Posted By colette hamilton
Hi All,

Looking for some information with regards to COSHH, CHIP and pharmaceutical products.

We are trying to obtain MSDS from pharmaceutical suppliers to enable COSHH assessments to be carried out for nursing staff who administer drugs to patients. With the exception of cytotoxic drugs we are experiencing problems obtaining these for other types of medicines and wonder if anyone else has come across the same problem.

Some companies are stating that because the medicines have a product licence they do not require a MSDS but advise that “if it gets on the skin it must be washed off”. Granted this could be a standard response and may not be an indicator of harm, but it does raise questions on the safety of the product. In addition to that, the same medicine can be supplied by two separate companies – one of which will supply a MSDS whilst the other does not. Again, this raises some questions.

I have been in touch with the Medical Healthcare Agency who oversees the product licenses but have had no response yet.

Any help / advice would be appreciated.

Thanks,
Colette

Posted By Jay Joshi
Chemicals (Hazard Information and Packaging for Supply) Regulations 2002 or CHIP 3, applies to most chemicals, but there are exceptions, which are identified in regulation 3(1). These are specialised chemicals such as cosmetics, medicines, wastes and several others which are covered by other regulations.

Posted By Adrian Watson
Whilst the Control of Substances Hazardous to Health Regulations 2002 generally applies, Regulation 5(c) of the Control of Substances Hazardous to Health Regulations 2002 applies except "where the risk to health is a risk to the health of a person to whom the substance is administered in the course of his medical treatment."
However, there is no need for the supplier to classify the product or provide a MSDS. Reg 3(3)of the Chemicals (Hazard Information and Packaging for Supply) Regulations 2002 states "These Regulations shall not apply to a substance or preparation which is -

(a) intended for use as a medicinal product within the meaning of section 130 of the Medicines Act 1968;

(b) specified in an order made under section 104 or 105 of the Medicines Act 1968 which is for the time being in force and which directs that specified provisions of that Act shall have effect in relation to that dangerous substance or dangerous preparation as such provisions have effect in relation to medicinal products within the meaning of that Act;

(c) a controlled drug within the meaning of the Misuse of Drugs Act 1971 except that these Regulations shall apply to drugs which are excepted from section 4(1)(b) of that Act (which makes it unlawful to supply a controlled drug) by Regulations made under section 7(1)(a) of that Act;

(d) a cosmetic product within the meaning of the Cosmetic Products (Safety) Regulations 1996;

(e) in the form of waste to which the Waste Management Licensing Regulations 1994 or the Special Waste Regulations 1996 applies;

(f) intended for use as food within the meaning of section 1 of the Food Safety Act 1990;

(g) intended for use as an animal feeding stuff within the meaning of section 66(1) of the Agriculture Act 1970;

(h) radioactive substances or preparations containing radioactive substances; or

(i) a medical device within the meaning of the Medical Devices Regulations 2002 which is invasive or used in direct contact with the human body,

in the finished state, intended for the final user."

Regards Adrian Watson

Posted By Adrian Watson
Whilst the Control of Substances Hazardous to Health Regulations 2002 generally applies, Regulation 5(c) states the regulations do not apply "where the risk to health is a risk to the health of a person to whom the substance is administered in the course of his medical treatment."

However, there is no need for the supplier to classify the product or provide a MSDS. Reg 3(3)of the Chemicals (Hazard Information and Packaging for Supply) Regulations 2002 states "These Regulations shall not apply to a substance or preparation which is -

(a) intended for use as a medicinal product within the meaning of section 130 of the Medicines Act 1968;

(b) specified in an order made under section 104 or 105 of the Medicines Act 1968 which is for the time being in force and which directs that specified provisions of that Act shall have effect in relation to that dangerous substance or dangerous preparation as such provisions have effect in relation to medicinal products within the meaning of that Act;

(c) a controlled drug within the meaning of the Misuse of Drugs Act 1971 except that these Regulations shall apply to drugs which are excepted from section 4(1)(b) of that Act (which makes it unlawful to supply a controlled drug) by Regulations made under section 7(1)(a) of that Act;

(d) a cosmetic product within the meaning of the Cosmetic Products (Safety) Regulations 1996;

(e) in the form of waste to which the Waste Management Licensing Regulations 1994 or the Special Waste Regulations 1996 applies;

(f) intended for use as food within the meaning of section 1 of the Food Safety Act 1990;

(g) intended for use as an animal feeding stuff within the meaning of section 66(1) of the Agriculture Act 1970;

(h) radioactive substances or preparations containing radioactive substances; or

(i) a medical device within the meaning of the Medical Devices Regulations 2002 which is invasive or used in direct contact with the human body,

in the finished state, intended for the final user."

However, Section 6 of the HSWA 74 requires the supplier, etc to provide information for the purposes of health and safety.

Regards Adrian Watson