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BOARD OF PHARMACY

 

DIVISION 90

AEROSOL SPRAYS

855-090-0005

Approved Aerosol Sprays for Legitimate Medical Use

(1) The Oregon State Board of Pharmacy finds that the following aerosol sprays are essential to their intended use for a legitimate medical purpose and pursuant to ORS 468.605, as amended. In addition to the aerosol sprays authorized to be sold or offered for sale by that statute, the following aerosol sprays may also be sold or offered for sale in the State of Oregon:

(a) Cortico Steroids and Combinations:

(A) Aristocort A Spray Lotion;

(B) Terra Cortril Topical Aerosol Spray;

(C) Aeroseb-Dex;

(D) Aeroseb-HC;

(E) Metiderm Aerosol;

(F) Metiderm with Neomycin;

(G) Metiderm with Neomycin Veterinary;

(H) Kenalog Spray;

(I) Respihaler Decadron;

(J) Turbinaire;

(K) Decaspray;

(L) Terra Cortril Spray;

(M) Neo Decaspray.

(b) Skin Preparation Materials:

(A) Vi Drape Adhesive;

(B) Aeroplast Dressing;

(C) Hollister Medical Adhesive;

(D) Frigiderm;

(E) All Aerosol Benzoin Preps;

(F) Hollister Medical Adhesive;

(G) Hollister Medical Adhesive Remover;

(H) Aerosolv;

(I) Uni-Solve Adhesive Remover;

(J) Uni-Solve Non-Inflamable Remover;

(K) Skin Prep Protective Dressing;

(L) Truett Benzocaine Spray;

(M) Truett Silicone Skin Spray;

(N) Truett Tape Remover;

(O) Granulex;

(P) Proderm;

(Q) Rezifilm;

(R) H & L Silicone Skin Protector;

(S) H & L Golden Spray Bandage;

(T) Silon.

(c) Topical Antiseptics:

(A) Obtundia;

(B) Burn Tame.

(d) Fungicides:

(A) Tinactin;

(B) Aftate Antifungal Powder;

(C) Aftate Antifungal Spray Liquid.

(e) Topical Anesthetics:

(A) Gebauer Fluori-Methane Spray;

(B) Gebauer Fluro-Ethyl Spray;

(C) Aero Therm;

(D) Aero Freeze;

(E) Aero Caine;

(F) Aerocaine -- 5;

(G) H & L Skin Freeze;

(H) Burn Tame;

(I) Obtundia;

(J) Xylocaine Dental Spray;

(K) Solarcaine Spray;

(L) Amercaine Aerosol;

(M) Foille First Aid Spray;

(N) Dermoplast Aerosol Spray.

(f) Miscellaneous:

(A) Cryokwik;

(B) Medihaler Ergotamine;

(C) Spray-Cyte Cytological Fixative;

(D) Sulfamylon -- N;

(E) Truett Aerostat;

(F) Pfizer Buffered Iodine Spray;

(G) Blue Lotion Aerosol;

(H) Screw Worm Aerosol;

(I) Pfizer Live Stock Spray;

(J) Pro-Fixx Aerosol;

(K) Fast-Freezz;

(L) Trypzyme-Burns Biotic;

(M) Fivex-Burns Biotic.

(2) The list of aerosol sprays stated in section (1) of this rule is subject to amendment upon the Board's finding that any listed aerosol spray no longer meets requirements for exemption under ORS 468.605, as amended. This includes a finding that an alternative non-prohibited propellant has been developed and approved for the product or a similar product. Sections (1), (2), and (3) of this rule expire by operation of ORS 468.605, as amended, on July 1, 1983.

(3)(a) A determination by the Board under ORS 468.605, as amended, that the use of an aerosol spray is essential to its intended use for a legitimate medical purpose, includes, but is not limited to, the following considerations:

(A) Whether the aerosol spray is necessary in terms of providing an important medical advantage not achieved by other forms of treatment or delivery;

(B) Whether the use of the prohibited propellant is necessary to achieve the aerosol spray in question, i.e.:

(i) Whether a pump or bulb spray would achieve the result for which the medical benefit is claimed;

(ii) If chemical aerosolization is necessitated over other forms of aerosolization, whether other non-prohibited chemical propellants would achieve the desired result, and if so, whether such chemical propellants are available and approved either for the product in question or for a similar product.

(b) With respect to dermatological preparations, the following conditions are examples where the Board has found aerosol sprays to provide an important medical advantage over other forms of treatment or delivery:

(A) Painful (touch-sensitive) skin conditions;

(B) Vesicular (blistered) skin conditions;

(C) Weeping, infected skin conditions;

(D) Ulcerated skin conditions;

(E) Disease in hairy areas;

(F) Disease in anatomically occluded areas (axillae, groin, etc.);

(G) Disease about surgical stomas.

Stat. Auth.: ORS 468
Stats. Implemented:
Hist.: 1PB 49(Temp), f. & ef. 2-25-77; 1PB 52, f. & ef. 5-19-77

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