentiels et ils sont destinés uniquement au(x) destinataire(s) prévu(s).

Si vous n'êtes pas le destinataire prévu, veuillez (1) m'en informer immédiatement en répondant au présent message, (2) vous abstenir d'utiliser, de diffuser, de distribuer ou de reproduire une quelconque partie

du message et, s'il y a lieu, les pièces jointes, et (3) détruire toutes les copies du présent message et, s'il y a lieu, les pièces jointes.

STATEMENT OF CONFIDENTIALITY The information contained in this email message and any attachments may be confidential and is intended for the use of the addressee(s) only. If you are not an intended recipient, please: (1) notify me immediately by replying to this message; (2) do not use, disseminate, distribute or reproduce any part of the message or any attachment; and (3) destroy all copies of this message and any attachments.

Morning all,

In Canada, pharmacists very often remove tablets from their original bottles and place them in generic bottles with their own labels on them. Mostly this is where there is no child resistant cap on the bottle. Even if they do keep the tablets in the original bottle they put their own label over the manufacturer label. They also do not hand over the package insert but throw it and any secondary packaging straight in the recycling and issue their own information leaflet. I was wondering if this is standard practice in the US?? Given the amount of time and effort we put into negotiating the position and size and content of text on packaging with Health Canada, this pharmacy practice is frustrating.

Patricia R. Smith PhD RAC US

Directrice Principale, Affaires réglementaires, Assurance qualité, Pharmacovigilance et Information médicale/ Senior Director, Regulatory Affairs, Quality Assurance, Pharmacovigilance and Medical Information

Otsuka Canada Pharmaceutique

2250, boul. Alfred-Nobel, bureau 301

Saint-Laurent (Québec)

H4S 2C9

Bureau : 514-332-3057

Cellulaire : 514-945-3996

Télécopieur : 514-332-3107

ÉNONCÉ DE CONFIDENTIALITÉ Les renseignements contenus dans le présent courriel et toute pièce qui y est jointe peuvent être confidentiels et ils sont destinés uniquement au(x) destinataire(s) prévu(s).

Si vous n'êtes pas le destinataire prévu, veuillez (1) m'en informer immédiatement en répondant au présent message, (2) vous abstenir d'utiliser, de diffuser, de distribuer ou de reproduire une quelconque partie

du message et, s'il y a lieu, les pièces jointes, et (3) détruire toutes les copies du présent message et, s'il y a lieu, les pièces jointes.

STATEMENT OF CONFIDENTIALITY The information contained in this email message and any attachments may be confidential and is intended for the use of the addressee(s) only. If you are not an intended recipient, please: (1) notify me immediately by replying to this message; (2) do not use, disseminate, distribute or reproduce any part of the message or any attachment; and (3) destroy all copies of this message and any attachments.